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Meet the Experts


Jennifer B. Davis is counsel for Hyman, Phelps & McNamara (Washington, DC). She has a law degree from Emory University School of Law (Atlanta) and a BA in psychology from Duke University (Durham, NC). She is admitted to practice law in Georgia and the District of Columbia. She is a member of the American Bar Association. Contact her at

Leo Eisner is the head of Eisner Safety Consultants (Portland, OR), a firm that specializes in helping clients through the product safety and international regulatory processes. He is a registered professional engineer with experience in the product safety arena. Leo is the convener of SC62D JWG9 “Lens Removal and Vitrectomy Devices for Ophthalmic Surgery.” He is also a member of RAPS, AAMI, ASQ, and IEEE. He can be reached at

Jim Fitzgerald is executive vice president of sales and marketing for Vesta (Franklin, WI). He leads the company's global efforts to collaborate with new and existing customers. He has an MS in management from the Kellogg Graduate School of Management at Northwestern University (Chicago). Reach him at

Jeffrey N. Gibbs is a director at the law firm Hyman, Phelps & McNamara. Previously, he served in the Office of the Chief Counsel at FDA, where he became an associate chief counsel for enforcement. He is a graduate of the New York University School of Law. He can be contacted via e-mail at

Kevin Gingerich is director of marketing services for Bosch Rexroth Corp. (Buchanan, MI). He has written extensively on assembly technologies and techniques, and is the coauthor of the company's guidebook Lean Manufacturing: Principles, Tools, and Methods. Reach him at

Garry Lee is president of Global Advantage (Richmond Hill, ON, Canada) a company that offers product safety and EMC compliance services. He has significant experience in software validation, risk management, TPP/Health Canada Regulation, MDD requirements, and ISO 9001 audits. Lee is an active member of the Professional Engineers of Ontario, the Association for the Advancement of Medical Instrumentation, and the Canadian Biomedical Engineer Society. He was also part of a workgroup that assisted in the development of IEC 60601-1. Reach him at

Mark Leimbeck is program manager, health sciences, for Underwriters Laboratories (UL; Northbrook, IL). His main responsibilities include developing an overarching certification model for medical devices and coordinating implementation of the model globally. He has also been a contributor in several training and development programs at UL, including quality, technical and management training courses.He is a member of the American Society for Quality and is a Registered Professional Engineer. Contact him at

Bill St. Onge is director of manufacturing for KMC Systems (Merrimack, NH), an Elbit Systems of America company. St. Onge has transitioned both build-to-print jobs and programs that were designed at KMC Systems to the production floor. Contact him via e-mail at

Frank Pawlowski is manager of advanced technology and solutions at KMC Systems. He is exclusively involved with the management and development of medical instruments. He has put together many multidisciplined development teams to design a range of instruments. Reach him at

Charlie Whelan is a director of Frost & Sullivan's North American healthcare consulting practice (San Antonio). Focusing on the medical device and patient monitoring sectors, Whelan has partnered with such companies as Medtronic, 3M Healthcare, and Johnson & Johnson. Reach him at

Alpaslan Yaman, PhD, is a principal consultant for Biotech, Pharma & Device Consulting LLC (Parsippany, NJ). He is a certified black belt and has a PhD in pharmaceutics with a minor in physical chemistry from the University of Missouri. Contact him at

Five Ways to Ensure a Successful Tubing Project

(Photos courtesy of VESTA)
The medical device industry continues to grow, but at the same time its supply chains are consolidating. The challenge is to deploy outsourcing strategies that bring value to a company today without adding future risk. With cost pressures forcing companies to look for new ways to compete, now may be a good time to assess tubing vendor relationships.
Evaluating and selecting tubing partners requires scrupulous review. The best opportunity for success begins with a solid plan to determine needs and identify the most appropriate short- and long-term partners. This article discusses five points a company can use as a discussion guide to ensure that it is strategically aligned with its tubing vendors.
1. Define Quality Expectations
Quality has become such a buzzword that it seems to have lost its significance. Most organizations say that quality is a top priority, and many have mission statements that allege as much, but some company's actions may indicate otherwise, even if the managers have the best intentions.
Because the definition of quality can vary so drastically within and between organizations, a company should discuss the meaning with its personnel, business partners, and suppliers. Quality can be product specific, service related, and systems based. For example, to a purchasing manager, quality could mean finding the lowest-priced raw materials. However, the manager may not realize how these choices will affect product performance if the vendor does not point out the tradeoffs that were made to reduce pricing. A quality manager may think quality means zero defects, but setting such a goal can create unreasonable expenses. Likewise, a tubing manufacturer may have a quality system in place, but it might not align with the customer's quality requirements (see the sidebar, “Quality at a Glance”).
Every design and manufacturing detail affects the success of a tubing project.
In addition, the level of certification is important. An ISO 9001 certification is much less stringent than an ISO 13485 certification, which is specific to medical device manufacturing. ISO 13485 is designed to ensure that the quality management system is integrated with the entire business in order to institutionalize and systemically reinforce risk management for the product.
An organization must ensure that its quality system and product risk management system flow through to the supplier. The supplier's quality system should truly function as an extension of the company's system. Finding and qualifying a high-quality tubing supplier requires parity between quality systems, open dialogue, consistency, and regular engagement for continuous improvement. Setting any expectations for quality up front and staying involved with the supplier throughout the product life cycle ensures quality results for products.
2. Discuss Tubing Designs
Table I. (click to enlarge) Discuss all aspects of tubing design that may impact the success of the finished medical device.
The design of medical-grade tubing often drives critical-to-quality attributes of a finished device and can make all the difference in its market success. The typical physical and dimensional requirements for profile, inner diameter, outer diameter, and wall thickness often take priority during design discussions. However, don't forget to consider the full implications of material selection, loading and handling, stress and strain characteristics, tube construction, and tube balance (see Table I). All of these design elements affect the product's performance as well as the process performance. It is important to work with a vendor that understands and can assist with design for manufacturability during the design phase, as process control and cost will ultimately be important. Striking the right balance of tight-tolerance design and manufacturability ensures the most suitable and cost-effective tubing design.
Understandably, many OEMs tend to feel guarded about their product designs during the early stages of collaboration with a vendor. Once the two partners have executed a mutual nondisclosure agreement, they should confident discussing the product's design for manufacturability. If an OEM doesn't feel comfortable, it might not have selected the right partner.
The tubing vendor's experience on the front lines of manufacturing makes it the best resource for helping refine a product design. For example, a good vendor should be able to recommend design adjustments that will make the manufacturing easier, faster, or more affordable. But in order to help, the vendor first needs to have complete information about the company's tubing and the medical device into which it will be incorporated. For example, designing a thin-wall thermo-
plastic balloon parison requires careful consideration of the tensile and elongation properties in order to optimize subsequent balloon blowing processes and, ultimately, the balloon expansion, pressure rating, and deflation profile characteristics.
Consider discussing the following points with the vendor:
• How the tubing component will be used at the point of care.
• Whether the tubing will be implanted in the patient and, if so, for how long.
• Whether the tubing component will be discarded after application or remain on the device.
• What secondary operations are required to produce the medical device.
Discussing this information enables the manufacturing partner to help refine the design, develop the proper tooling, and set the required production process parameters. Collectively, this information makes all the difference in the manufacturing of the tubing as well as the success of the finished medical device.
3. Talk Material
There is one best material for every medical-grade tubing application. Sometimes, choosing the correct one is the hardest part of the product development process. The tubing manufacturer should understand this challenge and should have the necessary materials expertise. The material directly affects three critical aspects of the medical device's clinical outcome.
Product Functionality. Specify the material that will allow the medical device to not only perform as intended, but also to last as long as necessary. One type of material may be better suited for a single-use device, while another material may feature the biomechanical characteristics required for long-term implants like a pacemaker or implantable cardioverter (ICD) leads. For example, material selection with respect to a pacemaker or ICD lead requires a discussion about biocompatibility, biomechanical performance, insulative and dielectric properties, optical clarity and gel count, stress and strain characteristics, and other critical-to-quality attributes.
Usability. The material used to manufacture the tubing may significantly affect ease of use. The healthcare community is more likely to embrace a user-friendly product.
Patient Comfort. Tubing material may also affect patient comfort. The product-patient interface with some materials can change slightly over time. This is particularly true with short-term implants that stay in the body for 30 days or less such as intravenous therapy or dialysis applications for which the presence of different bodily fluids and tissues can affect the contact site between the product and the patient.
Tubing Materials
New materials become available for medical device applications on a relatively frequent basis. In the thermoplastics category alone, there are many different classes of materials, each containing multiple durometers and other property variations within one family (see the sidebar, “Tubing Materials”). With so many options to choose from, how does a company know which material is the best for the product? The manufacturing partner should act as a guide through this decision-making process. The best tubing vendors have experience working with a wide range of materials and know how each performs during and after production. The partner, for example, understands the temperature and cure times required for processing each type of material and whether any shrinkage will occur. Again, be sure to discuss with the partner how exactly the product will be used so that it can provide complete and accurate advice.
4. Know Your Manufacturing Partner
It's important to consider the possible need for a tubing vendor that also provides assembly services and other secondary operations.
When considering long-term project needs, it's important to take the time to really get to know the contract tubing manufacturer. By learning the details of each other's businesses, the parties form a stronger, more strategic relationship. This enables an OEM to discover a feature or new addition to its partner's facility, staff, or manufacturing process. Frequent and open exchange, such as in quarterly business reviews, help the company experience all of the benefits of the vendor relationship.
Facility and Equipment. Ideally, every OEM would have the time and money to take a personal tour of its manufacturing partner's facility. Even when a tour cannot be justified, it's important to maintain an updated vendor questionnaire. Consider asking the following questions:
• Is the facility used to manufacture anything other than medical devices?
• Which and how many extruders are on-site?
• What type of metrology equipment is used for in-process inspection?
• Can equipment be custom built to accommodate special requirements?
• Does the work flow follow a logical order?
• Is the plant floor properly segregated by type of work?
• Do the air filters in the cleanroom comply with ISO 13485 standards for medical device manufacturing environments?
Personnel. A company can learn a lot about its manufacturing partner just by talking to some of the representatives on the phone. Feel free to discuss tubing projects with the operators or engineers working on them. They can explain details such as how a certain type of tubing product will run. This expertise may prove to be an excellent resource during product development. Plus, these conversations help gauge the manufacturer's credibility and establish a relationship built on trust. Consider asking the the tubing manufacturer the following questions:
• What is the experience and commitment of management to the relationship?
• Is there a single point of contact?
• How will communication be coordinated?
• Are there any Six Sigma certified personnel on staff? If so, what are their certifications?
• What type of operator training program is used?
• Are there engineers on staff who can assist with product design for manufacturability? If so, what are their qualifications?
To ensure the best possible product design, partner with a vendor who has experience working with a variety of materials and profiles as shown here.
Process. Even if the tubing production process can't be observed, ask the supplier about its manufacturing process. Process development and validation should be part of its standard operating procedure. The manufacturer should be willing to work with the OEM if it has concerns about the specified temperatures and cure times. Do not hesitate to conduct a thorough interview of the supplier to gather complete information about its facility, personnel, and the manufacturing process. Let the manufacturer demonstrate its commitment to the quality and success of the medical device. Consider asking the following questions:
• How is the manufacturing process developed and validated?
• Does the manufacturer allow the OEM to edit the work instruction as it sees fit?
• What types of process controls are in place?
• How are in-process inspections performed?
• What is the response to deviation and variation?
The partner should also monitor the manufacturing process and conduct complete analysis to determine why any deviation occurs. A process failure mode and effects analysis (FMEA) program is key for this type of evaluation.
5. Leverage the Partner Relationship
Finally, be sure to make the best use of the partnership with the contract tubing manufacturer. The supplier should truly operate as an extension of the OEM's own organization, and it's important to consider all of the benefits of this trusted relationship.
Figure 1. (click to enlarge) Critical transition points in the OEM-vendor relationship.
Take advantage of the complete offering. Even if the OEM thinks it needs only a partner to extrude a simple tube, do not underestimate the value of a tubing manufacturer that offers broad capabilities and expertise in a particular type of tubing manufacturing. For example, a vendor may offer design assistance, material selection services, supply-chain management, inventory management, and other services that go beyond the basics of manufacturing. A partner should apply best practice concepts to the tubing project, managing the transitions between each stage of development to ensure a seamless process (see Figure 1). Even if a company doesn't use additional services, the partner should offer advice—for example, if it notices something about the design, that could be adjusted in order to better achieve product goals.
Electing to use all of the services of a single-source provider streamlines the process, saves money, and speeds the product's time to market. Using a single provider for design assistance, manufacturing, inventory management, and other services also ensures consistency. A comprehensive approach allows the toolmaker, technician, and quality control inspector to collaborate during product development to eliminate errors up front and thus ensure optimal flow. Additionally, a single-source provider can often manage more of the project, which enables the company to focus on preparing the product to be marketed and sold.
A technician examines tubing during manufacturing to ensure quality control.
Ask the partner to accommodate needs. Because the manufacturing partner functions as an extension of a company's organization, the partner should reflect the image and values that the company wants to present to the marketplace. Primarily, the partner should share the same focus on quality. It should also support any corporate initiatives in the areas of lean manufacturing, Six Sigma quality, and sustainability. A thorough discussion will allow an OE< to explain its specific needs and concerns, while understanding its partner's capabilities and limitations. For example, an OEM might ask its long-term partner for support through a kanban program or blanket purchase orders that offer a volume discount even if the order is divided into several production runs.
Seek support in innovation. Because the medical device industry is constantly evolving, it's important to have the support of a partner that is willing to help advance products, pushing the envelope of yesterday's perceived manufacturing limitations. As a company strives to develop new products, the partner might offer expertise and assistance with new materials that require special processing and unique tubing configurations.
Ultimately, an OEM and its contract tubing manufacturing partner should share the same goals. Whether a company needs a new tubing supplier, wants to evaluate its current one, or hopes to grow with a manufacturing partner, a regular discussion about objectives provides confidence in the vendor relationship. Sharing the same values and objectives puts a company in the best position to bring its medical device to market with success.
Jim Fitzgerald is executive vice president of sales and marketing for Vesta (Franklin, WI.).
Copyright ©2009 Medical Device & Diagnostic Industry

Take a Hybrid Partnership Out for a Spin First

As anyone who has paid above-sticker price for a Prius knows, hybrids are in hot demand. In the life sciences, hybrids that blend elements of medical devices and pharmaceuticals are also hot-ticket items. Such combination products or convergent technologies often marry the best innovations of drug development with highly sophisticated delivery systems. Convergent technologies include innovative products such as drug-eluting stents, bone graft scaffolding/sponges coated with growth protein, implantable pumps that deliver drugs or biologics, transdermal patches, and implantable polymer wafers for chemotherapy.

When plaintiff lawyers survey convergent technologies, though, they see dollar signs of a different kind. When lawyers see drug-eluting stents, they run to studies of late-stage thrombosis. When they read about implantable pain pumps, they seize on reports of shoulder injuries. When they notice pain patches, they advertise for injured patients on their Web sites. Plaintiff attorneys, in other words, see opportunities for litigation, jury awards, and personal injury settlements for aggrieved consumers.

Companies developing convergent medical technologies can mine veins rich with opportunities, but, as you can see, they also face steep product liability perils if products cause patient injuries, have defects, or fail to perform as intended. These outcomes can trigger lawsuits that financially drain companies through jury awards, skyrocketing insurance premiums, exorbitant settlements, or eye-popping legal fees.

Risks Are Manageable

Such risks are manageable, however. Examining product liability risk factors and strategies can help to insulate convergent technologies against financial meltdown. While some convergent technologies are the product of a single company, often they are the fruit of collaboration between a medical device firm and a pharmaceutical company or biotech enterprise. For the purposes of our discussion here, the cross-sector partnership model will be the context for the following risk management commentary.

Companies developing convergent technologies should realize that, to some insurance underwriters, combination products may represent a different, higher risk profile for product liability. Underwriters who willingly write coverage on medical equipment may pause before placing coverage on convergent technologies.

At least five reasons for such reticence exist. First, many insurance underwriters view drugs as riskier than devices from a product liability standpoint. Second, the possibility of having a bad batch of drugs heightens the potential for mass tort, class-action claims. Third, introducing pharmaceuticals into a product can invite later coverage tussles over pinpointing the date of loss. Fourth, often the large pharma partner in a convergent technology alliance may represent deep pockets to the personal injury bar. Finally, underwriters may worry that multicompany collaboration adds to the honeypot attracting personal injury lawyers and complicates case defense.

Defending product liability claims for convergent technologies is fraught with risk management issues. Among the thorny challenges are:

• Situations in which both companies are sued and both have insurance. Which one's insurance is primary? In other words, which policy gets tapped first and which comes second?

• Injured patients who sue both companies. Which party picks legal counsel and controls the defense? Selection of legal counsel can be a sensitive matter and the pharma partner might not be comfortable with the choice made by the device firm and vice versa.

• Reconciling insurers' settlement orientation with corporate defense philosophy. If plaintiffs assert product claims that an insurance policy covers, insurers may want to curb legal defense fees by paying off claimants. Companies producing convergent technologies may want to defend their product, though, and settle only selectively. They may worry about the business ramifications of being seen as an “easy mark.”

• Coordinating defense efforts. One party wants to pinch pennies; the other wants to spare no expense. Which view prevails?

Management must address such questions in any convergent technology partnership. Spotting potential pitfalls before signing an alliance is a key step in a successful collaboration involving hybrid device technology.

Due Diligence Duty

In this regard due diligence is crucial in averting product liability risk. Management must assess the risk-management resources and skills of its business partner. These abilities or deficiencies will surface when claims and lawsuits arise from a combination product's alleged defects. It's best to learn about potential risks at the courtship phase, rather than enter a partnership, encounter choppy legal waters, and then learn that one's business partner bailed on product safety.

Careful investigation and evaluation of business partners apply to both the pharma and the medical device entity. Consider spot visits and independent product testing at various stages of the production process, for example.

Some other due diligence steps meriting consideration include the following.

Trust, but verify. Confirm that the business partner doing the manufacturing is making products in accordance with your guidelines. In addition, specify the quality of the materials. When a company faces a product liability claim, plaintiff attorneys will scrutinize the manufacturing agreement. Therefore, outline in the contract, not the purchase order, the process for changing specifications and sign-off procedures.

Require each convergence partner to carry liability coverage. Mandate contractually that each party obtain its own product liability protection from reputable insurance providers. Insist that each list the other as “additional insureds” on each other's insurance policy. Partnering does not mean you can safely forgo insurance coverage because the business partner has coverage. There are still many valid reasons why you need your own policy. Some examples:

• The partner's insurance policy may have inadequate coverage limits.

• The partner may have coverage with an insurer that has weak financials.

• Its insurer's claims-paying ability is suspect.

• Its insurer's claim service is inept.

• The partner's insurer has no business relationship with you and cannot be relied on to protect your interests if a claim occurs.

There are many reasons why you should not consider yourself fully protected just because your partner has insurance. Make sure that your business partner is adequately insured for product liability. If your business partner insists that it is self-insured, make sure it has the financial means and liquidity to pay claims as they arise.

Vet your partner's insurer. Not all insurance coverage is created equal. A business partner with an insurance policy from a shaky financial institution may be of little help when claims and lawsuits arise years after patients start using the product. Check the financial rating of the insurance company that your business partner utilizes. Rating services include A.M. Best, Moody's, and Standard & Poor's. In addition, check the policy limits written by the insurer on your business partner. A product liability insurance policy with a $1-million limit may sound sufficient, but in product liability litigation, it may be bare bones.

Create dispute resolution procedures in advance. What if one party thinks a manufacturing defect exists and the other party thinks it received flawed specifications? What if each party points the finger at the other when a patient injury occurs and there is a serious claim? These are not purely theoretical concerns. When deals are done, handshakes and high-fives abound. Later, when a claim arises or a product meltdown occurs, shaking fists and finger-wagging are often the result. Remember: Even promising marriages can begin with prenuptial agreements.

Be Safe, Not Sorry

Even if conscientious management has taken the above steps, liability problems from convergent technologies may still crop up. There are four additional tactics that can help to avert these risks:

Verify QA/QC systems. Make sure that your business partner has sound quality assurance and quality control systems. Your business fortunes and reputation may ultimately hinge on the soundness of these. Verify that such structures exist and are not just “paper systems.”

Assess safety program effectiveness. Does your business partner have a product safety program? Is it supported from the organization's C-suite or is it largely symbolic? Does your business partner see product safety as a “one-and-done” effort or as part of an ongoing, recurring process? Find out before joining a combination technology partnership.

Examine risk management programs and processes. How risk management-savvy is the business partner? Does your business partner have a full-time risk manager? Are processes in place to gather intelligence from the user environment regarding adverse events, trends, off-label use, physician or hospital feedback, and related matters? Are MDR procedures and adverse drug reaction reporting systems in place to provide distant early-warning signs of incipient problems?

Explore loss and claim history. Assess the claims history of one's business partner, whether the business partner is from the medical technology sector or the pharmaceutical arena. Request copies of your partner's loss runs for the past three to five years. Loss runs are similar to spreadsheets, and insurance companies issue them regularly. These documents list open and sometimes closed claims, amounts paid for claims, and sums set aside for future expected liabilities. This report is a barometer of loss activity in the past. Needless to say, the briefer the listing, the better.

As you can see, product liability claims in convergent technologies can highlight in stark relief the divergent interests of business partners. By paying close attention to insurance coverage and risk management, however, collaborative partners can keep their hybrid partnership on the road to success in a post-loss environment.

Kevin Quinley CPCU is vice president, risk services, Berkley Life Sciences LLC (Ewing, NJ). He can be reached at

© 2009 Canon Communications LLC

Regulatory Strategies for the Third Edition of IEC 60601-1

The third edition of IEC 60601-1 was published in December 2005, but few certification bodies (CB) certificates have actually been issued to this version of the standard and few agency mark projects have been completed around the world.1 There were five CB certificates issued in 2008 and 14 as of May 2009. Many manufacturers have asked safety agencies to conduct gap analysis comparing the second edition with the third edition requirements. Why is it taking so long to get this standard to be used for meeting regulatory requirements around the world? There are still challenges in determining the best approach to implement and use the standard, and there are several questions facing regulators and standards writers, including the following:

 • How should the CB scheme issue certificates to the standard, taking the requirements of ISO 14971 into consideration?2

• Will test labs and national regulators be ready for the shift to the third edition, including the major aspects of essential performance and risk management?
• How is the transition period going to work for countries that issue national versions of 60601-based collateral and particular standards? The national versions need to be updated and published to align with the third edition of IEC 60601-1.

 Answering these questions is a first step toward understanding the finer points of the standard and the path device makers should take. Medical device manufacturers should learn about the standard so that they can decide how to transition from the second to the third edition as smoothly as possible.

Looking Back and Looking Forward 
What is IEC 60601-1?

The IEC 60601-1 standard, “Medical Electrical Equipment—Part 1: General Requirements for Safety,” is the cornerstone document addressing many of the risks associated with electrical medical equipment. Ensuring that a device complies with IEC 60601 can be a complex, multifaceted task.

To better understand the standard, it helps to talk about its history. IEC and ISO standards development projects typically take 3–5 years. The third edition of IEC 60601-1 took more than 10 years of development before it was actually published. This unusually long development process was partially due to some significant changes to the standard. For example, the internal numbering system of the clauses has been totally redone, so that even those requirements that did not change require effort to find. To that end, a tool was developed, IEC/TR 62348:2006, which helps identify where certain second edition requirements are located in the third edition.3 This free document can be downloaded at the IEC Web store. Two errata sheets called corrigendum were issued.4,5 Also, two interpretation sheets (IS) clarified some of the requirements.6,7 The first says that the third edition does not apply to medical gas pipeline systems. The second clarifies that fire enclosure requirements of subclause 11.3 only apply when “…there is a significant likelihood of fire due to the presence of a source of ignition…and a significant source of fuel.” In most cases, these requirements do not apply to the medical device under test unless the device is intended to operate in an environment containing flammable anesthesia.8

Along with such documents, other work to align collateral standards (i.e., IEC 60601-1-XX) included updating the alarms standard IEC 60601-1-8 to the third edition. Most collateral standards were published based on second edition of IEC 60601-1. Alignment of the collaterals was completed in 2009. And, although not all of the particular standards (i.e., IEC 60601-2-XX) have been aligned with the third edition, it is hoped that the project will be completed by the end of 2009 as well. Any future dates mentioned in this article are estimates based on the most current information available.
The second edition of IEC/TR 62354, which details the testing procedures of medical electrical equipment based on third edition of IEC 60601-1, should hopefully be published by the first half of 2010.9 This technical report (a guidance, not a standard) primarily covers the third edition of IEC 60601-1. But it also covers the second edition where appropriate, since many of the test requirements from second edition carry over to the third. IEC/TR 62354 is designed to provide details on how to conduct the tests in 60601-1. The second edition of this guidance document will address the third edition of IEC 60601-1, which was not covered in the original version.
Going further into the future, the Amendment 1 (A1) to IEC 60601-1 is estimated to be published by June 2012. More than 150 comments have been collected during the last seven years in anticipation of adding corrections and modifications based on the experience of using this current version. These comments also include changes that didn't get into the published third edition of 60601-1. It is anticipated that a small portion of the particular standards may need to be aligned with IEC 60601-1 + A1 and that those efforts should be completed in 2015.
The CB Scheme
The CB scheme was originally established to facilitate the acceptance of test data (primarily electrical and mechanical) amongst member laboratories. Therefore, issuing certificates to IEC 60601-1:2005 related to the requirements of ISO 14971 represents a challenge. As documented on the IEC System for Conformity Testing and Certification of Electrotechnical Equipment and Components (IECEE; CB scheme) Web site, “….an international scheme is operated by the IECEE…based on the principle of mutual recognition…by its members of test results for obtaining certification or approval….”

However, IEC 60601-1 represents a departure from the traditional standards historically addressed by the CB scheme in that it involves more than electrical and mechanical testing. The third edition encompasses aspects never before considered, such as risk management, biocompatibility, and usability. Consequently, the CB scheme must develop an entirely new infrastructure to support methods for member laboratories to countercheck practices and procedures for certifying against new requirements.

When the CB scheme first approached the topic of risk management, it had to consider how the requirements of ISO 14971 should be evaluated. The two options are a desk review of a manufacturer's documentation or an on-site assessment of a manufacturer's risk management process.

To conduct an on-site assessment of risk management requirements per 60601-1, 3rd ed., all the safety agencies that issue a certification mark or CB certificate must employ trained ISO 14971 auditors. They must also have personnel experienced in the risk management process for ISO 14971, and biomedical experts that understand the necessary types of medical electrical equipment.

Recognizing such training as a significant challenge, the CB scheme conducted a workshop in October 2007 to train member test laboratories on the application of the risk management requirements. However, during this meeting, it became clear that divergent opinions existed, thereby frustrating hopes for a uniform acceptance of test reports generated by member laboratories.

Such challenges prompted the CB scheme to establish a Risk Management Task Force (RMTF) to set up a system for IEC 60601-1 to address the risk management questions. During the RMTF meetings, attendees discussed the need for training on risk management for safety agencies and the content of a new test report form (TRF).
A third edition TRF is published and has been in use for several years now. This TRF contains some of the risk management requirements but is set up more for desktop assessment of risk management than for on-site assessment. Further, the TRF does not provide sufficient detail on the content of elements that would normally be covered by a qualified auditor evaluating a given risk management process. To establish full compliance, the complete set of risk management process elements are required.
To establish uniformity of member test laboratories in ISO 14971 requirements, the RMTF has spent considerable time detailing the needed elements when “inspection of the risk management file” is called out in IEC 60601-1. Based on this work, it is anticipated that the TRF will be modified before A1 is published.
Several IEC committees are discussing the difficulty of desktop risk analysis. These groups (collectively, IEC TC 62/SC 62A–D) include the technical committee for electrical equipment in medical practice; the subcommittee for common aspects of electrical equipment used in medical practice; the subcommittee for diagnostic imaging equipment; the subcommittee for equipment for radiotherapy, nuclear medicine, and radiation dosimetry; and the subcommittee for electromedical equipment.
Once A1 is published, it is anticipated that certifying agencies will be required to do an on-site assessment of the manufacturer's whole risk management system.
Testing Labs

The second challenge is getting test labs and national regulators up to speed on the paradigm shift to the third edition. Both essential performance and risk management are new concepts for the IEC 60601 series of standards, and thus it has taken time for the labs and regulators to understand the processes. At this point most of the test labs have a pretty good understanding of the term essential performance because they tend to be involved in the standards development process.

Risk management is not a new concept for the national regulatory bodies of the medical industry. However, it is new for some of the safety test labs unless they happen to be a notified body for the Medical Devices Directive (MDD) or are auditors for national regulatory systems, which require ISO 14971 knowledge. Otherwise, risk management requirements are a game changer when added to the medical electrical product safety standard.

As mentioned previously, the CB scheme system is not set up for on-site assessments of risk management and TRFs are not structures for full risk management assessment. Some of the safety test agencies also were not set up to meet the challenges because their engineers are skilled at testing and certifying, not auditing.

In addition to these two problems, there is the new collateral requirement which, per the third edition, says that “any applicable collateral standard becomes normative at the date of its publication.” This means that any published collateral standard in the IEC 60601 series needs to be used in conjunction with third edition to meet the overall standard. The collateral requirement complicates the CB scheme's plans because the group has not always issued certificates for collaterals in effect at the time of the certificate issuance.

Also, the MDD list of harmonized standards has all of the collateral standards for third edition published except for EN 60601-1-9, which is the standard for environmentally conscious design of electrical medical devices.10 Protecting the environment is not in the essential requirements of the MDD. Reviews to determine whether 60601-1-9 addresses the EU Energy Reduction Directive are in process. All of these elements add to the conflict, which makes sorting out requirements difficult for manufacturers. 

Regulatory Timetables

The third question raised at the beginning of this article regards the transition period of adoption and how it will work for each country's regulatory framework. It is critical to discuss the timetable because the collateral and particular standards need to be updated and published so that they align with third edition of IEC 60601-1. 

United States. In the United States, the national version of third edition is ANSI/AAMI ES 60601-1:2005, released in February 2006. Note that UL 60601-1, which is the national version to second edition, is still in effect. FDA has been working on a guidance document to use the third edition for several years, and it is hoped that the guidance will be released by the end of 2009. The guidance document should explain FDA's perspective on the use of risk management to get a product authorized to market and also discuss the structure of the third edition. Currently, the second edition of IEC 60601-1 is the recognized consensus standard on FDA's Web site and is used during the evaluation of a premarket submission for medical devices. There is no reference to the third edition of IEC 60601-1 or to the AAMI ES 60601-1 standard on FDA's Web site.
At this point, FDA has not specified when it will add either the third edition of IEC 60601-1 or ANSI/AAMI ES 60601-1 as a recognized consensus standard. The authors' best guess is that the United States will align with Health Canada's requirements (outlined in the following section). Note that if a product is approved by FDA and there are no substantial changes, as defined by FDA, then whatever standards the manufacturer met to gain said approval are appropriate. There is no need to upgrade the product to newer FDA consensus standards as they are published.
To obtain a U.S. product safety agency–approved certification mark (e.g., UL, CSA, TÜV America, and ETL) on a product, the test lab needs to be approved under the Nationally Recognized Test Lab (NRTL) program of OSHA for the appropriate standard. Currently OSHA deems the appropriate electrical medical standard under the NRTL program to be UL 60601-1, and not AAMI ES 60601-1. OSHA is in the process of reviewing the standard and determining the approach and schedule for using AAMI ES 60601-1 as the appropriate standard per NRTL.
It is also important to note that NFPA 99, the standard for healthcare facilities, is being updated to align with the third edition of IEC 60601-1 and it will hopefully be published in 2011. On June 11, 2009, the document was voted to be returned to committee at 2009's technical committee meeting and won't be reintroduced for a vote until 2010. Once the document is approved, the third edition should trickle down into the local U.S. fire codes fairly quickly.
Canada. After the third edition was published, Canada adopted a policy that seemed too early for manufacturers to meet. It required that a manufacturer needing a Health Canada certificate for a new product or for a reissuance of a certificate provide proof that it met the third editions of both IEC 60601-1 and IEC 60601-1-2.11 The drop-dead date for manufacturers to comply was December 15, 2008. Industry and the standards development community pushed back saying that the mandatory compliance date was unreasonable, and Health Canada backed off the requirement in October 2008. For now, companies have some options. Until May 31, 2012, a manufacturer can obtain a certificate using the second edition of IEC 60601-1 as well as the applicable collateral and particular standards. Alternatively, if they feel compelled, they can obtain a certificate by proving compliance with the third edition of IEC 60601-1, along with the applicable collateral and particular standards. After the May 2012 deadline, however, companies will be obligated to use the third edition requirements without exception to obtain a Health Canada certificate.
On June 1, 2012, it will be mandatory to comply with the third edition of IEC 60601-1 and the applicable particular and collateral standards for new product submissions to Health Canada. Any new product that is certified by Health Canada prior to June 1, 2012, will not need to meet the third edition unless there are substantial changes that would otherwise require a company to resubmit to Health Canada after May 31, 2012. The Canadian national version of the third edition is CAN/CSA-C22.2 No.60601-1:2008, issued July 31, 2008. The national deviations for this version are similar to the previous version CAN/CSA C22.2 No. 601.1-M90, which is the second edition equivalent national standard. At this time, there is no estimated transition period known for the withdrawal of CAN/CSA C22.2 No. 601.1-M90. Currently the Standards Council of Canada allow issuance of Canadian safety test lab agency marks to CAN/CSA C22.2 No. 601.1-M90 and CAN/CSA 60601-1:2008.
European Union. Previously, September 12, 2009, was the deadline for the MDD presumption of conformity for products that fall under EN 60601-1 to meet the third edition, which has no particular standards applicable. As of December 2008, both the second and third editions of EN 60601-1 and all the collaterals (related to both editions of EN 60601-1), other than EN 60601-1-9, are on the list of harmonized standards. Manufacturers can use either edition of EN 60601-1 and applicable collateral and particular standards to meet the presumption of conformity for the MDD.
On June 19, 2009 CENELEC TC 62 voted to change the date of withdrawl for EN 60601-1:1990 (second edition) to June 1, 2012. This vote was sent onto CENELEC Technical Board and should soon be sent to the EU Commission for ratification. This date lines up with the Health Canada date. Therefore, for any product that is CE marked under the MDD on or after June 1, 2012—even if CE marked based on the second edition—the product “placed on the market” or “put into service” (both MDD-defined terms) will need to meet the current list of harmonized standards as the standards are updated and published under the European Journal. In the EU, there is no national safety agency certification mark because the CE mark per the MDD is the only mark allowed.
Other Countries. Other countries are at various stages of getting their national versions of the standard ready for both regulatory and safety agency certification marks. Some of the countries that are working on their national editions of the standard include Brazil, Japan, and China.
Next Steps for Manufacturers 
How does a manufacturer deal with all the conflicting requirements? Should they should use second or third editions to get their products approved for national regulatory regulations and safety agency certification marks? This second question brings to the forefront that companies must put together a company strategy to transition from second to third edition for its product lines. To do so, consider the following:
• Determine what countries a product will be sold and marketed in.
• Decide how long new and legacy products will be sold or distributed in the specific country of concern.
• Decide what certification agency marks are required on the products.
• Conduct gap analysis for second and third editions on product lines early in the design cycle to minimize potential nonconformities. A safety certification agency or a consultant with expertise in the 60601 series and national regulatory requirements can help.
• Talk with the company's safety certification agency to get the current understanding of the applicable requirements.
• Talk with a notified body (EU), a CMDCAS registrar, or other national regulatory agencies to get an understanding of the changing requirements for the applicable requirements related to IEC 60601-1.
Once such analysis is conducted, a manufacturer should have a solid basis for determining whether certification and national regulatory approval to the second edition, third edition, or both standards is best. For many companies, the strategy until 2012 continues to be to obtain certification to the second edition, but also plan for a third edition certification. Such decisions must be based on the design life of the product and market.
Leo Eisner is the head of Eisner Safety Consultants (Portland, OR). Garry Lee is president of Global Advantage (Richmond Hill, ON, Canada) and Mark Leimbeck is program manager, health sciences, at Underwriters Laboratories (Northbrook, IL).

1. IEC 60601-1:2005, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance” (Brussels: International Electrotechnical Commission, 2005).

2. ISO 14971:2007, “Medical Devices—Application of Risk Management to Medical Devices” (Geneva: International Organization for Standardization, 2007).

3. IEC/TR 62348:2006, “Mapping Between the Clauses of the Third Edition of IEC 60601-1 and the 1988 Edition as Amended” (Brussels: IEC, 2006); available from Internet:

4. Corrigendum (Brussels: International Electrotechnical Commission, 2006); available from Internet:{ed3.0}b.pdf.

5. Corrigendum (Brussels: IEC, 2007); available from Internet:{ed3.0}b.pdf.

6. Interpretation Sheet 1 (Brussels: IEC, 2006); available from Internet:{ed3.0}b.pdf.

7. Interpretation Sheet 2 (Brussels: IEC, 2006); available from Internet:{ed3.0}b.pdf.

8. 62A/623/DC, “Proposal for an Interpretation Sheet for IEC 60601-1:2005”(Brussels: IEC, 2005).

9. 62A/647/DTR, “General Testing Procedures for Medical Electrical Equipment” (Brussels: IEC, 2009).

10. EN 60601-1-9:2008, “Medical Electrical Equipment—Part 1–9: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Environmentally Conscious Design” (Brussels; CENELEC, 2008).

11. IEC 60601-1-2, “Medical Electrical Equipment—Part 1–2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests” (Brussels: International Electrotechnical Commission, 2005).

Copyright ©2009 Medical Device & Diagnostic Industry

Ten Steps to Speeding Product Development While Meeting FDA Mandates

The path to successful product development for medical device companies is rife with roadblocks. The recession has only added to the pressures of mounting regulatory requirements, particularly those from FDA. And then there is the skyrocketing number of product recalls, which reached unprecedented 845 recalls in 2008—up 43% from just a year earlier.

No one is immune. Start-ups and multi-billion-dollar companies alike have been hit with injunctions, faced product recalls, or found themselves operating under an FDA consent decree.

Device manufacturers are attempting to navigate the convoluted path of regulatory compliance while facing unprecedented pressures for growth. Many of these companies recognize the need to reevaluate their current processes and implement a development approach that meets the requirements for both design control and a fast flow of successful new products. Yet more than half of the firms interviewed in a recent study conducted by our firm, Kalypso, admitted they were falling short of their new product development (NPD) success goals.

Striking a Balance

The majority of product recalls occur because manufacturers aren't properly validating their processes and products, Melvin Szymanski, FDA senior recall coordinator, told The Silver Sheet medical device quality control newsletter (February 2009). At the same time, many companies implementing NPD processes that comply with regulations have overcompensated. As a result, manufacturers are faced with overly bureaucratic systems that delay delivery and cause them to come up short on goals for time-to-market, return on R&D investment, new product revenue, and schedule predictability.

Despite the frustrations of many medical device providers, it is possible to achieve speed-to-market while avoiding an excessive compliance burden. Several innovative companies have gone beyond common industry practices and are applying the lessons learned from past failures. These firms are now implementing next-generation techniques and tools to make step-function improvements in product development effectiveness while complying with increasingly stringent regulations.

Here are 10 innovation and NPD best practices from device industry leaders that have achieved a successful balance between compliance and time-to-market.

Use Separate but Aligned Systems. They allow flexibility where appropriate. NPD processes are typically structured according to one of two approaches. One is a single-process structure encompassing both business and design control work flows. The other offers two separate but aligned systems.

A single-process design has the advantage of one system for both business and quality system needs. However, this approach increases opportunities for noncompliance because process bureaucracy can grow as layers of procedural detail are added to cover each work flow scenario—regardless of whether or not the tasks are governed by design controls. This hinders project teams that need flexibility to adapt business processes to specific project needs.

Separating business-oriented processes from rigidly enforced design control procedures is the alternative. This approach enables project teams to use judgment and experience in adapting the process guidance to specific project needs without jeopardizing design control compliance. While an important part of the overall process, deliverables such as business plans, go-to-market strategies, and sales plans do not go through the same level of scrutiny as design control deliverables. These deliverables include the design and development plan, requirements traceability matrix, risk management plan, and design validation report.

Companies that have adopted separate but aligned systems have discovered additional opportunities to streamline by decreasing the total number of development deliverables and reducing the number of deliverables that need to be circulated for sign-off. One leading medical device company went so far as to not require any signatures on its business deliverables, since going back to each executive to collect a signature provided no added value and only delayed the process. Instead, governance committee approval at each phase gate ensures that the deliverables are complete and provide the information necessary to make the phase gate go/no-go business decision.

Meet with FDA Early. Companies can save time and avoid delays by meeting with FDA early to receive feedback on regulatory plans well before starting full-scale development. FDA representatives are often glad to provide candid feedback, and they can save a company countless hours of pursuing the wrong path.

However, it's best to avoid presenting FDA with open-ended questions. Instead, approach the government officials with a preconceived solution along the lines of “here is what we are planning to do.” If there are flaws with a planned approach, FDA will point them out, leaving time to adjust. This approach avoids problems further downstream when corrections will cost significant amounts of time and money.

Move Validation Activity Upstream in the Design Cycle. Firms should invest in rapid prototyping capabilities and start testing as soon as production-equivalent test units can be made. There is some risk that a subsequent design change could trigger repeat testing and drive up development costs, negatively impact resource utilization, and even delay product introduction. However, the early validation offsets this risk, especially for Class I devices. The key is to manage the risk.

The 20% Test

Test Only Those Subsystem Design Elements That Are New. One company that had recently made time-to-market gains through a design reuse initiative was also able to improve its test efficiency. The firm realized how much time and money it was wasting by testing complete product systems when only certain subsystem design elements had changed. By testing only those subsystems that were new, the manufacturer not only saved time and resources but also eased a significant test-reporting burden.

As one of the company's executive explained, “If the design is 20% new and 80% design reuse, we now test 20%, not 100%.” This approach is facilitated by utilizing a new modular platform architecture and software automation tools that simplify archival and retrieval of past test reports.

Be Mindful of Regulatory Submission. It may sound obvious, but simply keeping regulatory submission in mind at each stage of the design cycle boosts efficiency and a company's regulatory filing success rate. Early stage reports should be written to support—and build toward—the final regulatory submission. This concept needs to be reinforced in all deliverable templates and training materials.

Structure Executive Governance Teams and Decision-Making Processes for Clarity. The top-performing medical device companies are making improvements and achieving transparency around the “who, what, when, and how” of the decision-making process. To fully leverage the formal phase-gate process with an appropriately staffed executive governance team, firms should align gate decisions with portfolio objectives, establish clear leadership, and leave implementation-level decisions to empowered project teams.

Successful companies appoint a governance team leader who holds team members accountable, actively drives the team to make the tough calls, and ensures that implementation-level decisions are made by the empowered project teams who are closest to the day-to-day work. The governance team leader also is responsible for using pre-established gate objectives and decision-making criteria to ensure that gate decisions align with portfolio objectives.

Staff Project Teams with a Regulatory Affairs Representative. It is critical for companies to staff core project teams with a knowledgeable regulatory affairs representative. On successful project teams, the regulatory representative not only advises team members on how to comply with design controls but also helps the project team make the delicate and all-too-common trade-offs needed to meet higher-level business objectives.

The primary role for regulatory representatives is to keep implementation-level decisions consistent with corporate-wide quality and regulatory strategies. At the same time, projects can get into trouble when their regulatory representatives take on an enforcer role and are viewed as “process policemen” who only speak up when there is a process “violation.” To succeed, these representatives need to go beyond pointing out problems and instead take an active role in guiding the team toward solutions.

A Behavioral Change

Establish Project Team Roles to Achieve Both Compliance and Project Success. Teams must be structured so that they achieve regulatory compliance and overall project success. This means aligning implementation-level decisions with quality and regulatory strategies, anticipating issues, and planning appropriate contingencies during the early planning stages. This approach is a behavioral change for many firms, and it requires a mindset transformation that is best achieved when reinforced from the highest levels in the organization.

The regulatory representative plays an important role here. Successful project teams willingly consult this representative as someone who knows how to interpret regulations and has the experience to figure out what FDA really wants.

Leverage the Regulatory Representative to Create a Strategy Early in a Project's Planning Stages. Leading companies that have realized the benefits of early regulatory involvement in project planning reap the benefits through fewer project redirects, more accurate budgets, and improved schedule predictability. Regulatory representatives can anticipate issues and help their project teams create a strategy early on.

Some companies assign a dedicated regulatory representative while the project is still in the concept phase and, in some cases, as early as idea approval. Even at this early stage, enough information is known about the product concept that this representative can begin to formulate a robust regulatory strategy in parallel with market confirmation and project planning tasks.

In formulating a regulatory strategy, the regulatory team member looks at the proposed product's intended use, desired objectives, “must-have” claims, and known label requirements. Plans for clinical studies are formulated, including study objectives, the number of studies, duration, timing, and cost. Included are determinations about FDA classification, international regulatory requirements, predicate devices, approval requirements, alternate submission approaches, submission risks, contingency plans, and timing. The regulatory team member also looks at the regulatory plan's impact on production, product cost, competitive positioning, and the overall project schedule and budget. Many companies have also added reimbursement strategy as a regulatory affairs responsibility.

Ease Challenges through Automation. Software tools can aid business processes and speed up development. They can also improve team collaboration and remove much of the administrative burden associated with regulatory compliance. These tools include product and portfolio management (PPM), requirements management, electronic document management, and idea management software.

An important, but costly, aspect to the implementation and use of software solutions is that these systems must meet Quality Systems Regulation (QSR) requirements. QSR requirements state that if “computers or automated data processing systems are used as part of production or the quality system, the [device] manufacturer shall validate computer software for its intended use according to an established protocol.” (See 21 CFR §820.70(i)).

Medical device companies installing enterprise software should always use vendors that provide a validation protocol for the software program's baseline implementation state. Companies that use these suppliers save approximately 50% of the typical time and cost of system validation, research shows. For example, some systems come “out of the box” with validated work flows for corrective and preventive action.

The advantage of software tools can be significant when applied at the right time with a well- thought-out, strategic implementation plan. The old adage rings true that automating poor processes just amplifies problems and that broken processes should be fixed first. Additionally, companies shouldn't underestimate the importance of executive-level and cross-functional “buy-in.” Firms can avoid problems by taking a more strategic approach to system selection and implementation, first by gaining agreement on the business imperatives.

Improve Process Definition, Work flow

Improving product development effectiveness in the face of regulatory scrutiny is a challenge for many of today's medical device companies. However, firms can smooth the road to getting a product to market by deploying the methodology detailed above. As is noted, these methods include improvements in process definition and work flow structure, innovation governance and decision-making, project teams and team structure, and software systems and tools. The benefits of taking these actions include the following:

• Meeting and exceeding development effectiveness goals.

• Achieving time-to-market goals.

• Hitting planned product launch dates.

• Eliminating unnecessary process bureaucracy.

• Accelerating product development process maturity.

These advantages already are being realized today by medical device companies that have achieved an effective balance of product development processes maturity and regulatory compliance. These top-performing businesses are demonstrating how it is possible to overcome the many challenges the industry faces today to deliver safe, effective, and commercially successful products.

Noel Sobelman is a partner at Kalypso (Beachwood, OH), an innovation consulting firm serving the medical device industry. He heads the firm's development and new product introduction practice and has more than 19 years of consulting and industry experience. Sobelman can be reached at

© 2009 Canon Communications LLC

Flexible Assembly in a Lean World


In designing lean cells for flexibility, the typical cell design is either U-shaped, J-shaped or L-shaped with stations interlinked by manual roller conveyors.
In the midst of a global recession, it's critical to examine manufacturing processes for waste and to pursue strategies that eliminate it. Some process review takes place naturally during tough times as companies cut costs and reduce staffing levels. Work gets shifted around, and work practices are changed for the better as companies look for new ways to get the work done. But it's also important to look beyond the recession to more normal production volumes and to put systems in place that can respond to upswings in the business cycle as well as downturns. This is where lean manufacturing principles come in. By providing a systematic way to identify waste and remove it, lean manufacturing is more than just an extra tool in the manufacturing toolbox. It's a way of life. To be good at lean, companies must commit to it and pursue lean techniques vigorously—and permanently.
Are there any special challenges to implementing lean principles for medical device manufacturers? Although the short answer is no, a good place to start is to look at the flow of material through the production process. Typically, this is the source of the greatest waste: employees hunting for parts, build-up of work-in-process (WIP) inventory, and long travel distances. The pace of innovation in medical products is also extreme—items that start out in low-volume production may quickly become high-volume products. This presents the age-old challenge: getting better products to market faster while maintaining profit margins and lowering manufacturing costs. To do this, medical manufacturers must optimize material flow and build as much flexibility as possible into their assembly and manufacturing systems. But how does a manufacturer decide on the most appropriate technologies and systems? This article examines how medical manufacturers can implement lean practices. Itoffers a matrix for determining the most appropriate methods to implement lean assembly and material flow processes in their operations.
Lean Production System Matrix
Figure 1. (click to enlarge) A lean production system matrix.
A helpful approach to choosing the right assembly technologies is to think in terms of production volume and product mix, and to chart these factors in a matrix (see Figure 1).
In the most unpredictable assembly environment—low volumes, high product mix—manual assembly is usually the most reasonable choice because most companies would never recoup their investment in automated equipment. But as volumes increase, automation can help to increase efficiency and quality and reduce waste. The lean production system matrix shown in Figure 1 can give manufacturers a critical head start in identifying the best options for their specific material flow and assembly situation.
Sometimes, it is suggested that automated assembly and lean production are contradictions in terms. Indeed, lean production is often associated with manual production systems, many of which have been integrated into assembly operations with outstanding results. Sometimes, however, automated assembly is the only way to achieve the desired quality and productivity improvements. For example, high-precision, repetitive assembly operations may require conveyors for positioning repeatability and robotics for assembly speed. In other circumstances, handling of sensitive components may be too difficult to achieve with manual assembly. In these and other situations, the lack of an automated parts-routing strategy may lead to a loss of valuable time, resulting in increases in per-piece costs, lower margins, and less profit.
It's worth noting here that the country that is most known for its lean companies—Japan—also has the highest deployment of robotic technologies in the world, according to the Robotic Industries Association. (The United States has the second-highest rate of robot use.) This serves as an example that lean and automation are not mutually exclusive.

The Simplest Case: Manual Production Systems
For manufacturers with a high degree of product variation and either low or unpredictable product volumes, the most flexible approach is manual assembly, because a device company can simply add workers to a well-designed system to increase production. If a company manufactures medical equipment, for example, and sells 50 pieces each year, much of the assembly is likely manual. Or if a device is relatively new to the market and demand is growing but still unpredictable from month to month, manual assembly is probably the right choice there, too. But what is a well-designed system? Material flow, people flow, and information flow are just as critical in a manual environment as they are in mixed or fully automated assembly systems.
Achieving the optimal flow of material, people, and information begins and ends with a properly designed cell. For starters, a typical cell design is either U-shaped, J-shaped, or L-shaped, with stations interlinked by manual roller conveyors.
There's no set rule for the size and exact shape of a cell because production requirements vary so widely. But these shapes eliminate wasted space and enable the operator to move swiftly from station to station with no excess steps or energy. They also keep the value-added operations on the inside of the cell.
Before any rearranging of equipment, however, the first critical step is to analyze the assembly process and segment it logically into time-balanced increments of work. Because a work cell should be designed to optimize the flow of product through the cell, the defined work segments become steps in the assembly process, which in turn may become stations in the cell. If a company is making a large machine, many of the same rules apply, although the company may want to focus on shortening parts supply routes and reducing process-related waste (painting, welding, shipping, and other commonly performed tasks). Regardless of the situation, the goal is to pare the assembly process down to value-added processes only. Anything not value-added is waste.
The cell should be laid out so that the work can be divided into time-balanced increments for one, two, or three operators, which allows the company to shift existing resources into and out of the cell as demand dictates. In a well-designed cell, adding one person, for example, doubles the output in the available time. Good cell design helps optimize the material flow.
Assuming that the processes and work cells are well designed, assembly costs in a manual system remain relatively constant. This is because time-balancing the operations allows a company to add workers to the cell only as it adds demand. However, as production speeds increase, automation might become the appropriate method because companies can often increase the speed of the conveyors and other machines without spending beyond their original investment. In other words, with automation, costs go down as speed increases. So with extremely fast production cycle times and high-volume production, a more mechanized approach may be the right choice, especially if conveyor systems and other automated technologies are designed specifically for assembly flexibility.

A Word About Outsourcing
Figure 2. (click to enlarge) A comparison of costs per transfer cycle of various systems.
Many companies outsource their assembly operations to countries with low-cost manual labor, with the idea that it's easy to add workers to increase production as needed instead of investing in expensive automated equipment. The chart in Figure 2 compares the costs per transfer cycle of manual transfer, a pick-and-place system, and an automated system. As cycle time goes down (i.e., the speed of manufacture increases), automated transfer begins to make greater economic sense—even compared with manual assembly in low-wage countries.
Outsourcing often carries with it unexpected or unplanned costs, as many manufacturers of toys, pet food, baby formula, and other products are now beginning to understand. The cost of manufacturing may be lower, but it may not be easy to resolve process issues or quality problems across great distances and considerable language barriers. For medical products, government rules and regulations come into play, too. When thinking about lean, it's worth remembering that travel distance is a kind of waste. That's why companies that practice lean as a culture try to manufacture as close to their customers as possible and insist that their suppliers do the same.

Individual Automated Work Cells in a Manual Production Environment
Some production environments may need one or more automated processes and the rest of the assembly steps are performed manually due to volume or mix issues. Highly sensitive medical subassemblies, for instance, may require assembly in a cleanroom environment before they can be added to the larger assembly operation. Certain high-precision operations may also require robotics, automated welding, or other equipment. Unlinked automated cells are also frequently used in packaging, inspection, and other postassembly operations. But even here, lean practices apply: Keep travel distances short, avoid overproduction, and eliminate waste wherever possible.
Due to the cost of robots and other automated production equipment, individual automated production cells are most effective with:
• High-volume processes with a predictable product mix.
• High-speed or precise assembly.
• Heavy or repetitive operations.
• Non-value-added load and unload.
Nonlinked automated production cells can dramatically reduce cost per unit produced, improve quality, and make more efficient use of human capital.
The exact type of automated assembly tool depends on the application. For example, modular systems built using a combination of electromechanical and pneumatic actuators are often a good choice because they are less expensive, more modular, and offer a broader range of work envelopes than a pedestal type four- or six-axis robot. But these latter types offer higher speeds along with a more humanlike arm movement. The key is to make sure that the technology used is the one that eliminates the most waste. In the right application, automated pick-and-place and robotic systems can dramatically reduce cost per unit produced, improve quality, and allow device firms to make more efficient use of their human capital.
Flexible, Modular Production Systems
Moving from a manual production system to one that incorporates automation, such as automated conveyor systems, is typically determined by production pace and product mix or type. Conveyor systems are generally classified into two basic types: nonsynchronous and synchronous. Nonsynchronous conveyor systems provide independent movement of parts from station to station on an as-needed basis as they become ready for the next operation. Work can be routed independently along a flexible path to optimize material flow through each assembly process. Also, nonsynchronous systems can accommodate the full range of product sizes and weights. These types of conveyors are best for:
• Medium- to high-volume production.
• Predictable product mix.
• Any combination of manual, automated, or mixed production lines.
• Electrostatic discharge–safe transport of sensitive components.
• Safe transport of heavy components.
Additionally, there are virtually no limitations on the number or complexity of assembly steps with nonsynchronous systems. Manual tasks can be readily integrated with automated operations because the system allows for varying station cycle rates. In addition, a company can easily add buffers as needed to balance assembly line work flow. The ability to smoothly integrate manual and automated operations, as well as alter the mix as market forces or product changes demand, lets manufacturers remain flexible and still stay lean.
A Hybrid: Nonsynchronous Conveyors and Lean Production
A typical nonsynchronous, pallet-based conveyor system is made up of modular components.
The drive to become lean, even in a mostly automated assembly environment, has recently led clever manufacturers to develop a kind of hybrid system that incorporates lean ideas. Such hybrid manufacturing systems combine the economies of a manual system with the safety and efficiency of an automated system. The result is a system in which some assembly is done manually while more dangerous, ergonomically difficult, or other nonmanual tasks are accomplished by machine.
In a hybrid system, workstations or cells may be combined with nonsynchronous assembly conveyor systems to achieve desired production goals. For example, automated nonsynchronous assembly conveyors can be situated as feeder lines to a central U-, L-, or J-shaped manual lean cell. The powered conveyors transfer parts between automated operations behind the scenes, so to speak, then supply subassemblies or parts to the lean cell. Machine loading and unloading, a non-value-added task, is also automated in this model to allow the workers in the cell's manual assembly area to exclusively concentrate on value-added work. This is an ideal combination if volumes are high enough to merit automation. The powered conveyors add value by delivering parts on an as-needed basis to the cell, while the high-value-add manual workforce is not tasked with wasteful activities.
For many medical device companies, such hybrid systems offer a promising alternative that would allow them to redeploy existing conveyors in a lean configuration or to add automation where needed if growth demands it. Flexible assembly conveyors based on a T-slotted aluminum frame (which most now are) allow for easy assembly, disassembly, and reconfiguration since they are simply bolted together. These conveyors also come in a wide range of sizes, styles, and even cleanroom capabilities to handle products from pacemakers and home defibrillators to wheelchairs and hospital beds.

Synchronous Conveyors and Fully Automated Production Systems
A fully integrated automated production system allows manufacturers to make better use of high-value human resources.
Synchronous conveyor systems are most commonly found in fully automated assembly systems, especially in very high-speed, high-volume assembly where there is little or no variation from part to part. Medical products such as syringes, catheters, tubing, and other products not requiring much additional assembly might benefit from synchronous conveyor systems, provided that volumes are high enough.
Synchronous conveyor systems use indexed movement of parts from station to station, along a fixed path, and at a fixed cycle rate. Examples include rotary dial machines and CAM-operated in-line machines. Short cycle rates, standardized production, and a high level of automation are features of the synchronous system.
Synchronous systems have limitations in assembly applications. System throughput, for example, must be geared to the slowest operation on the assembly line. And there is no provision for cycle independence; all parts of the production line move in lock step, similar to Lucille Ball in the famous “I Love Lucy” chocolate factory episode. This is a fundamental characteristic of fully automated production.
To offset these disadvantages, many manufacturers accomplish fully automated systems by using modular nonsynchronous conveyors, Cartesian robots, and other automated systems for assembly. Such systems are easier to reconfigure than purpose-built synchronous conveyor systems. Modular flexible chain conveyors can also be used for high-speed synchronous product transport, especially in the system's packaging operations. The key to all of this is the use of modular technologies. It's possible for a company to grow into full automation more easily if it has started with modular nonsynchronous conveyor technologies. The manufacturer can simply add robotics, additional conveyors, vision systems, or other required components to its original investment.
In any case, full automation only makes sense when a device company has long product life cycles and high production runs. Only then can it take full advantage of its investment in sophisticated equipment. Full automation for certain processes also allows a manufacturer to make better use of high-value human resources by deploying them in new lean initiatives.
A fully integrated automated production system is the best choice for manufacturing that has the following features:
• High-volume, predictable mix.
• High-speed assembly that doesn't require manual efforts.
• Transport of sensitive components.
• Safe transport of heavy components.
• Complex, linked assembly sequences.
To stay competitive in today's economy, manufacturers must seize every opportunity to increase productivity and throughput, reduce costs, eliminate waste, and improve product quality and reliability. They must achieve this while managing change on an almost daily basis.
Lean manufacturing principles, when effectively applied, can make these benefits an ongoing reality for medical manufacturers. It is important to remember that the technology a company uses to get lean very much depends on its assembly requirements. By looking at the best way to optimize material flow, people flow, and information flow—even if the manufacturer is sourcing products or components from overseas—it's possible to take big steps to eliminate waste.
Normally, there's a best way to manufacture any product. That way might be simple manual workstations, sophisticated lean manufacturing cells, or semi- or fully automated production. No matter which system is used, manufacturers should be committed to continuous improvement and to reevaluating and retooling their assembly system as needs change.
Kevin Gingerich is director of marketing services for Bosch Rexroth Corp. (Buchanan, MI).
Copyright ©2009 Medical Device & Diagnostic Industry

IVD and Pharma Alliances Fuel Growth of Personalized Medicine

Table I. Companion diagnostics partnerships announced in 2008.
(click image to enlarge)
Personalized medicine is becoming more fact than fiction with advances in genetic testing technologies. PricewaterhouseCoopers (PwC) points to an emerging trend of increased alliances between diagnostic companies and pharmaceutical firms. In its report, “Diagnostics 2009: Moving Towards Personalized Medicine,” the advisory firm speaks to this trend and its implications.

During the past year, industry saw significant mergers and acquisitions in the diagnostics sector, says Doug Mowen. He is managing director, health industries advisory, pharmaceutical and life sciences at PwC. He believes that this signifies more partnerships between diagnostics and pharmaceutical firms. “Payers are interested, the pharmaceutical companies know they need it, and the government is driving a requirement to take cost out of the healthcare system. All these elements are motivating diagnostic alliances.”

The evolution has been coming for a while. “Five years ago, diagnostics was a supporting actor. Today, everyone is looking at it as a leading role.” Mowen says. “Every pharmaceutical executive I talk to is interested in building strategic relationships with in vitro diagnostic [IVD] companies. They know that such partnerships are key to getting products to market and funded, and that they will help drive proper use of their products—that is getting people to take the right medication at the right time.”

In particular, the PwC report discusses an important marker of the trend, companion diagnostics. These are products that evaluate an individual patient's likelihood of benefiting from a particular therapeutic or risk of suffering certain adverse events from a particular therapeutic. Companion diagnostics products represent a greater integration between diagnostics and therapeutics and are a key enabler of personalized medicine. The table shows significant companion diagnostics mergers from the past year.

Mowen says that all types of diagnostics firms stand to benefit, particularly those that opt to innovate. “Companies may step out of just being an IVD company and look at something a little more broad, such as offering more complete services. If a company can innovate, it will certainly be an acquisition target or perhaps [will] introduce the next blockbuster technology.”

In addition, the report highlighted that new players are becoming more active. “Players in this sector will start to come from unexpected places,” says Art Karacsony, pharmaceutical and life sciences marketing director at PwC. For example, he says, the report points out that Siemens, traditionally thought of as an imaging company, is now in the second-largest IVD market position behind Roche, following three major acquisitions in 2006–2007.

The report says that the diagnostics sector is concentrated, with the 10 largest IVD players representing approximately 75% of the market in 2007. Roche is the largest IVD business with a 20% market share; Beckman Coulter, the largest pure play company, has a 6% market share; and Inverness Medical Innovations, the most acquisitive player in recent years, has a 3% market share. The full report is available at

© 2009 Canon Communications LLC

Professional and Consumer Healthcare Technologies Converge


The Motiva, a communication plat-
form for patients and care providers,
helps patients manage their lifestyle
habits, nutrition, and self-care.
For at least the last decade, there has been a quiet revolution under way in the healthcare field. Most Americans are well aware of the challenges facing the country's healthcare system—escalating costs, denied tests and treatments, fragmented care, less time available for a patient-physician relationship, medical errors, inefficiencies, and other woes. However, a number of important cultural, technological, and demographic trends are increasingly putting more control into the hands of patients themselves to manage their health. This transformation has an enormous potential to change how medicine is practiced and how the healthcare system as a whole operates.

In many cases, the catalyst for this change has been new technologies that have taken advances made in the realm of professional medical products—i.e., those used by doctors, nurses, and other clinicians—and modified them for use by patients in a consumer environment. Consumers have always had access to medical devices to meet their basic needs, such as first aid kits or thermometers. But in recent years, highly advanced technologies have been increasingly rolled out to consumers themselves.

Some of the best examples of this convergence between professional and consumer devices are automated external defibrillators (AEDs), blood glucose monitors, insulin pumps, home diagnostic kits, and remote patient monitoring systems. Medical technology will follow a path similar to that of computers. Large, complex scientific instruments will ultimately become small, powerful consumer appliances for communication and entertainment. This convergence zone represents one of the greatest opportunities to manufacturers in the medical technology and consumer health markets today.

Figure 1. (click to enlarge) The medical technology spectrum. Convergence is causing more high-tech professional devices to be available in forms accessible to consumers.
The medical technology field, understood in its broadest sense under FDA regulation, spans across an incredibly wide spectrum, as shown in Figure 1. Very few companies compete across the entire spectrum, but it is important to take such a broad perspective to see how convergence is taking place and where the particular nexus points are occurring. The greatest point of convergence is in the middle of the spectrum where products that were once primarily professional devices are now becoming primarily consumer technologies. Despite the exciting developments occurring relative to convergence, the professional and consumer medical technology markets have different dynamics, as shown in Table I.

Convergence between professional and consumer medical technologies is being driven by a number of trends listed in sidebar, “Major Drivers of Professional to Consumer Convergence.”

A major theme driving convergence of professional and consumer medical technology is the rise in healthcare consumerism in the United States. The term refers to a recent market phenomenon that describes how the healthcare system has begun to mimic and converge with the markets for other traditional consumer products. The term is somewhat broad but is largely driven by a shift of decision-making and purchasing power from entities in the healthcare system itself and more toward the patient. This shift has a number of underlying components, all of which are giving consumers more control and responsibility over their healthcare than in the past:

Table I. (click to enlarge) Differences between the professional and consumer medical technology markets.
Shift in demographics. Population composition, attitudes, affluence, education, disease states, etc.
Shift in technology. Small, wireless, Internet-enabled, information-gathering technologies creating new opportunities to extend the reach of care.
Shift in care settings. Hospital based to nonhospital to home; inpatient to outpatient.
Shift in caregivers. Using technology to move care to less-skilled caregivers and the consumers themselves; healthcare practitioners to patients, family, or nonprofessionals; patients more informed on disease states and treatment options thanks to the Internet.
Shift in care practices. More scientific, data-driven, preventive, technology-intense form of medicine than in the past; physicians more collaborative with patients; greater fragmentation across healthcare system, and more defensive medicine.
Shift in payment for care. More available technologies, but less willingness for insurers to pay leaves patients to pick up more costs associated with their own care, if they see value.

Major Opportunity Areas of Convergence

The convergence of professional and consumer medical technologies opens up a significant number of market opportunities. Some of the hottest sectors to watch are listed in the sidebar, “Major Areas of Opportunity for Convergence.”

Diagnostics. Manufacturers and clinicians recognize diagnostic technologies as a field with some of the greatest opportunity for the consumer market. Blood glucose monitoring evolved into a $4 billion market in the United States in the span of a few decades by only tracking a single diagnostic indicator for a single patient population.

Innovative companies see significant opportunity in developing similar markets around new diagnostic paradigms, especially for patients with chronic conditions. Compared with therapeutic devices, diagnostic technology is often simpler to develop and easier to get approved by FDA. In addition, many manufacturers believe that it is easier to educate consumers in the use of diagnostic devices compared with therapeutic devices.

In 2008, Welch Allyn, a leading company in medical technology used in front line care provided by primary care providers. It was launched a subsidiary company named Blue Highway that is focused exclusively on innovation. Most of the development in the organization is focused on healthcare, and within that, the company has decided to focus on technologies related to screening, diagnostics, and prevention during its first year in existence. As such, consumer-level medical technology is clearly an area of interest by Blue Highway, according to Al Di Rienzo, president and CEO.

Like others in the medical technology market, Di Rienzo sees a major trend toward convergence between professional and consumer products. A major focus of Blue Highway is on preventive medicine. The organization is pursuing technologies—whether used in an acute care, physician's office, home, or other setting—that can anticipate a catastrophic event, such as an abdominal aortic aneurysm, heart attack, or respiratory failure, before it occurs.

Di Rienzo reports that Welch Allyn has a chip technology that can identify the type of respiratory infection in less than 10 minutes. Using a patient's saliva, the physician could determine right in the physician's office whether a patient has influenza A, influenza B, mononucleosis, or a strep infection. All four conditions present themselves in similar ways, and the test would give physicians and patients important information about which course of treatment to take. Similar technology is likely to become more common in the future in both physician's offices and the home.

Billions of dollars worth of home diagnostic kits are already sold every year for infertility, hepatitis, HIV, drugs of abuse, fecal occult testing, high cholesterol, and other applications. While most kits currently require that patients mail their sample to a testing facility, future technologies will likely provide more immediate results. The market potential for such products is profound, especially when combined with genetic profiling and personalized medicine. But it raises a host of ethical, regulatory, clinical, technical, and reimbursement questions.

Remote Patient Monitoring (RPM). RPM is a branch of telemedicine that focuses on providing home healthcare to patients with chronic diseases. With the use of technology, patients can play a more central role in managing their conditions. RPM provides a remote interface that collects and transmits regular patient monitoring data between a home-based patient and the remotely located care provider.

RPM technology offers a strong value proposition for patients, providers, and physicians. It holds the potential to deliver improved quality of care to patients, to reduce costs associated with avoidable emergency room (ER) visits, and to help manage a host of chronic diseases by providing timely intervention and care.

The market for RPM is in its infancy. Currently, there are 8–12 established players in the market. However, there are at least 35–40 new entrants with innovative technologies under development. By 2010, total revenues for the remote patient monitoring devices market are forecasted to reach $260 million at the compound annual growth rate (CAGR) of 25% from 2004 to 2010.1,2

In 2006, Philips launched the Motiva system, a TV-based platform for remote patient management. The system does vital signs monitoring and also serves as a communication platform between patients and care providers to help patients manage their lifestyle habits, nutrition, and self-care. Paul Bromberg is senior vice president and general manager of the Senior Living Solutions group at Philips Healthcare, which is focused on improving the health and wellness of residents of senior living communities and assisted living facilities. Motiva is currently being tested in a number of focused pilot programs. The major challenge facing the Motiva, and remote monitoring in general, is finding payors willing to reimburse for the technology and related services. The same challenge could be expected for other types of revolutionary medical technologies that can enable patients to care for themselves.

Tests and Treatments for Chronic Conditions. Patients with chronic diseases and conditions are the top targets for most companies moving into the convergence zone between professional and consumer medical devices, and for good reason. According to the organization Partnership for Solutions, in 2000, more than 125 million Americans had chronic health conditions, such as cardiovascular disease, diabetes, asthma, and Parkinson's disease, and the care of these patients generated direct costs of $510 billion. This number is expected to grow to 157 million people by 2020 with $1.07 trillion in direct costs.3 Approximately 80% of all healthcare spending will be on this population.

Providing technologies that will allow patients with chronic conditions to manage their own care is a major opportunity for medical device companies according to David Nexon, senior executive vice president of the medical industry technology trade group AdvaMed. He also reports that remote monitoring, molecular diagnostics and lab-on-a-chip technologies are all areas of significant potential for the future of medicine and how patients will manage their own care. A list of the chronic conditions of greatest interest to both industry and the healthcare community is provided in the sidebar, “What is a Chronic Condition?

“Caring for individuals with chronic health conditions will be the public health challenge of the 21st Century,” according to Gerard Anderson, PhD, at the Johns Hopkins Bloomberg School of Public Health. Much of the increase in these costs is due to advances in medical practices and technology which often turn an acute condition into a chronic one. For example, since 1980 there has been a greater than 40% drop in mortality from coronary heart disease since, but more people are living with deleterious effects of these acute events. The same is true for patients surviving cancer, stroke, premature birth, renal failure, trauma, and other conditions.

A chronic disease is defined by the fact that a patient lives with it for a long time; therefore, the management of the disease requires more involvement by patients and their families, including the evaluation and use of medical products related to their care. Because patients with chronic conditions are likely to rely on their medical devices for a long time and entrust them with their health, patients hold the potential to develop a strong relationship with the manufacturers of the devices they use. For example, users of insulin pumps are noted for their strong brand loyalty to particular pump manufacturers because these companies are renown for their attentive and personalized service that includes patient education, insurance processing, and product delivery. Medical device companies that already serve patient populations suffering from chronic conditions should recognize that the number of these patients is on the rise and that their long-term needs for medical technology will provide an ideal opportunity for building consumer relationships.

Products Focused on Wellness, Nutrition, and Weight Loss. With almost two-thirds of American adults now overweight and obesity classified by the American Heart Association as the second-leading cause of death, the healthcare community, government entities, industry, and consumers themselves are increasingly interested in new technologies related to weight loss and nutrition. A number of medical technology companies have pointed with admiration to the recent launch of the Nike + iPod Sport Kit, which uses a sensor implanted in a Nike running shoe. The sensor captures and transmits information on the wearer's progress to his or her iPod. The system is designed to motivate runners during exercise and to track their performance. Medical technology manufacturers believe similar sensor and data feedback solutions could be used to motivate consumers to adopt other healthy behaviors as well. For example, sensors that could capture metabolic information on calories and fat consumed by an individual and calories burned could give a person real-time information on how they are tracking toward a diet.

The United States healthcare system does not place as strong an emphasis on preventive medicine as other Western countries. However, many manufacturers are counting on a slow evolution toward a healthcare model that is focused more on maintaining wellness and managing chronic conditions as opposed to a more reactive approach focused on acute interventions. David Lawson, the associate director of global healthcare at Proctor & Gamble, envisions a wellness monitoring device akin to the warning lights on a car dashboard, which are early indicators of the vehicle's general functional status.

Such a device would help patients to quantitatively know how well they are and their current predisposition toward future illnesses, as opposed to most consumer devices that already presume an existing health condition. Lawson sees significant opportunity in technologies that would give consumers information to know definitively how well they are from one day to the next, and what steps to take to avoid illness and track their progress toward health goals.

Technologies and Services to Improve Adherence and Compliance. For some of the most serious health conditions, such as diabetes, high cholesterol, and hypertension, about half of adult patients stop taking their medications after 18 months. Poor adherence is estimated to cause approximately 125,000 deaths annually and account for 10–25% of hospital and nursing home admissions in the United States.

Fig2.jpgDepending on the technology, nonadherence for medical devices used by consumers can be just as much a problem as with medication. As an example, one would anticipate that the aging population would be a boon to the hearing aid market, but the number of actual new customers for the devices has remained fairly flat for years despite significant advances in the size and functionality of the instruments. Many people who could expect significant benefits from hearing aids refuse to use them because they make them “feel old” despite the fact that new designs can be hidden nearly entirely in the ear canal.

Bromberg also sees significant potential for technologies that help improve patient adherence to their care programs. Philips Lifeline offers a telephone-based subscription service that prompts patients to take their medications, eat properly, exercise, and keep important appointments. Philips also sells a product called MD2, which is a monitored, automated pill dispenser. These products are among many in the growing market for consumer adherence technologies and services. Bromberg notes that although these types of adherence devices are currently focused on changing very specific patient behaviors, over time he expects similar technologies in the consumer medical device sector to expand beyond simply the patient to change the complete healthcare value chain.

Quality of Life and Pain Management. The current population of older Americans has more disposable income than any other previous generation and is willing to spend it on products that improve comfort, save time, make them more attractive, and provide a sense of well being, even if there is no additional clinical benefit provided. Compared with past generations, current patients have a much higher standard for the level of emotional and psychosocial benefits they expect to gain from the treatment of their health conditions. This places greater responsibility on clinicians for delivering more compassionate and personalized care, but it also provides medical device companies opportunities to market their products to patients based on more than simply clinical benefits and technological features.

In addition, while many insurers remain hesitant to reimburse for products whose benefits they deem to be unnecessary, patients may disagree and wish to assume financial responsibility for the products because they see value in them. The benefits of these products most commonly fall in the areas of improved aesthetics, decreased pain, more favorable designs, greater freedom for the patient, or other factors that are more subjective and indirectly related to treating the underlying condition.

Tapping the Consumer Medical Technology Sector

Develop a Deep Understanding of Patient and Clinician Needs Across the Continuum of Care. Due to the intimate nature of ostomy management and the fact that customers are often customers for life, ConvaTec works extremely closely with its customers in developing new products. In addition to regularly gathering feedback from advocacy groups, the company also conducts one-on-one interviews, focus groups, and surveys with customers and the healthcare professionals who care for them.

Marcus Schabacker, senior vice president and chief scientific officer at ConvaTec, notes that the research approach it takes with consumers is less scientific and technical than with physicians and is focused on understanding what the patient needs to feel as normal as possible. While clinicians are typically interested in clinical and technical data, ostomy patients generally have more practical concerns. “The patient is asking themselves, ‘If I put this device on, am I going to have a leak? How often do I need to change this? Is it going to hurt? Can somebody smell it? Can somebody see it?' This is a totally different perspective that the surgeon is probably not even aware is a problem for the patient,” Schabacker states.

Focus on a Clear Unmet Need with a Simple-to-Use Solution. Freedom Meditech is a development-stage medical device company working to develop a noninvasive ocular glucose measurement device that would free diabetics from the need for current finger-prick testing. The product is designed to operate like a pair of binoculars that shine light on the eyes and displays a glucose reading. Craig Misrach, president and CEO, states that the motivation for developing the technology was rooted in the fact that diabetics do not like the pain and inconvenience associated with finger-prick testing. This causes the vast majority of diabetics to avoid testing their blood sugar as regularly as they should contributing to associated complications. Misrach also describes the device as a potential future platform for measuring other analytes and for detecting and monitoring other diseases of the body that manifest throughout the eye.

Misrach notes that the current design of the device does not have the same disposable revenue streams that conventional blood glucose meters do with strips. To make up for that loss, the company has been considering other business models in which a user might connect the device to the Internet pay a fee to recharge the device for a period of time or number of uses. Misrach notes that while the idea of adopting an iTunes-style strategy is appealing, challenges exist related to data privacy and reimbursement. “The Internet is absolutely important to try to create ease of use for the consumer. We think there is a lot of opportunity in data management and the Internet with healthcare,” Misrach states.

“At Freedom Meditech we are interested in hearing about behavioral characteristics of the consumer that the consumer may not recognize themselves. Many times you will hear consumers say, ‘I will use that or I will do that,' but then when push comes to shove, they won't do what they said they would do, because they are behaviorally disposed to doing something else,” Misrach states.

Misrach affirms that simplicity is often the key to getting patients to adopt new devices because it promotes use by the patient. “As more bells and whistles are added to technologies, they sometimes become more advanced than what the market is ready for. Manufacturers should focus on exactly what will increase use by the individual, especially for screening and diagnostic devices. That is integral to continue health maintenance.”

Exploit Synergies and Copromotion Opportunities. Being one of the world's largest consumer goods conglomerates, Proctor & Gamble has significant opportunities for product synergy and copromotion in consumer medical devices. Lawson notes as an example that the company might launch a home cholesterol test that prompts people to take the company's Metamucil fiber supplement to reduce their cholesterol levels. He notes that opportunities targeting weight loss and improving adherence and compliance with consumers are also of great interest. “Everyone has a bathroom scale in their homes, but we are all still obese. So, will people really do anything about their health conditions with the extra information they are getting from these devices?”

Enter Joint Partnerships with Complementary Companies. In 2007, Proctor & Gamble and Inverness Medical Innovations jointly formed a company called SPD Swiss Precision Diagnostics to develop, manufacture, and market rapid at-home diagnostic products in fields other than cardiology, diabetes, and oral care. The company is now the leading provider of home pregnancy tests and fertility and ovulation monitoring products in the world. Proctor & Gamble's acquisition of Gillette in 2005 is also causing the company to look at new product categories in the healthcare space that might have a similar razor-razor blade business model, such as test strips or sensors, to generate consumable revenue streams. Lawson notes that partnerships such as the one between P&G and Inverness are an excellent way for companies to make a quick entry into the market for consumer medical technology.

Bring in Outside Expertise in Product Development Focused on Consumer Medical Technology. Even leading medical device and consumer products companies that dominate their current markets recognize that a move into the convergence zone of professional and consumer medical technology poses new challenges. Chief among these challenges are how they conduct market research and develop new products. Many of these companies have found value in working with outside firms that focus on consumer research, in the case of medical device companies, or on the professional healthcare market, in the case of consumer companies.


Significant market opportunities exist for more advanced medical technologies placed in the hands of consumers. More educated, empowered, and affluent consumers are demanding new approaches to dealing with their health conditions. A growing burden of chronic disease, soaring healthcare costs, and a shortage of clinicians are further driving the shift toward healthcare consumerism. The technology available to address many of these challenges is already well developed, but regulatory and reimbursement barriers stand in the way, as does resistance from the healthcare establishment to adopt new clinical paradigms.

To succeed in this market, manufacturers must have a strong understanding of consumer psychology and a commitment to developing products that provide simple, easy-to-use solutions that address unmet needs. Superior product design must also be coupled with a strong business model for payment, distribution, and regulatory approval.

Few companies currently in the professional medical devices or consumer goods industries possess the complete breadth of knowledge across both sectors to develop and commercialize these converged products. Companies interested in this market should strongly consider partnerships with complementary companies. In addition, engaging with outside consulting and research organizations specializing in new product development in this highly specialized area can prove highly valuable.

Manufacturers can expect a much more competitive consumer marketplace in the future, both within product categories and across product categories. With an ever-widening variety of testing and treatment choices available to consumers, manufacturers not only need to make a case for why their products are better, but also why their particular care pathway is the most beneficial to the patient.

Charlie Whelan is director of consulting, healthcare and lifesciences, for Frost & Sullivan. He can be reached via e-mail at


1. “Health and Health Care 2010: The Forecast, The Challenge,” (Palo Alto, CA: Institute for the Future, 2003); available from Internet:

2. “Analysis of American Hosptial Association Annual Survey Data, 1980–2001 for Community Hospitals,” (Falls Church, VA: Lewin Group).

3. Gerard F Anderson, PhD, “Better Lives for People with Chronic Conditions,” (paper presented at Partnership for Solutions, March 2003).

Copyright ©2009 Medical Device & Diagnostic Industry

The MX Q&A: Craig Turner

The estimated number of annual needlestick injuries in the United States varies. The National Institute for Occupational Safety and Health (NIOSH) has cited studies showing that between 600,000 to 800,000 healthcare workers incur injuries yearly. NIOSH also notes that workers at an average hospital suffer approximately 30 needlestick injuries per 100 beds per year. Some experts say U.S. workers are injured by sharps every 30 seconds.

The exact number of injuries may be hard to pin down because of underreporting and other problems. However, there's no disputing the severe consequences that threaten workers, including hepatitis, HIV, and other blood-borne diseases. OSHA has tried to mitigate these risks with its 1991 bloodborne pathogens standard. The agency revised the benchmark in 2001, requiring employers to select safer devices and keep a log of injuries.

That revision came in response to the U.S. Needlestick Safety and Prevention Act, passed in 2000 with the participation of MedPro Safety Products (Lexington, KY). Founded in 1995 by Craig Turner, MedPro specializes in passive technology designed to reduce the risk of accidental needlestick injuries. MedPro Safety's product line includes the Tube Touch and Skin Touch Vacuette Premium Safety Needle Systems, both of which feature a safety shield that activates after a patient's blood has been withdrawn.

As CEO, president, and board chairman since the company's launch, Turner has overseen the acquisition of eight different passive medical technologies. MedPro Safety focuses on four related product sectors: blood collection devices, syringes for clinical healthcare market, IV devices, and prefilled medicament safety delivery systems.

Turner calls MedPro Safety “a nimble and emerging company.” It went public in 2007, and in 2008 the company signed two agreements with European-based Greiner Bio-One for manufacturing and distribution of the tube- and skin-activated blood collection and safety needle devices. Turner shared his thoughts with MX on these business developments, the impact of the federal needlestick safety legislation, and MedPro Safety's transition from needle destruction to its current focus on passive technology.

MX: MedPro Safety Products has been busy recently on the business front. You took the company public in December 2007 and signed a five-year production and six-year sales contract with Greiner Bio-One in 2008. Then Greiner opened a new plant in Austria. MedPro also received ISO 13485 certification. How would you grade each of these steps in terms of meeting your expectations?

Craig Turner: Each of these steps was critical. Taking the company public in 2007 provided liquidity for our shareholders and allowed us to gain quicker access to capital. Our partnership with Greiner validated our technology and provided a foundation for moving forward with our business model. Receiving our ISO 13485 registration established market acceptance of our product by both our customer and end users. Together, these accomplishments built the foundation for MedPro to become a strategic player in the launch of the next generation of safety products for the healthcare setting—needlestick avoidance technology.

In the 2008 annual report, MedPro's balance sheet showed about $23 million in total assets for the year ended December 31, 2008, compared with a little over $16 million the year previous. How has the overall business climate affected MedPro in terms of investor confidence and stock price?

Having access to capital since December 2007 has enabled us to accelerate the development of our technology, and we have the capital resources to keep our business plan on track. We are sharply focused on achieving our corporate development milestones, which we think our investors appreciate.

What are some of the most striking changes you've seen in the medical device industry since the founding of the company in 1995?

The federal Needlestick and Safety Prevention Act has changed the risk management landscape more than any event since MedPro's inception. Healthcare organizations are looking for new products that increase worker safety in the healthcare setting, and billions of dollars are being spent to develop new safety technologies. We plan to offer a portfolio of products that markedly improve the risk management choices now available to healthcare facilities.

How did MedPro Safety Products become involved in the Needlestick Safety and Prevention Act?

During the process of commercializing our first legacy device, MedPro became aware of the Cal/OSHA initiative that led to the introduction of legislation in approximately 25 states to decrease the risk of needlestick injuries. MedPro's involvement was direct and detailed, and we participated in all states and then in the legislation approved unanimously at the federal level.

What lessons did the company learn from its involvement with the federal government that might apply to the healthcare reform and to business going forward?

We have been directly involved with legislative initiatives to ensure that our product development activities will comply with anticipated refinement of regulatory requirements. By staying involved, we made sure we developed forward-looking products in an industry that was in flux. We also gained access to developers seeking an outlet for new and innovative activities by keeping our name visible to the public. MedPro continues to stay fully engaged in legislative activity to follow trends in the industry.

What business challenges do you foresee over the next three to five years for both MedPro in its market segment and for the device industry in general?

MedPro's goal is to accelerate commercialization of passive safety technology by virtue of its strong capital position, internal and external resources, and current IP portfolio. With the development of our internal resources, one challenge will be to identify appropriate partners to help penetrate the market. We must also meet higher expectations for effective safety solutions at a time of increasing pressure to reduce cost.

Healthcare reform remains a series of open questions, and new legislation may increase regulatory and financial pressures on all industry participants. MedPro must appropriately target its development strategy to remain competitive and promote its product portfolio.

How would you describe the regulatory burden for your company's products?

The establishment of regulatory requirements by FDA has remained consistent and is designed to ensure the public that quality is built into devices that protect human lives. We believe adherence to our ISO 13485 quality plan will continue to ensure operational compliance with FDA guidelines and regulations and enhance risk management.

Speaking of MedPro's agreement with Greiner, what are the differences in selling your products to domestic and international customers?

The U.S. marketplace has a legislative mandate to evaluate and adopt safety products to prevent needlestick injuries. Markets in the rest of the world do not have the same incentive, but awareness of the risk of needlestick injuries is clearly increasing throughout the world, as is the demand for effective safety products. In all of our target markets, MedPro's message will remain focused on delivery of achievable risk management through cost effective quality products.

What effect, if any, will healthcare reform have on MedPro?

Healthcare reform may increase the use of medical devices in the U.S. International expectations for healthcare may see similar increases as the standard of care is raised in the U.S. MedPro fully anticipates that while the use of medical devices may increase, there will also be an ongoing pressure to reduce cost.

How might a shift toward better preventive care discussed in the healthcare reform debate benefit a company such as MedPro Safety Products, given its focus on prevent needlestick injuries for healthcare workers?

Better preventive care may increase the use of medical devices. For example, more physicals and more maintenance will require increased use of diagnostic devices. However, the focus on preventing needlestick injuries is a federally mandated requirement for healthcare employers. As the use of these devices increases, the chance of a needlestick injury may also increase, affirming the importance of using devices that will automatically prevent needlestick injuries for healthcare workers.

You've mentioned that MedPro puts a lot of energy into evaluating markets by investigating what healthcare workers like and dislike about the products. How does MedPro conduct these evaluations? Do you receive anecdotal feedback from your customers, for instance?

MedPro spends a significant amount of time and energy in ensuring that its final product has been evaluated by several different types of end users. We accomplish this by building high quality proof of concept tooling and participating in multiple premarket product evaluations with a wide variety of end users. These evaluations are sourced through third-party independent research organizations that solicit users from multiple disciplines. MedPro then incorporates this feedback into final product design for release to market.

How many direct competitors do you have?

It is difficult to quantify the number of competitors we have. While the medical device industry is dominated by a limited number of large corporations, there are numerous providers of single-product solutions that may compete with one part of MedPro's diverse portfolio. Our reach into multiple market segments likely creates a long list of companies that would compete directly or indirectly with our products.

MedPro offers what you call “passive” design safety technology that will change the market sector's paradigm. How does a company with direct competitors such as MedPro position itself in order to grow its business?

Our products employ distinct functionality that we believe will achieve quantifiable risk reduction. By integrating intuitive passive design, not changing patient sharps access techniques and not requiring additional steps to activate safety mechanisms, we believe MedPro's passive product portfolio will contribute to a safer environment for the healthcare worker.

Why did the company evolve from needle destruction to passive technology?

Our experience during approximately 24 months of field research in support of our activities around the federal Needlestick Safety and Prevention Act provided us with insight into operational safety requirements. [It also gave us] a better perspective at a very diverse level. We saw first-hand what was working and what was creating injuries. We also sat with end users and listened to their concerns and suggestions to determine what they felt worked and what didn't. We didn't impose any preconceptions on them. From this experience, we realized that we had to find functionality differentiation within safety technology.

In October 2008 you selected Leo Kiely and Dr. Ernest Fletcher to join MedPro's board of directors. What do you look for in making appointments to your board, and are your criteria different from any company in choosing new board members?

We expect our board to provide strategic leadership and guidance across the entire business continuum, from technical industry knowledge to corporate and financial expertise. As we assemble that group, we look for leaders in their fields who possess desired skill sets and can fit with our culture at MedPro. As a small company, we promote direct interaction between our board and our entire organization, so our directors must be dedicated and willing to be directly involved in our business.

© 2009 Canon Communications LLC

Conflict of Interest? Hamburg Recuses Herself from Device Issue

Only two months into her appointment, FDA commissioner Margaret Hamburg found it necessary to recuse herself from a controversial rule making to reclassify dental amalgams containing mercury. The rule's proponents feared that Hamburg's move could delay a resolution, but FDA issued a final regulation in time for the July 28 deadline.
Mercury amalgams as tooth fillings are the leading source of Americans' exposure to mercury, a known kidney toxin, and a suspected neurotoxin that may be hazardous to fetuses and young children. An estimated 30–40% of new tooth fillings continue to use mercury amalgams, although the device is being gradually phased out.
The reclassification rule making began May 30, 2008, under a contractual settlement between FDA and Consumers for Dental Choice. Hamburg's recusal from the rule making shifts responsibility for it to principal deputy commissioner Joshua Sharfstein, according to acting chief counsel Michael Landa. He confirmed this in a terse June 8 letter to Consumers for Dental Choice national counsel Charles G. Brown.
Why did Hamburg recuse herself? According to FDA assistant commissioner for public affairs George Strait, in an equally terse e-mail to me, it was “based on the requirements of federal ethics laws and the standard of ethical conduct.”
Brown, however, says that a fuller explanation could be that for five years before she came to FDA, Hamburg was a board member at Henry Schein Inc. (Melville, NY). The company is the leading distributor of dental products including mercury amalgams.
In a June 9 letter to Hamburg, which Brown says Hamburg never answered, Brown cited a Forbes article that said Henry Schein paid her $285,365 in 2007, and he asked, “Was Henry Schein your number one source of earned income?” Brown also asked Hamburg the following three questions:
• Were you in any way involved in the mercury amalgam issue at Henry Schein?
• Did you ever contact FDA, the American Dental Association (ADA), or a dental manufacturer about amalgam?
• Were you involved in keeping amalgam unclassified by FDA or in keeping its mercury content away from consumer knowledge?
That last question is at the core of a long-running battle, which led to a federal court case against FDA. Brown has been waging that battle to get the agency to warn the public about mercury amalgams.
Brown's lawsuit alleged that CDRH Dental Devices Branch chief Susan Runner had initiated and sustained an effort to keep the amalgam's mercury content from the public, even proposing a rule in 2002 “directing dentists to instead disclose the nutrient zinc.”
Historically, Brown says, ADA has patented and promoted mercury's use in dental amalgams. Although less than half of its members still use it, he says that ADA continues to defend the toxin's use in dentistry.
Although Runner's effort was repudiated by two joint advisory committees four years later, Brown told me that it was supported by former CDRH director Daniel Schultz, his deputy Linda Kahan, and FDA associate commissioner for science and health coordination Norris Alderson.
“It's a huge problem at FDA,” Brown told me, adding: “They won't critique each other. Managers back up their scientists all the way to the top.”
The exception is deputy commissioner for policy Randall Lutter, whom Brown credits for breaking Runner's pro-mercury program and for setting in motion the change in policy that ended Brown's lawsuit and produced last year's agreement.
Lutter apparently saw CDRH's support of mercury amalgams as inconsistent with actions against using mercury by other FDA centers. Examples include the Center for Veterinary Medicine's 2002 ban on equine Miracle Leg Paint, a late 1990s ban by the Center for Drug Evaluation and Research on topical mercury-based treatments like Mercurochrome, and the Center for Food Safety Applied Nutrition's prohibitions and warning about mercury in fish.
Fore more information on CDRH's position on mercury amalgams used in dental applications, visit
GAO Sees ‘Serious Shortcomings' at CDRH on 510(k)s
FDA's premarket and postmarket activities continue to highlight “serious shortcomings” in the agency's ability to regulate medical devices, said Government Accountability Office (GAO) health director Marcia Crosse at a House hearing on June 18. She said that FDA should be reviewing all pre-amendment Class III devices through the premarket approval (PMA) process and not through the 510(k) process, unless the device is reclassified to a lower level (Class I or Class II).
Acknowledging that FDA began a process in April to reevaluate whether certain preamendment Class III devices should be approved under a PMA, Crosse still faulted the agency for not specifying a time frame for when this determination will be completed.
Device postmarket surveillance continues to be a challenge for the agency because the volume of adverse-event reports prevents the agency from analyzing many of them, Crosse told the House Energy and Commerce Health Subcommittee hearing.
Noticeably missing from the hearing was FDA. “If the hearing is about science and solutions, why wasn't FDA invited?” asked Representative Michael Burgess (R–TX). If the hearing is looking for a solution to gaps in the device approval programs, “then we need to hear from the FDA commissioner or [the agency's] surrogate,” he said.
Former CDRH deputy director Phil Phillips said at the hearing that the new FDA leadership should be given a chance to develop strategies to improve the agency's performance before any legislation should be drafted. He was one of several hearing participants that conflict-of-interest charges were levelled against (see the story, “Conflicts of Interest at Approval Hearing?”).
Public Citizen's Peter Lurie believes that FDA allows a too-permissive interpretation of a device's “same intended use,” which allows some devices to skip the more rigorous PMA process and proceed through the 510(k) process.
His testimony discussed unacceptable practices such as failure to randomize, after-the-fact examinations of data, comparing groups studied at different points in time, and failure to adjust for multiple statistical tests.
Lurie also told the hearing that the agency's “least burdensome” provision gives “the industry recourse to challenge many requests it regards as onerous.” He said that in the case of ReGen's Menaflex collagen scaffold, the firm invoked this language “when FDA considered the unfavorable findings of its randomized, controlled trial, asserting that the agency was ‘required' to consider the least burdensome information necessary to demonstrate substantial equivalence.” And, he said, FDA has permitted scientific approaches that fall well short of rigorous.
“These lax scientific standards can be the result of any combination of the lower standard for device approval, the inappropriate routing of devices through 510(k) instead of PMA, the ‘least burdensome' requirement, and lack of rigor at the agency level,” Lurie said.
Conflicts of Interest at Approval Hearing?
Phil Phillips's invitation to testify reportedly stoked a controversy between Republicans and Democrats after it was learned that he consults for ReGen. Apparently he was invited by the subcommittee's Republican members, who weren't aware of his ReGen affiliation and who said that Democrats should have advised them of the conflict of interest after vetting him for the hearing.
At the beginning of his testimony, Phillips said he was appearing on his own behalf based on the knowledge he gained while working at the agency and since moving to private consulting.
Ironically, subcommittee chairman Frank Pallone (D–NJ) was one of four lawmakers who intervened at FDA on ReGen's behalf to push its device through the 510(k) process. It has been disclosed that Pallone had earlier received almost $9000 in campaign contributions from the company.
“It is my job to ensure that FDA is abiding by the laws as they were passed by Congress,” Pallone said earlier when asked about his involvement. “In this case, I was obligated to get involved because FDA was applying an inappropriate and possibly illegal standard. I asked FDA to follow the law and provide a fair process for the review of this product, so that in the end only sound science would determine whether or not it was safe.” No lawmakers questioned Pallone's actions regarding ReGen during the hearing.
Read more about potential conflicts of interest at the hearing at
Pilot Challenges Safety-Efficacy Rule
Pilot says that FDA may not have the authority to issue an order that requires the device makers to submit more information.
Attorney Larry Pilot is challenging the legal basis of an FDA order to manufacturers of 25 pre-1976 Class III medical devices. The order requires them to submit information on the devices' safety and effectiveness in order to confirm or revise their classifications. FDA's action was a response to public criticism of the way the agency has allowed such devices to enter the market through the 510(k) “substantially equivalent” process.
In comments to the April 9 order's docket, Pilot suggests that FDA has no explicit authority now for the order. He bases this on the 1990 Safe Medical Devices Act mandate at sect. 515(i), which required the agency to complete the classification process for all devices by December 1, 1995.
In the order to 25 manufacturers, FDA did not mention the deadline date and gave as additional authority sect. 519, which empowers the agency to require reports bearing on classification. FDA can also require reports of any death or serious injury caused by a device or its malfunction.
Pilot, a former FDA director of medical device compliance, questions that foundation for the order as well. He says that sect. 519's scope as codified by FDA at 21 CFR 860.7(g)(2) is limited to individual manufacturers in specific cases and not to all manufacturers generally. He also says that sect. 519 applies only to manufacturers and importers—not to distributors.
Pilot says that because FDA's order “is vague and subject to possible challenge,” it is disappointing that the agency “threatens manufacturers that it ‘will use its enforcement power to deter noncompliance.'”
Quality System Violations Alleged at St. Jude Plant
An FDA inspection last March and April at St. Jude Neuromodulation Systems (Plano, TX) found quality system violations in the manufacture and distribution of a spinal cord stimulation system. Specific violations cited in the FDA-483 include the following:
• Failure to investigate the cause of nonconformities relating to product, processes, and the quality system.
• Failure to establish and maintain adequate procedures for validating the device design to ensure that devices conform to defined user needs and intended uses.
The warning letter says that FDA acknowledges the company's commitment to take all necessary actions to ensure compliance with the quality system regulation and provide quarterly updates until all corrective actions are completed. However, the agency is not satisfied with the company's response.
FDA told the firm to respond in 15 days with specific steps taken to correct the noted violations, along with documentation of the corrective actions taken and a timetable for their completion.
FDA Finds Violations at Frantz Design
A June 5 warning letter to Frantz Design (Austin, TX) says that agency inspectors in February and March found quality system violations in the specification developer's manufacture of the Elastic Mandibular Advancement Appliance Kit. The product is an oral device intended to treat obstructive sleep apnea and snoring.
The letter, issued by FDA's Dallas district office, says that the company verbally promised to correct the inspection observations listed on the FDA-483. The inspection also revealed, the letter says, that between March 31 and April 10, 2008, the company retrieved defective blue elastic device straps from dental laboratories and replaced them with new straps in response to several complaints of the blue straps breaking during patient use. The firm was encouraged to contact the district office recall coordinator to determine whether future product corrections or removals must be reported to FDA.
The company was told to take prompt action to correct all the violations. However, FDA says that further inspections will be needed to verify that the corrective steps have been taken.
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