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Who Is Filling the Innovation Gap?

But that doesn't mean innovation is dead. In fact, during the MD&M Minneapolis show, many of the companies I met with were poised to charge ahead with their own unique innovation platforms. Nature abhors a vacuum, and it was encouraging to see how new ideas will continue to drive this industry.

First, Medtronic has formed its own ventures division, designed to encourage its global employees to put forth ideas for early stage medical technologies. "We are not just thinking for the next 5–10 years," explains Ven Manda, vice president of MDT ventures and new therapies. "We are looking maintain innovation for 20–30 years." To do so, the company has allocated approximately 20% of its R&D budget (about $100,000,000 annually) to the most worthy ideas submitted by Medtronic staff.

To draw out those worthy ideas, Medtronic had to change its thinking, says Manda. "Failure had to become a valued part of the process." he says. "We have to encourage risks, but we want things to fail quickly and for the right reasons—that is, not because of poor execution, but because of poor outcome."

But innovation from large firms, such as Medtronic, is unexpected in this industry, primarily because the many firms (well, really including Medtronic) are the types that start out with a doctor's good idea or a few people tinkering in the garage. Humble and homegrown Eurekas are part of this industry's history and has become its mythology. But innovation is also coming from other unexpected sources.

I also met with Lake Region Medical, known primarily as a guidewire service provider and supplier. The company has begun spending more time at physician conferences to learn directly from healthcare practitioners. The company plans to work with the end user to develop and patent more complex parts that can be used in medical devices. "If we just supply the guidewire, then that is all we can hope to add to the process," says James Mellor, vice president of sales and marketing. However, Mellor believes that if Lake Region Medical can work directly with doctors, it will be able to create device components that offer real innovative benefit to finshed device firms.

"Leading medical device marketers are increasingly focused on core technologies and will rely on vendor partnering relationships to deliver R&D and manufacturing of critical, but non-core devices, such as guidewires and other interventional accessories," says Mellor. "For Lake Region Medical, the pressure on major medical device companies presents a growing opportunity to further serve the industry."

There is of course, no guarantee that these efforts will be able to drive innovation if economic, regulatory, and political climates do not make the necessary changes to provide the support. But it is encouraging to see that medical device firms are not just standing around waiting to see what will happen. If the best defense is a good offense (have you had enough of my metaphors yet?), maybe its time to get moving.

What ideas for innovation has your company instituted in the last year?

Heather Thompson

Report claims that U.S. medical device market will near $95 billion

It comes as no surprise that the U.S. is home to seven out of the world's top ten device manufacturers. However, according to the report, imports to this market now account for about 31% of the total market.

Unlike many countries, much of the health care industry falls into private hands. However, recent proposals may change that. Some of those changes were outlined and discussed at the recent MD&M event in Minneapolis. The highlights of that address can be found in a video interview.

Richard Nass

Memory Device Withstands Gamma Sterilization of Disposables Without Data Loss

The GammaSafe memory token can withstand up to 45 kGy of gamma radiation.

Disposable device manufacturers can now incorporate anticounterfeit and limit-use functionality into gamma-sterilizable attachments without the threat of data loss. Manufactured by Datakey Electronics (Savage, MN), the GammaSafe memory device can store an encrypted product-authentication code to protect against counterfeit disposables and can be employed to limit attachment usage to ensure proper use and patient safety.

Although functionally similar to SPI EEPROM devices, the reprogrammable, portable GammaSafe memory token can withstand up to 45 kGy of gamma radiation without compromising performance. EEPROM devices, in contrast, may experience significant data loss or even device failure when subjected to intense gamma radiation, according to Datakey.

The company also touts the simplicity of the device: It does not require integration of any complex circuitry into OEMs' embedded designs, unlike radiofrequency and other technologies. Instead, it requires the addition of one receptacle. "The contacts of the GammaSafe receptacle simply connect directly to the microcontroller's SPI port. When the GammaSafe memory token is inserted into the receptacle, the microcontroller can read and write to it just as if it was an SPI EEPROM IC soldered to the board. Further, because the GammaSafe system is contact-based, as opposed to wireless, there is no ambiguity as to which memory device is being read--a frequent concern with RFID and other wireless systems," the company notes. In addition, the token can be applied to disposable attachments such as tubing and filters, for example, that plug into a base controller, even if the attachments do not contain active electronics.

As an optional feature, the memory token can be equipped with a sterilization indicator that changes color to provide a quick visual cue that a product has been sterilized. It can also come with an optional integrated tether for easy attachment to disposable devices.

"Our rugged SlimLine memory tokens have been used with disposable medical devices for more than 15 years," says Paul Plitzuweit, business development engineer for the GammaSafe product line. "Our traditional SlimLine tokens survive both EtO and autoclave sterilization methods. Now, with the addition of the GammaSafe line, we have a portable memory solution for OEMs of medical disposables no matter which sterilization method they use--EtO, autoclave, or gamma."

Recycling for Pacemakers

Such a program could be especially helpful for patients in poor countries. Foreign manufacturers have reduced the cost of the device to as little as $800, but that price tag is still beyond the means of many.

“Establishing a validated pacemaker reutilization program could transform a currently wasted resource into an opportunity for a new life for many citizens in the world,” says study senior author Kim A. Eagle, MD, cardiologist and a director of the U-M Cardiovascular Center.

The MedSun Strategy for Manufacturers

FDA launched the Medical Device Safety Network (MedSun) in 2002 as a supplement to mandatory and voluntary MedWatch reporting. Currently there are 350 healthcare facilities (primarily hospitals) that participate in MedSun. There is evidence that user facilities, physicians, nurses, and other healthcare professionals (HCPs) report at a much lower frequency than manufacturers. In part, this is a result of the specific regulatory requirements for adverse-event reporting, which are somewhat different for manufacturers than for device users, and the extent of FDA’s jurisdiction over those who file adverse-event reports.

Medical device manufacturers are required to file reports (i.e., medical device reports or MDRs) of all deaths, serious injuries, and malfunctions that, if they were to recur, could cause serious injury. In contrast, the mandatory filing requirements of user facilities are limited to deaths (which are reported to FDA and the manufacturer, if known) and serious injuries (reported to the manufacturer only). User facilities include, but are not limited to, hospitals, ambulatory care centers, outpatient clinics, and similar health providers. In contrast, HCPs and consumers are not subject to manufacturers’ and users’ mandatory adverse-event reporting but are encouraged to file voluntary MedWatch reports. Hospitals and other user facilities that are subject to user reporting requirements are required to establish and follow written procedures for investigating and reporting adverse events to ensure conformance with the regulations. Employees must be trained on these procedures.

Like medical device manufacturers, FDA recognizes that the most accurate information regarding adverse events comes from an HCP (or patient) who has first-hand knowledge of the incident. If too much time has elapsed following the incident, companies using traditional complaint and adverse event investigation methods may find that the HCP cannot recall details regarding the event, might be difficult to reach if on a different shift, or is too busy to discuss an event that happened a week or two earlier.

Some companies have improved the quality of their investigations by ensuring that the first incoming call from an HCP who reports an adverse event or serious malfunction is immediately transferred from a general customer service group to a person with a medical background or someone who is trained to ask questions concerning the event. Using the technique of a warm handoff, the customer service representative stays on the line with the customer to ensure that the call is connected to a person trained to record event information and is not lost in the transfer. Scripted questions are best developed by a cross-functional team that includes an HCP. Questions are listed in priority order according to the information that is critically necessary to make an MDR filing decision and as necessary to assess the performance of similar products in the field.

Under the MedSun strategy, FDA trains hospital staff personnel including doctors, nurses, and administrative personnel on how to recognize problems with medical devices, especially those involving human factors. In addition, hospital staff is informed of the benefits of active adverse-event reporting and the methods for filing these reports. MedSun encourages reporting of not only deaths and serious injuries, but also of close calls with the potential for harm.

Another strategic way in which FDA has used MedSun is to target certain device types to obtain additional detailed safety information. This often follows an increase of adverse events above historical levels for a particular device for which FDA is concerned about possible undetected changes in device performance or HCP use of the device. This aspect of MedSun is particularly transferable to manufacturers that can benefit from vigilance on the use of their devices and on possible changes in use patterns.

Applying the MedSun Strategy to Postmarket Surveillance

An excellent link between a product’s performance profile and the manufacturer’s vigilance regarding complaints and adverse events is risk management. The product and process risk assessments established during product development describe the severity and probability of hazards associated with the use of a device. Part of the value of these risk assessment tools is that they are thoughtfully and thoroughly derived by a cross-functional team of engineers, scientists, medical personnel, and others from functions such as quality assurance, research and development, manufacturing, regulatory affairs, clinical research, medical affairs, and marketing. One objective of the MedSun approach is to verify that the performance of the device under actual conditions of use conforms to the initial estimates of risk. As necessary, the manufacturer can revise ratings for factors such as severity and probability of occurrence.

Current Use of Using Risk Information. Manufacturers use product, process, and usability (human factors) risk assessments (commonly failure mode and effects analyses) as an objective basis for decision-making in several important areas including validation, process control, and adverse-event reporting. Examples include but are not limited to the following:

  • Establishing a priori requirements for those adverse events that must be reported to FDA and other regulatory bodies as part of mandatory reporting programs. 
  • Designing product and process validation studies to ensure that critical aspects of the product (components, subassemblies, final assembly, and packaging) are studied and sampled at a level commensurate with risk.
  • Implementing process controls to ensure that critical process variables and device specification outputs are consistently maintained within preestablished limits.
  • Sampling and testing incoming raw materials and subassemblies to ensure that performance specifications affecting a finished device performance are met.
  • Ensuring that human factors are accounted for in product design and ongoing postmarket surveillance activities.
  • Establishing appropriate controls over subcontracted services (e.g., sterilization, packaging, and testing).

Similar to the manner in which risk assessment tools such as failure modes and effects analysis are very useful throughout the product life cycle as part of the manufacturer’s quality system management process, risk assessment can be the foundation of a company’s own MedSun-like medical surveillance network. Designing a postmarket process for a particular device can start during the design and development phase that precedes design transfer to manufacturing. At this stage, the risk assessment documentation is at or very near its final revision and will likely reflect the final product design based on testing that, for some devices, includes clinical trials.

Human factors engineering deserves special mention here. Having a close relationship with hospital, medical, engineering, and risk management staff provides the ability to learn about the suitability of the device design under various installation conditions as well as when used by individuals with different training and skill levels. If not valid, root cause conclusions of user error are not tolerated by hospital personnel, but clear feedback on patient and user interfaces is invaluable.

In general, complaint and failure investigations should not stop with a simple high-level failure such as “the tubing was kinked” or “the battery failed early.” There should be a follow-up action that includes process or component changes and the selection of a new supplier.

Incorporating Risk Assessment Tools. A manufacturer’s field-based sales and service personnel are typically trained at national or regional sales meetings and with computer-based training on procedures for complaint and adverse-event reporting. Adopting a MedSun approach would further heighten vigilance among employees who have daily contact with users of a company’s medical devices.

As part of the product launch at a sales meeting with field personnel, product development personnel who participate in device design and development can identify aspects of a device and its use that are particularly relevant to safe and effective performance. Field personnel can also be trained on the failure modes experienced among other manufacturer’s similar devices and the company’s previous generation products. It is important to stress what’s in it for them and for their customers, consistent with the five points discussed later.

One approach would be to create a training tool for field personnel that alerts them to particular adverse events, malfunctions, and user complaints when the company wants complete and timely reporting. Field personnel include sales, marketing, service, and clinical specialists. These field personnel should understand that this information can help the company in several important ways.

Patient Safety. In the event that there is an unanticipated design issue or product malfunction that could adversely affect the health or safety of a patient or user, it is important to respond quickly with a remediation and, if necessary, a notification. There are advantages to maintaining a separate database for use-related issues that include categories such as design, labeling, and training.

Product Improvement. Reporting malfunctions and use problems to the complaint department, regardless of whether there is an injury or illness, facilitates continuous improvement of products and processes. Such reports lead to greater safety assurance, increased customer satisfaction, increased sales, fewer service calls, and reduced cost of poor quality. For example, problems with electromagnetic interference in an unusual use environment might not have been detected in the manufacturer’s design validation. Good vigilance after launch can lead to a rapid design or labeling improvement, if required.

Regulatory Compliance. A proactive method for gathering complaint and adverse-event data on targeted hazards and malfunctions can increase compliance for global surveillance reporting processes. The method also helps to ensure that regulatory requirements for investigation, documentation, and reporting are met.

Employee Satisfaction. It is important for field personnel to know that product performance issues they report as complaints are acted upon quickly and effectively. Companies observe that field reports increase when it is clear that input from field personnel results in meaningful quality improvements. Although there can be an increase in complaints, the quality of reports will improve and the resulting gains in product quality will ultimately reduce complaint volume as part of this program.

Business Interruption. Failure to detect product problems at the first available opportunity prevents a manufacturer from making changes quickly, which can prevent a widespread field correction and cause a loss of revenue and customer confidence. As a result, sales personnel are left without the affected product to sell during the recovery period.

Overcoming Barriers

There are several hurdles that must be overcome when dealing with complaint and adverse-event reporting.
Failure to Understand the Rationale and Importance of Reporting. As discussed earlier, field personnel might not realize that their input could be what enables their company to take immediate action to either prevent patient or user injury or to correct a product performance issue. Let sales personnel know that their input will be taken seriously, acted upon quickly using established and reliable investigation and root cause analysis tools, and result in effective corrective actions. Stress the importance of retrieving and returning complaint devices to improvements in product design and customer satisfaction.

Acting in Haste and Without a Valid Reason to Recall a Product. Some people that acting in haste causes the volume of MedWatch reports from HCPs to be low compared with manufacturers’ reports. There appears to be a concern among some HCPs that a device that is imperfect (but which in their eyes provides patient benefit) could be recalled and as a consequence be unavailable for an extended period of time. The remedy for this problem is to demonstrate that actions taken on the product will be based on facts-for example, an objective health hazard evaluation that is prepared with strong cross-functional input and review. Engaging customers and field-based employees in a creative postmarket surveillance program modeled after MedSun can establish the basis for a partnership that has field staff recognizing the extremely important role that they serve in protecting patients and users as well as accelerating product improvement efforts.

Complexity of Reporting Systems. It is essential that the manufacturer’s reporting forms contain all essential information that is required for the initial assessment by FDA or by a company to determine the level of risk reflected by the report. On the other hand, it may not be deemed necessary to request information that can be obtained upon subsequent follow-up and whose nature is not critical to a health hazard evaluation when contact time with the HCP is extremely limited. 

Manufacturers can adopt a MedSun approach by developing reporting processes that are neither complex nor time-consuming. Some companies have incorporated a means whereby a service technician sends a complaint to the complaint department with the push of one button on a handheld computer. Service personnel are taught the regulatory definition of a complaint to assure that reporting is complete. For adverse events, field personnel report immediately by a direct means such as a phone call to customer service or the medical department.

Failure to Develop Standardized Questionnaires for Interviewing HCPs. One reason why field surveillance activities fail to gain support is a lack of effectiveness of the reporting tools. This problem can stifle product improvement when the information collected does not support a meaningful failure investigation. The lack of improvement based on field reports causes field personnel to assume that their actions have been wasted and the level of reporting can diminish.

It is important to establish structured questionnaires for anticipated adverse events and significant malfunctions prior to commercial distribution of a new device. Medical input is useful when designating these tools and can include internal clinical staff or outside experts. As discussed earlier, these questionnaires can be based on the design risk assessment (severity levels) and experience with this particular class of devices through the company’s own experience with a current generation of the device or reports on other companies’ similar devices. Reports of experience with other manufacturers’ devices can be found in the literature and in FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which can be accessed on FDA’s Web site.

Using Available Risk Information from One’s Own Device and Similar Devices.
The final version of the questionnaire should be reviewed with HCPs who routinely use the specific device and those marketed by the device's competitors. The use of prioritized questionnaires anticipates that one’s contact time with the HCP who has the greatest knowledge of the event will be limited. Accordingly, the questions are prioritized to ensure that essential information is collected (such as the patient’s or user’s condition, the device failure mode, information about the device including model and serial numbers, interventions, and human factors concerns).

Lack of a Simple Means for Returning Product Complaint Units. Companies have developed creative means for enabling rapid failure investigations. For large devices, onboard diagnostics with transmission to a central service depot is helpful. For smaller disposable devices, some companies have provided high-volume users and field staff with overnight mailers that fully comply with applicable regulations for air shipment of used devices that have been exposed to blood or other body fluids. For sites that refuse to return a device that has been associated with an adverse event or malfunction, creative measures might be needed. Some companies send engineers to the hospital to test the device in the presence of hospital biomedical engineers. Consideration could be given to arranging for a hospital biomedical engineer to travel to the company with the device and participate in the complaint investigation to gain a better understanding of the device design.

Using FDA’s Strategy to Enhance Postmarket Surveillance

MedSun is an important part of FDA’s postmarket surveillance effort. FDA relies on the program to collect data from hospitals, nursing homes, and other healthcare facilities about product problems that may warrant action by FDA or device manufacturers. The primary goals for MedSun are to identify, understand, and share information about problems with the use of medical devices. A company can create the same sense of importance among field personnel regarding the benefits of focused and proactive postmarket surveillance to patients, users, and the company.

MedSun is designed to foster a partnership between clinical sites and FDA. The MedSun program helps FDA work with manufacturers to produce a safer product when problems have been identified in the field. The program also serves as a powerful two-way channel of communication between CDRH and the clinical community. Once a problem is identified, MedSun researchers work with each facility’s representatives to clarify the situation and understand the problem. Reports are then shared without facility identification so that clinicians can take necessary preventive actions.

A company can target high-volume users who will be the first to use a new product and whose use of the company’s products over time is high. It is important for a company to impress upon the institution’s staff that it seeks to establish a partnership in surveillance and reporting to help increase safety assurance and product quality. The relationship between the institution’s staff and the sales and service personnel who support them will not only foster the business relationship, but also can result in improved medical devices.

Requirements and Benefits for Participation

FDA selects MedSun participants based on a number of factors, including size and location of the facility, to ensure a representative sample of healthcare facilities.

Requirements. Participants in the MedSun program must do the following:

  • Commit to reporting for a 12 months.
  • Designate at least two staff members to be the facility’s MedSun representatives—one from risk management or quality improvement and one from biomedical or clinical engineering. Other staff from materials management, patient safety, and specific clinical areas are optional.
  • Have the representatives participate in an orientation session that provides details about the online system.
  • Participate in periodic surveys and special studies concerning particular medical products. These activities serve as an important source of ongoing communication between the clinical community and FDA on critical product problems.

A company can target high-profile surveillance customers in a manner similar to FDA's method with respect to staff functions, orientation, training, and surveys. As with MedSun, in-house and customer partners must demonstrate a commitment to openly and completely share injury and malfunction experience.

Benefits. How does FDA encourage facilities to participate in MedSun?  In addition to the important role that the facility will play in ensuring the safety of medical devices, FDA points out that the institution will benefit from the feedback it receives. This includes personal follow-up from MedSun project staff members after filing a report, as well as information sharing among healthcare organizations in the MedSun system. Additionally, MedSun staff members are available to present materials to facility staff to aid in increasing awareness of the safe use of medical devices and the importance of reporting problems.

In a similar manner, a manufacturer can communicate the benefits of engagement in its active surveillance program to selected customers and to sales and service personnel. Establishing trust and a strong relationship between the healthcare institution and company personnel in this area encourages HCPs to provide feedback to the company regarding not only adverse events, but also suggestions for improved product designs. The overall results are greater satisfaction for the customer and focused feedback for the manufacturer.

MedSun Newsletter

CDRH posts information about MedSun reports and other feedback on its public Web site at Such information includes

  • Descriptions (without identifiers) of reports received by MedSun.
  • Articles by FDA analysts concerning device problems.
  • Information from other MedSun participants concerning their uses of the MedSun project.
  • Articles of timely interest concerning patient safety.

In addition, MedSun participants receive a monthly electronic newsletter that contains project updates, information about MedSun educational programs, and a summary of recent FDA actions.

Companies that have the best results with respect to receiving prompt, complete input from the field personnel typically excel in communicating outward on what is being done in response to their input. Some companies fail to recognize the importance of communicating important quality and safety information to field sales, service, and clinical personnel. This communication is particularly important when a problem arises with a company’s product or a similar product produced by another manufacturer.

Special Database Analyses

MedSun participants can request special analyses of the MedSun database, as well as the MAUDE database. FDA tells prospective participants that the MedSun staff will assist facilities in their research, helping to retrieve quality information quickly.

As much as some hospitals have staff that are motivated to monitor product safety and are willing MedSun partners, some sales, service, and clinical personnel are particularly interested in the performance of the products they support. These individuals are great target candidates for a company’s proactive postmarket surveillance program.

In a company program, field support personnel should be kept apprised of product improvement activities so that they can provide information to customers who have experienced issues with a particular product. This feedback can strengthen the relationship and trust between the company and the customer.

FDA has contracted with Social and Scientific Systems Inc. to manage the patient safety reporting project. A large corporation could possibly benefit from a similar approach of using outside expert consulting experience to help establish a proactive postmarket surveillance program.

Other Advantages

MedSun representatives at participating facilities can reap the benefits of receiving  CDRH alerts, advisories, and recall notices soon after release. They can also participate in educational programs, conference calls, and meetings where they hear news from FDA and discuss recent problems and solutions regarding medical device safety issues.
Similarly, companies can proactively involve field sales, service and clinical management in activities that increase awareness of product safety, problem reporting, and continuous improvement initiatives. Regional and national sales meetings are an appropriate venue for these types of communications. Overall, these interactions can materially improve a company’s safety assurance programs.


Proactive postmarket surveillance has several important benefits—not the least of which is early detection of safety hazards, which can prevent or minimize harm to patients and users. A company’s risks can be reduced in other areas including regulatory compliance, product liability, loss of customer goodwill, and loss of sales. Medical device manufacturers can adopt several elements of the MedSun program to strengthen their postmarket surveillance programs and foster increased communication between the company and the healthcare providers who use its medical devices.

More information about MedSun can be found at It is also important to review FDA guidance and other agency publications on human factors considerations in medical device design labeling.

The following links are examples of such documents:

Presentations Focus on Cardio Innovation

At the heart of Minnesota's medtech industry is the cardiac device market. Home to the global industry giants Medtronic (Minneapolis) and St. Jude Medical Inc. (St. Paul), the Twin Cities area has cultivated an active supplier base and innovative R&D environment for supporting the design and development of cutting-edge cardiac devices. Catering to this local market, the MD&M Minneapolis trade show will, for the first time, feature a series of presentations focused exclusively on innovative solutions for cardiac device manufacturers.

Consisting of 11 half-hour presentations, the free event will cover topics that run the gamut from novel enabling technologies to the impact of healthcare reform on the supply chain. The latter topic will be addressed by Chris Oleksy, president of Atek Medical (Grand Rapids, MI), in a talk titled, "Navigating Health Care's Impact on Medical Device Value Chains."

"No matter where your organization sits within the value chain of healthcare, we must navigate properly the winds of healthcare change," Oleksy says. "Topics such as automation, off-shore manufacturing, product development, and product redesign are only some of the topics that will be discussed. What is key is proper value-chain configuration in order to navigate correctly. Incorrect configuration could lead to your organization solving the wrong problem and therefore not surviving healthcare reform's required changes."

A need for change is also among the central themes of the presentation, "Technology with Heart: Developing User-Centered Solutions." In this case, however, the need for change applies to OEMs' approach to product design. Too often, the needs and abilities of end-users have taken a backseat to clinical, technical, and business goals, according to presenter Ed Geiselhart, director of product development and planning for Insight Product Development (Chicago). Overlooking or disregarding user-centric solutions could ultimately compromise the success of the finished device, he says.

"Accounting for user-centered considerations is a critical aspect of development that is absolutely within reach for any medical device manufacturer," Geiselhart asserts. "The development process, if navigated effectively, can integrate the necessary activities that will ensure a device effectively accounts for utility, usability, and emotional connections. This can serve to provide distinct competitive advantages for device manufacturers and identify new opportunities for growth and profit." Geiselhart will discuss the potential benefits of user-centric design and will provide real-world case study examples involving St. Jude Medical and Thoratec (Pleasanton, CA).

In addition to examining how to optimize design with users in mind, Cardio Innovation Briefs will focus on various topics relating to materials for cardiac device applications. NuSil Technology (Carpinteria, CA), for example, will elaborate on "Using Silicones for Drug-Delivery Applications." Biocompatible, customizable, and processable by various manufacturing techniques, silicones are suited for cardiac applications that can benefit from the inclusion of anti-inflammatory, antimicrobial, or antibiotic agents, notes presenter Brian Reilly, product director, healthcare materials.

"Silicone is one of the most diverse and well-established biomaterials in the healthcare industry; it can be processed in a variety of ways and offers a wide variety of mechanical properties," he says. "Silicone chemistry isn't simply compatible with a host of actives but can be customized to deliver dramatically different customer-specified elution curves."

Materials for cardiac devices are also the subject of a presentation by Larry D. Hanke, principal engineer at Materials Evaluation and Engineering Inc. (Plymouth, MN). "The reliability of these devices is strongly dependent on the quality and integrity of the materials from which they are manufactured," Hanke states. "For metals, nonmetallic inclusions are one inherent feature of the material that has a strong influence on the mechanical behavior and corrosion resistance of the device. " In the presentation, "Characterizing Inclusions in Materials for Cardiac Devices," Hanke will highlight the company's systematic process for characterizing the size and type of inclusions for common cardiac device metals, which can help determine the reliability of the end product.

Free to registered attendees, the Cardio Innovation Briefs event will take place on Wednesday, October 13, at booth #717.

TPE Compounds Enhance Functionality of Prosthetic Fingers

Material selection was crucial in enabling a prosthetic hand device to perform movements and function like natural fingers.

Following the trauma of losing a limb or digit, many patients want nothing more than a return to normalcy. Luckily, advancements in leg, arm, and other prosthetics over the years have helped to restore their confidence and improve their quality of life.

But progress in prosthetic hand and finger design has lagged behind that of other prostheses, according to Matthew Mikosz, president of Partial Hand Solutions (Southington, CT). "While there were a number of prosthetic hand designs on the market, no functional mechanical fingers had yet been developed," he says.

Troubled by the high volume of veterans with hand and finger injuries and the lack of natural function in existing prosthetics, Mikosz decided to take matters into his own hands. From his basement, he developed a prototype of a prosthetic finger device, dubbed M-Fingers, designed to feel and operate as naturally as possible.

To achieve this goal, however, Mikosz needed help. He found it in RTP Co. (Winona, MN), a compounder of custom-engineered thermoplastics. The company assisted in material selection based on several criteria set forth by Mikosz. It was imperative, for example, that the base material featured good structural integrity to ensure that the fingers would not easily break. In addition, Mikosz required materials that would create a chemical bond between the hard structural fingers and the urethane finger tips. He also sought a material that would allow the fingers to firmly grip objects.

Offering strength and stability to the M-Fingers, RTP's 2300-series glass-filled rigid thermoplastic polyurethane ultimately was selected for the inner structure of the fingers and multiposition thumb. These parts were then overmolded with an RTP 1200-series thermoplastic polyurethane elastomer.

During the development process, however, Mikosz found that the standard thermoplastic urethane that was employed for the fingertips was too slippery and unable to grasp objects as desired. To solve this problem, RTP modified the material to enhance its tackiness and optimize it for the application, thereby providing each finger with dexterity to independently and gently conform to whatever it grasps.

The mechanical fingers are actuated by wrist flexions and even feature molded-in fingernails for picking up small objects. "With so many M-Fingers being used by soldiers in rehabilitation, it was very important that RTP's materials provide both structural stability and, at the same time, the ability to move and operate the prosthesis smoothly," says Chris Budnick, general manager of Vanguard Plastics (Southington, CT), which performed the molding operations for the M-Fingers.

"They really brought their plastics knowledge and expertise to the table, and provided great materials," Budnick says of RTP's role in the process. "The M-Finger design is truly amazing and the feedback has been very positive."

Brushless Dc Motors Breathe Life into Portable Respiratory Equipment

Maxon's EC flat motors feature high torque and a small profile for portable oxygen concentrators.

The smaller respiratory equipment shrinks, the bigger the advantage for patients. Portable respiratory equipment such as oxygen concentrators and ventilators can free patients from the confines of hospitals and even from their homes, thanks to compact designs and battery-powered operation. These portable systems allow patients to be mobile--whether that means going shopping for the day or traveling on a plane--and can ultimately improve patients' outlook and, consequently, their quality of life.

Integral to achieving this small system size over the years has been the downsizing of motor designs. And yet, a small form factor isn't the only critical design requirement for optimizing motors for portable respiratory equipment. Motor selection also hinges on application-specific functionality, such as meeting the necessary speed requirements, as well as characteristics that factor into patient acceptance of the finished system, including noise. Additional benefits can result from working with motor suppliers capable of customization. Together, these product features and supplier custom solutions can enable respiratory OEMs and patients alike to breathe a little easier.

The Brush-Off
Offering lower noise, longer life, and greater efficiency than their conventional brushed counterparts, brushless dc (BLDC) motors tend to be the driving forces behind many respiratory applications. "With brushless motors, you have to run them with electronics--that's the down side," observes Paul McGrath, regional sales manager for Maxon Precision Motors (Fall River, MA). "The advantage is that you can run them at much higher speeds than brushed motors. You've eliminated the brushes and the commutation system as a failure mode, so you're really only limited in life by the bearings." Brushless motors generally boast a lifetime of tens of thousands of hours, compared with a lifetime of only thousands of hours demonstrated by brushed motors, McGrath adds.

In addition to significantly longer life, BLDC motors emit lower noise than brushed versions. And quieter motors contribute to a quieter finished product; audibly quiet motors are highly desirable in respiratory equipment because of the systems' proximity to patients. Noisy medical equipment can scare, stress, or annoy patients, preventing them from getting the rest they need--and that's likely the last thing OEMs want to do with their products.

Flat as a Pancake
But not all brushless dc motors are created equal; different kinds of respiratory equipment demand different features and capabilities. During the past decade, for example, portable oxygen concentrators have emerged as a breath of fresh air for patients. The portable nature of these oxygen concentrators requires motors marked by a small profile and high torque. "They're small units, and as they get smaller and get more portable, they now need a smaller motor," McGrath states. High torque enables the use of smaller motors for these space-restricted applications.

Equipped with these desired characteristics, Maxon's EC flat motors feature a large diameter coupled with a thin profile. The flat motor resembles a pancake--hence, the nickname pancake motors--and is configured with an external, multipole rotor.

"There's a shaft coming out one side of the motor. The shaft and the outer part of that pancake are rotating and the flange is the only thing that is stationary," McGrath explains. "The motors also offer a higher number of pole pairs in the motor. The higher the number of pole pairs, the more torque you can get out of the motor."

On All Cylinders
Ventilators have experienced an evolution in portability over the years similar to that of portable oxygen concentrators. Loic Lachenal, medical segment manager at Portescap (West Chester, PA), recalls the old-fashioned ventilators that once could be seen in hospitals. Enormous by today's standards, the equipment was built with giant air pistons that moved up and down to help deliver therapies to patients.

Now, he notes, ventilators are often barely bigger than a shoe box and deliver therapies via a fan component called a blower. Critical to system performance, current ventilator motors must also be able to rapidly accelerate and decelerate to ensure effective delivery of air and oxygen. To do so, the system needs to correspond to the patient's breathing patterns. Upon receiving a signal, the motor has to rapidly accelerate to ensure that therapy delivery coincides with patient inhalation. Likewise, the motor quickly decelerates during exhalation or when therapy is not needed.

To accommodate these high speed and small size requirements, motor suppliers often suggest small-diameter, cylindrical motors for high-end ventilator applications. Featuring a 22-mm diameter, the low-inertia, slotless 22BH-series brushless motors manufactured by Portescap fit the bill. "The range of Portescap 22BH-series motors allows medical treatments to be delivered in the common bilevel, pressure-controlled mode, as well as the volume-controlled mode, which usually is the most demanding and involves invasive therapy through the trachea in the ICU as opposed to using a face mask," Lachenal says. "This is to say that the range of our 22BH product covers all ends of the ventilation business--from the slightest breathing disorder to life support."

Portescap 22BH-series motors can meet the high speed and rapid response requirements of portable ventilators.

Although current 22BH motor models meet speed and torque requirements for ventilators, next-generation versions will be optimized to achieve higher speeds in respiratory applications, according to Lachenal. Higher speeds, he notes, can increase the pressure at which therapies are delivered. Consequently, a broader range of conditions could be treated. Speeds could increase from about 30,000 rpm up to roughly 50,000 or 60,000 rpm. "Portescap high-speed motors are being qualified in next-generation ventilation devices capable of delivering more than 100 cmH²0 of pressure and 200 L/min flow," Lachenal states. "This is significantly higher pressure and flow than current devices."

Higher speeds generate more heat, however. With this in mind, Portescap has worked to optimize coils and lamination materials in order to maintain or to lower temperatures despite the increasing speeds achievable by the new motors. Keeping temperatures down can ultimately help to prevent overheating and ensure reliability of the end product.

Able to Adapt
While many motor suppliers specialize in standard designs, Ametek Technical & Industrial Products (Kent, OH) prides itself on offering customized solutions to suit a given respiratory application, according to Phil Faluotico, director of motor engineering. "A high percentage of our products are 'highly engineered' solutions to meet a custom application," he says.

Such an engineered solution may derive from simply modifying a product from the company's standard line to meet an OEM's needs. For these cases, Ametek may optimize the 1.7-series Pittman BLDC servomotors, which are available in 1.7 × 1.5-, 1.7 × 1.9-, and 1.7 × 2.6-in. versions for a variety of portable respiratory equipment applications. They feature a continuous torque of 3, 5.75, and 11 oz-in. and a speed at continuous torque of 10,750, 2425, and 3000 rpm, respectively.

In terms of customization, however, the company can work with OEMs to tailor the motor, blower, or drive specifications. "We offer motors only, motors with Hall sensors, and motors with integrated drives," Faluotico states. "The drives are customized and depend on the level of sophistication of control of the motor." The company counts its ability to integrate the motor with the air-moving force in the drive among its specialties.

"I think a lot of companies will look to offer one standard motor and produce just that model," Faluotico says, "while Ametek is willing to go in either from a ground-up design or a modified standard to be able to work with a customer from a startup phase to pilot production into full production."

Focus on Prototyping and Rapid Prototyping Equipment

Waterjet Cutting System Performs Micromedical Prototyping
Serving as an alternative to other conventional machining methods, a waterjet cutting technology can allow for fast and accurate prototyping of medical parts. Micro waterjet nozzles developed by the company enable systems to cut smaller parts than was previously possible and to create prototypes from CAD drawings in fewer than five minutes without the need for extensive setups or tooling, according to the company. When combined with the firm's A-Jet tilting waterjet head and 2626|xp JetMachining center, the miniature waterjet nozzles can assist in the machining of complex 3-D components for biomedical applications. Able to machine such materials as stainless steel, titanium, plastics, glass, ceramics, composites, and laminates, the machining center is suited for the prototyping and manufacture of difficult-to-machine precision medical instruments and devices.
Omax Corp.
Kent, WA

Desktop Milling Machine Provides Rapid Prototyping of Medical Parts
Building on its manufacturer's existing advanced subtractive rapid prototyping technology, a 3-D desktop milling machine is equipped with additional features, bundled software, and a variety of options to promote versatility and ease of use. Designed for modeling and reviewing design concepts in-house, the compact MDX-40A machine emulates manufacturing processes to produce prototypes of medical devices and components that accurately reflect the finished part's functionality and appearance, according to the company. It also yields a smooth surface finish on a variety of materials. Features include a user-friendly virtual panel and support for G-Code programming, which makes the system compatible with such software programs as Mastercam, EdgeCAM, SurfCAM, and GibbsCAM. It also comes with the SRP Player CAM software, which allows the system to quickly move from CAM model to physical prototype.
Roland DGA Corp.
Irvine, CA

Laser System Yields PCB Prototypes for Medical Applications
Used for prototyping and production volumes, a UV laser system can make clean, burr-free cuts on FR-4, FR-5, CEM, ceramic, polyimide, and other PCB substrate materials. Capable of cutting PCBs measuring up to 250 × 350 mm, the MicroLine 1000 S laser system handles flexible and very thin substrates better than conventional cutting systems, according to its manufacturer. The UV laser beam can also cut along delicate components or circuit paths without thermal or mechanical interference. Applications include prototyping PCBs for such devices as implantable cardioverter defibrillators. The system can perform such operations as cutting, routing, skiving, drilling, cutting pockets, structuring of etch or solder resist, and micromachining of ceramic substrates for medical applications.
LPKF Laser & Electronics
Tualatin, OR

3-D Printer Produces 'Instant' Prototypes
A personal 3-D printer yields durable plastic parts with a smooth surface finish for medical applications. Designed to drill, machine, paint, or metal-plate parts, the V-Flash printer builds parts at a rate of 0.4 in. per hour in the z axis. Furthermore, the addition of parts on the build job does not significantly affect build speed, according to the company. The manufacturer also claims that the printer boasts higher capacity, faster build times, and better efficiency than comparable products. The printer has good small-feature resolution as well. In addition to the personal 3-D printer, the company offers the iPro 8000 stereolithography center and the sPro selective laser sintering center for prototyping medical components.
3D Systems Corp.
Rock Hill, SC

Outsourcing Outlook on Plastics Processing

Medical device OEMs interested in evaluating a plastics processor should consider capabilities such as scientific molding, automation, and assembly. In particular, in reviewing prospective suppliers' injection molding capabilities, OEMs should ascertain whether they can provide scientific injection molding.

The ability to perform scientific molding requires a certain infrastructure, such as a properly designed cooling system. Without such a system, calcium builds up, impeding proper heat removal. Furthermore, molding machines with capabilities such as volumetric injection functionality are essential. Most importantly, scientific molding demands a knowledgeable and experienced staff that understands the science of polymers and polymer behaviors and that can analyze data extracted from molding machines. Unfortunately, many manufacturers do not have such systems in place.

When seeking an outsourcing partner, OEMs should also consider manufacturers that are willing to develop creative ways for reducing production costs. This can be done by utilizing runnerless systems or equipment that does not generate waste, such as hot-runner systems. Suppliers should also be able to build 'smart' molds equipped with sensors, process controls, and automated cavity-separation features.

Another area that OEMs should review is suppliers' environmental systems. All waste materials that cannot be recycled end up in landfills. While this represents an environmental burden, it also increases production costs. Over the last several years, technology has advanced to the point at which it is possible to produce completely runnerless and flashless molds. OEMs should ensure that their suppliers consider these options. --Anura Welikala, executive vice president, global business development, Helix Medical.

Plastics molding and assembly
Offering turnkey medical device manufacturing to OEMs, a full-service contractor produces plastic components for diagnostic devices, drug-delivery devices, and pharmaceutical packaging. The company can also assemble end products while handling complex projects and manufacturing customized solutions. The service provider takes customers' concepts from design through full-scale manufacturing, helping to select appropriate materials, production processes, and packaging. Providing injection molding, two-material molding, silicone injection molding, insert and overmolding, blow molding, and stretch blow molding, the company also specializes in product design, in-house toolmaking, welding, and sterilization.
Medisize Corp.

Plastic-component machining
Polycarbonate bezels, Teflon and polycarbonate manifolds, and components for arthroscopic and orthopedic devices are among the plastic medical parts offered by a machining specialist. The company processes dozens of different materials and makes large parts as well as microcomponents with precision-drilled holes and dimensions as small as 0.060 in. Concentrating on machining Teflon, Ultem 1000, polycarbonate, PEEK, glass-filled PEEK, Delrin, and polysulfone, the manufacturer can perform a range of machining and turning techniques. Using vapor polishing and other polishing methods, its machinists can produce plastic components with optically clear or other specified finishes.
East Coast Precision Manufacturing

Cleanroom plastic molding
A molding services provider offers single-resin injection molding; two-, three-, and four-shot in-mold assembly tooling systems; and continuous-extrusion shuttle blow molding. The company manufactures components such as luer fittings and other connectors, disposable plastic cannulae and piercing devices, and housings for diagnostic, transfusion-therapy, and drug-delivery applications. Its facilities include four Class 100,000 cleanrooms, the newest of which is scalable to suit future production needs. Each press in the new cleanroom is capable of performing multishot molding, and automation equipment facilitates such value-added operations as assembly, inspection, decoration, and packaging.
MGS Mfg. Group

Tube extrusion and processing
Offering services to medical device OEMs, a designer and fabricator of standard and custom extruded plastic products operates a manufacturing facility with 23 extrusion lines and two Class 100,000 medical cleanrooms. The company specializes in medical-grade flexible tubing, rigid tubing, and custom profiles made from such USP Class VI materials as PVC, non-DEHP and nonphthalate alternatives, polyethylene, polypropylene, polyurethane, polycarbonate, nylon, polyimide, high-impact styrene, thermoplastic elastomers, and thermoplastic rubber. It can produce single- and multilumen tubing, thermobonded paratubing, multilayer tubing, flared and bump tubing, high-pressure tubing, radiopaque tubing, striped tubes, coextrusions, triextrusions, and custom profiles. In-house contract manufacturing and general assembly capabilities include specialty tube cutting, coiling and banding, solvent-bonding of components to tubing, and chamfering.
Pexco LLC

Injection and insert molding
Specializing in the manufacture of plastic medical components in volumes ranging from 500 to 50 million units a year, a custom molder is equipped with valve-gate and open-tip hot-runner systems and two-shot injection molding machinery for processing such materials as silicone and thermoplastics. With competencies in rapid prototyping as well as insert and vertical insert molding, the manufacturer can produce parts with complex geometries and zero defects. It operates FDA-registered and ISO 13485-certified medical device production facilities featuring Class 10,000 and Class 100,000 cleanrooms. It also offers scientific molding and design of experiments capabilities. In addition, the company can provide extrusion services; the development and manufacture of complex catheter systems; and assembly, packaging, and sterilization services.
Helix Medical LLC