MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Midwest Medtech Firms Garner Increased Investor Attention

Shah: Investor eyes on the heartland.

The Midwest continues its emergence as a hotbed for medical device innovation and start-up activity. In 2007, many of the region's medtech companies attracted significant levels of capital, while others completed successful public offerings or were acquired by strategic partners. These recent regional successes have attracted the attention of healthcare investors across the country.

In 2007, 49 medical device start-ups across the Midwest raised $329 million from venture capitalists and other investors, according to a recent report from BioEnterprise (Cleveland).1 The financings included several high-profile, later-stage cardiovascular companies. For example, CVRx (Minneapolis) received $65 million from investors including ABS Ventures, Frazier Healthcare Ventures, InterWest Partners, Johnson & Johnson Development Corp., New Enterprise Associates, SightLine Partners, and Thomas Weisel Healthcare Venture Partners. In addition, Acorn Cardiovascular (St. Paul, MN ) received $22 million from investors including Cardinal Health, CSFB Private Equity, Fidelity Biosciences, New Enterprise Associates, and SightLine Partners.

Overall, the financed companies reflected a wide array of medical device sectors, mirroring the region's broad industry base.

The Midwest's innovation pipeline is built on its established base of medical device companies and leading research institutions. The Midwest is home to leading medical device companies in many sectors, including cardiovascular devices, medical imaging, orthopedics, and medical supplies. Companies include Medtronic Inc. (Minneapolis), GE Healthcare (Waukesha, WI), Biomet Inc.(Warsaw, IN), Stryker Corp.(Kalamazoo, MI), Baxter Healthcare Corp.(Deerfield, IL), and Cardinal Health (Dublin, OH) . The Midwest's prominent research universities and institutions include the University of Wisconsin, Mayo Medical Center, and Cleveland Clinic. Increasingly, the talent and innovation being developed in the region are connecting to create successful new medical device companies.

National investors are continuing to discover new investment opportunities in the region. Many East Coast and West Coast firms made their first Midwest investments in 2007. In part, they are being drawn to Midwest deals by peers who are actively investing in the region and reaping the benefits of the rich—but still relatively undiscovered—deal flow. In an annual survey of national investors active in Midwest healthcare opportunities, investors noted that they favored Midwest medical device investments in part due to the availability of seasoned medical device management teams.2 They are also being drawn by the favorable pricings of Midwest deals, which tend to be lower than similar-stage deals on the coasts. In the survey, investors noted that Midwest deals perform the same as or better than investments they make outside the Midwest.


Table I. Top 20 Midwest medical device financings in 2007. Source: BioEnterprise.
(click image to enlarge)

National investors are also taking note of successful medical device public offerings emerging from the nation's heartland. In 2007, several companies—including TomoTherapy Inc. (Madison, WI) and EnteroMedics (St. Paul, MN)—completed successful, high-profile initial public offerings. Both companies emerged from clusters of industry strength in the Midwest.

TomoTherapy manufactures and sells the Hi Art system, an advanced radiation therapy system for the treatment of a wide variety of cancers. The company is the latest successful start-up to emerge from the Midwest's medical imaging and radiation oncology cluster, which is concentrated in Wisconsin (U.S. home to GE Healthcare) and Cleveland (key sites for Philips Medical and Hitachi Medical Systems of America).

EnteroMedics is a neurostimulation company developing devices using neuroblocking technology to treat obesity and other gastrointestinal disorders. The company builds on the region's strengths in electrical stimulation that emerged from the cardiac pacing industry.

In addition, a number of other neurostimulation companies in the Midwest received substantial funding in 2007. For example, Envoy Medical (St. Paul, MN) received funds from individual angel investors. Meanwhile, Intelect Medical (Cleveland) received financing from Boston Scientific Corp. and Greatbatch Inc., and Synapse Biomedical (Oberlin, OH) received financing from Vivo Ventures, Palo Alto Investors, and JumpStart Inc.

Finally, the region was also the source of a number of notable acquisitions in the medical device industry in 2007. In August, NimbleGen Systems (Madison, WI) was acquired by Roche (Basel, Switzerland) for $273 million. In November, Renal Solutions (Warrendale, PA ) was acquired by Fresenius Medical Care AG & Co. KGaA (Bad Homburg, Germany) in a deal with a potential total value of $190 million.

The 2008 outlook for Midwest medical device investment remains strong. Nationally, venture investors are allocating more dollars to medical devices and searching for opportunities in the Midwest. In addition, the pipeline of Midwest medical device start-ups continues to mature, providing opportunities for more public offerings and strategic sales. Such a combination should lead to continued record years for Midwest venture investment.


1. Midwest Health Care Venture Report (Cleveland: BioEnterprise, 2008); available from Internet:

2. Midwest Health Care Venture Survey (Cleveland: BioEnterprise, 2008); available from Internet:

Baiju R. Shah is president and CEO of BioEnterprise (Cleveland), a business formation, recruitment, and acceleration initiative designed to grow healthcare companies and commercialize bioscience technologies.

© 2008 Canon Communications LLC

Return to MX: Issues Update.

CDRH Promises Crackdown on Risky Devices


In response to a series of Seattle Times exposés about two unapproved medical devices, Timothy Ulatowski told the newspaper in December that the agency is taking action against the products. Ulatowski is CDRH compliance director. Both products are manufactured overseas. Both are considered risky and are being blocked by U.S. Customs from entry.

One device is the PAP-IMI ion magnetic inductor, manufactured in Greece by Panos Pappas and illegally marketed to clinics for pain relief. The other is the EPFX (electrophysiological feedback Xrroid), manufactured in Hungary by William Nelson and illegally marketed to hospitals and clinics to treat cancer and AIDS.

FDA turned over its 2001–2005 investigation of the PAP-IMI to the state of California—a decision that kept hundreds of the devices in use elsewhere. California regulators treated the device as an economic fraud rather than a health hazard.

Michael Marcarelli, left, told Pappas to stop institutional review boards from enrolling new subjects in device studies for the unapproved PAP-IMI device.

Before FDA ceded its interest, CDRH Division of Bioresearch Monitoring director Michael Marcarelli declared the device “adulterated” in a letter sent to a Chatsworth, CA, address for Pappas, who is based in Athens. He also directed the manufacturer to “notify all involved IRBs [institutional review boards] of FDA's determination that your investigation is a significant risk device study” and said that the IRBs “must immediately discontinue enrollment of new subjects.”

In making this determination, CDRH effectively overruled Pappas's IRB, Texas Applied Biomedical Services, which Marcarelli acknowledged had “determined that these studies present a nonsignificant risk.” The Seattle Times reported that Pappas had shipped the devices—mislabeled as agricultural seed germinators—to his U.S. collaborator even though FDA denied him permission to market them in 1995.

His collaborator, salesman Charles Wallace, now deceased, set up Bio-Energy Services for the devices as a treatment clinic in Tarzana, CA. FDA investigators James Fleckenstein and Vanessa Mullen inspected the facility after being alerted by an anonymous whistleblower. In September 2002, they issued a damning establishment inspection report and a 14-observation FDA-483.

Fleckenstein told the Seattle Times that he was horrified by what he saw: a baby being pulsed by the PAP-IMI. “We went through the roof,” he told the newspaper. “We knew we had to pursue this.” The PAP-IMI was one of the most egregious cases in his 30-year career, he said.

A photo promoting the PAP-IMI appears on, which is a Web site “for U.S. and Canada” audiences.
FDA decided to turn the case over to the California Food and Drug Branch. Bio-Energy Services continued sales and treatments, and a patient died, the newspaper reported. FDA inspected three PAP-IMI clinics outside California, but the agency appears to have taken no enforcement actions against Pappas other than Marcarelli's untitled letter to him in 2005.

Meanwhile, with the PAP-IMI now denied admission into the United States, local entrepreneurs have been filling the void with imitation, and equally unapproved devices, the Seattle Times reported. One of these entrepreneurs, it said, is Mike Davis, president of PEMF Systems in Las Vegas, who is marketing imitation devices under a variety of names, including Magnapulse. He told the newspaper that he planned to get FDA approval to use the machines in a clinical study, but in the meantime has reportedly sold 300 worldwide, half of them in the United States. The original PAP-IMI is still being promoted at

In the case of the EPFX machine, the Seattle Times quoted Ulatowski as saying, “This is pure, blatant fraud. The claims are baloney.” FDA acknowledged that it took action as a result of the newspaper's reports.

Also in response, the House Commerce Subcommittee on Oversight and Investigations opened its own investigation into how these manufacturers have taken advantage of federal loopholes to profit from the machines. In addition, the Washington State Chiropractic Association asked its state regulatory board to ban the EPFX.

According to the Seattle Times, Nelson registered his company, Eclosion, with FDA in 1989. But within three years he was warned to stop making fraudulent claims that the EPFX could diagnose and heal. In 1996, the newspaper said, he fled the United States after he was indicted on nine counts of felony fraud and reestablished marketing operations in Budapest, where they continue.

Ulatowski told the newspaper that Nelson's registration as a medical device manufacturer has recently been revoked, allowing the agency to seize the EPFX machines at U.S. borders. Five of Nelson's six largest distributors are in the United States.

FDA Preemption Backed by Bush Administration

The Supreme Court (Chief Justice John Roberts shown here) is expected to issue an opinion on Riegel v. Medtronic by this summer.
The Bush administration told the Supreme Court in December that the federal preemption clause in the Medical Device Amendments of 1976 protects device companies from being sued in state courts by patients allegedly injured by an FDA-approved device. Arguing in Riegel v. Medtronic, U.S. deputy solicitor general Edwin Kneedler told the nine justices that there would be a “serious undermining of FDA's approval authority and its balancing of the risks and benefits, if a state jury could reweigh those.” The case involves a New Yorker who was treated with a Medtronic balloon catheter that burst, necessitating emergency bypass surgery. He subsequently died.

Medtronic's lawyer, Theodore Olson, argued that state tort claims would be preempted even in situations in which the manufacturer became aware of a new risk and failed to share it with FDA. “(T)hat's a judgment that Congress made, because the manufacturer would then be violating the law by failing to tell FDA what was going on, perhaps committing fraud, and be subject to criminal penalties, recall penalties, and civil penalties.”

Several of the justices asked for clarification from Olson about what happens when significant risks are discovered about a device in the marketplace, and whether device makers are liable when injuries occur before devices are modified to address the new risks. Olson said preemption would still apply to such claims. “And the reason for that is that someone must make a judgment that the information the manufacturer may have learned may [compromise] some aspect of the safety or effectiveness of the device, but it still might be the best product available. As the government points out in its brief, there are some devices that are used in situations [in which] a child might die. There's a 50% mortality rate even with using the device. So there have to be individual judgments with respect to variations of risk and safety and availability.”

Arguing on behalf of the injured patient, Public Citizen Litigation Group's Allison Zieve said that although FDA approved the device, if the device maker knew of a risk and could have made it safer by modifying the label or changing the design, those changes should have been made. It's negligence on the manufacturer's part to market a device—even if it was approved by FDA—when there is a better one that would reduce the risks, she said. Chief Justice John Roberts interrupted her for clarification: “It's not that it is not reasonably safe, it's that another design would be safer?” he asked. “And you think that's a basis for negligence because you say, yes, FDA approved it, but that doesn't mean [the agency] required the manufacturer to market that device?” That's right, Zieve responded.

The Supreme Court is expected to issue its opinion before July 2008.

Revoking FDA's Self-Policing Power May Not Be Enough

FDA's authority to investigate itself when employee misconduct is alleged was rescinded in November when the HHS Office of the Inspector General (OIG) reclaimed that authority. However, Roland Jankelson quickly told the House Energy and Commerce leadership that this step may not be enough to prevent continuing abuses. He cited alleged CDRH abuse of TMJ Implants (TMJI; Golden, CO) and his own company, Myotronics Inc. (Kent, WA), in 1997.

OIG improperly abandoned a strong case it had built several years ago against CDRH employees in the TMJI matter, Jankelson wrote in a letter to committee chairman John Dingell (D–MI) and Subcommittee on Oversight and Investigations chairman Bart Stupak (D–MI).

OIG had been “presented with compelling evidence of multiple abuses—[including] conflicts of interest and manipulation of the premarket approval [PMA] process to assure a desired outcome,” Jankelson wrote. He said this abuse included the “manipulation and stacking of a review panel and treating TMJI's PMA review with different (harsher) standards than the review of another company favored by the lead reviewer.” OIG's investigator, Matthew Kochanski, informed Jankelson on several occasions “that the investigation was nearly complete and would provide findings of criminal wrongdoing,” but then Jankelson was no longer able to make contact with Kochanski and “no results were ever made public. Someone had the capability to ‘bury' these findings from ever being revealed.” Kochanski is no longer listed in the HHS employee directory.

“Hopefully,” Jankelson's letter concluded, “the Office of the Inspector General will not be allowed to be just another level of bureaucracy behind which misbehaving FDA employees can hide.”

Precision Biometrics Warned About Off-Label Claim

FDA has accused the company of marketing the MyoVision 8000 for unauthorized uses.
CDRH has issued a warning letter to Precision Biometrics (San Carlos, CA), alleging that the firm has been marketing its MyoVision 8000 Static Surface EMG system and Dynamic Surface EMG system for diagnostic uses that go beyond its 510(k) marketing clearance. The letter said the MyoVision received a 1988 substantial equivalence determination as a biofeedback device.

However, CDRH said, the company's Web site contains statements indicating that the devices can be used in evaluating the areas or levels of the nervous system that are adversely affected by vertebral subluxations. CDRH said that such language indicates a major modification in the devices' intended use and requires a new premarket submission.

The company was told to immediately stop marketing the systems for diagnostic use and to submit a letter describing intent to comply.

FDA Seeks More Data on Stimulator

FDA has asked Cyberkinetics Neurotechnology Systems (Foxborough, MA) for additional analyses and data for a humanitarian device exemption (HDE) marketing application. The application is for the Andara oscillating field stimulator system, which is a nerve growth stimulator designed to treat acute spinal cord injuries. The company said agency approval may be delayed until at least the first half of 2008 while it provides the additional information.

The Andara device is designed to be implanted in patients within 18 days of a spinal cord injury to stimulate nerves to regrow across the injury area. Although the device is removed after 15 weeks of treatment, the company says improvement in sensory and motor function may continue for months or even years as nerves form new connections to transmit information to and from the brain.

Company officials said FDA had identified additional information related to clinical and engineering data that must be provided before agency review can be completed. The officials said they would work with FDA to fully understand the requirements and believe the information can be included in an amendment to the HDE application early in 2008.

New FDA Warning on Vail Beds

An updated FDA public health notification says that anyone who has a Vail enclosed bed system should stop using it. Patients should be moved to alternative beds. The notice was directed to hospitals, nursing homes, and consumers.

Vail enclosed bed systems are canopy-like padded beds covered with nylon netting that is zipped into place. They are used for at-risk patients with cognitive impairment, unpredictable behavior, spasms, seizures, and other disorders. They are used as an alternative to physical or chemical restraints in preventing patients from falling from the bed or wandering.

Vail Products Inc. (Toledo, OH) stated on June 16, 2005, that it had permanently ceased manufacture, sale, and distribution of the enclosed bed systems and can no longer provide accessories, replacement parts, or retrofit kits. A June 24, 2005, FDA public health notification warned that the systems pose a health risk because patients can become trapped in them and suffocate.

FDA says it is aware of at least 30 adverse-event reports, including at least eight deaths, resulting from entrapments, falls, and other incidents. More than half of the incidents involved children age 16 and younger.

Safety Precautions

The latest notification says that if the Vail bed is the only option, these safety precautions recommended by Vail should be followed:

  • Only use the beds for patients who are at least 45 in. tall and weigh at least 46 lb.
  • Do not use the beds for patients who exhibit burrowing behavior.
  • Only use the mattress recommended by the manufacturer to reduce the possibility of entrapment between the bed rails and mattress.
  • Always leave the side rails in the up and locked position.
  • Always return the bed to the flat position when the patient is unattended, unless head elevation has been ordered by a physician.
  • Keep all canopy sides zipped and locked at all times.
  • Have engineering staff check the beds for possible entrapment zones in all possible bed positions.

Cardinal Health Recalls Alaris Pump Modules

Cardinal Health has recalled all Alaris Model 8100 pump modules (also known as Medley pump modules) shipped before September 27, 2007, because of potential problems related to misassembled springs during manufacturing or servicing.

A company recall notification stated that Cardinal has received reports of inaccurate flow rates due to a misassembled spring. The company said that it has implemented a new manufacturing inspection process for Alaris pump modules that eliminates the potential problem for new products shipped as of September 27.

The company plans to inspect each Alaris module at the customer site and remove any modules with misassembled springs. Acceptable devices may be placed back in service, the company said.

Until all devices can be inspected, Cardinal recommends that customers perform an occluder pressure test every six months to confirm the occluders are functioning properly as of the test date. The firm said lack of occluder pressure is a strong indicator of a misassembled spring, warranting removal from patient use for further inspection.

Last year, FDA and Cardinal agreed on a consent decree involving the Alaris SE pumps. The company had to recondition 1300 Alaris Signature Edition Gold drug infusion pumps. The issue then was with the pumps' keypads, which had the potential to stick, creating the risk of overinfusion.

Copyright ©2008 Medical Device & Diagnostic Industry

Revised EU Directives: Many Changes in Store


For the expanded online version of this article, click here.

Since the European single market activities of the late 1980s, three main medical device directives have passed into law in the countries that make up the European Union (EU). These New Approach directives regulate how devices may be placed on the market and identify postmarketing vigilance requirements. These three directives are as follows:

  • Active Implantable Medical Devices Directive (AIMDD), 90/385/EEC.1
  • Medical Devices Directive (MDD), 93/42/EEC.2
  • In Vitro Diagnostic Medical Devices Directive (IVDD), 98/79/EC.3

The two-digit numbers at the beginning of the directives indicate the year in which the text was published in the Official Journal of the European Communities (OJ); it can be concluded that there was a span of eight years between the first and the third. During this period, a number of the generic elements of the directives changed, so it was logical that at some stage in the directives' lives, their requirements should be aligned.

The opportunity for alignment came with the review time scale included in the MDD, article 11, paragraph 4. It required the European Commission to review the operation of specific aspects of the directive five years from the date of its entering into force. These aspects included four areas: adverse incident reporting, clinical investigations for Class I and Class IIa devices, design dossier examination by notified bodies, and combination products.

Photo by iStock Photo

The MDD took effect June 15, 1998, and the review of its operation began in 2003, with the European Commission and member national competent authorities (NCAs) taking the opportunity to review all three directives at the same time.

This review resulted in a revising directive, 2007/47/EC, which was published in the OJ on September 21, 2007.4 This directive makes no changes to the IVDD, but in many respects it brings the other two directives broadly into line with the IVDD.

This article will not cover the details of the four-year revision process, with its many disagreements and eventual compromises between the European Commission, European Parliament, and European Council. Suffice it to say that some areas, such as the reuse of single-use devices, are still not covered by the directives. In addition, to avoid repetition, only changes to the MDD will be covered in any detail. In general, the same changes apply to the AIMDD.

Table I. (click to enlarge) Major areas of the MDD amended by the revising directive 2007/47/EC.
Unfortunately, consolidated versions of the revised directives were not available at the time of writing, although these were promised by the European Commission before the end of 2007. Until they are available, interested parties will have to read the 35 pages and 141 amendments of the revising directive together with the current consolidated versions of the directives to understand all that has changed. The most significant amendment topics for manufacturers are indicated in Table I.


The revising directive clarifies what constitutes software within the scope of the MDD. Software that is intended to be used specifically for diagnostic or therapeutic purposes will be subject to the directive's requirements. Recital (6) of 2007/47/EC amplifies this by stating that software for general purposes when used in a healthcare setting is not a medical device. The classification definitions in Annex IX have also been amended to include software as an active medical device.

Clinical data is defined as “the safety and/or performance information that is generated from the use of a device.” Such data may be sourced from clinical investigations of either the device itself or equivalent devices, published scientific data on equivalent devices, or from published or unpublished reports on other clinical experience of either the device or equivalent devices.

Device subcategory and generic device group are defined in the context of the extent of documentation that notified bodies (NBs) must, in the future, examine during quality management system audits. The definitions are virtually indistinguishable from each other (device subcategory means “a set of devices having common areas of intended use or common technology;” generic device group means “a set of devices having the same or similar intended uses or commonality of technology”). However, device subcategory applies specifically to Class IIa devices, whereas generic device group applies specifically to Class IIb devices. The quality system annexes have been amended to require NBs to assess the technical documentation for at least one representative sample for each device subcategory or generic device group to determine compliance with the directive.

Single-use device is defined as a device intended to be used once only for a single patient. The definition has been included because of concerns that regulation of the reuse of single-use devices within Europe is not universal and, in some cases, is contradictory. During development of the revising directive, arguments were presented for both control under the revising directive and for an outright Europe-wide ban. The European Commission has always presented the view that the directives apply only up to the point of putting a device into service, as defined. The control of reprocessed devices, unless marketed as fully refurbished under the refurbisher's name, is outside of the directives' scope and should, therefore, be left to the NCAs to decide. The European Parliament did not agree, however, and has required the Commission to develop proposals for the regulation of reprocessed single-use devices by September 2010. The Commission has already started this process by posting a public consultation questionnaire regarding reuse on its Web site, which has received approximately 75 replies.

Two additional essential requirements have been included in the revising directive where single-use devices are concerned. However, these state that manufacturers must ensure that the indication of single use is consistent across the community, and that information on factors that could pose a risk if the device were to be reused. The requirements must be included in the instructions for use.

Inclusions and Exclusions

The revising directive confirms which types of devices are included or excluded from the scope of the MDD. Specifically, it addresses devices including or containing pharmaceuticals, human blood derivatives, blood products, tissues or cells of human origin, and tissues or cells of animal origin. It takes into account the publication of the Advanced Therapy Medicinal Products (ATMP) regulation at the end of 2007.5

Two directives that were previously excluded from consideration by medical device manufacturers must now be taken into account.

The MDD made a demarcation between itself and the Personal Protective Equipment (PPE) Directive (89/686/EEC) by requiring the principal intended purpose of the product to be considered; for instance, whether a manufacturer primarily intends a surgical mask to protect the patient or the clinician. Directive 2007/47/EC amends the MDD by requiring manufacturers to fulfill the relevant basic health and safety requirements of the PPE Directive as well as the MDD requirements if the intended use is within the scope of both directives. Only one CE mark will be required, but if more than one NB has been involved in the assessment process, it is believed that both NB numbers will have to appear with the CE mark. This will hopefully be clarified by future guidance.

In addition, the original MDD allowed medical device manufacturers to consider only the essential requirements of that directive, even if the device included aspects that would otherwise fall within the scope of the Machinery Directive (recently revised and published as 2006/42/EC). The MDD revision, however, requires that: “Where the relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC must also meet the essential health and safety requirements set out in Annex I of that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I of this Directive.”

This is a controversial change, introduced by the Parliament without consultation with the medical device industry or support from the Commission. One industry association commented that this was “another example of intransparent policy making.”

It may be helpful to include here an extract from the definition of
machinery from Article 2(a) of Directive 2006/42/EC, to give an idea of the type of medical device that might now be captured by this new requirement:

  • An assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application.
  • An assembly of linked parts or components, at least one of which moves and that are joined together, intended for lifting loads and whose only power source is directly applied human effort.

The interpretation by manufacturers, NBs, and NCAs of “more specific than the essential requirements set out in Annex I” will be interesting as time passes. The Commission will issue new guidance notes before full implementation of the directive. It is hoped that these new guidances will provide clarification.

Custom-Made Devices

There are a number of changes to the requirements for custom-made devices. Those changes include the following seven items:

  • The custom-made statement required by Annex VIII for Classes IIa, IIb, and III devices must be made available to the particular patient for whom the device has been made.
  • The patient may be identified on the statement by means of name, acronym, or numerical code.
  • The statement must now include both the name and address of the manufacturer.
  • In the documentation that must be kept available for inspection by NCAs, the manufacturer must now include names and addresses of the manufacturing site(s).
  • If the device is implantable, the documentation must be kept for at least 15 years instead of 5 years.
  • Custom-made devices will in the future be subject to the vigilance requirements applicable to devices in serial production.
  • Registration of custom-made devices in the European databank (EUDAMED) will no longer be required.

Article 7 Committee and the Device Registration

Under the earlier wording of Article 14, NCAs were allowed, for Class IIb and Class III devices, to “request to be informed of all data allowing for identification of such devices together with the label and the instructions for use when such devices are put into service within their territory.” The revision extends this to include Class IIa and active implantable devices.

Device registration is one area of the directives' implementation in which subsidiarity, or the ability of member states to make their own decisions on what to include in their national regulations transposing the directives, has already played a major role. Some NCAs require little or no information on devices for which there is NB involvement, whereas others have already implemented, or are now planning, comprehensive registration regimes.

Italy, for instance, has a dedicated online databank. It requires 55 questions to be answered for each device or device family being marketed in Italy, the upload of some elements of the technical file, and the use of an electronic signature SmartCard for validation of the data entry. Once reviewed and approved by the NCA, the manufacturer must also register to be able to sell devices to medical facilities within the Italian national health service. Payment of a €100 repertorio fee per device or device family is required.

The French NCA, AFSSAPS, has also launched a more detailed registration scheme, although it is voluntary at the moment. The scheme allows the NCA to sort devices on a hierarchical basis according to their degree of innovation. One of the 30 sections within the questionnaire that must be completed requires manufacturers to identify into which of six innovation levels their devices fall. Levels range from
“no innovation” to “major innovation.” In addition to answering the questions, manufacturers must also supply a photograph of the device, copies of the labeling and instructions for use, the declaration of conformity, a description of the technical operation when applicable, and the sales literature.

The revising directive paves the way for such comprehensive registration schemes to become more commonplace. It allows the nature of such data collection for Class IIb and Class III to be decided by the Article 7 Committee, with oversight from the European Parliament.

Transposition and Future Plans

The revising directive requires member states to publish the national laws implementing the revisions by December 21, 2008, with full application of them by March 21, 2010.

It would be comforting to think that with these amendments, the European device regulatory picture would be stable for a significant period, but this is unlikely for a number of reasons. First, the European Commission is in the final stages of developing a regulation to implement revisions to the underlying structure of the New Approach directives. The device directives, along with around 20 other sectoral directives, are part of this structure. High on the priority list for these amendments are improvements in the consistency and quality of work performed by conformity assessment bodies, as well as improved market surveillance. Finalization of the regulation is expected during the first half of 2008. A review of how the changes affect the device directives will then have to be completed.

In addition, in 2005, the medical device unit within the Commission was charged to begin a review in 2008 of the MDD and AIMDD, together with the directive on human blood and blood derivatives, 2000/70/EC. This review is aimed at simplifying the regulations to make the market more accessible, especially to small companies. The potential result may be that these directives are combined into a single piece of legislation.

With the soon-to-be-implemented regulation on advanced therapy medicinal products, the Commission must consider whether the full set of medical device directives and regulations should be combined into a single legislative package. But, given the ever-changing technological and political environments, it is probable that further changes to the regulatory requirements would be made at the same time. There is also the question of how to address medical products that currently fall outside of current and planned legislation. These include products that could be considered medical devices except that they contain human stem cells or contain or are made from viable tissues or cells of animal origin. Currently, these types of products are covered only by a variety of national regulations.


Although the exact nature of future legislation for medical devices in Europe is difficult to predict, it is safe to say that further changes are likely. The only wish from industry is that the inclusion of a hint of harmonization in 2007/47/EC will pave the way for greater international cooperation and harmonization, rather than the development of more regional requirements. Tucked away in a new article (Article 20a) in the MDD, it says: “Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed at an international level.” The Commission had already organized and chaired a workshop on the need for harmonized requirements at the 11th Conference of the Global Harmonization Task Force (GHTF) in Washington, DC, in October 2007. This new article may be a sign that, after 15 years, the importance of GHTF for the future of the global medical device industry is, at long last, being taken seriously.

Roger Gray is director of global regulatory affairs at Donawa Consulting (Rome). He can be reached at


1. Council Directive 90/385/EEC of 20 June 1990 on the Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices, Official Journal (OJ) of the European Communities, L 189.

2. Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, OJ, L 169, 199.

3. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices, OJ, L 331.

4. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 Amending Council Directive 90/385/EEC on the Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices, Council Directive 93/42/EEC Concerning Medical Devices and Directive 98/8/EC Concerning the Placing of Biocidal Products on the Market, OJ, L 247, 21–55, September 9, 2007 [online] available from Internet:

5. Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No. 726/2004, OJ, L 324/121.

Copyright ©2008 Medical Device & Diagnostic Industry

Understanding Human Factors


Reade Harpham
Over the next year, the term human factors must become very important to those who develop and market medical devices (if the term is not already). Developers must take a look at some common misunderstandings about the inclusion of human factors into the product development process. And many companies may need to alter their perception of human factors.
David Wourms
FDA wants evidence showing that human factors applications are used as a risk management activity in the device development process. Companies that do not have robust human factors integrated into their development process must consider how to include such applications so that medical devices meet FDA approval.
Donna Pydlek
Initially, the inclusion of human factors criteria may translate into increased development costs. However, the consequences of not implementing human factors could be much more expensive. A device could fail to gain FDA approval or get recalled because of use errors. Worse yet, a company may face litigation based on a lack of human factors. The long-term implications of overlooking human factors bear much thought. Pay now or pay more later?

Beyond the regulatory considerations, however, there is another aspect of human factors: it's just good business. To be plain, human factors works to create better and safer products. Device manufacturers should consider this aspect of the process as well, and embrace human factors to achieve product success.

Managers make the final decisions on how and when to integrate human factors into development. Therefore, this article also provides managers with the essential facts they need to consider when integrating human factors.

User-Friendly Isn't Enough

FDA requires the application of human factors as a risk management activity—focusing on foreseeable misuse and how that interaction affects the inherent risk of using a device. The agency's intent is reduce medical use error. FDA's focus on safety and error reduction presents a number of challenges, specifically to design firms for which human factors activities revolve only around empathy for the user and ease-of-use designs. This doesn't mean designers can forget ease to use as a design goal. In fact, the argument can easily be made that working to achieve ease of use in itself can help reduce errors.

As far as FDA is concerned, however, those issues are secondary to reducing medical use error. FDA needs testable data (proof) that illustrate that human factors were applied to risk management activities in the development process. Gathering such data for FDA requires the performance of human factors activities under scientifically based, testable, and repeatable processes not typically practiced by design firms (see sidebar “Achieving Testable Data”).

Although using human factors to create a positive medical device user experience is sure to impress focus groups and energize marketing, these activities add little or no value unless they also align with FDA's requirements for risk management and can be fully written into the design requirements. Making it pretty is not enough; you must also make the device safe to use. And although the entire development team should focus on safety, the human factors professionals must zero in on how design decisions affect user safety.

FDA defines human factors in terms of medical devices as “the study of how people use technology. It involves the interaction of human abilities, expectations, and limitations, with work environments and system design.”

It is clear that FDA places emphasis on the application of human factors in medical device design to reduce the risks associated with use. The frequency and consequences of medical device use errors far exceed those occurring from device failures.1 Therefore, FDA requires that medical device developers use human factors data for risk management to reduce or prevent use-related hazards.

Overcoming Obstacles

Adopting human factors into medical device development provides long-term benefits. However, such changes are likely to involve near-term hazards from those who lack extensive experience in the field or are not up to speed on changing regulatory standards.

As a growing number of design and development firms look to enter the medical device market to offset the exodus of consumer device development, human factors is sure to be one of the disciplines leveraged. However, the definition, planning, and execution of human factors activities vary greatly depending on a firm's experience with human factors. The manner in which human factors activities are integrated in device development determines the success or failure of market introduction.

Here are some common ideas that can hinder the implementation of or prevent changes to a human factors program.

It's Too Fuzzy. Technical thinkers can find it difficult to appreciate the subjective nature of human interactions with medical devices. However, these people are invaluable to the processes needed to write measurable specifications. Repetitive use of human factors data helps such personality types adapt to the process.

It's Just a Passing Trend. Not according to FDA. And if FDA approval is the ticket to the medical device market, it's time to look at the merits of human factors. Translating the subjective into objective is the synergy of human factors. Those involved must recognize the priority that management places on human factors and acknowledge that the process is here to stay.

Implementing Human Factors

FDA will not tell you how to bring human factors into the development process; it is interested only in whether a company can produce documented evidence of human factors applications. User safety and avoiding use error are of primary importance to FDA. Device development managers, then, must decide how they will implement these activities in order to achieve FDA approval.

Some guidance documents can help. FDA recognizes ISO 14971 as the primary risk management standard for medical devices. When considering human factors, issues including patient safety; reducing, preventing, and correcting use problems; and encouraging industry to focus on use safety have priority. The ISO document was developed for these types of problems.

AAMI is expected to release a new standard later this year. HE-75, “Human Factors for Medical Devices,” is a set of best practices that brings focus and application of human factors to medical device development. AAMI has realized that use-error risk has been consistently overlooked in device development. HE-75 attempts to clarify what makes a user interface easy to use and error tolerant. HE-75 is under review and is expected to be released in the fourth quarter of 2008.

One human factors philosophy to consider is based on William Howell's 2001 address to the Human Factors and Ergonomics Society (HFES).2 During his speech, Howell examined two philosophies to implementing human factors and influencing design, as follows:

  • The unique discipline model, which positions human factors as an emergent, independent discipline through which design is influenced directly.
  • The shared philosophy model, which promotes human factors awareness, concepts, and approaches through a variety of related design, engineering, and management disciplines.

A blend of these two models can work, especially for companies just beginning implementation. For example, Battelle established a system for which human factors and the applied human sciences exist as independent disciplines. In addition, the firm maintains a body of knowledge and resources recognized as valuable, direct input to the device development life cycle.

Blending enables a firm to leverage a diversity of skills and capabilities from all areas of expertise within a company. It tends to work best for firms that put an emphasis on a shared approach. At some companies, industrial designers act as the human factors experts. And they are, because of their focus on user needs. But industrial designers may lack the scientific, repeatable processes required for design controls and FDA's satisfaction. Industrial designers are the core building blocks of human factors, but they cannot work alone.

What is interesting is how this process has evolved. Increasingly, the shared philosophy approach is dominating Battelle's medical device development practice. The reason for this is logical and relatively simple. Once a company begins to acquire familiarity with human factors, it makes sense to widen the goals so that each discipline shares its application. All facets of design and engineering use human factors research in device development. Therefore, they have equal need for the contributions made by each sector.

The shared philosophy approach for the type of human factors information captured, analyzed, and implemented during the device design process results in actionable data. Actionable data provide information that is scientific, repeatable, and testable. The data help build proof so that another engineer or scientist can take action. Actionable data speak the language that engineers and other scientists understand.

Adopting a shared philosophy among all relevant design and engineering disciplines sets up an environment for collaboration. It enables human factors practitioners to understand the needs of the designers and engineers. This includes not only user perception information, but also quantitative human and device performance data that can be used to increase safety and reduce use error. By sharing human factors philosophies and data collection, developers can create devices in which users, equipment, and the operating environment are appropriately matched for optimal, safe, and effective use and performance.

Human Factors and Device Development Teams. Human factors professionals must build collaborative relationships with other design team members, especially project managers and engineers from other disciplines, to convey the beneficial use of human factors data. If these data are not used or challenged at the beginning of device design, use error may germinate. All team members must understand how human factors data affect their work on the device, as well as the work of their colleagues. Collaboration builds respect and improves understanding of others' design challenges.

Management's Role

The collaboration necessary to implement human factors in the development process cannot be successful without strong commitment from management. A manager's language and decision-making process must demonstrate the value of integrating human factors. Design teams invariably model the values they observe in their managers.

Managers must be willing to commit resources to human factors efforts, as well as to openly discuss the changes with development. Discussions of risk management and project time lines with the design teams, it's an opportunity to discuss the integration of human factors. If human factors involvement is new to your design teams, use every opportunity to reinforce its value.

Managers must decide where in the device development process they will incorporate human factors professionals' involvement and data. FDA's concern is about using human factors data to make a safe device and to avoid use error. Managers can choose to use human factors information at the very beginning of the project, in the middle, or closer to the end. But they need to consider carefully where human factors benefit the most.

For Battelle, it is best to include human factors professionals throughout the entire development process. This is an integral part of risk management because potential device error does not always appear in initial device development activity. It may show up in verification or validation testing, or in postmarket surveillance (where it is expensive to correct).

The Human Factors Ripple Effect

Human factors input creates a ripple effect throughout the development process. This discipline does not confine itself to device planning stages. FDA may see red flags if an operating manual contains numerous hazard warnings. It may conclude that these warnings indicate residual risk. FDA may ask whether human factors considerations were included during assessment. In addition, an astute device manufacturer knows that the first document requested in medical device litigation is the operating manual. It is a critical practice to ensure that device manuals incorporate human factors as well as the device.

Marketing professionals can build stronger cases for the sale of a device by understanding the types of human factors usability performed or other safety particulars that would assure potential buyers.

Quality assurance personnel should view the human factors effort as supportive because their efforts to meet quality requirements are frequently intertwined with safety. The human factors' influence works best when it permeates all perceived boundaries.

Staying Alive in a Competitive Marketplace

Medical devices developed without the benefit of human factors application are at greater risk for use error and could face redesign. No developer wants to end up in litigation. Further, a developer must strive to meet FDA requirements. Managers with their eye on continued success recognize the necessary inclusion of human factors in the medical device development process.

Strong implementation of human factors is a good way to maintain successful product development. It is crucial that device manufacturers use resources, such as HE-75, as they become available. But even more important, companies must develop a culture in which human factors is a continued emphasis.

Reade Harpham, David Wourms, and Donna Pydlek work for Battelle Medical Device Solutions (Columbus), where Harpham is manager of industrial design, Wourms is a principal research scientist, and Pydlek handles technical writing. Contact the authors at


1. “Why is Human Factors Engineering Important for Medical Devices?” in FDA's Human Factors Program [online] (Rockville, MD, FDA, 2003 [cited 18 January 2008]); available from Internet:

2. William Howell, “The Human Factors- Ergonomics Parade: A Tale of Two Models” [online] (Santa Monica, CA Human Factors and Ergonomics Society, 2001 [cited 18 January 2008]); available from Internet:

Copyright ©2008 Medical Device & Diagnostic Industry

Lack of Resources Compromises Product Safety


Thomas Novelli, MDMA director of federal affairs, says that FDA doesn't ask for enough resources in its budget proposals to Congress.
Unless substantial resources are provided to improve FDA's workforce, the safety of products regulated by the agency could be in jeopardy. A yearlong evaluation of the scientific and technological capacities at FDA found deficiencies in the regulatory systems that oversee medical devices, drugs, cosmetics, and food.

The work was initiated at the request of FDA commissioner Andrew von Eschenbach. He asked FDA's Science Board to form a subcommittee to review whether science and technology at FDA could support current and future regulatory requirements. What they found might not have been a surprise to those who work at the agency. However, the findings alarmed the members of the Science and Technology Subcommittee, which released a 300-page report in December.

“I don't think it's news to FDA that [it] needs more resources,” says Thomas Novelli, director of federal affairs at the Medical Device Manufacturers Association (MDMA). “I think internally they're always saying ‘we need more resources and more appropriation.' The administration isn't necessarily meeting those demands, at least in its budget proposals. Congress, for its part, hasn't been meeting those demands either.”

The report states that FDA has “serious scientific deficiencies” that render the agency unable to meet regulatory responsibilities. According to the report, the deficit comes from high demand on FDA resources and the lack of increased capital to meet the need. Products are becoming more innovative and complex. There is pressure from the public and Congress to do more about safety issues. Yet, the resources the agency is getting aren't proportional to those expectations. “Today, not only can the agency not lead, it cannot even keep up with the advances in science,” the report says.

Anticipated Areas of Medical Device Development
within the Next Decade
Aging-related devices

Artificial organs and organ assists

Computerized devices and intelligent systems

Early diagnosis and detection technologies

Genomics, proteomics, metabalomics, and

Home- and self-care devices

Imaging systems

Minimally invasive technologies

Miniaturization technologies

Photonic technologies

Portable and mobile devices

Robotic devices

Sensor technologies


Wireless devices and systems

The subcommittee wants to see significant changes within FDA, including the establishment of a chief scientific officer, the development of incubators for innovation, which would increase networking between universities and industry, and the improvement of information technology (IT) and data analysis.

The subcommittee consists of three members of the Science Board and 30 additional experts in regulatory science, including leaders from industry, academia, and other government agencies. Some of them said during a media conference call that Congress has the power to correct the lack of resources within FDA. They documented that, in the last 20 years, Congress has enacted more than 125 separate statutes requiring FDA to carry out various actions and programs, while providing the agency with just 817 new employees.

“Only Congress can provide the money and people needed to restore FDA science to the level necessary to implement its statutory obligations to protect the public health,” says Peter Barton Hutt, senior counsel at Covington and Burling LLP (Washington, DC). “Unless Congress appropriates additional money and personnel, none of the recommendations of our subcommittee can possibly be implemented.” Hutt is a former chief counsel for FDA.

The main problem areas cited in the report are a weak scientific organizational structure, major gaps in scientific expertise, and an inadequate IT infrastructure, which the subcommittee called disturbing. In addition to recruitment challenges, the turnover rate of the science staff is double that of other government agencies.

“We have insufficient IT expertise to support emerging sciences such as genomics, nanotechnology, and wireless devices,” says Dale Nordenberg, MD, managing director of healthcare industry advisory at PriceWaterhouse­Coopers LLC (Atlanta). “This means that FDA can't effectively support innovation in the industries that it regulates.” The shortcomings could also affect the nation's global competitiveness, he says.

Nordenberg adds that clinical trial data are trapped in piles of warehouse paper, which prevents valuable analysis from helping people. According to the report, there are no backups of such records either. FDA's computer systems and networks are also out-of-date and cannot keep up with evolving science. “We've seen an IT infrastructure [that] can't support the growing regulatory burden caused by globalization, including the need to monitor 300,000 sites globally,” Nordenberg explains.

The report asserts that increased funding is critical for FDA to get the resources it needs. However, the question remains whether such funding would be sufficient.

(click to enlarge)
The report recommends a commitment by Congress to a two-year appropriations program that increases the number of FDA employees by 50% and doubles funding.

MDMA and AdvaMed are working with two advocacy organizations, the FDA Alliance and the Coalition for a Stronger FDA, to push for an increase in agency resources.

“AdvaMed believes FDA must be given adequate resources so that it can continue its vital work of protecting and promoting the public health,” says Janet Trunzo, executive vice president of technology and regulatory affairs at AdvaMed. “The Coalition [for a Stronger FDA] is committed to working with the administration and Congress to ensure that FDA has the resources it needs to meet its mission.”

Unfortunately, there is also a disparity between FDA's budget and that of other government agencies. For example, FDA's annual IT budget is about $200 million, whereas the yearly IT budget at the Centers for Disease Control is $500 million. “When you consider the regulatory mandate of FDA, and the impact on industry as well as on medical products and consumer safety, it seems reasonable that the IT budget for FDA needs to be increased substantially.” Nordenberg estimates that the IT budget needs to be increased by 100–150%.

External subcommittee adviser Roy Vagelos suggests a yearly plan to bring in new leadership, build statistics, and develop an extension of resources, which he thinks should be doubled over a five-year period.

Steven Grossman, executive director of the FDA Alliance, says the coalition discussed a 15% budget increase, which probably won't be enough. “We believe the size and magnitude of the needs range from $250 million to $450 million a year, and you're looking at four to six years to accomplish all that needs to be done at that level.”

The subcommittee's report, FDA Science and Mission at Risk, is available on FDA's Web site.

Copyright ©2008 Medical Device & Diagnostic Industry

Manufacturers Lose R&D Tax Credit

Too-frequent lapses of the R&D tax credit by Congress have weakened the credit's intended effect, says AdvaMed's Stephen Ubl.
A research and development tax credit that has saved manufacturers billions of dollars expired at the end of 2007. The credit provided much-needed assistance to companies engaged in domestic R&D activities, according to AdvaMed.

But this isn't the first time the credit has lapsed; it has expired 13 times since its inception in 1981. Therefore, AdvaMed has called on Congress to make the credit permanent.

“Extension of the R&D tax credit has unfortunately turned into a bi­ennial event for Congress, weakening [the credit's] intent by interrupting ongoing research and creating a sense of uncertainty, particularly for small and emerging-growth companies,” said AdvaMed CEO and president Stephen Ubl.

A national survey in 2006 showed that 79% of medical equipment manufacturers use the R&D credit. AdvaMed and other trade organizations, such as the National Association of Manufacturers (NAM), are concerned that innovation may be impeded. Small device firms, often drivers of innovation, can particularly feel the effects of not having an R&D tax credit. It could compel manufacturers to move their R&D operations to countries with more­generous incentives.

“The R&D credit is a jobs credit. Most of it is going toward salaries of people in R&D,” said Monica McGuire, senior policy director of taxation at NAM. “It's keeping those high-wage, high-skill jobs in the United States.”

McGuire, who is also the executive secretary of the R&D Credit Coalition, said the immediate goal is to get the credit enacted retroactively and strengthen it for future years. With R&D endeavors often lasting 5–10 years, a permanent credit would ensure the availability of assistance for the duration of a project.

(click to enlarge)
R&D Tax Credit by the Numbers
“Having the credit repeatedly expire like this does have a negative effect on R&D,” she said. “Companies cannot plan their R&D budgets [with the reassurance] that the credit exists. The credit's incentive value is mitigated by its continual lapses. Several companies cited a negative impact on their quarterly earnings [when the credit expired in 2006].”

Ubl also stressed the importance of making the tax credit equitable for all companies. The recently lapsed version of the credit includes three formulations that result in some companies receiving a higher tax credit.

“The credit should be permanent so companies can have the full benefit of the credit for long-term planning and research projects,” Ubl said. “An evenly applied 20% rate will encourage more companies to locate their R&D operations in the United States and help to attract the most-qualified workers from around the world.”

The credit appears to have broad bipartisan and bicameral support, and a one-year extension of the credit was included on a tax reform bill passed by the House in November. But the extension was left off a pared-down version of the bill passed by the Senate in December.

NAM also says that the United States has fallen behind its counterparts in the Organization for Economic Cooperation and Development in terms of R&D tax support. In 2007, the United States ranked 15th among the 30 member countries in this metric. Without R&D tax benefits, some form of which are now offered by 20 member countries, the United States drops to last.

“Other countries clearly get it. There's been a tremendous growth of countries offering R&D incentives,” McGuire said. “R&D is the fuel for innovation. It drives new product development and increased productivity. These are the lifelines for growth in manufacturing.”

Copyright ©2008 Medical Device & Diagnostic Industry

AdvaMed Appoints Associate VP


AdvaMed has named a new associate vice president of technology and regulatory affairs to head policy efforts in diagnostics. Khatereh Calleja will also aid in the association's work to improve patient access to innovative diagnostic tests.

Calleja previously served as the federal affairs manager at the American Society of Plastic Surgeons. She also led the group's advocacy for FDA approval of silicone breast implants.

Sleep Apnea Therapy Hits the Big Time


International conglomerate Royal Philips Electronics announced in December that it will buy Respironics (Murrysville, PA) for about $5.1 billion.

Respironics is best known for being the market leader in continuous positive airway pressure (CPAP) devices, which treat obstructive sleep apnea, a condition in which patients repeatedly stop breathing during sleep. Between 15 million and 20 million people in the United States suffer from it, and it has been linked to heart disease, stroke, and diabetes.

Respironics is also known for noninvasive ventilation products and has recently introduced technologies to serve the needs of respiratory-impaired patients in the home.

Device Trials Get More Efficient Via Software


Medical device clinical trials generate astounding amounts of data. When the data are in paper format, they are extremely cumbersome to manage. Such information takes researchers much time to process, leading to delays in getting trials finished. That, in turn, costs sponsors money, sometimes millions of dollars.

It is no surprise, then, that software firms that can provide Web-based clinical trial data input that can streamline the data collection and analysis processes are doing very well. One, MedNet Solutions Inc. (Minnetonka, MN), has been named to Entrepreneur magazine's “Hot 500” list of fastest-growing companies, thanks to an 80% annual growth rate since 2002. Despite still being a relatively small company, MedNet has snared large device clients such as Medtronic and Boston Scientific.

Larger competitors such as Phase Forward Inc. (Waltham, MA) and Medidata Solutions Worldwide (New York City) have shown strong growth as well.

Copyright ©2008 Medical Device & Diagnostic Industry

Alternative Hygienic Aid Protects Incisions


Made from commercially available materials, the absorbent pad can shield postsurgical incisions from debris.
After facing few comfortable options to treat a cesarean section infection, a stay-at-home mother from Utah developed a hygienic aid that can both help prevent infections and accelerate healing. The JIBS, which stands for the initials of the inventor's children, is a product that protects the incision made during a cesarean section. It shields the site from outside debris and keeps it free of irritation and moisture buildup.

The inventor, Denise Howland, used off-the-shelf materials to make the prototype and is hoping that a medical device company will have interest in manufacturing and marketing the device. She says the JIBS should also be fairly inexpensive to manufacture on a large scale.

Howland has undergone four cesarean sections and has firsthand experience with the complications of the procedure. After surgery, moisture forms in between the skin that hangs over the incision, which can cause an infection. JIBS, which is made of cotton and rayon fibers with a rayon overwrap, is placed under the flap of skin to keep the area dry. If an infection is present, the product keeps anything from entering the area, allowing the wound to heal faster.

Available in three different sizes, the current prototype is free of dyes and doesn't require glue or adhesives. Since it's made of a cotton-rayon blend, it bends to the contour of the body. Howland says it's better than gauze or large bandages. Gauze pads tend to be thin and irritating, and can't absorb excessive moisture.

“This is solid, so it can soak up a lot of wetness,” says Howland. “[You can] wear it half of the day and change it. An adhesive bandage sticks to the body and hurts when it comes off. This doesn't stick to the body at all. It stays there to keep [the area] dry.”

The skin fold keeps the device in place and absorbs any moisture or sweat that is created in between the folds. “It doesn't smell, itch, or irritate the skin,” says Howland. “You're numb there anyway, so you don't know it's there.” Her doctor was impressed with the product, because it could provide an option for women who need to keep the incision area dry.

The product can also be used on obese patients to prevent skin irritation, rashes, and open sores, and for patients who undergo a hysterectomy.

Howland has had assistance from InventHelp, a Pittsburgh-based inventor service company, in conducting research on the product's target population. The company can be contacted for more information on licensing or selling the product to device manufacturers.

Copyright ©2008 Medical Device & Diagnostic Industry