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Gastric Bypass Works. And It Could Change the Western World

Claire Ainsworth explores the history and future of treatments in NewScientist.

Nanotechnology Aided by the 'Write' Tools

A collaboration between multiple California-based researchers has produced the NanoPen, a method enabling the quick, low-power, light-actuated patterning of various nanomaterials in real time. Although such processes as dip-pen nanolithography, nanofabrication, contact printing, and self assembly have been employed to pattern nanostructures, "these techniques lack the capability to create real-time configurable patterns without the use of complicated instrumentation or processing steps," the researchers surmise in a report on the product published in the most recent issue of the journal Nano Letters. The NanoPen, however, permits the manipulation and organization of nanoscale components by using an optoelectronic tweezer (OET) optofluidic platform for "writing" patterns of nanoparticles. The NanoPen takes advantage of several electrokinetic forces to assemble and immobilize such nanostructures as metallic nanocrystals, carbon nanotubes, and nanowires on the OET surface. With this capability, the NanoPen could contribute to the development of next-generation, nanotechnology-enabled products for diagnostics and sensing, among other applications.

Process Yields Uniform Dispersion of Antimicrobials

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AdvanSource Biomaterials incorporates its antimicrobial silver ions during polymer synthesis for uniform dispersion.
Material suppliers have traditionally incorporated antimicrobial additives into their products using prefabricated resin and secondary operations that can add cost and complexity to the manufacturing process. Because this technique can diminish the performance characteristics of the base polymer and does not always result in uniform dispersion of the antimicrobial additive, AdvanSource Biomaterials has created its own manufacturing process to produce antimicrobial versions of its core materials.

Antimicrobial agents are typically added to a finished resin through a secondary process such as compounding or kneading. This is accomplished using melt extrusion and pelletizing equipment, and requires the additive to be heat-stable for extended periods of time. But the antimicrobial characteristics of polymers produced in this manner are often inconsistent due to a lack of homogeneity, according to AdvanSource.

Instead, the company is producing polymers containing active silver ions, which are renowned for their antimicrobial properties and maintain heat stability during processing. In order to achieve uniform dispersion of the silver ions throughout the material, the company has created a process that allows for the incorporation of the antimicrobial additive during polymer synthesis, according to Khristine Carroll, vice president of sales and marketing.

"By adding the [antimicrobial] material during synthesis, we're able to maximize the mechanical properties of the polymer while maintaining the antimicrobial properties of the silver," says Andrew Reed, vice president of science and technology. And, because the antimicrobial characteristics are formulated into the chemistry of the material, secondary operations will not diminish the polymer's antimicrobial properties, he adds. Moreover, OEMs can easily transition to the antimicrobial version of a material they were previously using and still maintain consistency in the mechanical characteristics of their design. Using its proprietary processes also enables the company to achieve lot-to-lot consistency and tailor the material to the specific application requirements of its customers, adds Carroll.

"Various coatings, for example, are becoming more important to manufacturers of short-term implantables, guidewires, catheters, and drug-delivery devices," says Carroll. The company's HydroMed D series of hydrophilic polyether-based urethanes are designed for use as coatings of such products. They can be manufactured with various degrees of water absorption and offer kill rates of 99.99% of such bacteria as MRSA.

AdvanSource Biomaterials
Wilmington, MA
www.advbiomaterials.com

Copyright ©2009 Medical Product Manufacturing News

Slimmed-Down Mid-Infrared-Laser Sensor Could Make Waves in Handheld Devices

BREAKTHROUGHS

Slimmed-Down Mid-Infrared-Laser Sensor Could Make Waves in Handheld Devices
Bob Michaels

Daylight Solutions’ ECqcL technology enables users to access many different wavelengths across a wide spectrum.
Mid-infrared lasers have traditionally been large and bulky, making them far too unwieldy for many medical device applications. But if Daylight Solutions has anything to say about the matter, the technology will soon find its way into a range of handheld medical devices thanks to the start-up’s success in cutting the technology down to size.

Designed to detect and measure chemical vapor, Daylight’s external-cavity quantum-cascade laser (ECqcL) technology is based on the quantum-cascade laser (QCL) developed by Bell Labs in 1992. But Daylight’s and Bell Labs’ techniques differ markedly, insists Eric Takeuchi, Daylight’s director of business development. While QCL allows users to obtain laser light in the mid-infrared range, it emits light at one wavelength only. “So if I take a QCL and use it for molecular detection, it’s extremely difficult because I don’t have the ability to tune the wavelength,” he notes. “All I can do is look at one color.”

Using a 1 × 3-mm semiconductor chip, ECqcL, on the other hand, enables users to access many different wavelengths across a wide spectrum. Molecules such as ammonia in the breath, for example, absorb colors of light in the mid-infrared range. And because different molecules absorb light in different ways, they have a unique fingerprint. “If you can tune the color of the light in this wavelength regime, you can uniquely identify molecules,” Takeuchi explains.

Daylight’s ECqcL core technology can do just that. The secret is in the packaging—the sensor’s external cavity. “When I take the chip and embed it into an external cavity, I can liberate photons of different colors over a wide range,” Takeuchi comments. “That’s the enabling factor that allows me to tune color, which allows me to obtain true molecular fingerprint information because I can look at a range of colors with a single chip, or single device.”

Having shrunk the sensor from the size of a desk to the size of a fast-food hamburger container, the company is exploring prospects for shrinking medical devices. Breath detection is a nascent field, Takeuchi states, which has potential for diagnosing an array of ailments from diabetes and liver malfunction to lung disease and renal failure. Daylight is also working on monitoring glucose noninvasively. “By looking at the reflections of mid-infrared wavelengths through the skin, you can detect glucose in interstitial fluid because glucose, as a molecule, has an infrared signature that’s unique,” Takeuchi says.

Replacing surgical laser scalpels with more-compact devices is another possibility that could prove useful for performing field surgery in military environments, according to Takeuchi. Bringing man-portable systems into the field and still being able to do surgical procedures in the mid-infrared wavelength regime is a very interesting area.”

Daylight Solutions
Poway, CA
www.daylightsolutions.com

Copyright ©2009 Medical Product Manufacturing News

Diagnostics On Demand

EDITOR'S PAGE

Diagnostics On Demand
Big Brother is watching. But this time, he could be saving lives.

Constant surveillance is the aim of a new generation of pacemakers that continuously monitor a patient’s heart and transmit data to physicians—all from the comfort of your own home. With the Accent and Anthem radio-frequency (RF) pacemakers, manufactured by St. Jude Medical and approved by FDA in July, remote patient monitoring is continuing to make the transition from conversations to the clinic.

Supported by the recently approved version 4.0 of the Merlin.net patient-care network, St. Jude’s cardiac devices employ RF telemetry to securely and wirelessly communicate patient data from a home monitoring system, which reads data from the implanted device, to the clinician. The manufacturer claims that the Accent and Anthem products represent the “first pacemaker devices with automatic test results and complete diagnostics that can be accessed via wireless communication in a clinic or remotely.” Patient information can be obtained on a regular—even daily—basis via the remote-monitoring system without any interaction between the physician and patient.

“The pacemakers were designed in response to physician and patient needs for devices that provide timely, actionable information,” according to Eric S. Fain, president of St. Jude Medical cardiac rhythm management div. “Using the remote-monitoring capabilities, physicians can more efficiently follow patients while patients enjoy the convenience of care from home.”

Among the more-efficient means of monitoring patients cited by St. Jude is
the inclusion of an alert function. The atrial tachycardia/atrial fibrillation (AT/AF) Alert can be programmed to emit an audible alarm when a patient experiences AT or AF in excess of a preprogrammed value or for a worrisome duration. In addition to notifying the patient of such an irregularity, the device communicates the abnormal activity to the clinician from the home monitor. Ultimately, this type of immediate communication between the device and the caregiver could lead to improved, more-proactive patient care.

The introduction of pacemakers capable of communicating with physicians from a remote location will likely have a significant impact on the future of such devices. Assuming that the device performs as planned, this remote-monitoring-capable pacemaker could be a game changer. Once end-users get a taste of constant monitoring coupled with the convenience and freedom supplied by remote monitoring systems, a new standard will likely be set for pacemakers. After all, these communicative cardiac devices are enabling physicians to keep constant tabs on a patient’s heart health without skipping a beat.


Copyright ©2009 Medical Product Manufacturing News

Cables and Connectors Strive for Minimalism

TECH UPDATE: ELECTRONIC COMPONENTS

Cables and Connectors Strive for Minimalism

Bob Michaels

From the nurse’s station and the OR to the laboratory and the retirement home, cables and connectors are everywhere. They help power drug delivery devices, activate robots, run imaging equipment, and pump fluids. But because cables and connectors are everywhere, users demand models that minimize hookup times, shrink real estate, and reduce management and maintenance requirements.

Planar cables fit that bill, according to Paul Warren, lead design engineer at W. L. Gore & Associates Inc. (Landenberg, PA). Used for managing pneumatic lines, liquid tubes, and electrical signals, they can eliminate the need for traditional cable carriers, particularly in medical lab automation equipment in which the stroke length is less than 20 in.

Planar cables are bundles of tubes and electrical cables consisting of two or three insulated copper conductors in one small round bundle. “Not all manufacturers use the same process for making them,” Warren notes. “Some manufacturers extrude a jacket material such as silicone or polyurethane over the constructions. We make them by laminating the inner construction—whether it be a power cable, a pneumatic line, or fiber optics—between two sheets of Gore-Tex-expanded PTFE.” The advantage of this type of process, according to Warren, is that it has very little influence on the materials inside the cable. It doesn’t deform them or heat them beyond their maximum temperature tolerance. And because the jacket material is lighter and stronger than extruded types of jackets, it provides an organized method for managing the cables without the need for a cable chain. “You can also stack these cables on top of one another because the jacket is very slippery,” Warren adds.

Cable management and reliability is foremost in customers’ minds, Warren emphasizes. “They ask us, ‘how can we get longer life out of our cables? How can we make them easier to install?’” To increase reliability, cables must be properly routed and managed—a time-consuming process for discrete round cables, air lines, and cable chains. In such instances, clamps are required, and the cable chains need dividers. “By contrast, in planar cable construction, cable management is taken care of in a single manufacturing step,” Warren says. “All of the cable components are held in place so that they don’t move, cross over, and cause premature component failure.”

Connecting the Dots

Cables are useless without connectors. And like cable manufacturers, suppliers of connectors are offering designs that minimize setup times while ensuring that connections are as unobtrusive as possible.

A case in point is Souriau USA Inc. (York, PA), whose Push Pull connectors can be connected and locked by a single push motion and disconnected by pulling on a sleeve. “Whereas customers used to pick more-general-purpose connectors in the past, now they’re looking for specific connectors designed for the medical industry,” remarks Riaz Mohammad, Souriau’s business development manager. “With medical electronics, the trend is to pack an increasing number of channels, lines, or wires into as small a form factor as possible.” Thus, the company’s Push Pull connectors range in size from size 00, which accommodates cables approximately 1 mm in diameter, to size 3, which accommodates 12-mm cables. “We have high-density patterns in each of these sizes to accommodate the special needs of the medical industry,” Mohammad adds.

“One connector trend we see in the medical industry is miniaturization,” Mohammad says. “More and more, customers are requesting that our connectors become part of the equipment design, so that they don’t stick out like separate components but look as if they were designed with the specific piece of equipment in mind.”

In addition, OEMs are becoming interested in mixed power and signal designs. While users in the past separated power and signal in different channels and different connectors, today’s systems are integrated and miniaturized. Users are also clamoring for designs that carry power and signal over a composite cable, eliminating the need for additional connectors. “Instead of using two connectors—one for power and one for the signal—composite shielded cables are being used to separate power and signal but through one connector,” Mohammad comments.

In short, for cables and connectors, the word is minimalism.

Copyright ©2009 Medical Product Manufacturing News

Five Steps for Smoothing the Transition from Design to Manufacture

MANUFACTURING STRATEGIES


Technical personnel such as engineers and designers need to have input on a device's features and intended functions.
In the fiercely competitive medical device and instrumentation industry, speeding time to market is important to edge out competitors and begin generating revenue for products that often carry long and expensive research and development cycles. Pushing products through the development life cycle is essential for distinct market presence.

A common obstacle to successful market launch is the transition of medical products from design to manufacture. Problems at this stage often lead to unnecessary costs and significant delays. To ensure a seamless handoff from design to manufacture, companies must begin planning for transition early in the product design phase and assemble cross-functional teams. Further, medical device companies should conduct regular reviews to ensure that the project is moving according to schedule. OEMs must also train the manufacturing team and maintain morale far beyond the transition phase—this is critical to ensuring that quality products are delivered to market. Implementing these tips and techniques can help smooth the transition from the product development stage to full-scale production and help products reach the market on time and on budget.

1. Plan for the Transition Early

Figure 1. (click to enlarge) Cost of change during product development. OEMs should have clear product requirement specifications before the design activities begin.
The first and perhaps most important step in a smooth transition from design to manufacturing is to start planning early. Making changes to the product design once the handoff to manufacturing has occurred will only create additional costs and time delays. The cost of change increases as the product development cycle time progresses (see Figure 1).

Planning for transition must begin in the product development stage, well before the software and system verification and validation efforts have been completed. The timing is critical because manufacturability, testability, and serviceability must be considered during the design phase. Further, planning in advance allows the manufacturing team to be involved in the initial design reviews and to verify that the concepts meet the objectives of design for manufacturability and assembly (DFM/DFA).

Managing the cost of change also means making sure that the product requirement specifications are solid before the design activities begin. To do so, companies must gather input about the desired features and intended functions of a device or instrument from all stakeholders, including marketing, regulatory, safety, and technical design personnel. Once a comprehensive list of potential features and functions has been developed, the company must begin making trade-offs to satisfy cost, time to market, and product size parameters. For example, a project that has a six-month development cycle might need to trade-off custom software for a commercial off-the-shelf product to shorten the development time. Clearly defining these requirement specifications up front in the development cycle is paramount to reduce the risks associated with product changes.

Further, medical OEMs must make manufacturing a priority during the design process by involving production and quality control personnel as well as key vendors. Input from these parties can help avoid additional design revisions at later stages. Although change during the development process is inevitable, using the appropriate resources early on can minimize the probability of major change downstream.

At this point, the manufacturing team should begin developing detailed instructions for instrument assembly and setting up the production area during the pilot-build phase. Such preparation ensures rapid start-up once the transition phase is complete.

2. Assemble Cross-Functional Teams

Forming and utilizing cross-functional teams, composed of mechanical, electrical, compliance, systems, manufacturing, and quality engineers, can also smooth the transition from design to manufacture. The team should include members of the supply chain, such as buyers or planners, as well as suppliers, program managers, marketing personnel, and industrial design and human factors experts.

Members of these teams must bring a broad knowledge base. Combining their diverse skill sets and areas of expertise enables a holistic approach to device manufacturing and the regulatory approval process. Together, they can devise well-defined goals and objectives for each phase of development that minimize manufacturing obstacles and ensure that the devices adhere to FDA and European Union (EU) regulations.

Cross-functional team members can work closely together to review product requirements, address technical risks, and manage instrument costs. Assembling the experts and cross-functional teams early on facilitates manufacturability, serviceability, reliability, and a manageable supply chain for a given product.

Team dynamics play an important role in the efficiency of any multidisciplined project. The principles of “Forming-Storming-Norming-Performing,” or FSNP, can be utilized to develop a strong team. First proposed as a theory of group dynamics by American psychologist Bruce Tuckman in 1965, the FSNP concept provides an excellent starting point for the development of efficient teams in today's medical device industry.1

First, the forming stage is simply when team members are chosen and thus form the group of people that will be working on the project. Once the team is set, storming, or the process of confronting each individual's ideas and perspectives, takes place. This is the stage in which the team grows and becomes comfortable working with one another. Following the storm of ideas, challenges, and solutions is the norming stage, in which individuals feel more comfortable with their roles and begin working well together. It is typically during the norming stage that team members agree upon and establish common standards and procedures to increase efficiency. Finally, the team begins performing tasks efficiently and functioning as a true unit. Team members and vendors that are familiar with each other and have been through previous successful transitions can accelerate this process.

It should also be noted that a product can actually move through product development and transition to manufacturing too quickly. Moving too rapidly can result in a product that may require redesign to address manufacturability, serviceability, or reliability. By contrast, going too slowly could mean lost opportunities for the OEM.

For example, a diagnostics OEM developing a clinical chemistry analyzer paid the price for not assembling a cross-functional team at the outset of the project. The company developed the chemistry and assay protocol needed to perform the in vitro diagnostic tests on the bench and commissioned a contract design firm to develop an instrument to automate the process. When the company began transitioning the product to manufacturing, however, it became apparent that the assay protocol required additional functionality that was incompatible with the hardware. As a result, the product was never brought to market.

Most situations may not end in such catastrophe. But by involving both the development and hardware design teams prior to the transition process, the OEM could have saved an enormous amount of time and money and produced a commercially viable and potentially profitable product.

3. Implement Staged Reviews

Continual checkpoints should be set up throughout the product design and development process, including critical design, pilot production readiness, and manufacturing readiness reviews.

Critical Design Review. A critical design review should occur at the completion of the product prototype phase and prior to the release of documentation for the procurement of pilot material. This review must assess product design to ensure that the hardware and software meet system requirements prior to pilot production.

Pilot Production Readiness Review. A pilot production readiness review can help determine whether a product can begin its transition to manufacturing. This review verifies that all appropriate design and program activities are satisfactorily completed and that the program team is prepared to build pilot production units. It ensures that the system design meets all applicable specifications and customer requirements and is mature enough for pilot production units to be built by operations. During the review, team members record findings, deficiencies, and technical issues. They compile an action items list and identify the individuals responsible for resolving them.

Manufacturing Readiness Review (MRR). A final MRR is conducted after pilot production units are built and design validation is complete. This review verifies that the product is ready for full-scale manufacturing. A designated review leader should identify and request personnel from appropriate departments and functions to act as reviewers. Ideally, a review team includes representatives from engineering, operations, strategic sourcing, and quality assurance. The review verifies that all appropriate design, validation, and manufacturing preparations are complete and the program is adequately prepared to move to the production phase.

Because the MRR should be stringent and thorough, some companies use an MRR checklist to understand the status of the design and associated documentation. Ultimately, the checklist can prioritize outstanding tasks that need to be completed to meet schedule and production requirements. During a recent product transition of an automated microbiology system, for example, KMC Systems used its MRR checklist to prioritize remaining development and transition tasks prior to production. Each task was then delegated to either the engineering or manufacturing team for efficiency. The process helped the OEM meet its product launch date.

4. Train the Manufacturing Team

A crucial part of transitioning a product from design to manufacture is the transfer of knowledge and technique from the engineering development team to the production team. An effective training path ensures complete knowledge transfer and minimizes wasted time on faulty products. Many different strategies can be utilized to train the manufacturing team. One of the most important is to allow team members, including assemblers and testers, to be involved in developing the procedures that will ultimately be used to manufacture the instrument or device. Such involvement gives them ownership of and comfort in their work.

Additionally, utilizing a computer-aided design (CAD) or manufacturing execution system that provides simple text and picture-based instructions can minimize training time and ensure quality. For example, certain CAD systems with product data management add-ons can generate enhanced PDF documents based on the geometry used to design the product. These types of systems can help quickly establish a training program and create service manuals for a new product.

Finally, cross-training is a valuable tool that provides flexibility of resources and can enhance efficiency. Cross-training the manufacturing team helps assemblers and testers develop an appreciation and knowledge for downstream and upstream processes. This method also allows team members to provide feedback that could enhance the manufacturing processes. In addition, the manufacturing team needs to be in tune with Current Good Manufacturing Practices as well as other FDA guidance regarding medical device manufacturing.

5. Maintain Morale During and After Transition

Even after the manufacturing team has been trained, it is important to take steps to maintain morale. For example, daily morning stand-up meetings can keep all team members abreast of production goals while allowing them to play an active role in the management of the production cell. A company can also keep a large progress board, which should be updated each time an end product or major subassembly is completed, to communicate the status of each project. Implementing a lean improvement program is also a win-win because it increases team spirit and contributes to a more efficient manufacturing process. For example, allow assemblers and testers to submit suggestions for a way to improve a specific process they perform as well as a basic cost analysis. Each month or quarter, hold a drawing and award a cash bonus to someone who participated in the lean improvement program.

Conclusion

Whether an OEM plans to outsource manufacturing or not, the transition from design to manufacturing can be either a path to success or a roadblock to final product launch. Getting products to market on time and within budget is highly dependent on the transition stage. Manufacturers that take manufacturability into account early and train cross-functional teams can reap rewards of condensed development cycles—which may mean even larger profit margins.


Frank Pawlowski is manager of technologies and solutions and Bill St. Onge is director of manufacturing at KMC Systems (Merrimack, NH).

Reference

1. B Tuckman, "Developmental Sequence in Small Groups," Psychological Bulletin 63: 38-99.

Copyright ©2009 Medical Device & Diagnostic Industry

Appropriateness Criteria for Imaging

News Trends
The Medicare Improvements for Patients and Providers Act of 2008 established a two-year project to assess the appropriate use of diagnostic imaging services. According to the law, the secretary of Health and Human Services must select a group of volunteer physicians for the project that represent a wide range of geographic areas, demographic characteristics, and practice settings. The law also states that the criteria the secretary selects to determine the appropriate use should

• Be developed or endorsed by a medical specialty society.
• Be developed in adherence to appropriateness principles developed by a consensus organization.

Among the issues that the law instructs the project to evaluate are

• Whether potential use of appropriateness criteria could have an effect on the volume of advanced diagnostic imaging services furnished.
• Whether expansion of the use of appropriateness criteria to a broader population of Medicare beneficiaries would be advisable.
• Whether there is potential for using methods (including financial incentives) to ensure compliance with such criteria.

AAMI Honors MedTech Contributors

News Trends


Trade group AAMI has honored six medical technology professionals and four leaders in standards development. Here is the full list of award winners.
  • AAMI Foundation/Laufman—Greatbach Prize—Forrest M. Bird, MD, for his efforts to combat cardiopulmonary problems.

  • AAMI Clinical/Biomedical Engineering Achievement Award—Carol Davis-Smith, a director at Premier Consulting Solutions and chair of AAMI's Technology Management Council, for her efforts to promote the biomed profession to clinical and biomedical communities.

  • AAMI/BD Professional Achievement Award—Guruprasad Madhavan, a research fellow and consultant at the State University of New York at Binghamton, for his pursuit of an innovative medical device concept that could result in a noninvasive, portable, neuromuscular stimulation therapy to enhance lower-limb circulation.

  • AAMI/GE Healthcare BMET of the Year Award—Dave Scott, biomedical technician in the equipment management program at the Children's Hospital in Aurora, CO, for his leadership with the Colorado Association of Biomedical Equipment Technicians.

  • AAMI Foundation/ACCE Robert L. Morris Humanitarian Award—J. Tobey Clark, director of the Instrumentation and Technical Services Department for the University of Vermont, for his efforts to bring clinical engineering to developing countries.

  • AAMI Foundation/Institute for Technology in Health Care Clinical Application Award—Julian M. Goldman, MD, an anesthesiologist at Massachusetts General Hospital and director of interoperability for the Center for Integration of Medicine and Innovative Technology, for his work toward medical device interoperability.

  • Standards Developer Award—Trabue D. Bryans, vice president and general manager of the research and development company WuXi AppTec's Atlanta division, for her commitment to the development of numerous standards.

  • Standards Developer Award—Harry F. Bushar, a recently retired math statistician for FDA, for his contributions to standards committees and working groups.

  • Standards Developer Award—Jim Gibson, who is being honored posthumously for the development of several sterilization standards.

  • Standards Developer Award—Veronica Ivans, standards manager for the Cardiac Rhythm Disease Management Division of Medtronic, for her leadership on AAMI working groups and subcommittees.

Copyright ©2009 Medical Device & Diagnostic Industry

Farewell, Dr. Schultz; Good Luck CDRH

FROM THE EDITORS

Daniel Schultz has resigned as head of CDRH. Given the recent—although perhaps unwarranted—criticism of Schultz, CDRH, and even the 510(k) process, it's no surprise. More importantly, his departure will not repair the deeper troubles at CDRH.

Schultz leaves the agency with a solid record of accomplishments. He tackled some tough problems including the user-fee system and inconsistencies in inspections. “Dr. Schultz has done a great service for CDRH,” says Jonathan Kahan, a partner with Hogan & Hartson. Kahan says Schultz brought organization and common sense to CDRH. “His leaving is based on a number of misconceptions on the part of upper management at FDA,” says Kahan. He suggests that FDA's management may have been “listening too much to whistle-blowers and other critics, and not enough to people who really know what's going on within CDRH on a daily basis.”

In a letter to agency staffers, Schultz wrote that he and FDA Commissioner Margaret Hamburg agreed that his resignation “would be in the best interest of the center and the agency.”

But Kahan insists that a majority within CDRH supported Schultz and that only a vocal minority believed that Schultz was “too pro-industry and not scientific enough.” Rather, a handful of recent missteps became the focus of his ability to lead the center. Kahan points to controversial CDRH decisions on Cyberonics and Menaflex and notes that both led to a lot of criticism of Schultz, and ultimately may have been part of his downfall.

“He's been a very honest, very conscientious, hard-working, straightforward public servant, and I will be sorry to see him go,” says Kahan. “I hope that [FDA] has someone who is as conscientious and as smart as [Schultz] to take the helm.” Given the turmoil swirling around Schultz's resignation, selecting the new head of CDRH may not be so easy. But the new director should be an insider.

Kahan says there are some very good people within the Office of Device Evaluation and Office of In Vitro Diagnostic Devices who could step into the director role. The key, he says, is that the new head of CDRH must have credibility and the respect of people within the center.

“If FDA feels it has to go outside CDRH, it should find someone who understands FDA—maybe someone from another center or someone who's previously been with FDA.” He says bringing in a total novice who has never worked at FDA would be a mistake.

Jeffrey Shuren, the assistant commissioner for policy at FDA, has been named acting CDRH director. Kahan says that Shuren, who is a neurologist as well as a lawyer and has been at FDA on and off for the last 10 years, might be a good choice for the job but that he may not even want it.

The biggest problem FDA will have in filling the job is finding someone who can relieve some of the worry and tension within the center. “Right now, from the division directors down to the newest reviewer, there's a lot of concern and angst,” says Kahan. “That leads to a more-difficult path. For industry, it's harder to communicate with the agency. And people are less willing to go out on a limb or do anything novel.”

With this tension has come “a clear slowdown in clearances and approvals and a clear change in direction.” Kahan also notes that some CDRH policies have changed “without a lot of forethought about the effect of some of these policy changes.” In particular, he says CDRH shifted its policy on what entails substantial equivalence in the 510(k) process. “The 510(k) process has been under incredible criticism, and it's been called a loophole,” he says. Kahan praised Schultz for correcting this inaccuracy and for defending the 510(k) process.

Schultz's resignation is not going to fix the problems at CDRH. Finding the right person to step in and step up is imperative. CDRH must stay focused on its mission and find ways to restore the public's (and industry's) confidence.

Sherrie Conroy for the Editors