Medical Device News and Insights

FDA Public Meeting - Incorporation of New Science into Regulatory Decision Making within CDRH

Wednesday, February 17th, 2010 | FDA Medical Device Regulations | No Comments

The FDA Public Meeting, “Incorporation of New Science into Regulatory Decisionmaking within the Center for Devices and Radiological Health,” was held on February 9, 2010 despite challenging weather conditions in the Washington, DC metropolitan area, both before and after the meeting.

The weather conditions caused the meeting schedule to be compressed by nearly 30% to accommodate rapid cancellation of transportation options, and resulted in sparse attendance at what FDA expected  to be a “sold out” event. Despite the challenges, meeting participants aggressively addressed all four pre-defined case studies on the agenda, including accommodating probing questions by Agency staffers.

The meeting was chaired by Jeffrey Shuren, MD, Center Director, and was directed through its various stages by Jonathan Sachner-Bernstein, MD, Associate Director for Postmarket Operations, CDRH. Agency participants included members of the Office of Surveillance and Biometrics, Office of Science and Engineering Laboratories, Office of Device Evaluation, Office of In Vitro Diagnostic Device Evaluation and Safety, Office of Communication, Education, and Radiation Programs, Office of Compliance, and Office of Chief Counsel.  Invited discussants included members of the industry, medicine, academia, trade groups, and engineering sciences.

In his opening comments, Dr. Shuren explained that science guides the regulatory process and, therefore, the process of evaluation and re-evaluation is common to medical devices as their technologies mature. Within the regulatory framework for medical devices, he stated that adaptability is key to addressing new technologies while maintaining reasonably predictable regulatory processes with communication of issues to affected stakeholders in a timely manner.

Four case studies, each with several scenarios and questions of interest, covered the Agency’s use of postmarket safety information for cleared devices with possible impact on pending reviews; changes in the validity of clinical study endpoints and their impact on ongoing premarket clinical trials, incremental technological improvements and the notion of FDA involvement in ultimate device obsolescence, and the rigor to be applied to the regulatory process for novel technologies.

The focus of the directed discussion was to determine if there is a way for CDRH to be transparent, adaptable, and predictable in its actions. Final discussions were directed to identifying how the Center can measure the impact of their task force activities on the regulatory processes for medical devices.

Common threads in the discussions were that the Center should communicate expectations more proactively with both the industry and clinical practitioners; that the Agency staff should frequently interact with practitioners, the industry, and other sister Agency’s on common concerns; that the risk/benefit analysis should drive the regulatory process for both maturing and novel devices; that isolated information should not automatically stimulate regulatory action without considerable additional analyses; there must be a balance of reasonable regulatory restraint while still providing beneficial medical devices within a reasonable amount of time; and finally, it is not possible to provide absolute assurance of safety and effectiveness in the premarket process without denying potentially beneficial medical devices to address public needs.

Stakeholders have only until February 24, 2010 to make comments to the Docket (FDA-2009-N-0575), so interested parties are encouraged to review the proceedings and submit comments quickly. Instructions for submitting comments electronically or in hard copy were provided in the December 18, 2009 Federal Register Notice (http://edocket.access.gpo.gov/2009/E9-30114.htm) announcing the meeting. Meeting transcripts will be made available at http://www.regulations.gov/search/Regs/home.html#home.

Tags: CDRH, FDA Public Meeting, medical device regulatory process, Regulatory Decision Making

Massachusetts Life Sciences Center Launches Small Business Matching Grant Program

Thursday, January 28th, 2010 | Industry News and Innovations | No Comments

The Massachusetts Life Sciences Center has launched its new Small Business Matching Grant (SBMG) Program.

The primary objective of the SBMG is to provide grants to commercialization-ready life sciences companies that have received at least the equivalent of a Phase II small business innovation research (SBIR) or small business technology transfer (STTR) grant from federal agencies such as the National Institutes of Health (NIH), National Science Foundation (NSF), Department of Defense (DOD), etc.

Grants will provide “matching” support – capped at $500,000 per company — to Phase II or Post Phase II SBIR or STTR grants already received by applicant companies. Through the SBMG Program grants, the Massachusetts Life Sciences Center will help companies that have developed new commercialization-ready technologies reach production and create jobs Massachusetts.

Target applicants are emerging life sciences companies whose products are production-ready and have high potential for market adoption and penetration, are poised for rapid growth that will create jobs in the Commonwealth, and are positioned for additional financing.

For full details or to apply click here.  Online applications will be accepted starting on February 1, 2010. The Center will be offering information sessions for interested applicants on February 11, 2010 and February 25, 2010.

Tags: Massachusetts Life Sciences Center

Expect Greater FDA Enforcement of 510(k) Summary Content

Monday, January 25th, 2010 | FDA Medical Device Regulations | No Comments

It may be time for sponsors of 510(k) premarket notifications to revisit the fundamentals.

MDCI has learned that CDRH review staff have been directed to pay closer attention to 510(k) Summary content and that FDA is now including a reminder about 510(k) content in its standard Agency letters verifying receipt of 510(k) premarket notifications.

While there has been no formal announcement of this closer scrutiny, our review of the relevant Device Advice page revealed that information about 510(k) summaries was updated on January 8, 2010 and now directly reflects the information specified in 21 CFR 807.92.  The updated Device Advice content is available here.

The updated Device Advice page recommends the following:

“If you choose to meet the conditions for a 510(k) summary (21 CFR 807.92), it must be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. As required by section 807.92(a), FDA will accept summaries or amended summaries until FDA issues a determination regarding substantial equivalence.  The 510(k) summary must contain the information described below. Please make a copy of the following to use as a checklist and check off each item to make sure your summary is adequate and complete.”

MDCI’s random inspection of 510(k) Summaries for medical devices cleared by CDRH between December 1, 2009 and December 31, 2009 shows considerable variation in the content and compliance of these summaries with the current document specifications.

Tags: 21 CFR 807.92, 510k submissions, 510k summary, CDRH, FDA Device Advice, FDA enforcement

Haitian Earthquake Relief

Friday, January 22nd, 2010 | Uncategorized | No Comments

All of us at Medical Device Consultants, Inc.,  share in the shock and sorrow caused by the earthquake in Haiti.

MDCI and its employees are donating to Partners in Health, a Boston-based organization with over 20 years of on-the- ground experience of bringing medical personnel and supplies to Haiti.  There are many excellent groups providing relief to the people of Haiti.  If you wish to provide support, please consider PHI or one of the charitable organizations below.

• American Red Cross
• Doctors Without Borders
• Unicef

Our thoughts are with all the families affected during this ongoing crisis. Thank you in advance for your generosity.

Tags: american red cross, Doctors Without Borders, earthquake relief, haiti, partners in health, Unicef

Thoughts on InHealth’s Evidence and Reform Summit

Wednesday, November 18th, 2009 | Industry News and Innovations | No Comments

I recently attended a special health technology summit meeting on “Evidence and Reform”. The summit was presented by InHealth, an independent, non-partisan 501(c)(3) charitable foundation, founded in 2003 at the initiative of the board of directors of AdvaMed.
The summit meeting addressed topics in healthcare policy and health technology research in the light of the current US administration’s focus on health care reform.  Attendees included medtech industry leaders, academic researchers, and clinical professionals. The objective was to increase understanding of how rapidly advancing healthcare technologies contribute to the enhancement of healthcare systems in the United States and around the world by improving patient outcomes, productivity, and quality of life.

Here are the issues that struck me as being unusually interesting:

• A recurring topic of discussion was the notion that the patient needs to be an integral part of research into such topics as which technologies should be evaluated and which outcomes matter most to patients.  Likewise, there was expression of the position that the patient’s voice is not currently given enough recognition in the selection of appropriate treatment when treatment choices exist.
• Another related focus of discussion was that to have sustainable health reform encompassing all our citizens, we may find ourselves with a new paradigm in health care, namely lower cost for a new treatment that is almost as good or not worse than current treatment(s).  Insured citizens may find themselves making medical decisions based on cost information and their willingness to pay.
• Finally, the summit attendees raised a broad question that applies to all clinical effectiveness studies, namely, what does one do with the information?  Specifically, how is information disseminated to doctors and their patients, and who sees to it that optimal treatments are widely adopted?

From the foregoing, it is clear that there are more questions than answers, and that the health care reform initiative is likely to be an ongoing process over many years.

Tags: health technology research, healthcare reform, InHealth

MDCI to Present Session on IVD Clinical Trial Management at ACRP 2010 Global Conference

Thursday, November 12th, 2009 | FDA Medical Device Regulations | No Comments

Tags: ACRP 2010, IVD Clinical Trials, Medical Device Clinical Trials

MDCI Attends Connected Health Symposium

Wednesday, November 11th, 2009 | Industry News and Innovations | No Comments

On October 21-22, 2009, I attended the 6th annual Connected Health Symposium in Boston. Considering the current debates over health care reform, universal coverage, and comparative effectiveness initiatives, the timing of this meeting was ideal. The sponsor of the symposium, the Center for Connected Health, a division of the Partners HealthCare system and an active member of the American Telemedicine Association works with Harvard Medical School-affiliated hospitals in the Boston area.  This organization promotes the development of communications technology and online resources to improve access to, and the quality of, patient care.

What is Connected Health?
The term “connected health” indicates a wide range of technological solutions to bring medical care to “where the patient is”.  Their focus is to increasingly engage patients in their own health care and wellness through technology driven by the convergence of online consults, improved wireless platforms, and remote monitoring medical devices.

The Connected Health attendees agree that the adoption of e-health will be difficult. The major challenges are physician resistance and payor/insurer reimbursement hurdles.  As supporters of telemedicine, the members feel that the patients themselves will be very eager for, and capable of managing these systems.  Although it is agreed that more effectiveness studies and cost analyses need to be done, the connected health proponents cite numerous references in support of e-health.  For example, they state that the rapidly growing diabetes arena will benefit from the “connected health” approach, both from a patient compliance and a cost containment perspective.

All presenters appeared to agree that in order for this approach to take off, it must be easy to use and cost-effective, doctors must be paid based upon outcomes rather than on the number of services/procedures performed, and, not insignificantly, patients must be accountable for their health (or adequately incentivized or penalized). The topic of behavioral medicine spawned lively debate over the effectiveness, value, and ethics, of using behavioral ‘nudges’ to drive changes in patients’ actions, and presumably their health outcomes.

How Will Connected Health Be Regulated?
An important issue centers on the fact that medical devices are a regulated industry. Obtaining FDA clearance for a medical device often means validating its performance on a variety of systems, in different environments, or with various connected platforms or attachments.  Representatives of several monitoring device companies speaking at the Symposium stated that they are in discussions with FDA about the classification of their devices related to the integrity of the transmitted data, what medical decisions will be based upon the results, and the degree of validation required to gain 510(k) clearance of the device for use with different software on different electronic platforms. Medical manufacturers and the transmission system manufacturers continue to try to understand the value proposition to patients and where the profit resides.

Because the Connect Health vision is to create an environment where all monitoring devices or feedback communication devices can perform within any system, a standards group called Continua has developed out of this Connected Health community.  This group, comprised of head-to-head competitors in their core technologies, is working to establish software specifications and validation norms to be used across the telehealth industry, with the objective of complete and universal connectivity.  It remains to be seen, however, if FDA will accept this approach.

The challenges and the rewards of e-health will be great.  It will require collaborations like these forming in the Connected Health community and partnerships between the biotech industry, insurers/payors, and care providers (such as this joint venture between Cisco and UnitedHealth) to make e-health a reality.

Tags: American Telemedicine Association, connected health, Continua, e-health, telemedicine

FDA Issues New Guidance Document on Clinical Trial Investigator Responsibilities

Tuesday, November 10th, 2009 | FDA Medical Device Regulations | No Comments

FDA has issued final guidance on “Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects.” The guidance document is now available from FDA’s website at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf

The clinical trial investigator responsibilities within the FDA regulations are specific but, at the same time, limited in depth.  This guidance document expands FDA regulations by specifying more clearly the agency’s intent. For example, the guidance expands the scope of a principal investigator’s (PI) responsibility to oversee the clinical trial, including training staff, selecting appropriate staff when delegating tasks, ensuring control over third -party team members, and maintaining written records to document the delegation activities.

This new FDA guidance document clarifies the PI’s role and raises the importance of PI oversight to a more visible level. The guidance addresses a real need to add substance to the PI’s responsibility in FDA regulated clinical trials.

Tags: clinical trial investigator, FDA guidance document, Medical Device Clinical Trials

Human Factors for Medical Devices

Wednesday, November 4th, 2009 | FDA Medical Device Regulations | 2 Comments

I recently attended the “Human Factors for Medical Devices” course sponsored by the Association for the Advancement of Medical Instrumentation (AAMI).  The three-day program provided an introduction to human factors, discussion of FDA regulatory requirements related to human factors, and the role of human factors in design controls. Among the faculty was Ronald Kaye, Human Factors Specialist in the Office of Device Evaluation (ODE) at FDA’s Center for Devices and Radiological Health (CDRH), as well as experts in the field of human factors engineering.

Human Factors Engineering in Medical Devices
Human factors engineering (HFE) plays an important role in creating safe, highly-usable, and innovative products. It will be more and more important for device manufactures to understand and address a number of HFE related issues, including; the development of user profiles that identify traits that may impact device design; the creation of use scenarios that define the interactions of the user with the device; and task analyses that prioritize tasks in consideration of their risk.

I was particularly interested to hear FDA officials speak about the agency’s plans to ensure that medical device manufacturers utilize HFE in device design and provide evidence in premarket submissions that user interfaces are tested to verify usability. FDA’s focus during the review of HFE documentation will be on data collected during formative and summative usability assessments to support the safe and effective use of the medical device.

Objective Data is Critical
A key takeaway from this training program was hearing the importance that FDA will place on objective evidence to demonstrate HFE principles in medical device premarket submissions. Manufactures will need to provide well-written and comprehensive usability validation reports that include a detailed explanation of the evaluation process and how it relates to device safety.  FDA expects that usability validation reports will also include a thorough analysis of each failure and the residual risk remaining. The agency also cautions against leaving interpretation of the usability test results to the FDA reviewer. As more medical devices are required to incorporate HFE in principles in their design and development, a smooth review and rapid product clearance or approval will be dependent on well-written reports to demonstrate the proper application of HFE principles and thorough testing of the device in the use environment.

Tags: AAMI, human factors engineering, usability validation reports

AdvaMed 2009 Summary

Tuesday, November 3rd, 2009 | Industry News and Innovations | No Comments

Recently, my colleagues and I had the pleasure of attending AdvaMed 2009, the premier medical technology conference for CEOs, business executives, policy-makers, media, financiers, and other leaders from the medical device and diagnostics industry.

This was MDCI’s second year of participating, as an exhibitor and sponsor. While other medical device industry events and conferences have seen a drop in attendance , the numbers remained steady for Advamed, with more than 1,500 industry leaders – including CEOs, Presidents and C-level executives. The speakers and presenters were top notch and I was especially excited to have the opportunity to listen to former President Bill Clinton, who spoke at the plenary breakfast session.

When we participate in any industry event, exhibit, or conference, we have a number of specific objectives in mind. Generally, our mission is threefold; to connect with existing clients; to speak with new or potential clients; and to stay informed of industry changes and new technological advances.  AdvaMed provides the perfect opportunity to accomplish all three.

We were able to meet with a number of current clients, some who came from as far as New Zealand . We had two full days of partnering meetings with new and existing client companies to learn about their progress and development plans,  and, just as important, we all attended sessions and heard from key industry leaders on the hot topics of the day, including 510(k) review, healthcare reform, and comparative effectiveness research.

For those readers who did not attend the conference, I’ve asked each of my colleagues to share their personal thoughts and takeaways below.

New Technologies / Company Presentations
Susan Rockwell moderated one of the four company presentation sessions at the meeting, focused on companies developing a range of products, in cardiovascular, drug delivery, renal and aesthetics. Susan reports that “the presentations encompassed a diverse group of entrepreneurs and leaders in the med tech industry whose presentations covered the stage of development, expectations for raising capital, corporate missions, and in many cases, results from early clinical trials.  The company presentations were an accessible and immediate opportunity for AdvaMed attendees to learn about exciting new medical technology and identify potential partnership and investment opportunities.”

Evidence-Based Decision Making
Michael Feldstein attended a number of session on evidence based clinical trials, comparative effectiveness and other issues surrounding health care reform and reported that “evidence-based decision-making, an emphasis of the Obama administration, was also a topic raised by former President Bill Clinton in his plenary address.  President Clinton raised the issue in the context of lobbying Washington to make the case against a $40 billion tax on the medical device industry as part of health care reform, it is likely that the funding behind comparative effectiveness research will give rise to programs for establishing the evidence needed to help lower health care costs for the nation.”

Changes at FDA
Vicki Anastasi commented on the address by Dr. Joshua M. Sharfstein, Principal Deputy Commissioner, FDA. “Dr. Sharfstein highlighted the importance of the independent report commissioned by the agency to review the current 510(k) review process.  The report will be complete in early 2011 and the intent is to enable the FDA to respond to innovative technology and move it through the system to reach the public.  Dr. Sharfstein indicated a willingness to listen to the industry and asked for feedback and commentary now and throughout the review process.  Dr. Sharfstein’s talk is an important first step in evaluating the system at the agency and implementing the necessary revisions to process increasingly innovative devices.”

Advamed Exhibits
MDCI was one of more than 50 exhibiting firms at the conference. The exhibit hall was open throughout the conference with a dynamic collection of domestic and international booths, featuring world-class medical technology firms, cutting-edge technology and design, and a full range of service solutions for the industry. The “CEOs Unplugged” series was a very popular series of discussions, held in the exhibit hall each day, where top executives of the medical technology industry gathered for open discussion of key issues, ranging from health reform to government regulation to economic forces.

Kim Myette, an AdvaMed “first-timer”, was responsible for managing and staffing the MDCI exhibit booth throughout the meeting. She shared her thoughts on the quality of the exhibits in general and her interactions with visitors. “My first AdvaMed experience was great. The booth traffic ebbed and flowed, as people came and went to the various sessions and networking events. The people that I spoke with during the meeting had a real interest in the regulatory, clinical trial, and quality assurance services we provide. Some needed our services directly. Others talked about how we might collaborate on projects. I especially enjoyed the chance to speak with small and large medical technology innovators. It is great to hear the excitement that they all have about their new medical technologies, devices and diagnostics.  AdvaMed is a great way for the industry to meet and share ideas.”

Your comments are always welcome. If you were an AdvaMed attendee, please share your thoughts.

Tags: 510(k) review process, Advamed 2009, evidence based decision making