Welcome to Boston MedTech Advisors

Included in this issue...

BMTA Updates:

• BMTA and CMC Consulting Group Collaboration
• Dr. Imhoff to Discuss Outcomes Studies with Non-Therapeutic Technologies

Industry Updates: 

• Changes in 510(k) to Affect Medical Device Companies
• New Considerations in Clinical Trial Design: The Placebo Response
• New IEC Connectivity Standards Affecting Hospital-Based Medical Devices

Please call us at 781-407-0900 if you have any questions about the information in this newsletter or if you would like to discuss our services.

BMTA News

Boston MedTech Advisors and CMC Consulting Group Collaboration

Boston MedTech Advisors and CMC Consulting Group have entered into a collaboration agreement intended to offer their respective clients and portfolio companies broader range of integrated value-add services. Primary areas of collaboration include assistance to non-European medical device companies seeking to develop effective distribution networks throughout Europe and to assist European companies contemplating expansion into the US market to better assess and plan their pre- and post-marketing activities, including development of optimal regulatory strategy and preparation of regulatory filings, assessment and planning of required reimbursement activities, planning and conducting clinical studies in the US, developing marketing plans and supporting business development initiatives.

CMC Consulting Group operates through seven European offices located in Germany, France, UK, the Netherlands, Italy, Spain and Poland, offering strategic planning, outsourced sales management  as well as selection and negotiations with appropriate distributors throughout the continent, utilizing its extensive database containing over 80,000 European organizations engaged in the sales of medical technologies. 

For additional information about CMC Consulting Group, please refer to www.cms-co.net.  To learn more about how BMTA and CMC can help you to plan and enter either the European or US markets, respectively, contact Boston MedTech Advisors.

Dr. Imhoff to Discuss Outcomes Studies with Non-Therapeutic Medical Technology

Michael Imhoff, MD, PhD, Managing Director, BMTA Europe, will speak about the need for outcomes studies with non-therapeutic medical technologies at the 5th Annual Conference on Clinical Evaluations & Investigations for Medical Devices, Amsterdam, on April 21, 2010.  The presentation will address the complexities of developing a study strategy that meets regulatory, reimbursement and marketing requirements.  Expectations from medical users and reimbursement authorities will be discussed with strategies identified to address potential pitfalls.

Changes in 510(k) to Affect Medical Device Companies

Medical device companies seeking US regulatory approvals for their products have realized in recent month extended review cycles, as well as additional scrutiny of the applications, whether the application is filed as a regular 510(k) or De-Novo. A recent analysis completed by Boston MedTech Advisors found that the duration of the review process of new submissions, from initial filing of an application until clearance under the 510(k) De-Novo provision, has increased from an average of 8 months (up to 2007) to over 16 months since 2007. Recently, the FDA has initiated a major review of the 510(k) clearance program, by which the majority of medical devices are approved. One of the areas under review is the determination of 'predicate'devices, as reviewers are finding it increasingly harder to determine if a new device is truly similar to an approved product or if there are enough differences to classify it as an entirely new product. The changes contemplated by the FDA could further extend review times, prompt requests for additional clinical data supporting the regulatory filings, and ultimately, lead to higher costs to manufacturers of medical devices. To assist it in this comprehensive review, the FDA requested the Institute of Medicine (IOM) to assess the required changes in the 510(k) program. While a report from the IOM is due only next year, Dr. Jeffrey Shuren, the new head of FDA's Center for Devices and Radiological Health, said in a recent public hearing that the agency may start making changes to the 510(k) process even before the IOM releases its report.

BMTA follows closely changes in the 510(k) program and can discuss the specific implications with companies determining their regulatory strategy, companies outlining their clinical study plans, and companies already selling their products and contemplate revisions and enhancements to their technologies. For a copy of the report analyzing recent timelines of 510(k) applications or to discuss how the changes at the FDA may affect your company contact Boston MedTech Advisors.

New Considerations in Clinical Trial Design Addressing the Placebo Effect 

Much has been studied about placebo effects in drug therapy as pharmaceutical companies are finding that more of their products are failing in comparison to placebos.

This phenomenon is seen in Phase II and Phase III clinical studies for newly developed products as well as trials of existing drugs. Currently, the Foundation for the National Institute of Health is leading the Placebo Response Drug Trials Survey, which involves the analysis of past trial data to look for trends and variables responsible for the increase in the placebo effect.

As acceptance of new medical devices is subject to growing requirements for evidence, placebo effects are questioned also in many device-based therapies, requiring sponsors of clinical studies and the designated principal investigators to carefully consider such effects in their study designs. Properly studying placebo effects is critical - not only when developing data to support regulatory filings - but also to gain providers' support, and ultimately, payers' acceptance to covering these therapies.

BMTA, through its Boston MedTech CRO Group, focuses on the unique requirements of clinical studies for medical devices and assists developers of new technologies to properly design, monitor and manage clinical studies that support regulatory requirements as well as post-marketing product adaption by providers and third-party payers.

For more information on the range of services offered by Boston MedTech CRO Group, and how we can assist your company to gain most value from sponsored clinical studies, please contact Andrea Nadai, BMT CRO Group Coordinator.

New IEC Connectivity Standards Affecting Hospital-Based Medical Devices 

Interconnecting medical devices to hospital healthcare IT infrastructure is becoming a reality, requiring manufacturers of medical devices used in hospitals and clinics to address new challenges when ensuring the safety, performance and efficacy of their devices, as well as the integrity of the information derived from them, once integrated with third-party enterprise electronic medical record systems.  A new standard - IEC 80001-1 Ed. 1.0 - which addresses many of the evolving issues and requirements for the expanded connectivity between devices and IT networks. Is expected to go into effect later this year. The standard will require healthcare delivery organizations to coordinate risk management activities and responsibilities with the respective medical device manufacturers, the networking infrastructure equipment vendors and system integrators. This standard recognizes the increasingly dynamic and complex deployment environment and creates multi-disciplinary and cross-functional risk management activities for the networked medical devices and IT systems.

Members of BMTA have been in the forefront of these issues, and have been assisting manufacturers of monitoring, diagnostic and therapeutic devices used in hospitals and other integrated medical information networks to understand the implications, starting with the initial drafting of marketing and technical requirements for new networked medical technologies, through their design, clinical studies, deployment and post-marketing phases. For additional information on the evolving networked environment, please contact Yossi Elaz, BMTA Senior Advisor.

About Boston MedTech Advisors

Boston MedTech Advisors assists medical technology companies and healthcare providers to achieve their business goals by offering ethical, result-oriented, professional and cost effective advice and services.

• Market analysis and business strategy
• Business development
• Regulatory affairs and clinical trials management
• Reimbursement and contracting strategies
• Financing support

Boston MedTech Advisors provides practical business services to:

• Established and growing medical technology companies
• Healthcare providers
• Young organizations and entrepreneurs
• Private and institutional investors

To learn more about our organization and services, please visit our web site at www.bmtadvisors. com or call us at 781.407.0900.