BMTA News
BMTA Collaborating with Western NY MedTech Leaders
The western New York area, including the Buffalo-Niagara Medical Corridor, is realizing growing activities of bioscience and medical technology companies.
To better support the companies in this region, the Boston-based BMTA with an office in Dortmund Germany and the local firm, Tino Bellanca & Associates (TB&A), have initiated a collaborative effort, offering business entities ranging from early stage start-ups to the well-established companies in the region a single-source solution for a broad range of services. Companies in the western NY area can now obtain well-coordinated services ranging from regulatory, clinical studies, reimbursement, business development, market analysis, and business strategy to downstream marketing and sales distribution services. BMTA, together with TB&A, can offer strategic, planning and implementation services, as needed to best meet the requirements of the local companies.
BMTA and TB&A met with and have begun collaboration with technology transfer and incubator personnel at the University at Buffalo, its New York State Office of Science, Technology Transfer and Economic Outreach (STOR). In addition, BMTA and TB&A have started dialogues with firms located in the University's Center for Excellence in Bioinformatics and Life Sciences at the Buffalo-Niagara Medical Campus in downtown Buffalo. A private not-for-profit firm, Insyte Consulting, has also provided helpful insight for BMTA in approaching local organizations seeking assistance in areas in which BMTA and TB&A specialize.
As BMTA has a European presence in Dortmund Germany, the Buffalo-Dortmund sister city connection is also an exciting opportunity for such transatlantic collaborations.
This joint team has already identified opportunities for business collaboration in the western NY region that BMTA and TB&A are pursuing.
To further learn about the western New York initiative, contact us at info@bmtadvisors.com
Tom Keegan Joins Boston MedTech Advisors
We are pleased to announce that Tom Keegan has joined Boston MedTech Advisors as a Senior Consultant.
An accomplished marketing professional with over 20 years of marketing, technical and clinical experience in the medical industry, Tom held senior management positions in private and public companies, including Haemonetics, UltraCision, Johnson & Johnson Ethicon Endo-Surgery, Smith & Nephew Endoscopy, Endius, and most recently, serving as the Vice President of Marketing for MIS (Minimally Invasive Surgery) Solutions for Zimmer Spine. Tom's experiences include development and implementation of marketing plans, market research and analysis, professional education, marketing communications, pricing strategy and reimbursement development. Tom has been responsible for key areas during the acquisitions and mergers of early stage companies into major corporations, overseeing the integration of sales forces, technology transition and personnel training.
BMTA Presentation on Addressing Outcomes Studies Challenges
Michael Imhoff, MD, PhD, Managing Director, BMTA Europe, spoke about the challenges facing new medical technologies when designing outcomes studies, at a MassMedic MedTech IGNITE meeting on February 9, 2010. The presentation and subsequent discussion addressed the complexities in designing clinical outcome studies and the potential pitfalls when analyzing the results. In addition to highlighting potential pitfalls, Dr. Imhoff also provided a number of suggestions for companies developing the required evidence to support market acceptance of their respective technologies.
If you would like a copy of the presentation, please email info@bmtadvisors.com. |
Regulatory Update
European Union Medical Device Regulations Becoming More Stringent, Raising the Regulatory Bar
 With the new Amendments to the Medical Device Directive (MDD) 93/42/EEC [in accordance with Directive 2007/47/EC] becoming effective on March 21, 2010, the requirements for providing clinical evidence for new and existing medical devices have reached a new, unprecedented level in the European Union.
While the formal CE and FDA requirements for securing marketing clearance have not been fully harmonized, many of the respective aspects associated with the design, development and manufacturing of medical devices and the conduct of clinical studies are now quite similar. Medical device manufacturers selling their products in Europe will now be required to provide clinical evaluation data based on external, published, or internal clinical data for the respective devices and technologies, in addition to the technical and safety data previously required.
The new directive clarifies the requirements for all device classes as to what constitutes "clinical evidence". BMTA is working with many of its client companies on defining the appropriate evidence necessary to satisfy the new guidance regarding clinical evaluations. BMTA CRO assists its clients plan, launch, manage and analyze the clinical data in order to generate clinical evidence in compliance with the new requirements.
Clinical studies are costly and lengthy. Effective early planning of clinical evaluations is now a necessity in order to streamline the process of satisfying both CE and FDA regulations. The clinical evidence can often be used to support marketing activities, develop favorable coverage and reimbursement and advance business relationships and partnerships.
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