Welcome to Boston MedTech Advisors

Included in this issue...

BMTA Updates:

• BMTA welcomes its summer intern
• David Barone to attend Biomed Israel 2010

Industry Updates: 

• Proposed Medicare Payment Rates for Inpatient Hospitals Released
• FDA Launches CDRH Website
• New Considerations for Clinical Trial Design: Statistical methods for clinical trial analysis
• Financing Medical Device Companies - Changing Landscape

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

BMTA welcomes its summer intern Adam Simone, who is currently pursuing a Master of Science in Biotechnology and Management at Carnegie Mellon University. Adam also has a B.S. in Mechanical Engineering from Northeastern University. Adam's intern program is supported by the Massachusetts Life Science Center, a workforce development program focused on enhancing the talent pipeline for Massachusetts life sciences companies.

David Barone, Principal of Boston MedTech Advisors, will visit the ILSI-Biomed 2010 conference in Tel Aviv, Israel. Companies interested in setting up an introductory meeting with David while in Israel may contact him at dbarone@bmtadvisors.com.

Proposed Medicare Payment Rates for Inpatient Hospitals Released

CMS recently released its proposed rule for the FY 2011 hospital inpatient prospective payment system (IPPS), reflecting a 2%-4% reimbursement rate increase for many of the DRGs. While in most instances payments from insurance companies to hospitals do not directly impact medical device prices, they do have an indirect effect since the amount hospitals are reimbursed for procedures influences what they can afford to pay for devices used in those procedures. The proposed rule is considered to be, overall, good news for medical device firms since it suggests that the healthcare system will not ramp up pressures on device prices in the near term. Yet, hospitals continue to adjust to demands to create more transparency, improve quality of care and adopt new technologies, in addition to responding to new mandates from accreditation agencies and governments. Such changes impact purchasing decisions often slowing adoption of new technologies intended to support inpatient care.

Boston MedTech Advisors is helping companies developing or marketing medical devices used in the inpatient, outpatient or home settings to evaluate how reimbursement policies and new healthcare initiatives affect clinical acceptance and pricing of their products, and assist them in the development of marketing and clinical plans that best respond to this complex healthcare environment. To discuss the impact of reimbursement regulations on product development and strategic planning, or how Boston MedTech Advisors can assist your company in that regard, please contact us at info@bmtadvisors.com.

FDA Launches CDRH website

The FDA has launched a new website for the Center for Devices and Radiological Health, part of its ongoing transparency initiative. The website provides information on regulatory decisions, compliance and enforcement actions, and details on CDRH-sponsored research. A searchable Total Product Life Cycle database will aggregate pre-market and post-market information on individual products from a number of sources. The site will eventually also post pre-market approval and clearance reviews.

New Considerations for Clinical Trial Design: Statistical methods for clinical trial analysis

On February 5, 2010, FDA released a guidance document on the use of Bayesian statistics in medical device clinical trials. The guidance discusses the potential applications for this statistical method when designing a clinical trial. Bayesian statistics differs from traditional (frequentist) statistical methods in that information from previous clinical studies is formally combined with current data considering prior information and trial results as part of a continual data stream, in which inferences are being updated each time new data become available. In some circumstances, when applying Bayesian statistical methods, prior information for a given device may justify a smaller-sized or shorter-duration pivotal trial.

Boston MedTech CRO Group helps medical device companies to design and manage clinical studies supporting regulatory, reimbursement and marketing goals, each with its own data requirements and end-points. As the FDA, payers and clinicians seek more rigorous clinical data, Boston MedTech CRO Group closely examines statistical methodologies to ensure the best option has been selected to evaluate the clinical trial data. To further discuss these issues, contact Andrea Nadai, Boston MedTech CRO Group Manager at anadai@bmtadvisors.com.

Financing Medical Device Companies - Changing Landscape

• During the first quarter of this year, venture capital, nationwide, declined by 9% in dollars and by 18% in number of deals, compared to last quarter of 2009. Yet, New England has seen a growth of over 8%, with biotechnology and medical device deals representing over 55% of all investments in the region. According to a recent report in the Boston Globe, seven of the ten biggest venture investments made in New England companies during the last quarter were in the life sciences, reflecting the strength of this industry in this region.
• The Center for Venture Research reported that angel investment in the US totaled $17.6 billion in 2009, an 8.3% decrease from 2008, although the number of deals increased in 2009 by 3.1% to 57,225. Seed and startup stage companies received 25% of the angel investments, including 17% in healthcare services and medical device companies, and 8% in biotech.
• A federal program that will provide $1 billion to small life-sciences companies is undergoing final planning. The funds will be in the form of tax credits or grants, covering 50% of project development costs in 2009 and 2010 for companies with fewer than 250 employees. The plan will be open to medical device, biotech and diagnostic companies, both public and privately held.

To learn more about potential financing opportunities and Boston MedTech Advisors' activities supporting companies seeking additional funding, please contact us at info@bmtadvisors.com.

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.