Health Care Reforms Target Medical Devices
Article preview reprinted from IN VIVO - May, 2009
Welcome to 2009. If you haven't been paying attention to the health care happenings in the nation's capital this year, you should be. The President and powerful members of Congress have put themselves on the line to remake the US health care system; whistleblowers within FDA's device review office are charging management with breaking the law; federal mandates for more transparency in doctor-manufacturer relationships have become the lesser of evils for many in industry; and one of the most significant device-specific US Supreme Court decisions in recent memory has become a vulnerable target of leading Democratic lawmakers. As Steve Ubl, president and CEO of AdvaMed, recently observed, "What happens over the next 25 weeks could affect the industry over the next 25 years." Read more...
Health Care Reforms Target Medical Devices
Article preview reprinted from IN VIVO - May, 2009
Welcome to 2009. If you haven't been paying attention to the health care happenings in the nation's capital this year, you should be. The president and powerful members of Congress have put themselves on the line to remake the US health care system; whistleblowers within FDA's device review office are charging management with breaking the law; federal mandates for more transparency in doctor-manufacturer relationships have become the lesser of evils for many in industry; and one of the most significant device-specific US Supreme Court decisions in recent memory has become a vulnerable target of leading Democratic lawmakers.
As Steve Ubl, president and CEO of AdvaMed, recently observed, "What happens over the next 25 weeks could affect the industry over the next 25 years." Issues on the table directly impacting the medical device sector include the long-term infrastructure of comparative effectiveness research as a means of better assessing medical therapies, 510(k) reform, removing personal injury lawsuit protection for PMA-approved devices, and new requirements for disclosing company payments to doctors.
The policy matters are front and center at a time when the device industry already finds itself under extraordinary pressure on a number of fronts. The IPO market for device companies closed prior to the credit crunch, severely limiting exit opportunities. The economic slowdown then caused many new investors, particularly private equity and hedge funds, to abandon device investing, while putting the industry's traditional sources of funding—venture capitalists—under severe limitations in their ability to access additional capital from their limited partners.
Purchase this article online as a PDF and receive it immediately via email. Questions? Call (800) 332-2181. 100% Satisfaction Guaranteed. Subscribe to IN VIVO.
Companies mentioned in this article:
IN VIVO delivers:
- Revealing, in-depth coverage of your competitors' strategies
- Incisive projections of future industry trends and their implications for your business
- Expert analysis of key industry developments
- Exclusive interviews with top industry executives and analysts
- In-depth examination of dealmaking, marketing, R&D, regulatory, and finance strategies -- those that were successful and those that missed the mark
