MDMA WOrking Groups
MDMA strongly encourages members to take an active role in the policy debates that affect our industry. In order to facilitate this process, MDMA has established a number of working groups where member executives come together to discuss the many significant challenges facing innovative medical device companies. Each working group meets monthly or quarterly via conference call to share experiences, review the latest legislative and regulatory developments, and assist in drafting comments to federal agencies. In addition to participating on conference calls, working group members receive regular email updates and breaking news on issues related to their task force.
The success MDMA has enjoyed over the past 16 years has been a direct result of the collaboration between the MDMA staff and member companies. As policies are developed in Washington, it is critical that the voice of the entrepreneurial sector of the marketplace is represented and heard.
Please engage in the process and join a working group today!
FDA/MDUFMA
The FDA/MDUFMA working group concentrates on issues surrounding the Food and Drug
Administration (FDA). The implementation of the Medical
Device User Fee and Modernization Act of 2002 (MDUFMA) continues
to be a top priority for the industry and our working group.
With many provisions of MDUFMA not yet in effect, it is critical
that industry have input in this process.
MARKET
ACCESS
MDMA believes that
a business climate which fosters innovation is essential to
improving patient care. The practices of certain hospital
group purchasing organizations (GPOs) continue to prevent
patients and caregivers access to innovative and cost
effective technologies. MDMA continues to promote policies
which improve competition in the healthcare marketplace.
REIMBURSEMENT
MDMA member companies
constantly face challenges related to the adequate payment
of their technolgies. The workin group provides an opportunity
to get the latest information concerning coverage, coding
and payment issues.
PATENT
Attracting the necessary investment into companies developing the next generation of treatment, therapies, and technologies, depends on a strong, reliable patent system to insure that these critical innovations remain proprietary for a period of time, especially for a new entrant. The Working Group focuses on the latest developments at the US Patent and Trademark Office as well Capitol Hill that impact the patent system
GAINSHARING
Through device contract gainsharing, hospitals attempt to cut short-term costs by enticing physicians to limit the kinds of medical devices used in patient care or to deliver less care by offering them a percentage of total cost “savings.” Offering financial incentives to doctors presents a troubling conflict of interest. Though it currently is illegal, some members of Congress currently are considering implementing a safe harbor that would sanction the practice. MDMA believes that this would harm patient care and innovation. We are working to educate lawmakers and industry on the pitfalls of device contract gainsharing. Working group members provide valuable input, help shape policy, and play a vital role with MDMA’s efforts in Washington.
INTERNATIONAL
With the global
marketplace that exists in the medical technology industry,
it is important that companies are aware of international
regulations and trends. While not all companies have
an international presence, many are exploring the possibility.
The International Working Group meets quarterly to address
recent developments abroad.