Advocacy & Engagement

MDMA works to ensure that FDA’s pre- and post-market efforts are predictable, transparent, and reasonable for medical technology innovators. Regulatory professionals work collaboratively through the FDA Working Group to develop priorities to communicate before FDA’s Center for Devices and Radiological Health (CDRH), Members of Congress, and other relevant stakeholders.

MDMA works with the Centers for Medicare and Medicaid Services (CMS), Congress, private payers, and others to ensure reimbursement policies of government health care programs and private payers support timely and adequate access for patients to innovative medical technologies. This includes policies related to coverage determinations, coding, payment setting, claims processing, and other reimbursement issues. The collaborative input of members informs MDMA’s proactive and reactive policy development efforts, including analysis of reimbursement-related legislation and the drafting of comments submitted on annual Medicare payment system updates and other proposed rules.

The Compliance Working Group facilitates interaction among member company peers, legal experts, and government officials to navigate the evolving compliance landscape and share best practices for interactions with healthcare providers and patients. In addition to monthly meetings, members receive opportunities to attend quarterly roundtables and other meetings focused on data privacy, security issues, and other compliance topics. Compliance working group members also receive access to MDMA’s “Compliance Toolkit”, which provides best practices for establishing or enhancing compliance programs at companies of all sizes.

As discussions around Artificial Intelligence/Machine Learning continue to expand with policy makers, MDMA has formed an Artificial Intelligence working group to address these issues and discuss priorities. With FDA authorizing the first medical device with AI in 1995 and hundreds more since, it is important that any new potential requirements are not duplicative or run counter to FDA requirements. There are also issues around reimbursement, assurance labs, and data privacy/ownership that this group explores.

This group focuses on maintaining the supply of critical medical technologies. Policies and other actions which seek to limit exposure to Ethylene Oxide (EtO) for medical device sterilization and use restrictions governing per and poly-fluoroalkyl substances (PFAS) should be balanced to ensure the global supply of critical medical technologies is not impeded. MDMA works collaboratively with member companies to engage local, state, federal, and international governments, key agencies, and other stakeholders to limit supply chain disruptions and advocate for risk-based regulatory solutions.

The International Working Group informs and educates members on policy developments, challenges, and opportunities with business implications that could impact expansion into international markets, especially in the EU, UK, and Germany. These include regulatory, reimbursement, trade, and/or political decisions that change the international environment for medical technology manufacturers and developers. Expert guest speakers frequently join our monthly calls to provide insights on rapidly emerging medical technology issues as well as market developments in China, Japan, India, and our North American trading partners.

MDMA’s Cybersecurity Working Group serves as a key channel to disseminate timely and relevant information to medical technology innovators as they institute and strengthen their cybersecurity functions. Members receive opportunities to comment on proposed regulations and participate in public/private partnerships, webinars and other events, as well as real-time alerts on vulnerabilities and threats facing the healthcare sector.

MDMA stays ahead of industry news and developments to inform the Public Affairs Working Group of anticipated or current media attention, and to consider the implications for member companies. The group shares strategies and insights to deal with media outreach and grassroots activities, as well as how the legislative agenda and debates are shaping media coverage of the issues that impact our ecosystem.

MDMA actively works with Congress and other stakeholders to make necessary changes to patent reform legislation that allows medical technology innovation to flourish. The Patent Working Group works to ensure proposed policy initiatives strengthen the patent system, not weaken it.

On an as-needed basis, MDMA will organize sub-working groups to focus on specific issues. Members are provided the opportunity to participate based upon the relevance of the issue’s impact to their business.