Medical Device Manufacturers Association

What Medical Device Manufacturers Association does

Medical Device Manufacturers Association (MDMA) is a private nonprofit trade association founded in 1992 and headquartered at 1333 H Street NW in Washington, DC. It represents hundreds of medical technology companies — ranging from small entrepreneurs to the largest multinational manufacturers — and serves as one of two recognized industry negotiators (alongside AdvaMed) for Medical Device User Fee Amendments (MDUFA) with the FDA. MDMA's core activities are policy advocacy, regulatory engagement, reimbursement support, and member education on issues affecting the medical device ecosystem, including FDA approval pathways, Medicare coverage, EtO sterilization supply chains, AI medical device regulation, cybersecurity, tariffs, and international market access.

MDMA delivers value to members through recurring advocacy representation, monthly member-only working groups across ten policy areas (FDA/Regulatory, Reimbursement, Compliance, AI, Emerging Chemicals, Tariff, International, Cybersecurity, Public Affairs, IP), and four annual conferences (FDA Forum, Annual Meeting, Executive Forum, and Health Policy & Reimbursement Conference). Revenue is generated primarily through annual membership dues — split between Active membership for FDA-regulated manufacturers and Associate membership for non-manufacturer ecosystem participants — supplemented by conference and event fees.

MDMA is governed by a Board of Directors composed of senior executives from member companies including Boston Scientific, Stryker, ZOLL Medical, Outset Medical, SI-BONE, AtriCure, Axogen, STERIS, Willow Laboratories, and Carl Zeiss Meditec. Its leadership team, led by President & CEO Mark B. Leahey, combines former senior FDA officials, Capitol Hill chiefs of staff, and veterans of major medical device companies. Notable policy wins include the 2019 full repeal of the federal medical device excise tax — credited with saving industry jobs and over $30B — and the first on-schedule MDUFA VI negotiation in six user fee agreement cycles.

Name

Medical Device Manufacturers Association

Legal name

Medical Device Manufacturers Association

Website

https://medicaldevices.org

Company type

Private

Founded year

1992

Operating status

Operating

Headcount range

11–50 employees

Short description

MDMA is a Washington, DC-based nonprofit trade association founded in 1992 that represents hundreds of medical technology manufacturers, providing policy advocacy, regulatory engagement, and member education on FDA, CMS, and Congressional issues affecting the medtech ecosystem.

Ownership category

akta.pro rank

Headquarters

HQ city

Washington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Membership Dues: MDMA generates revenue through membership dues from medical technology companies. Two membership categories exist: Active membership for medical technology manufacturers and/or developers of software regulated as medical devices by FDA, and Associate membership for non-manufacturers with vested interest in the medical technology ecosystem.
2. Conference and Event Fees: MDMA hosts four flagship conferences annually: MDMA FDA Forum, MDMA Annual Meeting, MDMA Executive Forum, and MDMA Health Policy and Reimbursement Conference. Events are open to members and non-members, with members receiving priority access.
3. Member-Only Resources and Working Groups: Members receive access to resources informing regulatory, reimbursement, market access strategies, and participate in monthly working group meetings and webinars.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

MDMA is a national trade association that provides advocacy, education, and member services to medical technology manufacturers. Its core offerings include policy advocacy before Congress, FDA, and CMS; member-only working groups covering regulatory, reimbursement, AI, cybersecurity, compliance, and other key issues; and four annual educational conferences. Members gain access to grassroots mobilization, regulatory intelligence, and a peer network spanning small entrepreneurs to the largest medtech multinationals.

Product overview

MDMA is a national trade association, not a product company. It provides advocacy, education, policy engagement, and member services for medical technology companies. The organization does not manufacture or sell products. Its services include advocacy and policy representation, working groups (FDA/Regulatory, Reimbursement, Compliance, AI, Emerging Chemicals, Tariff, International, Cybersecurity, Public Affairs, IP), educational conferences (MDMA FDA Forum, Annual Meeting, Executive Forum, Reimbursement & Health Policy Conference), and member stories showcasing member company medical technologies. The member stories highlight products from member companies including Boston Scientific (AMS 800 Artificial Urinary Sphincter, AdVance XP Male Sling System), Axogen (Avance Nerve Graft, Resensation technique), Stryker (Hoffmann 3 Modular External Fixation System), Outset Medical (Tablo Hemodialysis System), ZOLL (remede System), STERIS (truFreeze Spray Cryotherapy System), Willow Laboratories (Nutu platform), SI-BONE (iFuse 3D Implant System), and AtriCure (surgical ablation solutions).

Differentiator

Problem solved

Functional benefit

Products and services

• Active Membership Annual subscription membership for medical technology manufacturers and developers of software regulated as medical devices by FDA, providing advocacy representation, working groups, member-only resources, and conference access.
• Associate Membership Annual subscription membership for non-manufacturer organizations with a vested interest in the medical technology ecosystem, including suppliers, service providers, consultants, and other healthcare stakeholders, providing advocacy representation and networking opportunities.
• MDMA FDA Forum Annual educational conference focused on FDA regulatory engagement, with 125+ attendees and featuring senior FDA officials. Open to members and non-members.
• MDMA Annual Meeting Annual flagship conference hosted in Washington, DC, convening 250+ medtech executives with senior FDA and CMS officials and other federal agency leadership.
• MDMA Executive Forum Annual executive-level conference bringing together senior medtech industry leaders.
• MDMA Health Policy and Reimbursement Conference Annual conference focused on health policy and reimbursement issues affecting medical technology companies, with members receiving priority access.
• Member Working Groups Monthly member-only working group meetings covering FDA/Regulatory, Reimbursement, Compliance, AI, Emerging Chemicals, Tariff, International, Cybersecurity, Public Affairs, and IP. Open to all member company personnel.

Quantifiable outcome

• Saved industry jobs and over $30B with device tax repeal
• +1 more outcomes

Named customers10 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Seven partnerships are on record, tiered major and core.

• Memory Chip Industry CoalitionmajorStrategic or Co-development Partner · 3 June 2026Nine major industry trade groups including automotive, retail, medical devices, and telecommunications sectors sent joint letter to US Treasury and Commerce departments warning about memory chip shortage impacting production costs and supply chains. Coalition urged government action to support faster expansion of US semiconductor manufacturing capacity.
• U.S. Food and Drug Administration (FDA)coreStrategic or Co-development PartnerMDMA serves as the primary industry representative negotiating Medical Device User Fee Amendments (MDUFA) with FDA. Successfully completed MDUFA VI negotiations in record timeline. Works with FDA's Center for Devices and Radiological Health (CDRH) on regulatory policy, IT infrastructure, de novo programs, and pre-submission processes.
• Centers for Medicare and Medicaid Services (CMS)coreStrategic or Co-development PartnerMDMA advocates for reimbursement policies supporting timely and adequate access for patients to innovative medical technologies. Works on coverage determinations, coding, payment setting, claims processing, and Medicare payment system updates.
• U.S. CongresscoreStrategic or Co-development PartnerMDMA advocates with key Members of Congress and senior staff on policies impacting medical technology innovators. Successfully led efforts against the medical device tax, achieving repeal in 2019. Conducts annual Congressional Fly-In events.
• AdvaMed (Advanced Medical Technology Association)majorStrategic or Co-development PartnerCollaborated on FDA comments regarding AI-assisted medical devices, urging the agency to use existing quality management system requirements rather than creating new regulatory frameworks for monitoring AI-enabled medical devices.
• Health Innovation AlliancemajorStrategic or Co-development PartnerJoint submission with AdvaMed and other groups to FDA on AI-enabled medical device monitoring, advocating for regulatory efficiency and avoiding duplicative requirements.
• American Hospital Association (AHA)majorStrategic or Co-development PartnerCollaborated on FDA comments regarding AI-assisted medical devices. AHA noted that over 1,240 AI-enabled medical devices have been approved by FDA, with most approvals occurring within the past three years.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Regional players

• MedTech Europe: The European trade association representing the medical technology industry. Directly comparable in mission and structure to MDMA, but focused on EU regulatory (MDR/IVDR), reimbursement, and policy rather than US federal advocacy. Useful as the regional counterpart MDMA members also engage with.
• Medical Technology Association of Australia (MTAA): Australia's national medtech industry association, closely comparable in member-driven trade association model. Operates in a different geography but addresses similar regulatory, reimbursement, and market access issues for medtech manufacturers.

Others

• American Hospital Association (AHA): Major US healthcare trade association representing hospitals and health systems. Comparable in advocacy and member-based association model, and collaborates with MDMA on AI device comments, but represents the provider side rather than the medtech manufacturer side.
• National Association of Manufacturers (NAM): The largest US manufacturing trade association, representing manufacturers across sectors including medical devices. Comparable as an advocacy and member-driven organization with federal policy focus, but with a much broader manufacturing mandate rather than medtech specialization.

Broad incumbents

• PhRMA (Pharmaceutical Research and Manufacturers of America): The leading US pharmaceutical industry trade association. Highly comparable business model (membership dues, advocacy on FDA/Congress, conferences), with overlap on broader healthcare policy issues. Some MDMA executives (e.g., Ed Rozynski) previously served at PhRMA, evidencing personnel crossover.
• BIO (Biotechnology Innovation Organization): The largest US trade association for the biotechnology industry, representing companies across biopharma, diagnostics, and increasingly digital health. Comparable to MDMA in mission (advocacy, education, conferences) and member-based revenue model, but operating across a much broader life sciences portfolio.

Emerging players

• Health Innovation Alliance: A coalition advocating for health technology innovation including AI, digital health, and connected devices. Comparable to MDMA on technology-forward medtech policy issues, with overlapping collaboration on FDA AI device comments, but broader in scope and not medtech-exclusive.
• Medical Device Innovation Consortium (MDIC): Public-private partnership focused on advancing medical device regulatory science. Comparable to MDMA in medtech focus and FDA engagement, but operates as a nonprofit collaborative rather than a broad membership trade association, making it more of a niche emerging player in the medtech advocacy ecosystem.

Direct peers

• AdvaMed (Advanced Medical Technology Association): The largest US trade association for medical device and diagnostics manufacturers, directly overlapping with MDMA's member base and advocacy remit. MDMA and AdvaMed co-negotiate MDUFA user fees and co-file comments on AI device regulation, making them the closest direct peer and chief competitor for medtech advocacy influence.
• AdvaMed Accel: The division of AdvaMed specifically focused on smaller, entrepreneurial medical technology companies - directly competing with MDMA's positioning as the voice for innovative and entrepreneurial medtech firms. Offers overlapping member benefits for the same segment MDMA targets with Active membership for small manufacturers and SaMD developers.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/medicaldevices

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Medical Device Manufacturers Association