Medical Device Manufacturers
Industry Profile Report
Dive Deep into the industry with a 25+ page industry report (pdf format) including the following chapters
Industry Overview Current Conditions, Industry Structure, How Firms Operate, Industry Trends, Credit Underwriting & Risks, and Industry Forecast.
Call Preparation Call Prep Questions, Industry Terms, and Weblinks.
Financial Insights Working Capital, Capital Financing, Business Valuation, and Financial Benchmarks.
Industry Profile Excerpts
Industry Overview
The 8,260 medical device manufacturers in the US produce a range of products designed to diagnose and treat patients. Medical devices range in nature and complexity from simple tongue depressors and bandages to complex programmable pacemakers and sophisticated imaging systems. The key products include surgical appliances and supplies, surgical and medical instruments, electro-medical equipment, in-vitro diagnostic substances, irradiation apparatuses, dental-related products, and ophthalmic goods.
Challenges of Complex Regulations
Medical devices are subject to extensive regulation in the US by the FDA, and by comparable government agencies in other countries.
Developing New Hybrid Technologies
New hybrid technologies that incorporate pharmaceutical products with traditional medical device products are becoming popular.
Industry size & Structure
A typical medical device manufacturer generates $11 million in annual revenue and has fewer than 10 employees.
- The overall medical device manufacturing industry consists of about 8,260 companies with $92 billion in sales and 334,200 employees.
- The two largest segments of the industry, surgical and medical instruments and surgical appliances and supplies, consist of about 2,760 companies with about $76 billion in sales and 248,700 employees. These segments are the primary focus of this profile.
- The states with the highest number of medical device companies include California, Florida, New York, Texas, Illinois, Indiana, Pennsylvania, Ohio, North Carolina and Minnesota.
- Major US medical device companies include Medtronic, GE Healthcare Technologies, Johnson & Johnson, Boston Scientific, Baxter, Becton Dickinson, Beckman Coulter, Abbott Labs, and Stryker Corporation.
Industry Forecast
Medical Device Manufacturers Industry Growth
Recent Developments
Nov 4, 2024 - Medicare Advantage Payment Updates Finalized
- Medicare payments to Medicare Advantage plans are expected to increase an average of 3.7%, or over $16 billion in 2025, according to the Centers for Medicare & Medicaid Services. Medical device manufacturers are likely to benefit from the increase in expenditures. The finalized the Calendar Year 2025 Rate Announcement for Medicare Advantage is projected to result in payments of between $500 and $600 billion in Medicare Advantage payments to private health plans in 2025.
- Transparency and traceability are increasingly important to medical device suppliers, manufacturers, distributors, sales intermediaries, and providers due to the high level of supply chain regulation and complexity, according to Medical Products Outsourcing magazine. The Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH), and the EU’s Medical Device Regulation (MDR) are some of the more notable laws that they must adhere to. HIPAA and HITECH require full documentation for the privacy of health information that companies have access to. FDA regulations such as 21CFR, FDASIA, ISO9001, ISO/IEC 17025, and GMP require auditable books of record for compliance. The SEC in the US and the CSRD in the EU lay out ESG-related rules that companies must follow—and prove they follow—via disclosures around carbon emissions (including emissions from the whole supply chain, what we call Scope 3 emissions), supplier diversity, forced labor, and more. Transparency throughout all parties of the supply chain and the relevant data that passes up and down the chain is key in each of the above requirements, according to Medical Products Outsourcing. This requires that companies trace the origins of their products and maintain a record of all their third parties, including n-tier suppliers, to ensure that they’ve covered all their bases.
- Medical device manufacturers are seeking joint ventures to ensure that sustainable materials are used in packaging designs, according to Packaging Digest. Firms including Becton, Dickinson and Company (BD) and Abbott use sustainability ratings services to assess and improve supplier sustainability and ethical practices. Simplifying processes and early supplier engagement help reduce costs and build resilient supply chains in medical packaging. “As we’ve faced different challenges [such as] labor shortages, inflation, material qualifications, and a shortage of raw materials, we want to continue to invest more in strategic supply relationships to problem-solve,” said Preethi Kasthuri, director of global procurement at BD.
- Medical device manufacturing industry employment increased slightly and averages wages for nonsupervisory employees increased moderately during the first nine months of 2024, according to the US Bureau of Labor Statistics (BLS). Medical device manufacturers increased their prices only slightly during the first nine months of 2024, according to the BLS.
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