Opportunities and implications for ISO 9001 certified entities to access the lucrative medical device market through ISO 13485 certification.
Researchers estimate the total size of the U.S. medical device market somewhere between $170 billion and $240 billion in 2023. KPMG reports, “The medical device industry is poised for steady growth, with global annual sales forecast to rise by over 5 percent a year and reach nearly US$800 billion by 2030.”
The assemblers and manufacturers of record for those devices need components of superior quality in a variety of materials and production methods to ensure their products are “audit ready” and compliant with federal regulations. Even the simplest “Class I” devices commonly have dozens of component parts. Those assemblers and manufacturers of record are also interested in supply chain diversification via multiple suppliers given lessons learned from the Covid-19 pandemic and geopolitical forces to which supply chains frequently bend.
Manufacturers and component suppliers serving a variety of industries with ISO 9001 certification are well positioned to examine market possibilities in medical devices given their familiarity with the processes and documentation the standard’s certification requires. But achieving ISO 13485 certification or compliance for medical device manufacturers brings requirements that merit careful consideration before manufacturers make the leap.
In addition to the areas ISO 9001 and 13485 overlap, members of the GCMI and GaMEP teams discuss associated costs including personnel, the necessary rigors associated with ISO 13485 certification, areas and products of need ripe for market entry by the right businesses, the strongest elements of potential “upside,” and what interested manufacturers and component suppliers need to consider and do to get in the game.
A few highlights:
“If you have a robust, audit-ready quality management system that is reliable and ‘defendable’ with regulatory bodies like the FDA, ISO 13485 certification achievement may not be a massive leap. It may well be an economically viable, value-based step forward.”
Photo by Mike Glatzer Photography #mikeglatzerphotos
“Not all sections of the standard apply to every type of component, its materials, or how it’s made. For injection molding, design input documentation may not apply to the supplier, for example. The responsibility for that documentation lies with the responsible design party and manufacturer of record.”
“ISO 13485 demands multiple levels of proof that the product meets the standard because you’re trying to keep someone alive, not make a flashlight. It’s rigorous because of its high value.”
“Those seeking to achieve ISO 13485 certification must be committed to the medical device market as a business you want to be in. “[But] any manufacturer or component supplier already operating in a regulated industry like aviation or the automotive industry can make excellent candidates to expand their business into the medical device market. It’s a big industry with lots of upside, but it requires full commitment.”
We invite you to read the detailed, value-packed article in its entirety on the GaMEP blog. https://gamep.org/market-access-for-medical-device-manufacturing/
If you are considering expanding your capability to achieve ISO 13485 certification and access the high demand medical device and component market, contact us for a preliminary assessment.
Thanks for reading! You can start the conversation by filling out the form below. And remember, it’s never too early to get in touch.
RELATED: Advanced Manufacturing Pilot Facility Meetup October 3rd: Unlocking Medical Device Innovation: Industry Trends & Capabilities
Along with our colleagues at the Georgia Manufacturing Extension Partnership (GaMEP), the Advanced Technology Development Center (ATDC), and Georgia AIM, GCMI invites you to join us “for a unique opportunity to learn more about the current state of the medical device space and the specialized services and capabilities our programs offer to medical device companies. Learn more & buy tickets.