Opportunities and implications for ISO 9001 certified entities to access the lucrative medical device market through ISO 13485 certification
Estimates from Grand View Research and Precedence Research place 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. After all, 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. But they are also beholden to regulatory standards with extremely high levels of rigor to ensure patient safety. These levels of rigor increase in intensity depending upon a device’s classification.
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 – increasingly aligned with the section of the U.S. federal code that covers manufacturing, marketing and distribution of medical devices – brings requirements that merit careful consideration before manufacturers make the leap.
Where’s the overlap and what’s going to be needed to supplement your capabilities and market opportunities by adding ISO 13485 certification to ISO 9001? Dean Hettenbach, Rebecca Stonecipher, and Sanjana Singh of the Georgia Manufacturing Extension Partnership (GaMEP) at Georgia Tech along with Andrew Cole of the Global Center for Medical Innovation (GCMI) shared their insights with our colleague Paul Snyder.
Where ISO 9001 and 13485 Overlap
The greatest, most valuable area of overlap for prospective medical device manufacturers and suppliers is process management. ISO 9001 is a “high level chapter” in standard achievement especially as it relates to quality and quality management systems. The certification achievement demonstrates that you possess solid process management, repeatability and standardization in your enterprise. It further demonstrates understanding of requirements and mechanics of ISO certification processes.
According to Singh, you may need a different auditor for ISO 13485 versus 9001, but it’s not an entirely new universe. ISO 9001 certified enterprises have a meaningful advantage when it comes to accessing the medical device market compared to those without any type of ISO certification.
“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.”
“What the product or component needs to do can distinguish the demand for standard achievement,” Stonecipher said. “ISO 9001 may well suffice for a manufacturer or component provider to a low risk device that is not life supporting. It’s an entirely different story for components and products like an implant expected to last for decades.”
“Because ISO 13485 is more stringent in its risk mitigation, it is important for prospective suppliers to medical device manufacturers to fully understand the product or service,” Singh said. “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.
“And for those with ISO 9001 certification that have customers or prospects asking about ISO 13485, ask them why,” she continued. “ISO 9001 may well suffice for a particular device or component. But it may also be an indication that ISO 13485 is a goal worth achieving and an investment worth making.”
For more complex medical devices, especially implants and life supporting technologies, regulators require additional performance validation for componentry including before and after checks and robust documentation. If a component or product in the field fails, knowing why, throughout the product’s design, manufacturing and supply chain lifecycle with robust traceability, is codified in 21CFR820 and precisely aligned with regulators’ and auditors’ primary charge: safety.
Medical device customers who need vendors or component suppliers with ISO 13485 certification must rest assured that certified suppliers can speak to what they created, with traceability documented including who oversaw every layer and level of a product or component’s creation. Where did the raw materials come from? Did you receive it as ordered? Did you properly document that receipt? Is it the right gauge, made with the proper grade material? Is it properly coated if necessary? Will it carry the proper signal? Will it withstand acceptable testing conditions and methods?
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.
At what cost?
The operational cost of achievement and maintenance of ISO 13485 certification isn’t just a few thousand dollars in a “one and done” situation. It requires a dedicated person to oversee its adherence year round, ensuring all of the boxes are checked for audits and recertification.
“The certification creates a deliberate bottleneck to ensure quality and safety,” Cole said. “Exactly which release agents for injection molded pieces are being used? How much was put onto a mold? When was it acquired and what was its shelf life? For ISO 13485, every material and process requires precision in documentation so that all links in the chain can be examined at any given time.”
“Those seeking to achieve ISO 13485 certification must be committed to the medical device market as a business you want to be in,” Hettenbach said. “Doing it half-way is a recipe for waste. You should be ready to jump in with both feet because otherwise the certification will not be sustainable. That said, 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.”
Andrew said six to 12 months in addition to the personnel recruitment and onboarding process for certification and program management is reasonable to expect. The upfront expense could range from $50,000 – $150,000 inclusive in part of the personnel as well.
More on the upside
“Bottles, storage and packaging are overlooked areas ripe for suppliers to achieve ISO 13485 certification and open a strong medical device market,” Cole says.
“Electronic components and machined parts have promise for the right companies as well,” Rebecca says. “If your machine shop is equipped for hard materials like titanium or17-4PH stainless steel, you may be an excellent candidate as well. But the additional burden there lies in details like smoothness and residue removal in post production, as is the aforementioned burden on documentation including who oversaw production, precisely what products were used, where did they come from, when, and test results.”
Injection molding becomes a challenge due to clean room requirements and potential additional controls when machining plastics, but that challenge is not insurmountable and may be economically viable.
More quick hits about the upside of ISO 13485 achievement
- Even “simple” devices can regularly have dozens of components. And those companies and manufacturers of record need multiple suppliers of each component.
- Because you are providing the testing that assures ISO 13485 compliance, the value of your product or component is much higher.
- For customers seeking component suppliers, the ISO 13485 “icon” shortens the sales cycle for suppliers immensely. “That’s how we identify our top three suppliers for components we need as the manufacturer of record for devices. If we only see ISO 9001, we can still work with them, but the burden then falls upon us to fill all of the testing gaps. – Andrew Cole
“It would be hard to exaggerate the enhanced stickiness of customers in the med device field once you’re 13485 certified and supply successful components/products. For example, if I get a good bottle from someone and they have all the documentation and papers I need, or if I find someone who can properly mix and emulsify my active ingredient with my inactive ones while keeping it all the proper temperature and everything turns out stable and sealed well, I’m never going anywhere ever again, except to be responsible and have redundant supply chains. But my main orders would stay with Vendor A) because it’s so much time and work to vet, document, order, etc. that it would be worth staying put even if someone tries to woo my business.” – Andrew Cole
What else you’ll need to consider and / or do to get in the game
Beyond the assessment of your own ISO 9001 certification and processes in an evaluation against and comparison to ISO 13485 certification requirements, manufacturers considering a leap should jump into the medical device manufacturers’ world.
“Go to the industry leading events like Advamed or events hosted by organizations like Georgia Bio or Southeast Life Sciences,” Hettenbach says. “Otherwise, how will Stryker, for example, know about you? You have to get into their world. Then once you do, you can’t say you are ‘Thinking about it’ for too long. The window of interest can be quite small. Customers requiring ISO 13485 certification for their medical devices and components need to trust that you can play in their space and exist in the ecosystem. Talk the talk, walk the walk and be relied upon.”
“If you are considering expanding your capability to achieve ISO 13485 certification and access the high demand medical device and component market, contact us to come in and do a preliminary assessment.
If you are interested in learning more, you can start the conversation with an industry expert by filling out the form below. And remember, it’s never too early.
By: Paul Snyder, Global Center for Medical Innovation
