In general, manufacturing is manufacturing; just make a thing. When talking about a medical device, a “thing” that could affect human health, there’s more to think about than your production line, though.
Quality management systems…really exciting stuff, I know. Typically, poorly understood and unpopular subjects with fast-moving entrepreneurs, they are usually thought to be blockades to market entry or hoops you need to jump through. Unfortunately, these systems are also necessary evils in the world of medical device manufacturing and supply, and sometimes just good business practice.
Okay, so what is a quality management system? According to the definition, “A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.” Simplified, it’s making sure what you make meets your client’s needs and keeps them happy. Seems simple enough, right? But mention FDA inspections, audits, and potential jail time for the owner or principals of a company, and people get nervous.
I’ve been in the medical device manufacturing and supply industry my entire career and have found that many people really struggle with quality management systems and implementation. I think it may be out of fear of doing the wrong thing, but this stuff is pretty straightforward and can even be easy. And you should never fear the audit or the inspection…although jail time is a different story!
Really, the key to implementing a QMS is understanding your needs in the scope of your business model and how it’s most easily conveyed to your employees. If I were manufacturing a pen, for instance, a couple of bins of parts in front of a worker with a diagram of how those parts fit together may be enough. Machining a small, highly specific part with multiple pieces, like a stent, however, requires a more thorough document describing the nuances of the process; a simple diagram may not be so appropriate.
For medical device manufacturers or supply companies, there are generally two guidelines for your QMS: FDA 21 CFR part 820 and ISO 13485 (google the acronyms for a good time). Both FDA and ISO 13485 give an outline of what you, as a medical device manufacturer, need in your QMS. That said, the FDA regulations and ISO standards are open to interpretation as to how they apply to your company and process.
Basically, you need to have control over how you manufacture, starting with raw materials all the way through your product labeling for your customer. You also need to troubleshoot issues and prevent bad products from reaching the market (doesn’t everyone?). Not a wholly unreasonable proposition.
For a raw material supplier, for which I have worked for two (one supplying highly technical raw materials, one supplying a commodity type product), the ISO standard is for you. Unfortunately, there is another caveat depending on your business model. Certainly, the FDA regulations are not your concern, but supplying parts is different from manufacturing a final device.
On the one hand, if you specifically want to target device manufacturers, complying with the 13485 standards is a great selling point / marketing tool. It can make it easier for certain companies to use you as a supplier as well, and any chance to remove a blockade to sales is just good business sense. It is also expensive to set up and maintain, which can lead to premium pricing for your products.
Conversely, if you are making a more commoditized product, ISO 9001’s general QMS standards for manufacturing (think making refrigerators, paint, HVAC systems, pens, etc.) are enough. Even a manufacturer of a medical device wants to go to the lowest bidder. Although your product was never intended for use in a device, the device manufacturer has to control their supply; the onus is on them, not you. ISO 9001 is also cheaper and easier to maintain, allowing you to stay competitive with price.
In order to manufacture, market, and sell a final medical device, whether a tongue depressor, hip replacement, or blood test, you need to establish a QMS that meets all of the regulations defined in 21 CFR part 820. There’s no getting around this one; the FDA has to be involved if you want to be a device manufacturer.
To determine your path, just evaluate your overall business model. Solicit the opinions of your potential customers, but always do what’s best for your company’s particular situation. It’s not one size fits all when it comes to a QMS, and it’s a complicated business.
If you need an outside opinion, shoot me an email. I’d be happy to help.