Among many products, the US Food and Drug Administration (FDA) regulates medical devices such as stents and prosthetics. FDA regulations - and compliance - are predicated on an assumption that medical device production is an involved undertaking that requires expertise, monies, and physical manufacturing.
Yet, what would happen - is happening right now - if anyone can make a fully functional, complex medical device at home in about an hour?
3D Printing of Medical Devices
Late last year, two folks collaborating from opposite sides of the planet created an articulating prosthetic hand using only a cheap 3D printer.
Then, they went one step further – they uploaded the design specs on the internet so anyone can download, make and use this 3D printer prosthetic hand today. (*Note - this news story has embedded videos to watch as well so you can see the fully articulate hand in action.) The device design is now in the public domain.
Most prosthetics are Class I devices today, requiring only an FDA quality system (21 CFR 820) and compliance with the medical device reporting rules (21 CFR 803); a 510(k) is not required. Sounds straightforward when such devices are designed and made in traditional manufacturing firms. But using this public domain specification, anyone with access to the internet and a 3D printer can make this Class I device.
So…is every person who prints one of these now an FDA-regulated manufacturer?
FDA rules, regulations and statutes are predicated on an assumption that in order to start a business – in order to design and sell a product – there are significant fixed costs involved, investors may need to be sought, expensive expertise to obtained, and so on.
Now though, all one needs is a cheap 3D printer and an internet connection to download, make and use a fully articulate, Class I medical device prosthetic.
The times they are a changing.
Beyond just the FDA QSR and MDR rules, the new unique device identifier (UDI) regulation will be phased in over the next six year. 3D printed prosthetics – and other Class I devices – will need their own UDI as of 2019, if not sooner. How will this work if anyone can make their own fully functional, Class I device with a 3D printer? Keep in mind – this fully articulate, 3D printed prosthetic is just the first of future medical devices made onsite, at any site, in real-time with 3D printing.
In February 2012, a woman received an impantable replacement jaw made from a 3D printer. Presumably, any hospital could make such an implantable device on the fly, in real-time, fitted to each individual patient’s characteristics. Fabulous from a healthcare perspective but a real challenge in the context of regulations that date back to last century. Will this mean each hospital in the US has to seek its own UDI? Has to have its own quality system and device adverse event reporting programs?
FDA has an overwhelming workload now. Imagine in a few years when wide-spread 3D printing allows real-time, patient-side creation of almost any type of medical device, from prosthetics to implants, at any hospital, doctor's office or home.
Nanobots and the UDI Rule
It’s only going to get worse, though. A colleague of mine is working to commercialize injectable nanobots that scour arteries for plaque and other problems, and then, within 30 days, completely dissolve. Other firms are drawing up plans for similar nanobots to tackle digestive system issues and so on.
Thankfully for the agency, these nanobot based devices are almost a decade away. And the clinical trials will undoubtedly be highly scrutinized.
Here are just two questions injectable (or injestable) nanobots raise:
- Are these devices or drugs or combination products?
- How do you apply a UDI to something the eye cannot discern and that will disappear in 30 days?
Fundamentally, the challenge facing FDA – and facing all of us in compliance and quality – is that scientific and technologic progress is far outstripping FDA’s ability – much less any organization's ability – to understand its implications enough to be able to craft reasonable regulations and practical SOPs and policies. This is a challenge that will get far worse before it gets better.
When I give FDA compliance training and workshops to business execs and scientists, I make a point to note that regulation in the US today takes at least 8 years to go from blank sheet of paper to reality (note that the UDI rule was drafted long before Congress actually passed the authorizing FDAAA statute in 2007). The UDI rule took almost a decade to come to fruition in Congress and then be written so as to go into place this year...and with 3D printing (much less imminent nanobot devices), the UDI rule is already outdated before it formally takes effect.
How can FDA handle 3D printed devices, nano-technology medicines and other new advances?
FDA has little choice left but to regulate through guidance. Guidance documents can take less than a year to publish. And for those of us who provide expert regulatory intelligence and quality systems advice to clients, we’ve also noticed that FDA is increasingly reliant as well upon using Warning Letters to explain rules and requirements; see the recent push of late for FDA records management requirements in warning letters and this year's Ben Venue Laboratories consent decree.
Implications for Firms Today
Firms need to proactively manage the gathering and synthesizing of FDA regulatory intelligence, incorporating and applying it into their quality systems and product planning. Relying upon a regulation written before Y2K to tell you what to do in this era of social media, iPhones and 3D printing is akin to relying on a fax machine to quickly send a document. This is why FDA officials of late have cautioned against relying on former FDA officials whose last stint with the agency was twenty years ago; too much has changed since the 1990s.
Those firms large enough to dedicate a team of personnel to regulatory intelligence and its application will manage just fine over the 5-10 years, but what of firms that don’t have that kind of manpower and money? How will firms with more needs than personnel keep up with new FDA expectations and clarifications from guidance documents, warning letters, consent decrees, and even web-based FAQs?
Stay up with FDA guidance, warning letters and FAQs to avoid enforcement and new product delays.
Small to midsized firms should look to some type of outside service. Consider asking an industry expert with a good reputation to provide you regulatory intelligence services (if you need help determining how to get a good a consultant, follow the tips in this article). Ask the trusted compliance expert to provide ongoing review, analysis and suggestions stemming from “recent and newly published relevant FDA guidance documents, warning letters, consent decrees, and FAQs.” Be sure to scope out the service appropriately. Don’t ask for a weekly update if you only plan on incorporating suggestions on a quarterly basis. Most clients I deal with want advice on a monthly or quarterly basis. A good rule of thumb is to expect the expert to spend approximately 12-20 days a year providing you analysis and suggestions from relevant FDA items. Work this out for the consultant’s hourly rate or a fixed fee.
Another option, albeit much less tailored, is to subscribe to a regulatory intelligence newsletter or a quality systems newsletter such as Cerulean’s SmarterCompliance. Keep in mind that published newsletters have a large readership and so you may not find every issue to be of immediate impact. Make sure the newsletter offers a money-back guarantee of some sort so that if you cannot find anything of any value over a handful of issues, you can at least get some monies back.
FDA regulatory intelligence is only as good as its applicability. Talk with your quality system consultant or regulatory intelligence expert on how best to apply the ongoing advice in your organization; he or she should have some level of insight into what works best in day-to-day practice.
