tl;dr: We do precompliance so we build the right product, the first time.
Regulation in the healthcare industry is complex and can be hard to navigate. There are good reasons for regulation, of course: to keep consumers safe from false advertising claims (just look up the origin story for snake oil), but it also has its downsides. For anyone developing new healthcare technology, especially teams accustomed to working in agile environments, the industry’s strict regulatory environment makes compliance a major hurdle. Countless engineers and their companies have spent years and millions of dollars creating medical devices that end up getting scrapped or needing redesigns, because they were built without taking compliance into account.
Why does this keep happening? Is there a better way for your company to approach medical device development?
Yes, there is definitely a better way. At Nemedio, we call it Precompliance.
Let's back up... What does regular medical device compliance look like?
In healthcare, devices and products used to treat patients are heavily regulated by the Food and Drug Administration (FDA) to ensure that they are safe and effective. When it comes down to it, compliance in healthcare is really all about two things: safety, meaning the device does no harm, and efficacy, meaning that it is effective and solves the medical problem that your company claims it solves.
In the design, manufacture, marketing, and maintenance of a medical device, safety and efficacy are the “North Stars” that should guide your way. But claiming the safety and effectiveness of a product is easier said than done—and to create a product that is compliant per the FDA’s standards, you have to both play by the FDA’s rules (regulatory affairs) and prove that you played by their rules (quality affairs). (Note that the same applies for other countries’ regulatory agencies as well)
Maybe you’ve heard of “quality control” for everyday products, and you know there are regulatory agencies that govern those products. So when you go to Home Depot to pick up ¼-20 bolts, you know what to expect from them: the bolts will be exact in their dimensions, match with compatible products (¼-20 nuts), and function as bolts of their type should. Those quality standards are guided by ISO certifications. Companies that earn certifications have shown that they can meet certain standards of quality for one part, and can reproduce that quality when mass producing that same part at scale.
When it comes to parts and devices used in healthcare, things get more serious. Manufacturers not only have to meet quality standards for every part and component produced, engineers also often have to demonstrate compliance with their engineering processes (even if using an ISO-certified supplier), in addition to making sure that the finished device is safe enough for human contact and durable enough for long-term use.
Medical device development is a mission-critical undertaking, and even when you see news about a prototype for an incredible medical breakthrough, know that it’s not the end of the story. It takes a team of dedicated engineers, managers, regulatory, quality, and testing professionals to realize a medical device and get it to the point of FDA clearance. Then even after clearance, devices still have to be tracked for any issues and modified for continued compliance.
In other words, you are on the hook for compliance for the entire lifecycle of a device that is used on a person. The FDA expects device developers to have plans for each step in that lifecycle, and wants to see that those plans are actually used day in and day out.
So what is this better way? What is medical device pre-compliance?
Here’s a scenario that we’ve seen play out far too many times. Let’s say you’ve designed the greatest device since the red Swingline stapler. You’ve been at it for a while now and have a good prototype and have done some testing in the lab with the device. So now that everything is “finished,” it’s time to hit the regulatory path, get your clearance, and go to market—so you can plan your company’s IPO/acquisition and start your yacht purchase paperwork.
Your first step on the regulatory path: hire a compliance consulting company or a specialist.
They are excited to work with you and really believe in your product. They review your work to date and love it. Next, they want to see the risk analysis and the initial regulatory review that guided your design decisions.
*record scratch* Wait—what? Why would you need those, when you just hired them to do that type of analysis? They tell you there are guidelines around what you can build, how you can build, what materials you can use, what their mechanical properties are, and more. They are visibly stressed—but why? Can’t we just figure it out and go to market?
Then comes the really bad news. You have spent several years and millions of dollars from your investors on a device that doesn’t comply with regulations. You need to make changes—and not minor tweaks, but a full overhaul on this device because your PCBs don't comply with electrical safety standards, your software contains unvalidated open source code, and you did your clinical testing without a QMS in place. Trouble is, you don’t have the money to cover the cost of that kind of redo and your investors thought you had this all handled.
You spent a great deal of time and money to get to this realization. If only there was a way to have avoided all of this messiness.
The concept of Precompliance—bringing aspects of phase-appropriate compliance and regulatory work into your early engineering and prototyping phases—is the solution. The concept is a new one. Indeed, Nemedio invented it specifically to help companies avoid scenarios like the one outlined above: failing to bring a promising and industry-improving product to market because they ran out of money when they back-tracked their process.
Phase-appropriate compliance: the Nemedio way
Traditionally, medical device development has been understood as a linear process, from concept to launch and beyond. But in reality, modern product development is more agile and the process is more circuitous. Phase-appropriate compliance activities layer in regulatory and compliance work that will accelerate your innovative development, train your team on compliance, and ensure a smoother relationship with regulatory bodies—without slowing down your fast-moving R&D or imposing burdensome costs. And the best part? It will help you build the right product, the first time and get your life-saving or life-improving device to market safely, quickly, and with less capital.
To learn more about how Nemedio helps early-stage teams implement pre-compliance to accelerate their development and commercialization, just click here.
You can also view a recording of our latest webinar about precompliance here.
