Late last year, I had the honor of participating in a panel discussion during Greenlight Guru’s True Quality Roadshow, and I had the pleasure of meeting with numerous industry peers. They expressed concerns similar to those that have been echoed to me over the years regarding navigating the complex world of medical device product development. Their concerns can be summed up on one question:
How do we balance innovation with compliance?
Looking back on these discussions, I’ve put together four “gut-checks” that medical device leaders can use to ensure they get products to market while still maintaining industry best practices.
One. Am I just checking the boxes?
Over time I’ve watched medical device manufacturers neglect using good business and engineering principles to guide decision-making, and instead default to a check-box mindset. This often happens when designers approach regulations as an obligatory to-do list. In reality, regulations should be viewed as a summary of industry best practices for delivering quality and improving patient outcomes.
An example of this would be with design control methods. I’ve seen many examples of a team that designs a medical device and brings it to practice. The team then retroactively creates the design inputs and functional specifications to match the device that they already have in hand. This is opposite of the proper sequence and disobeys every standard method of design control. In order to provide quality to the end-user, their needs to be considered at the start of the project, not at the end! Including the voice of the customer from the very beginning and into the creation of design inputs will ensure that the end product meets customer needs.
In other words, following regulations (design controls) will lead to better business practice which will lead to ... customer satisfaction! It’s not just about checking boxes.
Two. How high should I really set the bar?
The trick is to make sure you are doing it right AND not overdoing it. Always do what’s right!
Often, I run into clients who simply set the bar too high because they know what it’s like to be hit with a 483. In those situations, as an advisor, it’s my job to ask, “When is enough really enough?” By running a risk-benefit analysis, we can identify whether a company, unknowingly, is spending too much time and resources out of fear rather than in pursuit of patient benefits. We at Azzur have seen many QSRs and can recommend the best fit for your business.
For instance, if you have a low-risk piece of equipment but treat it like a critical system, you’ll always be behind because you’re too busy requalifying your equipment. Instead, manufacturers should proactively establish qualification standards and schedules based on a three-tier risk assessment. This will help free up time and resources in order to move the needle forward and satisfy the FDA!
Three. Is my organization actually aligned for focus on quality?
In my 25+ years of experience, I’ve indeed seen my share of innovation for innovation’s sake—brilliant products and engineering feats that missed the mark when it came to actual usability and patient benefits.
I’d like to challenge my industry peers to move away from spending time and money bringing products to market just “because we can,” and more in the direction of taking a risk-based approach to commercialization through subject matter expertise, voice-of-the-customer data, and deep risk-based analysis.
Cross-functional collaboration between all departments of the medical device organization is more critical than ever before. This needs to start with senior management followed by a top-down approach throughout the organization. For example, the Marketing department typically identifies user needs while R&D translates these into product specifications. This fosters collaboration between the two groups.
A focus on quality also involves a focus on Risk Management, Design Control, and Compliance.
Continuously reiterating the mission of your company is incredibly important. One way to proliferate a quality culture is to focus on the importance of patient outcomes rather than operational excellence or sales numbers. By setting the expectation that higher quality work culminates in better patient outcomes, we take the burden off of Quality and stop “checking the boxes.” After all, quality is everyone’s personal responsibility.
Four. Am I ready for the MDR?
If you are selling in Europe, or plan to do so, ’m sure you’re well aware of the challenges facing our industry in the switch from MDD to MDR. With the move to the EU Medical Device Regulation, the directive we all knew so well is now four times larger, requiring global impact assessments and exponentially more data to prove patient safety.
Put another way, the roadmap to device clearance in Europe just got a whole lot trickier.
And, with Notified Bodies jumping ship and general confusion surrounding the initiative, some of us are wondering if the initiative will be successful at all. Others challenge that the stricter protocols set by EU MDR are the guidance we should have been following all along.
When all is said and done, however, the fact remains that moving forward in the age of EU MDR there will be two camps:
- The larger, more established manufacturers with in-house resources who can change course and uncover legacy documentation to support a transition to EU MDR, and
- Smaller, early-stage companies who began their quest on MDD because FDA regulations were more strict. Now, these companies are back-pedaling and in need of a strategy to meet European demands.
Time will tell the outcome of the transition to MDR and its effect on patient safety. In the meantime, it’s in our hands to identify and mitigate risk to patient safety, while pushing novel innovation forward.
Remember, the key is to take a risk-based approach to quality that betters the lives of our true customers—the patients.
How’s your gut feeling? Don’t know where to start?