Device Industry Should Strive for Quality and Compliance in Parallel, Experts Say

Simply being FDA compliant — even if you’re following every regulation as closely as it can be followed — may not be enough to make your medical device one of high quality, and it is high quality devices that will not result in recalls or adverse events.

That’s according to Michelle Boucher, vice president for research for Tech-Clarity, and David Wolf, program director of Medical Device Strategy for PTC, who together led an FDAnews webinar, Making the Right Choice—Your Case for Quality.

During the presentation, Boucher said it’s the recognition of this reality that led to the launch for the FDA’s Case for Quality, an initiative that calls together industry, healthcare providers, patients, payers, and investors to foster medical device quality via identifying and promoting practices that result in high-quality devices and adapting FDA regulatory approaches to align with those practices. The Case for Quality is part of CDRH’s 2016-2017 strategic priority to promote a culture of quality and organizational excellence

Better, Safer Devices

A robust focus on quality will of course be good for patients in the form of better, safer devices, said Boucher, but it also will lead to greater return on investment, which is good for medical device manufacturers who now have to spend, on average, $400,000 to clear a warning letter when one occurs.

Indeed, the medical device industry spends between $2.5 billion and $5 billion annually to rectify nonroutine quality events such as major observations, recalls, warning letters, consent decrees, associated warranties and lawsuits. The growth of those costs is outpacing the growth of the industry, said Boucher.

A new push for high quality could also pay off in different ways. The FDA is evaluating rewarding companies for high quality by potentially eliminating a PMA or 510(k) prerelease inspection, which, said Wolf, definitely could shorten the NPI. “The more you can shift the prevention, [the more] you’re going to significantly reduce that cost of poor quality,” he added.

Boucher added that research done by McKinsey & Co. shows that the focus on quality can really drive significant opportunities and can potentially increase profits by 3 percent to 4 percent.

Focus on Quality

How to approach a new focus on quality over simple compliance?

Being small helps, said Wolf. He has worked for a large company and a small company, and said the smaller one was able to be more nimble when it came to product-centric design quality. In the smaller company, Wolf said, “we had full design controls, the CAD, we harmonized our manufacturing software with our CAD software, so we didn’t have to IGES and put that out and have a lot of rework and scrap and downtime transferring from engineering to manufacturing. And then also being able to test everything in kind of a product-centric fashion, we actually produced higher quality products than the larger company that I worked for that was doc-centric and really compliant.”

Try to be less document-centric and more design centric, Wolf said. When you have a document-centric process in place, you have to shift all the design over in a document-centric way, and it really takes away from the resources, away from innovation.

“As you make that shift, think about your entire lifecycle, because quality issues can really occur at any point along the entire lifecycle of your product development process,” said Boucher.

To thrive in the high-growth period that’s expected in the medical device industry, Boucher said, one needs to be able to manage the high cost of compliance while keeping in mind that the cost of noncompliance is even higher. To do that, companies should look to implement processes and technology that are going to help lower the cost of compliance.

Also recommended, said Wolf, is connected remote service. “We have publicly available information on companies that have implemented remote service and diagnostics and are seeing tremendous gains, sometimes up to 20 percent of their revenue on connected and remote service,” he said.

In addition, Wolf says the Internet of Things remains an exciting and promising realm that medical device companies are getting into. “It is important to get data back and not be reliant on the customer to deliver that data and get through several channels in a timely fashion back to the people that need it internal to the company,” he said of IoT.

But a key cornerstone to improving quality and thus increasing profit is software.

“What I’m seeing a lot of companies getting value out of is software, lifecycle management — specifically being able to, on the service side, have connected service and remote service with IoT,” said Wolf, who added that PTC has acquired a company called Exeda that allows one to get that information back real time.

“Trying to take advantage of the technology — without doing massive rip and replace — to me is key,” said Wolf.