It’s that time of the year when journalists and bloggers do one of two things – look forward or look back. In the interest of leaving 2016 mercifully in the dust, we’re choosing to look forward at some of the challenges – or opportunities – awaiting medical device manufacturing (MDM) in the New Year.
We found this great quote from Steve Levine, the senior director of product strategy and the executive director of the Living Heart Project at Dassault Systemes SIMULIA. He said:
“To flourish, medical device makers must change the way they innovate, design for manufacturability and differentiate their products in the market. New models are needed to identify pathways for accelerated product development, improved quality, and patient safety, all while spending less and tracking more.”
Whew. That’s quite a task.
We’ve narrowed down this year’s list to three critical items – and don’t be too shocked, they’re remarkably similar to the list we published for 2016.
- Security of connected medical devices, including wearables
- Regulatory compliance
- Cost of product development
SECURITY OF CONNECTED DEVICES: BRING ON THE BLACK HATS
If a fitness tracker can’t get the wearer’s number of steps to the monitoring system, it’s annoying but not life-threatening. But let’s say you have a child with Type 1 diabetes wearing a glucose monitor or insulin pump and that data either can’t reach the monitoring system or, even worse, hackers break into system overriding the real data with false information. That’s not a movie plot.
PC World recently reported that researchers in Belgium and Great Britain were able to disrupt the signal between a heart pacemaker-defibrillator and the programmer. And in October, Johnson & Johnson (J&J) revealed to its customers that the Animas OneTouch Ping insulin pump had a security hole that could have allowed hackers to force a pump to deliver unnecessary insulin to the wearer. In a letter to 114,000 patients, J&J offered advice to insulin pump users about how they could enact safeguards against the security gap.
Incidences like the J&J episode serve as a warning that system security is as much a mission critical function as any new product development. The healthcare segment is one of the fastest growing markets for wearables. A company looking to move into that space is well advised to heed the advice of the U.S. Food and Drug Administration, the agency which regulates the industry. “Medical device manufacturers and health care facilities should take steps to ensure appropriate safeguards,” says the FDA website. “Manufacturers are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices, including risks related to cybersecurity. They are responsible for putting appropriate mitigations in place to address patient safety risks and ensure proper device performance.”
REGULATORY COMPLIANCE: WHO'S IN CHARGE HERE?
In answer to the question above, the FDA. They run a great comprehensive site which is a must-bookmark for anyone engaged in MDM. While it’s easy to get sidetracked into rabbit holes on the website, there is a page devoted solely to medical device regulations and guidance. It’s a safe bet that the average person on the street isn’t aware that the term ‘medical device’ is used to describe everything from thermometers to Magnetic Resonance Imaging (MRI) machines. That means the FDA has guidelines for all those products. They are classified (Class I, II or III) based on associated risks.
Of course, if your product is going to be sold in Europe you’ll need to apply for a CE Mark, the letters which appear on many products traded on the extended Single Market in the European Economic Area (EEA) signifying that the product has met the EU’s standards for safety, health and environmental protection.
We recommend reading this interesting article outlining the role labeling plays in helping MDM comply with regulations. Essentially it boils down to traceability, a crucial function in the med device supply chain.
COST OF PRODUCT DEVELOPMENT:
Already one of the most expensive industries for new product development, the price tag for innovation will continue to rise with the dual pressures of the previously mentioned challenges – technology and regulation. There could be modest relief in the form of the ongoing moratorium on the 2.3 percent excise tax on the sale of medical devices – one of the industry’s biggest complaints about the Affordable Care Act (ACA). The moratorium was put in place in late 2015 and was expected to expire in 2018. With a new administration already chomping at the bit to repeal and possibly replace the ACA, it’s possible that the excise tax is gone for good.
But regulations aren’t the only financial pain points for MDM. The way hospitals go about medical device purchases has changed dramatically. According to a March 2016 article in MDDI, “100 percent of hospitals used value analysis committees to evaluate new products under consideration. The research showed that a product’s price was the most important part of the committee’s assessment of value, over factors such as patient experience.” In a classic Catch-22 scenario, the same article points out that MDM must spend more money on studies and marketing materials to share with value analysis committees in order to make the case for purchase.
Obviously our list is by no means comprehensive, or even that nuanced. Hopefully it offers an idea of what's coming down the pike with regard to the challenges facing the MDM industry. This is the part of the post where I end with a pithy quote and, as I'm one who wants to live up to expectation, here's a good one from General George S. Patton:
Accept the challenges so that you can feel the exhilaration of victory.
For more information on growing your early stage medical device company, read 3 Tips to Grow an Early Medical Device Company.
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