The Medical Device Innovation Consortium is a public-private partnership that gets the FDA and industry at the same table to get patients life-saving medtech faster. (Read more about how MDIC came to life here.) But what sounds like a great idea is easier said than done, as one of MedCity’s commenters pointed out. So I talked to MDIC President and CEO Bill Murray (no, sadly, not the Bill Murray) about what to expect from this relatively new enterprise in 2014.
In terms of milestones, MDIC hired Murray in August 2013. Murray earned his stripes in the medical device industry in nearly two decades of work at Medtronic (MDT). Most recently, he was CEO of Envoy Medical, a healthcare startup with a hearing implant. (You might remember them from this video that went viral a couple years ago.) He was also President and CEO for ReShape Medical, an obesity treatment startup with a dual-balloon device. He’s served on the boards for several companies, and is currently a member of the board at MTS Systems.
Through this experience, he’s learned about how clinical need can sometimes be frustrated by regulatory hurdles and industry misunderstanding.
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“One of the reasons I joined MDIC is because new tech development review and approval has become more and more complex and challenging for medical devices, and there’s a need to take a different approach. I see MDIC as being a vehicle for changing the way devices are developed, assessed and reviewed,” Murray said.
MDIC operates in the pre-competitive space, meaning it isn’t focused on pushing through individual technologies or approvals. Rather, the organization works to standardize processes that can make the whole machine function with less hiccups. Both industry and government want the process to be smoother. MDIC is the mediator, who brings experts from both to the table.
Take, for example, one of the consortium’s current initiatives: computational modeling.
If you think about computational modeling and simulation, the industry representative oftentimes will use computational models in his or her submissions to the FDA but there isn’t a consistent approach or consistent methodology that’s used from representative to representative, Murray said. This means the FDA must spend more time deciding whether the simulations are accurate and methodology appropriate, while the industry rep may be confounded if the FDA says it’s not enough.
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A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
MDIC is at work to identify standards and approaches to create “regular grade tools that would be efficient,” Murray said. By adding consistency, efficiency is bolstered.
Because of the complexity of this initiative, Murray said it will likely take more time.
But in 2014, MDIC should have measurable results in the way of its patient preferences project, Murray said. This will involve coming up with a patient benefit-risk assessment model based on a 2012 FDA guidance. MDIC is researching all the information about how patient preferences weigh into (or should weigh into) benefit-risk decisions, then will develop a framework that could be used for assessment throughout the PMA process. The final step is educating its members on how to use such a tool.
MDIC is already getting a head start in 2014 on its third major initiative, streamlining the clinical trial process so the U.S. can stand a chance to have first-in-humans here. Murray said the consortium has meetings this month concerning its clinical-trial innovation initiative with CMOs from participant organizations.
Patient preference benefit-risk models and clinical-trial reform seem to be pet projects of Murray, who sees patient-centeredness as the bottom line (which is often said in medical devices but less often acted upon). He gets the changing medtech landscape: Patients are the reason for innovation. They’re also increasingly becoming customers who, as consumers, should be pleased with their purchases.
“I think that I am motivated to make a difference and have an impact on our industry to the benefit of patients. The reason I got involved in medical devices is because I found it very motivating and found it was my passion. I love technology and the application of technology to benefit patients. I think MDIC has the unique opportunity to reinvigorate the ability to deliver medical device technology to patients in the U.S.”
Murray said they started the groundwork for their three major projects in 2013, setting up the teams and beginning research.
Where does the money come from for all this?
The business model is member-based. Those member organizations provide “modest” undisclosed dues, of course, but also manpower and brain power. Member organizations promise to offer staff support for the consortium when needed and based on expertise.
The third option, which MDIC has yet to take advantage of, is grant funding for specific projects.
These are monumental projects with lots of tedious steps and fancy social footwork needed. It could be that in Murray, the Life Science Alley offshoot has found the rare combo to pull off such a balancing act: a person who’s an engineer at heart but has serious networking chops.
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