Disruptive, fast prototyping, iterative, warp speed.
These are not words people typically associate with the U.S. Food and Drug Administration’s medical device review process.
But in a media briefing on Monday, those words were bandied about liberally and signaled that federal bureaucrats are attempting to embrace a culture of innovation in their effort to help companies commercialize novel, safe products more quickly than before.
In announcing the next phase or version 2.0 to the Innovation Pathway program introduced in February last year, CDRH Director Jeffrey Shuren said that the program is going to bring about a new way of doing business at the FDA. The new regime will be one where safety and innovation are complementary rather than at odds with each other.
“It’s an approach that rejects the notion that safety and effectiveness are incompatible with innovation,” Shuren said. “It rejects the notion that getting devices out to American patients faster and at lower cost means we must lower standards.”
A Deep-dive Into Specialty Pharma
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.
Over the past few years, FDA has been on the receiving end from both sides — patient advocates who charge that the agency has cleared devices that are risky without requiring proper testing and medical device companies who complain that FDA has slowed down the device review process and made it extremely expensive for small companies engaged in bringing innovative products to the market.
Now through Innovation Pathway 2.0, it seems that the agency is trying to strike the right balance between its dual mandates of ensuring safety while encouraging innovation.
Through Innovation Pathway 2.0, the goal is to get entrepreneurs in companies or academia who are designing the next innovative, breakthrough product to collaborate with the FDA early on. That will help iron out regulatory uncertainty that tend to gobble up time when a novel product is actually submitted for a de novo or a premarket approval.
The FDA is concentrating on end-stage renal disease to pilot the program and announced that it had selected three products whose creators would spend 120 days in a collaborative, hands-on as well as virtual workshop with a dedicated case manager and other FDA staff and partners.
Those three products are:
- An implantable renal assist device (iRAD) being developed by the University of California, San Francisco
- A wearable artificial kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, California
- A Hemoaccess Valve System (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical.
One of the things that program participants and FDA staff can work on is the scientific evidence that would help companies overcome regulatory hurdles on the road to getting an approval. The Innovation Pathway 2.0 could bring in outside regulatory experts or scientific experts to help in this regard, said Megan Moynahan, acting associate director for Technology and Innovation at the FDA. Case managers dedicated to each team can also take advantage of experiential learning through hands-on demonstration of how a product works, she explained.
And all of this learning will increase the knowledge of FDA staff because they will review cutting-edge technology that venture capitalists get to see through dealflow, explained Jack Lasersohn, general partner with VC firm The Vertical Group. That will help to frame questions around benefit-risk analysis that is normally undertaken during the review process.
“One of the elements of this Innovation Pathway is that other very senior, experienced people at the FDA are going to be engaged in a routine manner with the applicant to help to make these decisions very, very quickly,” Lasersohn said.
He added that for these kinds of breakthrough products, the cycle from design to FDA approval could be anywhere from four to seven years, sometimes even longer. Most of the time is spent in development work and in clinical trials, and sometimes companies may spend a year and a half to determine the design of the clinical trial alone.
“That process I believe has the potential to be shortened dramatically as a result of this Innovation Pathway and the use of the decision tools that have been designed. …” Lasersohn said. “I am hoping we can save as much as half of that time, six months to a year.”
One company that might benefit from this early collaboration program intended to fast forward the device review process is CreatiVasc Medical, whose Hemoaccess Valve System was one of the three products chosen to be part of Innovation Pathway 2.0. The company is currently undertaking a phase 1 feasibility trial. President and CEO Steve Johnson said that he is most excited about the fact that through this program, he will be able to interact with outside scientific experts and collaborate with the FDA.
“What is exciting to us is when we hear we have the ability to interactively collaborate; when we hear about the ability to interact with a network of scientific experts brought in … this is extremely exciting for a small company and academia,” Johnson said. “For a small company, when you hear about shortening (review process) six months to a year, that is significant.”
FDA’s Moynahan acknowledged that the program is a “grand experiment.”
Only time will tell whether FDA is able to satisfy its dual goals of selling novel devices quickly while ensuring that they are safe.
