Companies combining valuable devices with known drugs may be able to land a high-value exit before ever hitting the market, MIT researcher Michael Cima told a group of medical device industry leaders today.
Speaking at the Cooley Medical Device Growth conference in Boston, Cima urged med-tech companies and investors to consider drug-device combinations, acknowledging a higher up-front risk with the potential for an earlier and larger reward.
“The strategy is to think of ways that I can control the therapy in much the way a drug does but with the risk profile of a device,” Cima said. “The biggest value is in marrying drugs or devices with procedures.”
A device incorporating a drug becomes a whole therapy, and companies can capitalize on the value of the combination as early as the end of the Phase II trials, he said.
“If you own a therapy as opposed to being just another syringe,” Cima, who is a professor of materials science and engineering at MIT, told MassDevice after his keynote speech,”if it works, the value proposition is very different.”
The concern for most companies and their investors is the intimidating regulatory pathway for drugs, he said. Often, however, the applicable drug may already have the FDA green light, making the subsequent process is much simpler.
Furthermore, the extra expense and time spent in the drug pathway could lead to a much higher payoff, and an earlier one as well.
The traditional exit strategy for a medical device includes delivering results not only in the clinic but in the marketplace, Cima said. “The potential for building value early, without building a salesforce – those are the types of potential increases in value we can achieve.”
Investors aren’t always ready to jump into the drug pathway, Cima says, but there’s a lot of valuable, unmet clinical need and the acceptance curve is much steeper when you’re working with tools that physicians have seen before.
“I think the untapped area is procedures that you can do better because you have a drug,” Cima told MassDevice. “If I design my product correctly, I can put it in front of a physician who does this all the time and they know what to do.”
“That’s what I’m working on now. I’m studying different types of procedures and I work with clinicians who do these procedures to see if I can bring my gizmo to their tools that they use every day.”