more important, and safer, to do smaller, iterative
clinicals, because your failures will become apparent much quicker. And you’ll be in a position with
the resources left to be able to pivot, redesign,
restructure, reorient, and move on to success.”
She drew an example of someone trying to
make a left hand turn, but instead opting for three
right turns, which offers the same end result. A
simple Google search yielded evidence that righthand loops lower vehicle idling time, reduce fuel
consumption, and increase driver safety. “So who
knew that going around in circles got you right to
where you want to be.” (Case in point, UPS drivers
are instructed to avoid left-hand turns.)
➎ Regulators: Check in Early and Often
So, you have your great idea, it works, you are
running clinical trials, obtaining funding, filing for a
patent… and then there’s getting approval, or more
likely multiple approvals in multiple regulatory
environments.
“It’s complicated,” said Susan Alpert, MD, PhD.
She should know: Dr. Alpert is the former Senior
Vice President and Chief Regulatory Officer at
Medtronic. Before that, she held a number of positions with the FDA including 6 years as the Director of the FDA’s Office of Device Evaluation. She
is currently the principal of SFA Consulting LLC, a
one-person firm focused on the strategies needed
to place medical devices into the global market.
In her extensive comments on the process of
obtaining regulatory approval for new devices,
products, and more, Dr. Alpert’s one overriding
message was the importance of defining a regulatory strategy early in the innovation process. This
will inform testing, choosing a market, getting
acquired by a larger company, defining your time
frame, and determining costs.
“Medical devices are regulated differently than
our pharmaceutical and biotech cousins,” said Dr.
Alpert. “In biotech and in pharmaceuticals there’s
basically one pathway and everybody’s on that
same pathway unless you’re a generic: the product is discovered, it’s developed, it goes through
clinical, it goes to market, and it has one regulatory
pathway in each jurisdiction.”
Devices, on the other hand, are regulated according to the actual risk of the product and knowledge about controlling that risk. That said, “every
jurisdiction in the world—and there are more than
50 of them—that regulate healthcare technology—each one of them has their own mindset
about protecting their population,” so a would-be
innovator has to understand how each jurisdiction
will view the risk of their product.
“Most important… don’t wait… your regulatory
strategy needs to be done early on,” Dr. Alpert
stressed. “You have to be objective about the
risks, and objective about the benefits. Craft your
plans carefully because that’s what determines
your risks and you’ll all be fine.”
ACC.org/CSWN
In Search of
“Innovation”
Who knew 1804 was a high-water mark for innovation? A Google Ngram search shows that
between 1800 and 1820, F