In uncertain times, focus on the mission, Cognito Therapeutics leaders say

Cognito Therapeutics CEO Christian Howell was a Medtronic VP when Geoff Martha was taking over for outgoing CEO Omar Ishrak and remembers asking Ishrak what advice he would offer his successor.

“I thought I was going to get this Jack Welch-ian perspective on leading a enormous company, and he said, ‘Christian, it’s unbelievably simple. It’s fidelity to the mission,'” Howell recalls. “He said, ‘Earl Bakken did us the greatest favor when he wrote the mission of Medtronic, because he wrote it in a way that it’s not just aspirational, but it’s strategic.'”

“When I came into Cognito and I assumed the role CEO,” Howell continued, “one of the first things that I wanted to do was to get focused on a mission so when times became challenging, when we were distracted, when we felt headwinds, when we had a surplus of opportunities, we could make decisions based on our fidelity to the mission.”

These are certainly challenging times. President Donald Trump’s import taxes kicked off a global trade war that is whiplashing device manufacturer’s supply chains and financial projections, while his administration’s cuts to the U.S. Department of Health and Human Services and agencies such as the FDA and Centers for Medicare & Medicaid Services are making it harder for device developers to predict if, when and how they’ll win regulatory approval and reimbursement for their products.

Cognito Therapeutics hopes to submit its Spectris device for Alzheimer’s disease to the FDA next year for approval sometime in 2027. The company won FDA Breakthrough Device Designation for the noninvasive headset in 2020 and needs a few dozen more patients with mild-to-moderate Alzheimer’s to get its pivotal trial to full enrollment of 670.

In the meantime, the device developer is planning its manufacturing strategy, component sourcing and global expansion, because there are 7 million people with Alzheimer’s in the U.S. but 50 million Alzheimer’s patients globally.

“We’re fortunate. Given where we are in our product life cycle, we are preparing our manufacturing models and footprints. … Tariffs are just one element to what has become a very volatile and uncertain, macroeconomic environment,” Howell said in a Medical Design & Outsourcing interview. “We’re always thinking about capital positioning and raising money and ideal market positions and right now there is just a great deal of uncertainty in those markets.”

Device developers need to give themselves more options for sourcing and manufacturing and be ready to adjust in the face of change or continued uncertainty, said Cognito Chief Strategy Officer Pritesh Shah.

“It’s really important to think about what’s happening today when your scale is small, but also think about how will the macro environment impact you as your scale gets a lot larger when you get to market,” he said. “… There’s more macro changes than we’ve been used to in the past, and they’re all converging at the same time.”

“Companies that are at the point of commercialization need to pivot quickly,” he continued. “You need to have option A, option B, option C, and predict to the best of your capabilities. Those companies that I believe will survive will have put thought into the pivot points: ‘What happens if this does not happen? How do we move the process forward? Or what happens if this variable — which we didn’t think was a variable — all of a sudden is dialed at the max? How do we navigate that?’ … This is the part that really drives companies to rise to the challenge.”

There’s always going to be uncertainty in medtech, Howell said.

“What doesn’t change is real clarity to the problem you’re solving,” he said. “Oftentimes we lose sight of that. We get caught up in the design reviews and the engineering and the studies, but [you need] to clearly articulate and validate the problem that you are addressing and why it has been unmet, and then how you are going about and solving that problem in a novel or unique way. … I don’t think until you’ve had a family member or until you’ve been a caregiver, that you understand what [Alzheimer’s] takes from people and how brutal the disease is.”

Especially for startups that are still laying out the blueprint for their organization, maintaining a focus on patients can help device developers and manufacturers push through obstacles, Shah said.

“It can be very motivating during challenging times if you’re thinking about the patient, if you’re thinking about the caregiver, if you’re thinking about the community that you’re going to be impacting,” he said.