Why Great Medical Devices Still Fail After FDA Approval featuring Brad Maruca

There's a common assumption in MedTech: build a better device, generate strong clinical data, earn FDA clearance, and the market will take care of the rest.
According to Brad Maruca, a Managing Director in Deloitte's Medtech Division, that's one of the biggest misconceptions in the industry.

"Clinical evidence, reimbursement pathway, and commercial incentive... should be in a potato sack race together. They should be feeding off one another."
It's a memorable analogy, but it reflects a much larger point. Too often, these three areas operate independently. Engineering focuses on the product. Clinical teams focus on generating evidence. Commercial teams worry about market adoption after approval.

Brad argues that's backwards.

FDA Approval Isn't the Finish Line
Regulatory approval is essential, but it's only one milestone on the journey.
A medical device ultimately succeeds when physicians choose to use it, hospitals choose to invest in it, and payers agree to reimburse it. If those pieces aren't considered early, companies risk launching products that are technically successful but commercially unsuccessful.

As Brad explains, the commercialization strategy should actually influence how clinical studies are designed.

If your clinical trial only answers the FDA's questions, but not the questions physicians, hospitals, and insurers will ask, you've created evidence that checks a regulatory box without building a compelling business case.

Better Doesn't Always Mean Adopted
One of the most interesting points Brad raises is that companies often assume clinical superiority alone will drive adoption.

Healthcare is far more complicated.

Physicians are balancing patient outcomes with workflow, efficiency, reimbursement, and procedural complexity. Hospitals are evaluating operational impact. Insurance companies are assessing economic value.

Brad gives a simple example.

Imagine a new device improves patient outcomes but adds 45 minutes to every procedure while reimbursement remains exactly the same.

From a clinical perspective, the device may be better.

From a physician's perspective, however, that additional time directly impacts productivity and compensation.

"If you have a new device that adds 45 minutes to a procedure and reimburses identical to a faster incumbent, you're going to have a near zero adoption rate."
That's not an indictment of physicians. It's simply recognizing the realities of modern healthcare.

Commercial Strategy Should Shape Clinical Strategy
Perhaps the biggest takeaway from the conversation is that commercialization shouldn't begin after clinical trials.
It should begin before they start.
Brad believes companies should ask difficult questions early:

• What evidence will physicians actually need before changing their current practice?
• Will hospitals see operational value?
• Can payers justify reimbursement?
• Does the pricing align with the health economic value being created?
• Are we designing a study for regulators, or for the market we'll eventually sell into?

Those questions should influence study design just as much as regulatory requirements.

Comparing Against the Wrong Competition
Another challenge Brad frequently sees is how companies position their clinical data.
Many studies compare a new device against conventional or outdated treatment options because demonstrating superiority is easier.
The problem?
That's rarely what physicians are deciding between in real-world practice.

"Who's making the case that it's better? Is it better intuitively, or is it better substantiated by compelling head-to-head evidence?"
Doctors aren't comparing today's innovation against yesterday's standard of care.

They're comparing it against the best available alternatives today, whether that's another medical device, a minimally invasive procedure, or an advanced pharmaceutical therapy.

If a clinical study isn't designed with those comparisons in mind, companies may find themselves with strong regulatory data but weak commercial evidence.

Success Requires Alignment
Throughout the conversation, Brad returns to one central theme: alignment.
Clinical evidence, reimbursement planning, physician incentives, commercialization strategy, and health economics shouldn't be developed independently.

They should inform one another from the beginning.
As he puts it:
"Clinical evidence to reimbursement pathway to commercial incentive... they should be connected."

When those pieces move together, companies create products that are adoptable. When they don't, organizations often discover too late that solving a clinical problem isn't enough.

Because in MedTech, success is measured by whether the people who make healthcare decisions choose to embrace the innovation.

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