News & Insights

One of the most expensive mistakes early-stage medtech companies make is treating regulatory as something that happens later, a box you tick after the device works and the data is in.

Part 1 looked at protocol design. Part 2 covers something more foundational. Most of the delay founders blame on “regulatory” starts long before any FDA submission, in how they framed the strategy on day zero.

The panel featured Lian Cunningham (VP of Clinical Affairs, Endogenex), Charles Dunham (Partner, Greenberg Traurig), Mark Swanson (medtech quality and ISO 13485 expert), and Lynn Carney (insurance and risk specialist, Medmarc). Joseph Panetta of Ascend Clinical Research moderated. Ascend runs clinical programs across Australia and the wider APAC region.

Regulatory strategy starts on day zero

Many device companies treat regulatory as a downstream activity. Build the device, generate data, work out the FDA later. The panel pushed back. Take that staged, sequential approach, Mark Swanson said, and you are already behind. Joseph Panetta framed the relationship:

“Regulatory is the glove part of the hand-and-glove relationship between clinical and regulatory.”Joseph Panetta, moderator

Regulatory strategy shapes the protocol. The protocol shapes the endpoints. The endpoints shape reimbursement potential. All of it drives timeline predictability and approval. Misalign them and you find out after the time and money are gone.

Quick takeawayRegulatory shapes the entire clinical pathway from day zero. You do not add it later.

Do you need US clinical data?

It is the first question Swanson’s team gets, and the answer surprises people:

“Do I need to have clinical data in the US? The answer actually is no. But … if you’re going to sell your product in the US, you should have some US data.”Mark Swanson

Regulators want to see patients who reflect the people who will use the product. A study designed for one market may not support another. Find that out late and you are left with unusable data, a delayed submission, or a repeat study.

Quick takeaway

Global clinical strategy needs global regulatory thinking. Where you generate data is a strategic decision.

Geography is a strategic choice

Different regions run on different competent authorities, quality expectations, insurance rules, and submission structures. Panetta called the decision “horses for courses”:

“There are different geographies you would go to, potentially, for different reasons.”Joseph Panetta

If you need clinical data to validate a direction for your board, some jurisdictions get you there faster without every tier-one deliverable. If you are building toward FDA clearance, you want your data to ladder up to that goal. Swanson added that your quality system has to account for those differences market by market. The requirements for Brazil are not the requirements for the US, and you need someone on the ground in each. A regionally embedded CRO brings that local judgment.

Quick takeaway

Choose where you run your trial on purpose. The cheapest geography today often becomes the most expensive one later.

The bigger lesson

Clinical, regulatory, quality, reimbursement, and geography work as one connected system. Treat them as a relay race and you discover delays after you have lost months. The teams that move best plan early and turn before they hit the wall.