KOL and Surgeon Champion Programs for Medical Devices: How to Build One

A KOL or surgeon champion program is a planned, documented set of relationships with the physicians whose use of your device other clinicians pay attention to: advisors who shape the product, trainers who teach peers, speakers who present at meetings, and early users who let colleagues watch a case. Build it in five steps. Choose physicians by what they do, not by title. Describe each role in a written agreement. Let your compliance team set the payment rules before the first conversation about money. Give each champion real work in the first 90 days. Measure the program by the work each physician delivered and what the clinicians they trained say they learned. One fact shapes the whole program: if your company is an applicable manufacturer under the federal Open Payments program, often called the Sunshine Act, most payments and other transfers of value to physicians must be reported to CMS and published every year.

KOL versus surgeon champion: what is the difference

People use the two terms loosely, so define them in your own plan.

• A KOL (key opinion leader) is usually a physician with national reach: publications, society roles, podium time at major meetings. KOLs shape how a specialty talks about a problem.
• A surgeon champion is usually a physician who uses your device regularly and helps nearby peers adopt it: hosting case observations, proctoring first cases, answering colleagues' questions.

You will likely need both, in different numbers. In my experience, a new device launching in one region needs more local champions than national KOLs.

What each role does in a champion program

Every row is a separate kind of work, so each should be described in a written agreement, with its own record of what was done.

How to choose the physicians

Choose physicians by evidence you can check, and write the criteria down before you pick names.

1. Clinical experience in your indication. A champion should regularly perform the procedure your device is cleared for, so they can teach it.
2. Teaching and speaking record. Look at faculty lists for courses and meetings in your specialty.
3. Publications and trial roles. These matter more for advisor and speaker roles than for local champions.
4. Location. Choose physicians near the clinicians who need training first. Your sales team can suggest names, but compliance, not sales, should make the choice.
5. Existing industry relationships. Open Payments data is public, so you can see a physician's reported relationships with other companies before you approach them to check for conflicts.

Open Payments (the Sunshine Act): what gets reported and when

Open Payments is a federal disclosure program run by the Centers for Medicare & Medicaid Services (CMS). The facts a device marketer needs to know:

• Who reports. Reporting entities, "including drug and medical device companies," report payments to covered recipients. A device maker counts as an applicable manufacturer if, among other criteria, it makes at least one product reimbursed by Medicare, Medicaid or CHIP, and for a device, that product "requires premarket approval or premarket notification" by FDA. Your compliance team confirms whether your company qualifies.
• Who is covered. Covered recipients include physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives who are not your employees, and teaching hospitals.
• What is reported. Payments and other transfers of value. The CMS list of payment categories includes consulting fees, compensation for speaking and training that is not continuing education, food and beverage, travel and lodging, royalties and licenses, education, grants and gifts.
• When. Companies collect data from January 1 to December 31, submit it to CMS between February 1 and March 31 of the next year, and CMS publishes it "on or by June 30."
• Who can see it. Anyone. The data is published in a public database at OpenPaymentsData.cms.gov. For program year 2025, CMS published 17.07 million records totaling $14.67 billion.

For marketing, the practical consequence is simple: every meal at an advisory meeting, every flight to a training lab and every speaking fee can end up in a public record with your company's name and the physician's name on it. Open Payments makes these payments public; it does not decide whether they are allowed. That question is covered below.

Questions to settle with compliance before paying anyone

Paying physicians who use or recommend your device also raises the federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)). Have counsel review how you select, pay and measure physicians against OIG's Special Fraud Alert on Speaker Programs (November 2020) and the AdvaMed Code of Ethics.

These are questions for your compliance team or counsel, not rules I am stating. Settle them in writing before the first physician conversation about money.

1. What business need does each role meet, and how is that need documented?
2. How is each physician's fee set, and who signs off on it?
3. What records prove the work was done: attendance, slides, time logs, reports?
4. Which expenses are allowed for travel, meals and lodging?
5. Who records each payment for Open Payments reporting, and when?
6. Is each fee consistent with fair market value for the work, and set without regard to how much the physician uses or recommends the device?
7. Who chooses the physicians, and what role does sales have in that choice?

Using champion content in your marketing

Champion content, such as a surgeon's video or a quote on your website, is advertising, and at least two sets of rules apply.

• Disclose the relationship. The FTC's Endorsement Guides say a connection between the endorser and the seller that could affect the weight of the endorsement, and that the audience would not expect, "must be disclosed clearly and conspicuously." The Guides name "monetary payment" among such connections. A line such as "Dr. [Name] is a paid consultant to [Company]" placed next to the quote, and said or shown in the video itself, tells the audience the nature of the relationship.
• Keep the words honest and on-label. Endorsements "must reflect the honest opinions, findings, beliefs, or experience of the endorser," and FDA's intended use regulation says a company's intent can be shown by its "advertising matter, or oral or written statements" by the company or its representatives. A champion describing an uncleared use in your ad can be read as evidence of that use, so run champion content through the same claims review as the rest of your advertising.

How to measure a champion program

Measure what the program delivered and what clinicians took from it, not how many champions you have signed or what they sold.

• Training sessions and case observations held, and how many clinicians completed them
• What clinicians who attended said they learned, and the questions they still have
• Speaking slots delivered, and the questions raised at each
• Content produced, and whether each piece passed claims review on the first round
• Whether each physician delivered the work in their agreement, on time

Keep sales results out of how you evaluate, pay or renew individual physicians. Review the measures each quarter with the people who run the program and with compliance.

Where I help with champion programs

Buzzbox Media works on the marketing side of champion programs: the speaker slides and training materials (with claims review), the event and speaker promotion, the case observation and training request pages, the champion content on your website with disclosure lines in place, and the conference presence around your champions' talks. Since 2018 I have produced speaker promotion and conference marketing for the AAGL Global Congress, the annual meeting of AAGL, a medical association focused on gynecologic surgery. I do not set fees, draft physician agreements or file Open Payments reports; those stay with your compliance and legal teams.