Medical device marketing: clearance is not a go-to-market

Medical device marketing is the work of turning a regulatory claim into a purchase: deciding what the device may say, proving that claim to clinicians and payers, and getting it in front of the people who sign. Most device companies treat FDA clearance or a CE certificate as the finish line, when it only settles which claims they may make. This guide is for founders and commercial leads who need clearance to become revenue.

Key takeaways

• FDA clearance authorizes a specific intended use. Under 21 CFR 801.4, intended use is read from labeling, advertising and what company representatives say, so every asset marketing ships becomes part of the regulatory record.
• Authorization and coverage are separate gates. Of 64 novel technologies FDA authorized between 2016 and 2019 that needed new Medicare coverage, 28 (44%) got it, after a median of 5.7 years.
• A company with a pending 510(k) may advertise and display the device, but it may not take orders or be prepared to take them.
• Carrying the claim to buyers is expensive. In 2025, selling, general and administrative expense ran from 23.7% of revenue at Intuitive Surgical to 68.5% at Inspire Medical Systems, which is still building adoption of a single therapy.
• The claim chain has six links (verb, pathway, evidence, coverage, carrier, buyer), and a launch moves at the speed of the weakest one.

This guide draws on primary regulatory text from FDA, CMS, eCFR, EUR-Lex and the MHRA, on peer-reviewed research and on SEC filings, checked as of September 30, 2026. Practitioner perspective comes from the interviews behind the TGS report Health Tech Marketing in 2026: What Actually Works and from TGS's founders. Nothing here is legal or regulatory advice, and claims decisions belong with your regulatory and legal specialists.

What is medical device marketing?

Medical device marketing covers everything a device company does to get a regulated product chosen and paid for: the claims it makes, the evidence behind them, the coverage that funds them and the people who carry them to buyers. It operates inside rules that treat marketing copy as evidence of what the device is for.

The word "market" means two different things in the medical device industry. FDA uses it in the regulatory sense, and its own guidance hub is titled "How to Study and Market Your Device", covering classification, premarket submissions and the controls that follow. Buyers use it in the commercial sense, where a device is marketed once someone chooses it and someone pays for it.

Most medical device companies are organized around the first meaning. The regulatory plan has dates, owners and deliverables, while the marketing plan is often a revenue forecast with a launch event attached.

Medical device marketing also differs from other healthcare marketing in one structural way: the product's permitted claim is fixed by a regulator before the first campaign runs. Generic marketing strategies built for software or consumer goods break on that point, because they assume the company can test whatever message converts.

The regulatory meaning carries a legal limit that marketing copy trips over often. Under 21 CFR 807.97, a 510(k) "does not in any way denote official approval of the device," and any representation that creates that impression "is misleading and constitutes misbranding." FDA's 510(k) page says the order "clears" the device for commercial distribution, so "FDA cleared" and "FDA approved" are different claims with different legal weight. The distinction is crucial on anything a buyer reads, from trade show banners to investor decks that end up in sales conversations.

The commercial meaning has its own history in large medtech companies, where marketing has often been a central service function built around events while sales and clinical specialists own the conversation with healthcare professionals. Marcel Alberti spent ten years at Philips in medical imaging and diagnostics before co-founding HealthSage AI, a TGS client that now operates as Coforix. He describes a business unit turning over a billion euros that ran with five or six marketers.

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"Marketing played, in my experience, for our products in Philips, a very limited role. We would look at marketing more as events."

Marcel Alberti Co-founder of HealthSage AI (now Coforix)

That model works when a large sales team carries a portfolio of cleared products into hospitals that already buy from the company. It works badly for a startup with one device, no installed base and potential buyers who have never heard of it. For that company, the marketing plan has to do the work a large company's brand and field force used to do for free.

Why is FDA clearance not a go-to-market?

FDA clearance answers one question: may this device be sold for this intended use? It says nothing about who will pay for the device or who will carry its claim to buyers. Those are separate gates, each with its own decision makers and its own timeline, and most take longer to clear than the regulatory review did.

Coverage is the clearest example. A 2023 study in JAMA Health Forum followed 281 technologies FDA authorized between 2016 and 2019 and found 64 that were novel enough to need new Medicare coverage. Twenty-eight of those 64 (44%) reached at least nominal coverage, and the median time to get there was 5.7 years.

Evidence is the second example. FDA's review asks whether the device is safe and effective for its claim, or substantially equivalent to a predicate, while a hospital's value analysis committee asks whether it beats what the hospital already uses, in its own patients, at its own cost. A clearance study rarely answers the second question, and a launch that presents it as if it does gets found out in the first committee meeting.

Clearance comes closest to being a go-to-market when a device joins an established category, where codes and payment rates already exist and buyers already purchase the product type. The newer the claim, the longer the chain behind it, and the more of the medical device industry's commercial work happens after the clearance letter arrives.

The claim chain: six links between a clearance and a purchase order

The claim chain is TGS's model for medical device marketing strategy. The verb in the claim (the intended use) triggers a regulatory pathway, the pathway determines what evidence exists, evidence underpins coverage, and someone has to carry the claim to a buyer who can pay. Each link has a different decision maker, and a launch moves at the speed of the weakest one.

The chain starts where the five-rung claims ladder in TGS's B2B healthcare marketing guide stops. The ladder decides which verb a product can use, from "supports" up to "diagnoses or treats"; the chain follows that verb through everything that has to happen before anyone pays for it.

Evidence sits before coverage in the chain because payers now ask for it first. CMS's newest coverage route for Breakthrough devices, covered below, requires an investigational device exemption study that enrolls Medicare beneficiaries, so the design of the clinical trials has to anticipate coverage years before launch.

The chain also loops, because use in the field feeds back into the verb. When FDA sent a warning letter to WHOOP in July 2025, it said the product's disclaimers were "insufficient to outweigh the fact that the product is, by design, intended to provide a blood pressure estimation," and added that "the inefficacy of such disclaimers is demonstrated by evidence of individuals using BPI to monitor their hypertension." FDA closed the matter in June 2026, after WHOOP modified the feature and the agency issued its revised wellness guidance, so the loop runs in both directions: field use can pull a claim into device territory, and a changed product and a changed policy can pull it back out.

How does intended use decide what you can say?

Intended use is the claim a device is authorized to make, and FDA reads it from everything the company says, including advertising, sales conversations and product design. Marketing copy that goes beyond the cleared intended use can turn a legally marketed device into a misbranded one, which makes claims discipline the first job of medical device marketing.

The rule is 21 CFR 801.4. It defines intended use as "the objective intent of the persons legally responsible for the labeling," and says that intent "may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives." The current text, last amended by a 2021 final rule effective September 1, 2021, also lists "the design or composition of the article" among the ways intent can be shown.

For a marketing team, that list is the job description of a claims reviewer. The website, the sales deck, the trade show booth, the rep's talk track and the product's own interface are all admissible evidence of what the company intends the device to do, and marketing copy can create a new intended use without anyone filing anything.

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"'Predicts,' 'prevents' and 'treats' are three different regulatory universes."

Nemanja Stamenovic Head of AI at Empedoc Labs

The verb is where the discipline starts. A device cleared to "measure" or "display" a physiological value does not also "detect" a disease, and a monitoring device does not "prevent" the event it monitors for, however tempting the copy is for the target audience. Positioning work in regulated categories starts from the cleared verb and builds the right message outward from it, which is why positioning and messaging for a device company is partly a regulatory exercise.

Where claims drift past the clearance

Claims rarely drift in the regulatory submission. They drift in the dozens of assets produced after it, by people who never read the clearance letter. The patterns below are illustrative, drawn from the rules they breach rather than from any one company.

The fix is procedural rather than creative. A claims register lists every permitted claim with its evidence, scope, approved channels and review date, and every asset is checked against it before release, including the ones sales produces. Medical device manufacturers that sell in several markets need a column per market, because the same device can carry different claims in the US and the EU.

Who regulates medical device advertising?

In the US, FDA regulates the labeling of every device and the advertising of restricted devices, while the Federal Trade Commission regulates advertising for most other devices. In the EU, the Medical Device Regulation prohibits misleading claims in advertising, and member states enforce it alongside their own advertising laws.

The US split comes from statute and a 1971 agreement. Sections 502(q) and 502(r) of the Food, Drug, and Cosmetic Act apply to "any restricted device," and under the FDA–FTC memorandum of understanding the FTC holds primary responsibility for the truth of most other advertising. A 2023 GAO report states it plainly: FTC "has primary responsibility for the truth or falsity of advertising for all devices that are not restricted, including most over-the-counter medical devices."

The split matters less in practice than it looks, because FDA reads "labeling" broadly. Its device labeling page says "Most, if not all advertising, is labeling," so a brochure, a product page or a post on social media platforms that accompanies or promotes the device can fall under FDA's rules whatever the device class. For advertising the FTC polices, health claims need "competent and reliable scientific evidence" under the FTC's Health Products Compliance Guidance of December 2022, meaning research "generally accepted in the profession to yield accurate and reliable results."

Europe has one claims rule and many enforcers. Article 7 of the MDR applies to labeling, instructions for use and "advertising of devices," and national laws add their own limits: Germany's Heilmittelwerbegesetz extends its advertising restrictions to medical devices, with tighter rules for advertising aimed at the public than at healthcare professionals.

Off-label promotion and scientific exchange

Off-label use is legal for clinicians; off-label promotion by the manufacturer is not. A physician may use a cleared device for a condition outside its intended use, but a company that promotes that use can create evidence of a new intended use its clearance does not cover. Truthful scientific exchange with healthcare professionals sits in a narrower, separately governed space.

The clinician's freedom is written into statute. 21 U.S.C. 396 says nothing in the Act limits a practitioner's authority "to prescribe or administer any legally marketed device to a patient for any condition or disease," and the same section preserves existing prohibitions on promoting unapproved uses.

The 2021 amendment to 801.4 added a safe harbor that matters for any company whose device is used off-label: a firm is not regarded as intending an unapproved use "based solely on that firm's knowledge that such device was being prescribed or used by health care providers for such use." The safe harbor covers what a company knows about off-label use by healthcare providers; a campaign built around that use falls outside it. The two activities that stay inside the rules, promotion of the cleared claim and scientific exchange, differ in who runs them and what they may contain.

FDA's framework for scientific exchange is its final guidance "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers", issued January 6, 2025. It describes how firms can share truthful, non-misleading scientific information about unapproved uses with medical professionals so clinicians can make informed decisions. FDA's page still states that the guidance "is not for current implementation, pending the Office of Management and Budget's (OMB's) decision on the collection of information," so as of September 2026 it signals FDA's thinking without yet being in effect.

Case law gives firms some room without removing the risk. In United States v. Caronia (2012), the Second Circuit construed the misbranding provisions "as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs." The case involved a drug and binds only the Second Circuit, and FDA continues to treat promotional statements as evidence of intended use.

The practical answer is structural. Scientific exchange belongs in a medical affairs or clinical function with its own review, and unsolicited clinical questions from the field should be routed there while sales materials stay on the cleared claim.

Can you promote a medical device before it is cleared?

Before clearance, a company can publish its science and describe the problem it is working on, and once a 510(k) is pending it can advertise and display the device. It cannot take orders or claim that an investigational device is safe or effective. The rules differ between investigational devices, pending 510(k) submissions and EU trade fairs.

For investigational devices, 21 CFR 812.7 prohibits sponsors and investigators from promoting or test marketing the device "until after FDA has approved the device for commercial distribution," from charging more than cost recovery, and from representing that it "is safe or effective for the purposes for which it is being investigated."

For a pending 510(k), FDA's Compliance Policy Guide Sec. 300.600 sets the line: a firm "may advertise or display a device that is the subject of a pending 510(k)" but "may not take orders, or be prepared to take orders, that might result in contracts of sale for the device unless limited to research or investigational use." Trade show booths commonly carry a notice that the device is pending clearance and not available for sale in the US; the CPG itself draws the line at orders.

"Prepared to take orders" is the phrase marketing teams underestimate. A price list at the booth, an order form on the website or a "reserve yours" campaign can all look like preparation to sell, so pre-clearance marketing efforts should create an audience for updates and clinical data, never commitments to buy.

In the EU, Article 21(3) of the MDR lets companies show non-compliant devices at trade fairs and demonstrations "provided a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance."

AI-enabled devices: when the model changes, does the claim change?

An AI-enabled device can change its performance after launch only in the ways FDA authorized in advance. A predetermined change control plan (PCCP) lets the manufacturer implement pre-specified modifications without a new submission each time. A claim that grows outside that plan needs a new submission, however good the retrained model is.

FDA's final guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions", was first issued December 4, 2024 and reissued August 18, 2025. FDA reviews the PCCP as part of the marketing submission "to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP."

The category is no longer niche. FDA says it has authorized "over 1,600 AI-enabled medical devices for marketing in the United States as of September 2026."

For medical device marketing, the PCCP is a boundary on release notes as much as on the model. "Now more accurate" or "now works on a new scanner" is a performance claim, and it is only safe to publish if the change sits inside the authorized plan and has been validated as the plan describes.

Evidence gaps show up after launch. A research letter in JAMA Health Forum (August 2025) examined 950 AI-enabled devices and found 60 (6.3%) linked to 182 recall events, with 79 of those recalls (43.4%) occurring within 12 months of clearance. Lack of clinical validation was independently associated with recall (odds ratio 2.8).

A recall is a patient safety event first, and it is also a commercial one, because it rewrites every claim the sales team has made, including claims for new devices built on the same model.

Europe adds a second regime. AI systems that are medical devices requiring notified-body assessment are high-risk under the EU AI Act, and Regulation (EU) 2026/1744, the Digital Omnibus on AI that entered into force on July 27, 2026, moved those obligations for Annex I products to August 2, 2028.

What is SaMD, and how is marketing software as a medical device different?

SaMD, or software as a medical device, is software that performs a medical purpose on its own, without being part of a hardware device. Marketing it differs from marketing hardware mainly because the product's own interface counts as labeling, and because updates can change what the software does faster than the company can change what it claims.

The definition comes from the International Medical Device Regulators Forum, which FDA adopts on its SaMD page: "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." FDA launched its Digital Health Center of Excellence on September 22, 2020 to coordinate its work on software and AI devices.

The IMDRF risk framework sorts SaMD by two factors: how serious the patient's condition is, and how much the software's output drives the healthcare decision. FDA's summary of the IMDRF framework sets out four categories, where "Level IV category is Software as a Medical Device with the highest impact on the patient or public health and Level I is the lowest."

The matrix is a marketing tool as well as a regulatory one. For a serious condition, software that "informs clinical management" sits in Category I, while the same software described as one that "treats or diagnoses" sits in Category III. One verb in the product copy moves the product two categories.

The practical challenges of marketing software solutions start with four differences from hardware:

1. The interface is labeling. Onboarding screens, dashboards, push notifications and the app store listing all carry claims, and FDA's revised general wellness guidance of January 2026 treats disease references in the interface as a reason a product is not a wellness product.
2. The product changes faster than the claim. Release cycles run in weeks, while claims change through submissions or an authorized PCCP, and every update can create a gap between what the software does and what the company may say.
3. There is no rep in the room. Adoption depends on workflow fit and IT and security review, which moves much of the persuasion into documentation and integration pages, and into digital marketing and content marketing aimed at clinical and IT reviewers.
4. Payment is narrower. Hardware often slots into an existing procedure code; software frequently has to wait for a code built around its classification.

Certification becomes the price of entry to a sales conversation, before any claim is heard. Ysabel Camus, Head of Growth at The Growth Syndicate, was the sole marketer at Fireleaf, a patient data interoperability company whose founders co-authored the FHIR standard.

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"There's a whole list of certifications and regulations and compliances that your company needs to have in order to even just be credible to start a sales conversation."

Ysabel Camus Head of Growth at The Growth Syndicate

Digital therapeutics and the coverage problem

Digital therapeutics are software devices that deliver a treatment, and their history shows that authorization and coverage are separate gates. Pear Therapeutics received a De Novo grant for reSET in September 2017 and later won 510(k) clearance for reSET-O and Somryst, yet filed for Chapter 11 on April 7, 2023.

Pear's own statements show where the effort went. In its third-quarter 2022 results, the company said it continued "to break down the barriers to patient access for PDTs, evidenced by our increasing payment rate and new coverage decisions," while committing to "grow revenue while reducing our reliance on fundraising next year." Its April 2023 filing reported the termination of about 170 employees, or 92% of its full-time staff.

Medicare coverage for this category arrived through codes rather than product decisions. CMS created payment codes G0552 to G0554 for digital mental health treatment devices, and the CY2026 physician fee schedule extended them to devices "classified under 21 CFR 882.5803, digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD)." The codes pay only for devices in named classifications, so the regulatory classification decision is also a payment decision.

Choosing the category is a regulatory decision

Some health software stays outside device regulation on purpose. Marcel Alberti's company builds generative AI solutions for hospital administration and deliberately stays clear of clinical decisions; his view in the TGS report is that companies which stay in low-risk areas find adoption easier.

Regulators have started drawing that line explicitly for AI tools. The MHRA wrote in 2023 that large language models "developed for, or adapted, modified or directed toward specifically medical purposes are likely to qualify as medical devices," and in July 2026 clarified that ambient voice tools used "solely for transcription, summarising of clinical conversations, drafting letters, or suggesting clinical codes for a clinician to review" are not regulated as medical devices, while those that support diagnosis or treatment are.

Sweden's Medical Products Agency announced in March 2026 that it would inspect makers of AI assistants used in care, on the basis that systems which compile patient-specific information for clinical decisions are likely to be medical devices. In this part of the healthcare industry, the category decision sets the verbs available to marketing for years, so it belongs in the first product meeting rather than the first launch meeting.

Medical device go-to-market strategy: from clearance to coverage to adoption

A medical device go-to-market strategy plans the gates after authorization in order: who pays and under which code, what evidence each buyer needs, which people carry the claim, and which care settings buy first. It starts before the submission, because the pathway and the study design decide which coverage and evidence routes stay open.

A medical device marketing strategy that starts at clearance starts too late. Marcel Alberti found the regulation itself legible after a decade inside Philips ("I think it's clear. So you can read it."); what founders underestimate, in his words, is "the time that it takes to bring a product to market, to have it being adopted and to build a business out of it."

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"I think the go-to-market is the hardest thing, because there's enough problems to be solved. You find them everywhere. I think the technology is also ready."

Marcel Alberti Co-founder of HealthSage AI (now Coforix)

The general mechanics of a go-to-market plan (segments, positioning, channels, sequencing) are the same as in any B2B market, and the go-to-market strategy guide covers them. What changes for devices is that several gates belong to parties the company cannot move with marketing alone, from the regulator and the payer to the clinician who has to change practice, so the marketing plan has to be sequenced around their calendars.

Medical device reimbursement and market access in the US

Reimbursement in the US runs through three separate decisions: a code that describes the service, a coverage decision that says the payer will pay for it, and a payment rate. FDA authorization triggers none of them. Market access work assembles the evidence and economics each decision maker needs.

Coding comes from the AMA. Category III CPT codes are "a temporary set of codes for emerging technologies, services and procedures," while Category I criteria require FDA clearance or approval where needed, performance "by many physicians or other qualified healthcare professionals across the United States" and clinical efficacy documented in the literature.

Coverage is where the calendar stretches. The 5.7-year median from the JAMA Health Forum study is the time a novel technology waited between authorization and nominal Medicare coverage, and 36 of the 64 novel technologies in the study had not reached even nominal coverage by the end of the observation period.

CMS has tried several times to shorten the wait. The Medicare Coverage of Innovative Technology rule, which would have given Breakthrough devices automatic coverage, was repealed in November 2021 before taking effect. The Transitional Coverage for Emerging Technologies pathway followed in August 2024, and CMS said in its final notice that it did "not anticipate being able to accept more than five candidates into the TCET pathway per year."

The newest route is RAPID, announced by CMS and FDA on April 23, 2026. For eligible Breakthrough devices whose investigational study enrolls Medicare beneficiaries and measures outcomes both agencies agree on, CMS would issue a proposed national coverage determination on the day of FDA authorization, with a final national coverage determination targeted about 60 days after authorization for Class II devices and about 90 days for Class III. The procedural notice published August 11, 2026 is open for comment until October 13, 2026, and TCET is paused for new candidates while RAPID is implemented.

Timing is crucial for companies that want RAPID: eligibility depends on how the clinical study was designed, so coverage strategies have to be settled before enrollment starts, years before any launch campaign.

Breakthrough status helps, but the scale is small against the pipeline. FDA's Breakthrough Devices Program reports 1,320 designations and 210 marketing authorizations as of June 30, 2026, and the add-on inpatient payment route for those devices is narrowing: the FY2027 inpatient payment final rule repeals the alternative pathway that let Breakthrough devices skip the "substantial clinical improvement" test, starting with applications for FY2028, with a two-year grandfathering window for devices designated by September 30, 2026 and authorized by May 1, 2028.

Remote monitoring is the other route many connected devices depend on. The CPT 2026 code set added five codes for remote monitoring over "2–15 days within a 30-day period," which widens the billing window for devices whose patients do not transmit data every day.

Market access in Europe

A CE certificate gives access to the EU market; it does not give access to any national payer. Each member state runs its own health technology assessment and reimbursement system, and digital products have a handful of dedicated fast-track routes with their own evidence bars.

Germany's DiGA route is the most studied. According to the GKV-Spitzenverband's 2025 report, 74 apps were listed between September 2020 and December 2025, 14 of them proved a positive care effect at admission, and 16 were later delisted.

High-risk devices also face a new EU layer. The HTA Regulation (EU) 2021/2282 has applied since January 12, 2025 and brings joint clinical assessments for selected high-risk devices, which moves part of the evidence conversation from national payers to an EU-level process. For companies selling in several countries, the practical challenges are mostly about sequencing, since each payer still asks for its own evidence and economics.

The medical device commercialization plan

A medical device commercialization plan is the document that connects the regulatory plan to revenue. It lists the claims the company may make in each market, the evidence each buyer needs, the coverage and payment route, the people who will carry the claim and the care settings that will buy first, with owners and dates for each.

Most commercialization plans fail by omission rather than by bad tactics, because they start at channel selection and skip the links that decide whether a channel can work. The template below is TGS's synthesis of the gates covered in this guide; regulators do not publish a standard template.

Marketing earns its seat in the claims, evidence and carrier sections. The claims register governs every asset, the evidence plan decides what the marketing materials can prove, and the carrier plan sets the rules for everyone who speaks for the device. Marketing strategies that skip the coverage section tend to generate demand that stalls at the purchasing committee, where the first question is how the device gets paid for.

Medtech product launch: what marketing can do at each stage

A medtech product launch runs in five stages, and each has a different legal ceiling on what marketing may say. Before submission the company can publish science, and while a 510(k) is pending it can display the device. Once authorized it can promote the cleared use, once covered it can state the coverage, and at scale it widens claims only through new submissions.

The stages overlap in practice, especially for companies launching in Europe first. A device can be CE marked and selling in Germany while its 510(k) is pending, which means the US website and the EU website need different claims and the team running trade shows needs to know which booth is in which jurisdiction.

What evidence sells a medical device after clearance?

The evidence that sells a device answers the buyer's question rather than the regulator's. FDA asks whether a device is safe and effective, or equivalent to a predicate. A hospital or payer asks whether it will improve patient outcomes or lower cost compared with what they already use, in patients like theirs, and that usually takes studies designed after clearance.

FDA has widened the role of real-world data in regulatory decisions. Its final guidance "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices," published December 18, 2025, supersedes the 2017 version, and the same registry and real-world data that support a new indication can support a value argument with buyers.

The commercial message often lags the evidence. James Eisner, Head of Growth at The Growth Syndicate, previously worked in growth at Dream, a regulated sleep-study device company whose proposition was sleep-lab-quality results at roughly half the cost, from the patient's home. The messaging still defaulted to patient outcomes, while one-to-one sales conversations went straight to cost.

That gap is common across medical device brands, and it runs through their messaging. Patient outcomes are necessary but rarely sufficient for the decision makers who hold the budget; a device that makes the same diagnosis for half the cost should say so, as long as the economic claim is as well supported as the clinical one.

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"Generic case studies carry less and less weight. What convinces buyers is proof from their own vertical, often shown live in the sales call by naming what will and won't work in their industry before they've said anything."

Clément Dumont Co-founder, The Growth Syndicate

Specific evidence travels. Case studies from one care setting convince buyers in that setting, and a peer-reviewed publication with a named investigator convinces clinicians in a way no brochure can. For medical device companies, a publication pipeline is the most durable form of content marketing available, and educational content built on published data can be shared with healthcare professionals without drifting past the claim.

The evidence strategies that work after clearance share one habit: they plan each study around a named buyer's question. A registry built to answer a payer's cost question, or a comparative study designed with a specialty society, produces case studies and publications that sales can use for years, which a single-site pilot rarely does.

Evidence thresholds vary with the chain. A Class II device with an established code and an incumbent to displace needs comparative and economic evidence; a novel Class III device needs outcome data strong enough for a coverage decision; a low-risk accessory may need little more than usability and workflow data.

Who carries the claim to the buyer?

The claim reaches buyers through people and channels the company pays for or influences, from key opinion leaders and advisory boards to sales reps, distributors, publications, events and the website. Each carrier works under different rules, and the company answers for what all of them say about the device, which makes carrier management a core part of medical device marketing.

Key opinion leaders in healthcare

Key opinion leaders in healthcare are clinicians whose practice and publications shape how peers adopt new devices. Device companies pay them for consulting, speaking, training and research, and payments above a small reporting threshold to US physicians and teaching hospitals are published in CMS's Open Payments database.

The scale is public. For program year 2025, CMS's Open Payments data shows $14.67 billion in payments and ownership interests reported by 1,833 drug and device companies, with 667,898 physicians holding payment records. Research payments made up $9.50 billion, general payments $3.92 billion and ownership and investment interests $1.25 billion; the published summary does not split the total between drug and device makers.

The link between payments and device choice is measurable. A 2020 JAMA study of 145,900 patients receiving implantable cardioverter-defibrillators found that between 38.5% and 54.7% received a device from the manufacturer that had paid the implanting physician the most. A 2026 study in JAMA Network Open of 20,313 surgeons found that receiving a payment from a robotic surgery company was associated with a 9.9 percentage point increase in robotic-assisted surgery.

Both studies measure association, and both are the reason the rules exist. The AdvaMed Code of Ethics governs US interactions with healthcare professionals, with its latest updates effective November 1, 2025, and the MedTech Europe Code ended direct company sponsorship of individual healthcare professionals to third-party educational events after December 31, 2017.

The durable KOL relationships are research relationships. Agha and Molitor found that patients in a lead trial investigator's region were initially 36% more likely to receive a new cancer drug, a gap that closed within about four years.

What a medical advisory board is for

A medical advisory board gives a device company clinical judgment it cannot hire full-time: which endpoints matter, how the claim will read to specialists, which sites can run a study and who else in the field should see the data. Its commercial value is the way it helps the company connect with healthcare institutions and investigators, long before any sale.

Marcel Alberti's advice to device founders in the TGS report is blunt: "You better get some medical advisor on your board," or build a co-creation arrangement with a hospital. Dream went further, according to James Eisner, and made its Chief Medical Officer, a recognized sleep specialist, a visible figure; researchers wanted to work with him, and that interest arrived as inbound.

Advisory boards also create obligations. Consulting payments to US physicians are reportable in Open Payments, and the industry codes expect advisors to be paid fair market value for real work. An advisory meeting that is really a product pitch to prescribers invites the scrutiny the codes were written to prevent.

Sales reps, distributors and the cost of carrying a claim

Procedure-based device companies tend to sell through direct sales forces, because the rep also trains surgeons and supports the procedure itself. That makes the sales team the most expensive carrier of the claim and the most influential one, and FDA reads its words as the company's own. Distributors extend reach where a direct team would not pay back.

The cost shows up in 10-K filings. For fiscal 2025, selling, general and administrative expense was 23.7% of revenue at Intuitive Surgical, 34.3% at Boston Scientific and 34.4% at Stryker, and 32.4% at Medtronic for its fiscal 2026, which ended April 24, 2026. Within the medical device industry, single-therapy companies still building adoption spend roughly double that share: 65.9% at iRhythm and 68.5% at Inspire Medical Systems.

Stryker's 10-K says "most of our products are marketed directly to doctors, hospitals and other healthcare facilities," and Inspire's 10-K shows what that kind of model buys. The company sells "through a direct sales force that primarily targets ENT physicians and sleep centers," uses distributors in Singapore, Hong Kong and Thailand, and reported 295 US sales territories and 275 field clinical representatives at the end of 2025, with territory managers focused on "therapy awareness, surgeon recruiting and training" while field clinical reps provide "technical and clinical expertise as well as educational and field support."

Reps in the operating room are an accepted part of procedural medicine, within limits. The American College of Surgeons' statement on industry representatives says their help "may facilitate the safe and effective application of surgical products and technologies," while their presence "is at the discretion of the operating surgeon." An ethnographic study in PLoS One found reps working to make themselves "unobtrusively indispensable," building loyalty to themselves as well as to the product.

Adoption follows the institution as well as the surgeon. A study of 73 Michigan hospitals found robotic surgery rose from 1.8% of common procedures in 2012 to 15.1% in 2018, and use increased 8.8% in the first four years after a hospital began performing robotic surgery.

Distributors change the economics without changing the rules. Many carry medical equipment from several manufacturers, yet their reps are still speaking about the company's device, and 801.4 treats statements by a company's "representatives" as evidence of intent. Training is crucial here: alongside the distribution agreement and the approved materials, it is how the claim survives the handoff.

Marketing's role in a rep-driven company depends on how much it knows. In technical industries, including much of the healthcare industry, sales teams are often hired for domain expertise while marketers are hired for channel skills, and marketing ends up running events and producing sales collateral with little say in strategy.

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"In complex B2B industries, the marketer has to become more technical. He needs to be able to talk to a sales guy and a product guy, and even without every detail, follow the conversation. Otherwise every time you join a strategy conversation, you're going to be lost."

Clément Dumont Co-founder, The Growth Syndicate

Trade shows, events and digital channels

Trade shows and specialty congresses put a device in front of many clinicians at once, and digital marketing does much of the work before and after the booth. Both run under the same claims rules, and both work better when aimed at a narrow target audience than at a whole specialty.

Events are where the timing rules bite. A congress booth abroad may be showing a CE-marked device that is still pending clearance in the US, and a scientific session may present data on uses the company cannot promote, so the booth and the session each need their own approved materials.

Digital marketing follows the same claims logic with a longer memory. Search engines index every product page and press release, and a post on social media platforms can outlive the claim it made. Organic traffic to a device website includes patients as well as clinicians, so product pages have to work for both readers without drifting past the claim.

Digital content marketing for a device company follows the disciplines of B2B content marketing, with one difference: every piece passes a claims review first. The best strategies here put published data at the center and use educational content to connect clinicians with the evidence, which is also the content least likely to drift.

For small teams with limited resources, focus beats frequency. Tailored campaigns aimed at the right people in one specialty and one geography reach the right audience more cost effectively than broad awareness spend, and more leads rarely fix a gap further up the chain. A device sales funnel that stalls at coverage or at a value analysis committee needs evidence and access work, not more top-of-funnel volume.

How to sell medical devices by care setting

How to sell medical devices depends on where the device is used, because the care setting decides which decision makers sign and which payment route applies. Hospitals buy through committees, surgery centers through physician-owners, practices through the physicians themselves, and consumer devices through patients.

For many device companies the first buyer is a hospital, and capital medical equipment in particular goes through its budget and committee cycle. That buying process gets its own treatment in our guide to selling to hospitals: champions, budget holders, IT and security review, value analysis committees, group purchasing and credentialing. For device companies selling into health systems, account-based marketing aimed at specific departments and specialist societies works because the right people in the buying group can be named before the first campaign; sales strategies built for a single buyer do not.

Care is moving out of the hospital, and the buyer moves with it. CMS added 560 procedures to the ASC covered procedures list for 2026, which puts more device decisions in front of surgeon-owners who weigh procedure economics directly.

Practices and home settings buy on workflow and payment. A remote monitoring device succeeds when healthcare providers have the ability to bill for it and patients keep transmitting data, so the marketing plan for that buyer is mostly operational proof.

Consumer and cash-pay devices skip the coverage gate and meet a different regulator. Their advertising usually falls to the FTC and their buyers compare them with consumer products, so the discipline that matters most is keeping lifestyle copy about benefits from implying a diagnosis the device was never cleared to make.

FDA vs EU MDR vs UK: what changes for medical device marketing?

The US, EU and UK share one principle: claims must match the authorized intended purpose. They differ on who authorizes a device and who enforces the claims rules, and on how long transition arrangements last. A company selling in all three needs one claims register with a column per market, and separate marketing materials built from it.

Article 7 of the MDR is the EU claims rule in one paragraph. It prohibits text, names, trademarks, pictures and signs that may mislead about "the device's intended purpose, safety and performance" by ascribing functions the device does not have, creating a false impression about treatment or diagnosis, failing to disclose likely risks, or "suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out."

The EU's certification queue shapes launch timing. The Commission's 20th notified body survey, with data to February 28, 2026, counts 31,902 MDR certification applications lodged since designation, and Regulation (EU) 2023/607 lets qualifying legacy devices stay on the market until December 31, 2027 for Class III and most Class IIb implantables, and until December 31, 2028 for other classes.

The rules may change again. The Commission's targeted MDR and IVDR revision, COM(2025) 1023, was proposed on December 16, 2025 to simplify certification and reduce administrative burden; as of September 2026 it is still with the European Parliament's health committee, so current rules apply.

Great Britain runs a third system that still leans on CE marking. Under MHRA guidance, MDR- and IVDR-compliant devices can be placed on the GB market until June 30, 2030 and MDD-compliant general devices until June 30, 2028 at the latest; the MHRA consulted in 2026 on recognizing MDR and IVDR CE marks indefinitely and has not yet published an outcome. New post-market surveillance requirements have applied in Great Britain since June 16, 2025.

The US and EU quality systems have moved closer. FDA's Quality Management System Regulation, which incorporates ISO 13485:2016 by reference, took effect on February 2, 2026, which removes one source of duplicated work for companies certified to that standard in Europe.

Market entry strategies differ by business model more than by regulator. A software device sold to clinics can test a new market with digital channels, while a capital device sold to hospitals needs local people and local references before the first sale, which is why expanding into a new market usually costs more than the plan assumed. Regulatory requirements are only the entry ticket.

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"Classic B2B SaaS can test cost-effectively with ads and light ABM. Enterprise usually needs boots on the ground and significant upfront commitment."

Clément Dumont Co-founder, The Growth Syndicate

Where this breaks down

The claim chain is a model of medical device marketing for regulated devices sold to clinical buyers who need evidence and a payment route before they commit. Several kinds of medical device companies will find some links irrelevant and others missing, and a few need a different model altogether.

The guide also stops short of legal judgment. It describes the rules without applying them to your device; claims review, off-label questions and payments to clinicians belong with regulatory and legal specialists, and TGS's health tech marketing work runs alongside those teams rather than replacing them.

What to do next

The right next step depends on where the device sits in the chain, and for most medical device companies the weakest link is coverage or evidence rather than awareness. More importantly, the order matters: money spent on reach before the claim and the payment route are settled mostly buys attention that cannot convert.

• If you have not yet submitted, write the claims register and the evidence plan alongside the submission, and design the clinical trials with the payer's questions in mind.
• If your 510(k) is pending, create an audience through content marketing built on science and clinical data, and keep order forms and price lists out of every channel.
• If you are newly cleared, audit every asset against the clearance letter before scaling spend, and train the sales team on routing off-label questions.
• If you are cleared but not covered, shift budget and focus from awareness to market access, because marketing efforts that build clinician demand before a payment route exists tend to stall.
• If you are covered and scaling, put claims review into the release process and track what KOLs and distributors say to potential buyers.
• If you are expanding between the US and Europe, sequence markets by coverage route, since the regulator is rarely the longest gate.

Frequently asked questions

What marketing strategies work for medical devices?

The marketing strategies that work for medical devices start from the cleared claim and work outward. Evidence is built around each buyer's question and the payment route is planned before launch, while reps, KOLs and content stay within the authorized intended use. Channel choice comes last, and the right channel depends on the care setting.

Can you market a medical device without FDA approval?

Yes, in most cases, because most devices are never "approved." Class II devices usually reach the market through 510(k) clearance or a De Novo grant, and many Class I devices are exempt from premarket review. Only Class III devices generally need premarket approval, and a company should describe its device with the exact term its authorization uses.

What is the difference between FDA cleared and FDA approved?

"Cleared" means FDA found a device substantially equivalent to a legally marketed predicate through a 510(k). "Approved" means FDA approved a premarket approval application, usually for a high-risk Class III device. Describing a cleared device as approved is misleading under FDA's regulations, so marketing materials should use the term on the authorization letter.

Is off-label use of a medical device legal?

Clinicians may use a legally marketed device for conditions outside its intended use as part of practicing medicine. Manufacturers may not promote those uses, because promotion is evidence of a new intended use the clearance does not cover. Truthful scientific exchange with healthcare professionals is possible, but it has to stay separate from promotion.

Can medical device companies pay doctors?

Yes, for legitimate work such as consulting, research and speaking, paid at fair market value under industry codes like AdvaMed's in the US and MedTech Europe's. In the US, payments to physicians and teaching hospitals are published in CMS's Open Payments database, and the federal Anti-Kickback Statute prohibits payments meant to induce orders paid for by federal health programs.

How long does it take to get Medicare coverage after FDA authorization?

When a device fits an existing code and coverage policy, there may be no new decision to wait for. For novel technologies the wait is long: a 2023 study found 44% of those authorized in 2016-2019 reached at least nominal Medicare coverage, after a median of 5.7 years. CMS's proposed RAPID pathway would shorten it for some Breakthrough devices.

How much do medical device companies spend on sales and marketing?

Public device makers report selling, general and administrative expense rather than marketing alone. In 2025 it ranged from 23.7% of revenue at Intuitive Surgical to around 34% at Stryker and Boston Scientific, and reached 65.9% at iRhythm and 68.5% at Inspire, where direct sales teams are still building adoption of a single therapy.

Do you need CE marking to market a medical device in Europe?

Yes. A medical device must carry a CE mark under the EU Medical Device Regulation before it is placed on the EU market, and most classes need a notified body's certificate first. A non-compliant device may be displayed at trade fairs only with a visible sign saying it cannot be made available until it complies.

Does the EU AI Act apply to medical devices?

Yes, for AI systems that are medical devices, or safety components of them, requiring notified-body assessment under the MDR or IVDR. Those systems count as high-risk, and after the 2026 Digital Omnibus on AI their high-risk obligations apply from August 2, 2028. A pending Commission proposal would change how the AI Act and device rules interact.

Are digital therapeutics medical devices?

Most are. Software that treats a disease or condition meets the device definition in the US and the EU, and prescription digital therapeutics in the US have been authorized through De Novo grants and 510(k) clearances. Medicare now pays for some through codes tied to specific FDA classifications, such as digital mental health and ADHD treatment devices.

What is the difference between SaMD and software in a medical device?

Software as a medical device performs a medical purpose on its own, such as an algorithm that analyzes images on a standard computer. Software in a medical device is part of a hardware device, such as the firmware that runs an infusion pump. Both are regulated, but SaMD is marketed and updated independently of any hardware.