Medical device marketing built from your clearance.
Plans from $3,500 a month.
For manufacturers of consumer and clinical devices: paid search and social, organic search and AI answers, launch strategy, lifecycle email and a partner pipeline for your reps, with every claim checked against your indications for use and signed off by your regulatory team.
For device companies nationwide, from Newport Beach, California.
AI-generated illustration.
- 0 of 6Page-one results we read for "medical device marketing agency" that explain FDA cleared versus approved
- $14.67 billionPayments and other transfers of value in Open Payments for 2025, reported by drug and medical device companies and other reporting entities
- No ordersWhat FDA's compliance policy lets a firm take for a device while its 510(k) is pending, outside research use
- 807.97The federal rule that makes implying FDA approval of a 510(k) device misbranding, quoted on this page
The 0 of 6 is our count of the six linked page-one results we could read for that search, from the SEO tool Ahrefs' snapshot of Google in the US, read November 9, 2026. The $14.67 billion (17.07 million records) is CMS's Open Payments figure for Program Year 2025. The orders rule is FDA's Compliance Policy Guide Sec. 300.600. The 807.97 figure is 21 CFR 807.97 at Cornell. All in the sources below.
Medical device marketing builds demand for a legally marketed device among the clinicians, buyers and patients who choose it, using only claims its FDA pathway supports. PELORA runs it from $3,500 a month: one ad channel, new ad creative and two search articles a month, with each claim checked against your FDA authorization and signed off by your regulatory team.
Last updated . What we checked: 21 CFR 807.97, 801.4 and 812.7, 21 U.S.C. 352, 15 U.S.C. 52 and 7704, 42 U.S.C. 1320a-7b and 16 CFR 255.2 and 255.5 at Cornell; FDA's "Is It Really FDA Approved?", De Novo Classification Request and Humanitarian Device Exemption pages and Compliance Policy Guide Sec. 300.600; CMS's Open Payments page; AdvaMed's Code of Ethics page; four guides from the last 90 days; the page-one results for "medical device marketing agency"; our own Brand Radar and Search Console reads; our published prices. Every read November 9, 2026 unless the page says otherwise.
By Preston Durnford, Founder and CEO, PELORA Marketing. He has owned and operated addiction and mental health treatment centers for 12 years.
What does a medical device marketing agency do for a manufacturer?
It turns a cleared device into demand: the ads, pages, videos and follow-up that reach the clinicians, buyers and patients who decide, all written from your indications for use. Here is what we run and where each piece sits in our prices.
| Piece | What it does | Where it sits |
|---|---|---|
| Paid search and social | Google or Meta campaigns by device, indication and buyer, with new ad creative every month | One channel, up to 2 campaigns, from $3,500 a month; Google and Meta together on Scale, $7,500 |
| Search and AI visibility | Answers to what buyers and clinicians ask, with structured data, so Google and AI tools can find and cite you | 2 articles a month on the $3,500 plan; the deeper program is $2,000 to $4,000 a month, on its own or added |
| Video and creative | Product demos and how-to videos, filmed and cut for ads and pages | Shoots priced by cameras and scope, from $3,500 for a one-camera interview shoot |
| Partner pipeline | The pipeline and follow-up sequences in your CRM, and a landing page for each partner type, that your reps use to reach clinicians, practices and distributors | CRM automation build $1,500 to $6,500; a campaign landing page $750 |
| Lifecycle email | Onboarding, how-to and reorder emails for device buyers, and follow-up after a demo request | From $2,500 a month, added to a plan; new flows quoted in writing |
A fit
- Makers of 510(k)-cleared, De Novo and exempt Class I and II devices, consumer or clinical
- PMA and Class III devices, with your regulatory team signing off on every claim
- Health tech and wearables that keep a clear line between wellness and medical claims
Not a fit
- Anyone who wants to take orders before clearance
- Anyone who wants to promote a use FDA has not authorized for the device
- Anyone who wants to pay clinicians or partners for referrals
What can a device company say in its marketing, and what can't it?
It can say what its FDA authorization supports, in the words that match its pathway, and back every claim with evidence. These are the rules and guidance we build every campaign around, in their own words, read at Cornell and FDA on November 9, 2026. Your regulatory team and counsel make the final call on each claim.
| Do and don't | The rule or guidance, in its own words | What we do |
|---|---|---|
| Do say "FDA cleared" for a 510(k) device. Don't say "FDA approved." | Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.(21 CFR 807.97) | Your exact authorization wording goes into the claims sheet before the first ad |
| Do keep every claim inside your indications for use. Don't market a new use. | Intended use may, for example, be shown by labeling claims, advertising matter, or oral or written statements(21 CFR 801.4) | Every ad and page is checked against your authorized indications for use; a new indication is a regulatory project first |
| Do show a device while its 510(k) is pending, if you choose. Don't take orders. | a firm 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.(FDA Compliance Policy Guide Sec. 300.600) | Pre-clearance pages collect interest, never orders or prices to buy |
| Don't promote an investigational device. | A sponsor, an investigator or anyone acting for them may not Promote or test market an investigational device, until after FDA has approved the device for commercial distribution(21 CFR 812.7) | No campaigns for an investigational device, and no promotion of a use under study |
| Do back every claim, testimonials included. | the advertiser must possess and rely upon adequate substantiation, including, when appropriate, competent and reliable scientific evidence(16 CFR 255.2) | Each claim is tied to a study or test on file; customer stories reflect typical results, not best cases, and any paid or free-product tie to the person on camera is disclosed |
| Don't run a false or misleading ad for any device. | The FTC Act makes it unlawful to disseminate, or cause to be disseminated, any false advertisement(15 U.S.C. 52); for a restricted device, it is misbranded if its advertising is false or misleading in any particular(21 U.S.C. 352(q)) | Restricted device ads carry the statements 21 U.S.C. 352(r) requires, written with your regulatory team |
FDA is plain that low-risk devices carry the lightest controls: Class I devices are subject to general controls only. Most are exempt from premarket notification requirements.
And FDA adds that Mere registration of an establishment or listing of a drug or device does not denote approval
, so we never use "FDA registered" as if it were a review. Our direct-to-consumer ad rules guide covers creator, review and platform rules for consumer health brands.
How should a device company plan marketing around FDA clearance?
In three stages, each with its own limits: before clearance, launch, and growth. The work starts well before clearance, because the clinicians and partners who drive adoption take months to reach.
Before clearance
Build the audience, not the order book: for a device with a pending 510(k), an interest sign-up that says the device is pending FDA review and not for sale (no prices, reservations or deposits); clinician education that makes no safety or effectiveness claim; conference presence; and the partner pipeline. No promotion of an investigational device or a use under study, and no orders while a 510(k) is pending.
Launch
Every claim maps to the final indications for use, with the right word for your pathway: cleared for a 510(k), granted marketing authorization for a De Novo, approved for a PMA. Paid search on the procedure and product terms buyers already use, demo videos, and the partner pipeline ready for your reps on day one.
Growth
Published outcomes, health economics for value analysis committees, more indications only after the regulatory work is done, and lifecycle email for reorders and accessories.
How do paid ads work for a medical device?
By buyer: search ads on the procedure and product names clinicians and patients type, and social ads that name the device and what it is authorized to do, never the viewer's condition. We start a consumer device on Meta or Google, and a clinical device on Google search for the procedure and product terms, then add the second channel once the first is counting demos or orders.
Google and Meta each limit how health products can target and what an ad can imply about the viewer. Those rules are quoted with their read dates on our Google Ads for healthcare and Meta ads for healthcare pages, and we re-read them before every launch, because platforms change them without notice.
How do device companies get found on Google and in AI answers?
With a dedicated page for each device and indication that answers the questions buyers ask, in plain words, with the authorization wording right. That is how we build our own pages, too.
In one Ahrefs Brand Radar read of answers captured November 6, 2026, three of the five AI engines we track named PELORA for "best energy drink marketing agency," and each cited our page for exactly that. For "best medical device marketing agency," none of the five named PELORA: we had no device page for them to cite. This page is our answer to that. One read is a baseline, not a trend, and we read it again every week.
For a device brand, that means a page per device and indication, clinician resources kept separate from patient pages, comparison pages that stay inside your claims, and structured data that matches what the page says. More on how we do it: healthcare SEO.
How do you build a referral partner program for a medical device?
By mapping who already sees the people your device helps, giving them on-label reasons to recommend it, and following up in a steady sequence run by your reps, or whoever owns partner relationships. Here is how a strong program works. We build the pipeline, the follow-up sequences in your CRM and the partner landing pages, and design the partner one-pager; your team owns the list, the evidence and the relationships.
Map the partners
The clinicians who prescribe or recommend, the practices and clinics that use the device, distributors and medical supply companies, and the specialists one step upstream. For a hospital sale, the value analysis committee and the clinical champion behind it. Your sales lead owns this map.
Build the list and the partner materials
A list by partner type and territory, an on-label one-pager and the evidence summary your regulatory team approves, with a landing page for each partner type and a demo or sample request form. Your team builds the list and the evidence summary; we design the one-pager ($250 to $750 a piece) and build the landing pages ($750 each); your regulatory team approves every piece.
Write the sequences your reps send
Email, LinkedIn and phone touches over several weeks, from your reps' own accounts, with a different first message for clinicians and for buyers. LeadHaste's 2026 medtech lead generation guide puts it bluntly:
Multi-channel sequencing is mandatory: email plus LinkedIn plus selective phone outreach.
Every email carries your company'svalid physical postal address
and a working opt-out, as CAN-SPAM requires (15 U.S.C. 7704), and a partner who says no stops getting messages. We set the sequences up in your CRM; your reps send them.Track it in your CRM
Every partner, touch, demo and order in one pipeline, built as a CRM automation build, with the monthly report showing which partner types and messages produce demos. We build the pipeline; your reps log their calls.
The rules that shape it. Knowingly and willfully paying to induce referrals or purchases of federally covered items can be a felony: the Anti-Kickback Statute reaches Whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate)
to induce a referral or purchase (42 U.S.C. 1320a-7b). Reporting entities, including drug and medical device companies, report payments and other transfers of value to covered recipients like physicians in Open Payments, which CMS publishes; Program Year 2025 holds 17.07 million published records totaling $14.67 billion
. AdvaMed's Code of Ethics gives medical technology companies guidance on ethical interactions and relationships with health care professionals
. So the program runs on education and on-label information, guided by the AdvaMed Code, never payment for referrals, and your counsel signs off on anything of value. Distributor and sales agent terms are set in your contracts with counsel.
Does lifecycle email work for a device company?
Yes, where people buy, use and buy again. For a consumer device: a welcome and setup email, how-to tips that stay inside the instructions for use, reminders for accessories and consumables, and a check-in when support is needed. For a clinical device: follow-up after a demo request, education for the clinician after the first case, and news when FDA authorizes a new indication.
The same claim rules apply to email as to ads, and so do the email rules: CAN-SPAM for commercial email and the inbox providers' sender rules. If your device is sold to patients, those emails can carry health information, so the flows are set up with your privacy counsel before the first send. Email campaign management is from $2,500 a month, added to a plan; new flows are quoted in writing.
How does PELORA run medical device marketing?
From your clearance outward, one channel first, with your regulatory team in the loop.
Start from the authorization
Your pathway, your 510(k), De Novo, PMA or HDE number (if it has one), exact indications for use and approved wording go into one claims sheet that every ad, page and email is checked against.
Your regulatory team signs off
The claims sheet and the first round of ads and pages go to your regulatory team or your MLR (medical, legal and regulatory) reviewers before anything runs.
One channel first
The channel where your buyers already search or scroll, measured on demo requests, sample requests and orders, not clicks.
The partner pipeline in parallel
The CRM pipeline, sequences and partner pages built while the ads run, so your reps start with a system.
Accounts in your name, a monthly read
Ad accounts, pages and the CRM stay yours. Each month: demos, orders and partners activated, by channel and by partner type.
Example. A company with a newly cleared Class II home-use device starts with Google search on the product and condition terms its indications cover and a partner pipeline for the clinics that recommend it, then adds Meta and lifecycle email once demos and orders are counting.
How does PELORA compare with the pages that rank for medical device marketing?
None of the six linked page-one results we read explains cleared versus approved or names the referral rules, and one of the six shows a price.
| What matters | The 6 page-one results we read | PELORA |
|---|---|---|
| FDA cleared versus approved explained | 0 of 6 | Quoted above, with 21 CFR 807.97 |
| Off-label or intended use named | 0 of 6 | 21 CFR 801.4 quoted |
| The Anti-Kickback Statute, AdvaMed or Open Payments named | 0 of 6 | All three, in the referral section |
| The FTC named | 0 of 6 | 15 U.S.C. 52 and 16 CFR 255.2 quoted |
| A price for the agency's own service | 1 of 6 | From $3,500 a month |
| A visible updated or published date | 3 of 6, all three list posts | At the top of this page |
| A device client result | Not counted | None published yet |
Counted from the six linked page-one results we could read in Ahrefs' snapshot of Google's US results for "medical device marketing agency," November 9, 2026: three agency pages and three "best of" lists. The top result's site blocks automated reads, so it is not counted. We also read three agency pages that Google's AI Overview cites; none names these rules either.
Medical device marketing, answered.
Can we call our 510(k) device "FDA approved"?
No. A 510(k) device is cleared, not approved. The regulation says a substantial equivalence determination does not in any way denote official approval of the device
, and that implying approval is misbranding (21 CFR 807.97). "Approved" is for devices FDA approved, such as through a premarket approval application or a humanitarian device exemption.
Can we market a device before it is cleared?
Only within tight limits. FDA's compliance policy lets a firm advertise or display a device with a pending 510(k), but not take orders or be prepared to take orders outside research use, and an investigational device cannot be promoted until FDA authorizes it for commercial distribution. We build interest before clearance and switch on sales after.
Can we pay clinicians or partners for referrals?
No. Knowingly and willfully paying to induce referrals or purchases of federally covered items can violate the Anti-Kickback Statute. A partner program runs on education and on-label information, guided by the AdvaMed Code, and reporting entities report transfers of value to physicians in Open Payments. Your counsel signs off on anything of value.
How much does medical device marketing cost?
Plans start at $3,500 a month for one channel (Google or Meta, up to 2 campaigns) with new ad creative every month and 2 search articles. Google and Meta together are $7,500 a month on Scale. The deeper search and AI program is $2,000 to $4,000 a month, shoots are priced by cameras and scope, from $3,500 for a one-camera interview shoot, and a CRM automation build for your partner pipeline is $1,500 to $6,500. Setup is one time: $1,500 to $2,000 on the $3,500 plan, $4,500 above it. There is a three-month minimum, and ad spend is billed to you directly, never marked up. Every price is on our pricing page.
Do you send outreach to clinicians for us?
Your reps send it. We build what they send from: the partner landing pages and the follow-up sequences, set up in your CRM, so the relationships and the records stay with your company.
Do you work with Class III and PMA devices?
Yes, with your regulatory team signing off on every claim before it runs. The rules are stricter, the buyers are fewer and the sales cycles are longer, so these programs lean on clinician education, outcomes data and the partner pipeline more than on broad ads.
Bring your clearance letter, or your submission timeline. We will show you the first channel to run.
Bring the device, its pathway and its 510(k), De Novo, PMA or HDE number (or where the submission stands), who buys it and who recommends it. You get the first channel to run, how the partner pipeline would work for your reps, and what it costs.