Medical devices
The growth agency for medical devices: 510(k) and PMA.
Isovertic is the growth agency for healthcare, biotech, medical devices, and life sciences. This page is about medical devices: 510(k) and PMA companies making implants, diagnostics, surgical instruments, capital equipment, in vitro diagnostics, and wearables. If your organization also has a therapeutic pipeline, a research-tools catalog, or a hospital-facing service line, our [biotech page](/industries/biotech), [life sciences tools and diagnostics page](/industries/life-sciences-tools-and-diagnostics), and [healthcare page](/industries/healthcare) show what changes when the buyer is a chief scientific officer, a laboratory director, or a practice administrator.
If you are a chief executive officer, president, VP of commercial, VP of marketing, VP of regulatory, director of clinical affairs, quality director, or chief medical officer at a 510(k) or PMA-track device company, you have likely received a page draft that says the device is "FDA approved" when it is cleared. The correction seems small to the person who wrote it. It is not small to you.
The honest big thing is that commercial language has to follow the device's actual path. FDA explains the [510(k) pathway](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k) and the [PMA pathway](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma) separately because they are separate. A Class II cleared diagnostic, a Class III PMA implant, and an investigational wearable cannot be described as though they share the same evidence and indication.
We help your commercial team say enough to earn the next meeting without asking regulatory to spend every Friday repairing adjectives. You get a claims process, a review record, and work that acknowledges the people who must use, evaluate, or purchase the device.
Start with Excitation at $5,000 per month plus advertising spend, and add the MLR review gate. Pricing is published.
What you'll take away
- How to describe a cleared or approved device without overstating its regulatory status.
- What a VP of regulatory needs from an MLR review gate before commercial work moves.
- How claims differ for implants, diagnostics, surgical instruments, capital equipment, and wearables.
- What a workable account plan looks like for a Class I, II, or III device company.
- Which package gives a president, VP of commercial, or chief medical officer a sensible starting point.
What actually breaks in medical device marketing
Cleared becomes approved
The 510(k) pathway concerns substantial equivalence. PMA involves FDA approval based on a different statutory standard. The words matter in sales materials, advertisements, conference graphics, and a LinkedIn post. They also matter when a hospital value analysis committee is deciding whether your team understands its own product.
A claim floats free of the IFU
A surgical instrument's time-saving statement, a diagnostic's performance statement, or a wearable's clinical assertion needs to stay within the authorized indication and supporting evidence. The source cannot live only in one regulatory person's memory.
The commercial calendar outruns review
A VP of commercial has a meeting, a congress, and a launch date. A VP of regulatory and a quality director have the labeling, evidence, and open questions. Without a defined review gate, every urgent request becomes a fresh argument about process. Nobody enjoys that meeting twice.
One message for every buyer
A surgeon evaluating an implant, a laboratory director considering a diagnostic, and a hospital executive assessing capital equipment need different proof. Clinical utility, workflow, service requirements, cost, training, and purchasing rules change by device and setting.
What we do differently for medical devices
Product-claim advertising aligned to 510(k) or PMA status
We begin with the device classification, current regulatory status, indication for use, and approved source material. For a 510(k) device, the language reflects clearance rather than approval. For a PMA device, it reflects the approved indication and evidence. We do not make regulatory status do more work than it can. FDA's device approvals and clearances materials support the distinction.
An MLR review gate
The MLR review gate, $500 to $1,200 per month plus setup, gives your VP of regulatory and director of clinical affairs a named reviewer, a sign-off log, and a reusable claim library. We route pages, advertisements, emails, and sales-support materials through the reviewer your company designates. The record supports the next approval rather than forcing your quality director to reconstruct the last one.
Evidence matched to the device category
For implants, we distinguish bench, clinical, and post-market evidence. For diagnostics and in vitro diagnostics, we keep performance claims tied to the appropriate validation and intended use. For surgical instruments, we examine training, workflow, and procedural statements. For capital equipment, we account for installation, service, throughput, and purchasing review. For wearables, we separate wellness language from clinical claims. Specificity is not decoration. It is how the page earns trust.
Commercial work that respects clinical affairs
Your director of clinical affairs should be able to see why a requested statement exists, which evidence supports it, and what audience will read it. Your VP of marketing should be able to plan work against real review time. We track the asset, source, owner, approval status, and release date. This is not bureaucracy for its own sake. It prevents an old deck from quietly becoming the current claim set.
Ethics and purchasing context
Many device purchases run through hospital value analysis, and physician interactions may implicate the AdvaMed Code of Ethics and the Open Payments reporting context. We do not provide legal advice. We do make sure commercial assets and meeting requests do not pretend those controls are someone else's concern.
Measurement that reaches the buying group
We report inquiries, booked meetings, clinical evaluation requests, and progression through the account's own commercial stages. For capital equipment, the path may include procurement and value analysis. For an in vitro diagnostic, it may include laboratory validation. Gartner reports that business buyers spend only 17% of their buying time with any one supplier, which is a useful reason to make each interaction specific and useful. Gartner's research has the detail.
What actually shows up each month
Every package includes named deliverables, not strategy. On Excitation at $5,000 per month plus advertising spend, each month you get one published article on your site, one newsletter to your list, 16 social posts, one managed Google Ads campaign built around the searches a surgeon, laboratory director, or hospital service-line lead actually types, one campaign landing page refreshed as needed, one-business-day inbound response, and a 60-minute monthly strategy call with the account lead. The website rebuild and hosting are included across the year. Add the MLR review gate on top. See every package and add-on on the pricing page.
What this looks like on an account like yours
Here is a hypothetical account. A Class II surgical instrument company preparing its first regional commercial push. The president wants meetings with health-system service-line leaders. The VP of regulatory has an approved indication and supporting evidence, but the current site mixes cleared language with broad claims about outcomes. The director of clinical affairs is fielding the same evidence question repeatedly.
We start by collecting the indication, IFU, approved references, current product language, and the questions sales hears most often. We form a claim library with the regulatory reviewer, then rebuild the product and meeting-request pages around what the device is cleared to do. We prepare a small set of approved supporting materials for the commercial team. When paid activity is appropriate, it directs prospects to a reviewed page and reports booked meetings and evaluation requests, not applause.
The first report may show that the obstacle is not interest. It may be training capacity, purchasing timing, a missing economic case, or the lack of a local reference site. That is useful news. A page cannot repair a missing clinical program, but it can stop inventing confidence around one.
The package you'd probably start on
Start with Excitation at $5,000 per month plus advertising spend, and add the MLR review gate. Excitation includes a website rebuild across the year, one published article, a newsletter, 16 social posts, one managed Google Ads campaign, a campaign page, one-business-day inbound response, and a monthly strategy call. It is a 12-month engagement.
The 12-month term is deliberate. FDA and clinical affairs review cycles do not become shorter because a launch date is close. Google also says search changes can take four months to a year. We report early operating signals every 30 days and review pipeline and revenue at months six and 12, matched to the actual commercial cycle.
The honest limits
We cannot obtain clearance or approval, create clinical evidence, or turn an investigational product into a commercially promotable device. We cannot override your regulatory reviewer or your quality director. We also cannot make a capital purchase happen before the hospital's budget and value analysis process permit it. We can make the commercial work clearer and easier to defend.
Disclaimer
This piece is a marketing operating framework, not legal advice. Regulatory obligations for a medical device depend on classification, indication, and the applicable FDA pathway. The controlling sources include the FDA's 510(k) pathway page, the PMA pathway page, and your device's cleared or approved labeling. Consult qualified regulatory counsel before implementing any of the above.
What founders ask first
Yes. For a 510(k) device, the language reflects clearance rather than approval. For a PMA device, it reflects the approved indication and evidence. We route commercial assets through the reviewer your company names.
Yes. The MLR review gate uses the reviewer you designate. We keep the sign-off log and claim library so the next approval does not start from a blank page.
Inquiries, booked meetings, clinical evaluation requests, and progression through your own commercial stages, with leading indicators every 30 days and revenue reviewed against the actual sales cycle.
Send us your best-converting landing page.
If you would rather talk it through, book a pipeline call and send us your best-converting landing page. In about ten minutes we will tell you what is unclear, whether the fix is an MLR review gate or a smaller correction, and what a rebuild would cost, or whether you need one at all. Sometimes the honest answer is you are already fine, and we are happy to say so and hand you back your afternoon.
George Stoff, Founder and Lead Engineer
Full-stack engineer with more than 30 years building the systems companies sell through. He built the method Isovertic runs on and stays on every account as the standards owner and the escalation path. When search algorithms shift or a compliance question comes up, you get his engineering judgment. Day-to-day execution runs on the team he trained.
LinkedInKristen Coughlin, Chief Operating Officer
Trained molecular biologist. Ten years selling translational research products, then institutional operations in the Department of Microbial Pathogenesis at the Yale School of Medicine. She reviews life-science work before it reaches a client's medical, legal, and regulatory reviewer. She also built the delivery operation: took the method George engineered, wrote it down, trained the team on it, and turned it into a repeatable engagement so the same system runs the same way on every account.
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