MedTech Marketing Playbook

Selling a medical device to US hospitals and clinics is slower and more careful than selling software to a business. A clinician usually has to ask for your product, a value analysis committee has to approve it, a contract has to let the hospital buy it, and nurses have to use it on every shift before the hospital reorders. So start with the people, the evidence and the words, not with cold email, and plan for the reorder from the first meeting.

I wrote this playbook for founders at Seed to Series B who sell a medical device or health technology to hospitals and clinics in the US. It is general information, not legal or regulatory advice: every legal or regulatory statement links its primary source, and you are responsible for checking the consequences for your product and market with a qualified professional before you act on it.

A device can often be used in several places: an academic medical center, a community hospital, an ambulatory surgery center, a physician’s office or clinic, or the patient’s home. Each buys differently. A hospital buys through a committee and is often paid a fixed amount for a stay (Step 5); a clinic may order through a distributor it already uses; an academic center adds research and teaching interests and, in my view, usually a longer path. Trying to sell to all of them at once spreads a small team across five buying processes.

In my view, score each candidate segment on five questions before you choose:

1. Does the problem hurt enough here? Someone owns it, it shows in a number the site already tracks, and doing nothing has a cost you can size. The B2B Marketing Foundations Playbook sets out these budget tests in full.
2. Can you reach a champion? A clinician who feels the problem and will ask for your product (Step 6).
3. How long is the path to purchase? Committee, contract and approval steps, and how often the committee meets (Step 2).
4. Does your indication cover this setting and patient group? If not, you cannot market there (Step 3).
5. Can you support it? Training, in-service on every shift, supply and reorders (Step 10).

Choose one primary segment, the one that proves the product and opens the larger accounts, and at most one secondary segment that brings revenue sooner. Write down the segments you are leaving for later, so the team stops chasing them.

In my view, hospital buyers rarely act on a cold email to procurement. A medical device startup reaches them faster through three things: a clinician who asks for the product, evidence built for the value analysis committee, and a contract route the hospital already uses. So the next job is a map of who has to say yes and who can say no (Figure 2).

How hospital purchasing works (my summary, not a cited definition). A new product usually goes through value analysis: a committee of clinicians, supply chain and finance staff that weighs clinical outcomes, total cost and workflow fit against what the hospital already buys. A clinical champion normally has to request the product first. In an integrated delivery network (IDN), a health system that buys for many hospitals, one system-level decision can open or close every site. Most community hospitals belong to a health system: the American Hospital Association counts 3,567 of the 5,121 US community hospitals as part of one^[1]. Group purchasing organizations (GPOs) sit above both. In the words of a 2010 report by the US Government Accountability Office, they “negotiate contracts between their customers”, hospitals and other providers, and the vendors of medical products, and the “contract administrative fee to be paid by the vendor” is the GPO’s “main source of revenue”^[2]. Nearly every US hospital buys through at least one: GAO’s 2014 review cites an estimate of 96 to 98 percent from the Healthcare Supply Chain Association, the GPOs’ trade association^[3].

What the newest data adds. A 2026 research letter in JAMA Health Forum, using American Hospital Association survey data and the IQVIA database, found that Vizient, HealthTrust and Premier together served 84.1% of 4,760 hospitals in 2024, up from 61.7% of 5,008 in 2014^[4]. Most of that rise is one merger: MedAssets, which held 20.3% of hospitals in 2014, was acquired by Vizient in 2016, and counting it as a large group, the large groups already reached about 82% of hospitals in 2014 (my sum of the letter’s counts). The shares describe each hospital’s primary pharmaceutical group; the authors report that pharmaceutical and medical-surgical affiliations agree in 94% of cases, so ask each hospital which group covers your category rather than assuming. KFF reports the share of hospitals affiliated with a health system rising from 58% in 2010 to 69% in 2023^[5]. The GAO figure above is a trade association’s estimate that GAO quotes, not a measurement.

Record the dates as well as the names. For each target hospital, note how often the value analysis committee meets and its submission deadline. A missed deadline adds a whole cycle, and those dates set the timetable for Steps 5 to 8. I found no public source with a stated method that reports how long a value analysis committee takes, so your own dates will be the only data you have.

In my view, a medical device startup needs a medical writer, plus regulatory review, for any copy that says what the device does, for whom, how well, or compared with what. A general copywriter is fine for brand, recruiting, event logistics and anything that makes no clinical or performance claim.

Why the line matters. FDA’s rule on the meaning of intended uses says a firm’s objective intent “may, for example, be shown by labeling claims, advertising matter, or oral or written statements”^[6]. The rule names advertising and statements, not only labeling, which is why I treat the website, ads, sales deck and spokesperson quotes with the same care as the instructions for use. FDA’s June 2018 final guidance on communications consistent with labeling says that, for its purposes, information consistent with the FDA-required labeling “is limited to information about the approved or cleared uses of a product”^[7].

Who polices your ads depends on the device. In practice, GAO reports, FDA oversees advertising for restricted devices and the Federal Trade Commission for all other devices, applying a 1971 agreement that treats restricted devices like prescription drugs^[8]. The intended-use rule applies either way.

Use the word on your FDA letter. The regulation says a 510(k) determination “does not in any way denote official approval of the device” and that any representation creating “an impression of official approval” because of the 510(k) process “is misleading and constitutes misbranding”^[9]. That is why I would write “FDA cleared”, never “FDA approved”, for a 510(k), and quote the indication for use word for word. FDA grants a De Novo request and approves a PMA^[10],[11], so the word follows your route (Figure 3).

A quick test for each sentence. Does it state an outcome, a population, a comparison, a number, or cite a study? If yes, it goes to the medical writer and then to review. If no, a copywriter can write it. Documents that need a medical writer: labeling and instructions for use; clinical evidence summaries and value analysis packs; white papers, conference posters and clinician-facing emails; ads, landing pages and sales decks that make claims.

How to brief a medical writer. Give them the indication for use word for word, the list of claims you want to make with the study behind each, the audience (clinician, procurement or patient), and words you never use. Ask for a claims table: claim, source, page, and whether it sits inside the indication.

How to review. Lock signed-off wording. A copywriter may then edit for voice, but any change to meaning goes back through review.

Plan the evidence. The claims table shows what you can say today; the evidence plan shows what you will be able to say in a year, and what it takes. Different people need different proof. Clinicians want results in the patients your indication covers. The value analysis committee wants cost per patient and, often, data from a hospital like theirs (Step 8). Finance wants cash savings it can check (Step 5). For each claim you want to make, write down the evidence it needs, where it will come from (published studies, your own studies, or local evaluations at customer sites), who will run it and when it will be ready. Two cautions. A single-site evaluation can show process and cost, such as dressing changes or nurse time, but rarely has enough patients to show a change in clinical outcomes; leave outcome claims to a properly designed study. And a claim outside your indication stays outside it however good the study: ask your regulatory adviser whether a new indication would need a new submission before you plan marketing around it.

What the FTC will want behind a health claim. The FTC’s Health Products Compliance Guidance says that, as a general matter, substantiation of health-related benefits will need to be randomized, controlled human clinical testing, that results must be clinically meaningful as well as statistically significant, and that there is no requirement for a specific number of trials^[13]. In my view that settles the planning question: an outcome claim needs a controlled human study in the population your clearance covers, while a single-site evaluation of nurse time supports a claim about nurse time and nothing more.

What the evidence costs. The best public estimate covers complex devices that need premarket approval, not the 510(k) route most startups take. Researchers at Eastern Research Group built a cost model from 151 of the 191 devices approved from January 2013 to September 2018: a pivotal study cost about $30.7 million on average, enrolled about 565 patients over about 57 months at $54,332 a patient, in 2018 dollars, and only 48% of the feasibility studies in their sample moved on to a pivotal one^[14]. I found no primary estimate of what a 510(k) clinical study costs, so get a research organization’s quote for your own design before you promise a study to a committee.

Two rules that catch startups. FDA’s January 2025 guidance on sharing scientific information about uses that are not cleared was still marked “not for current implementation” on FDA’s page on October 22, 2026, so route every question about an uncleared use to a trained medical or regulatory person, not to a salesperson with a PDF^[15]. And a prospective study that compares health outcomes for a device reviewed through 510(k) or PMA may be an applicable device clinical trial; unless it is a small feasibility study it has to be registered within 21 calendar days after the first participant is enrolled^[16]. Ask your regulatory adviser before the first patient.

The people on your map in Step 2 judge the same product on different things. A surgeon looks at the patient and the procedure. A nurse manager looks at time and training on every shift. Supply chain looks at the contract and the shelf. Finance looks at cost. Infection prevention looks at instructions and handling. One message will not serve them all, and five unrelated messages make you look like five products.

In my view, write one promise about the problem your device solves, then one line for each role that translates the promise into what that person is judged on, with the proof beside it. Two rules keep it honest:

1. Every line passes the claims review in Step 3. A line for finance is still a claim, and an outcome promised to a surgeon must sit inside your indication.
2. Lead with what you can prove now, and translate it into the signer’s outcome. Minutes saved become nurse hours, then cost. A measured process gain beats an outcome you cannot yet support. The B2B Marketing Foundations Playbook compares the outcomes buyers weigh (cost, time, quality, throughput, patient outcomes) and the proof each needs.

Choose what you charge for. Decide the unit before you set a number, because the unit decides whose budget pays and how the committee compares you.

If you place equipment, work out four numbers first: placement cost, your margin per supply or use, expected uses per month at a typical site, and payback (placement cost divided by monthly margin). Do it for a best, typical and worst site, and put a minimum monthly purchase and a term into the contract. Step 3 of the Pricing, Packaging & Monetization Playbook works an example through.

What public filings show about leasing. Intuitive Surgical placed 1,721 da Vinci systems in 2025; 872 of them (50.7%) went out under operating leases and 496 (28.8% of all placements) under usage-based arrangements^[17]. Its Form 10-K lists the usage-based offering as a risk of lost revenue and higher credit risk^[18]. Instruments and accessories were $6,018.9 million of its $10,064.7 million revenue (59.8%) and systems $2,473.7 million (24.6%). Intuitive is far larger than a seed company, so use it to see the trade a placement makes, an easier first sale for carrying the equipment and the risk, and not as a benchmark for your price.

Build the value analysis pack. The value analysis pack is one document with your clinical evidence, total cost of use (not just unit price), training and workflow needs, and your FDA status in its exact wording. Ask your champion which template their committee uses and answer it in the committee’s order. The pack makes claims, so it goes through the medical writer and review in Step 3.

Total cost matters because of how the hospital is paid. For an inpatient stay, Medicare pays hospitals “predetermined, specific rates for each hospital discharge” and, with few exceptions, does not pay separately for individual items, so your price comes out of a payment that does not change^[19]. A new-technology add-on payment (NTAP) can pay the hospital part of the extra cost, at most 65%^[20], while a qualifying technology is new. Both federal shortcuts for new devices changed in 2026. The final inpatient payment rule for fiscal 2027 ends the easier alternative NTAP pathway that Breakthrough Devices used, starting with applications for fiscal 2028^[21]. And in August 2026 CMS paused its Transitional Coverage for Emerging Technologies (TCET) pathway for new candidates while it consults on a replacement, RAPID, which would propose national Medicare coverage for some Breakthrough Devices on the day FDA authorizes them^[22]. Unless your evidence can meet NTAP’s standard test, which includes substantial clinical improvement, build the pack on the hospital’s existing payment.

How tight are hospital budgets, and how slow is coverage? MedPAC’s January 2026 slides give a preliminary fiscal 2024 all-payer operating margin of 6.5% and a fee-for-service Medicare margin of −12.1%^[23]. KFF finds 2023 operating margins of 14.0% for for-profit, 4.4% for nonprofit and 3.4% for government hospitals^[5]. Kaufman Hall’s August 2026 flash report says roughly 43% of hospitals operate at a loss, against roughly 33% before the pandemic; the report is hosted by Vizient, which is also the largest purchasing group, so read it with that in mind^[24]. Coverage is slower: in a 2023 study of 281 devices and diagnostics authorized from 2016 to 2019, 64 were novel, 28 of those 64 reached explicit or implicit Medicare coverage, and the median time from FDA authorization to at least nominal coverage was 5.7 years^[25]. So build the pack on the hospital’s existing payment and its own budget, as above.

What committees weigh. Two studies point the same way, and both have limits. A 2015 survey of 34 North American hospital executives, about orthopedic implants, ranked clinical evidence and cost effectiveness as the most important factors; for new technology the executives wanted enough evidence in the literature first, then key opinion leaders, then the cost of the device^[26]. A 2015 review of 14 studies found 74 types of information hospital decision makers found relevant, with clinical, economic and political or strategic information mentioned most^[27]. Neither shows how much any factor weighs at your hospital, so lead with the evidence you have and show the cost at the hospital’s own volume.

Speak to finance. The finance members of the committee will split your savings into two kinds, so do it for them. Hard savings are cash that stops leaving: lower supply spend, less overtime or agency staff. Soft savings are time or capacity freed, and finance counts them only when they turn into cash or into more paid work. Show the full case, then a conservative case that counts only part of the soft savings. In my view, a case that still works when cut down is the one that gets approved.

For finance, the pack adds a year at the hospital’s volume of about 1,200 eligible patients:

The only hard number is a cost increase, so the conservative case counts only the nurse time that removes overtime or agency shifts. If one third does, cash savings are $21,600 against $16,800 of extra supplies: $4,800 net, with $48,000 as the upside. The pack leads with the conservative case.

Clinical champions. Meet the clinicians who feel the problem at specialty society meetings, through your clinical advisers and through authors of research in your area. Give them what they need to bring you to committee: the pack from Step 5, the line for each colleague from Step 4, and answers to the questions their colleagues will ask.

Professional-body events. Go to your users’ specialty meeting, plus supply chain events such as the AHRMM Annual Conference and Exhibition^[28], run by the Association for Health Care Resource & Materials Management, one of the American Hospital Association’s six professional membership groups^[29].

Paying clinicians is public. If your device requires premarket approval or a premarket notification (510(k)) and Medicare, Medicaid or CHIP can pay for it, separately or within a bundled payment, you are an applicable manufacturer under the Open Payments rules: payments and other transfers of value to physicians, physician assistants, nurse practitioners, clinical nurse specialists, nurse anesthetists, nurse-midwives and teaching hospitals are reported to CMS^[30], which publishes each year’s data by June 30^[31]. In my view, put every paid adviser on a written agreement for defined work at a fair market rate, and have counsel check it against the Anti-Kickback Statute (Step 9).

LinkedIn ads. LinkedIn ads can reach clinicians and hospital decision-makers by role and by named hospital. In my view, use them to reach a defined list of roles and hospitals, not to find patients, and read LinkedIn’s rules for medical device ads before you build a campaign.

• Targeting options. LinkedIn’s ad-targeting best-practices page lists job function, job seniority, job title, member skills and years of experience; company industry, name and size; and groups and member interests. Its Matched Audiences options include website retargeting, contact targeting and account targeting, the last for account-based campaigns^[32]. The same page advises keeping audiences “over 50,000 for Sponsored Content and Text Ads, and over 15,000 for Message Ads”. Niche clinical roles may fall short, so combine related titles or target a list of hospitals.
• Policy. LinkedIn’s Advertising Policies (last revised November 18, 2025) say “Ads for medical devices and medical treatments are restricted”. They say such ads “may only promote medical devices and medical treatments where it is legal” and “must adhere to all applicable laws and regulations”, and “must not target members under 18 years of age”. Ads “must not target based on sensitive data or categories”, including “data concerning health”^[33]. Every ad goes through the claims review in Step 3.
• Cost. I have not found a reliable public benchmark for what clinician clicks or leads cost. Set your own: run a small test, then compute cost per qualified conversation with the right role at a target account.
• Measuring with long sales cycles. In my view, hospital deals can take many months, so judge ads on leading signals: engagement from target accounts, lead forms from the right titles, meetings booked, and champions who agree to bring you to committee. Tag each in your CRM and review quarterly.

Most of Steps 1 to 6 can be prepared before your FDA decision, as long as what you say in public is about the problem and your company, not the product for sale (see Common questions). The decision is the moment the work turns into selling. Announce an FDA clearance only once you hold the letter, in the word that matches your route (Step 3) and with the indication exactly as the letter states it. Treat it as news for customers, trade press and investors, and pitch a story only if there is one beyond the clearance.

Timing. FDA’s releasable 510(k) database can be searched “by Panel, 510(k) number, Product code or Device name”^[34], and FDA’s monthly list of 510(k) decisions is “normally available about the 5th of each month for the prior month”^[35]. So assume competitors and reporters can see your clearance within weeks of the decision, and prepare everything before it arrives.

Embargo and wire. In my view, offer an embargo only to a few trade reporters (one to three is my rule of thumb), and only after each agrees to the embargo time in writing. A wire release gives you a dated public record for investors and search. In my view, it rarely earns coverage by itself; direct pitches do.

Is it newsworthy? In my view, it is a press story if it is a first in its category, a new indication, or comes with a clinician or customer willing to talk on record. If not, it is a customer and investor announcement.

What to prepare. Four assets, all drafted before the decision with a blank for the 510(k) number, so that only the sign-off waits for the letter. Figure 8 is Example Co.’s schedule.

Each site is evidence for the next. At Seed, aim for a pilot or evaluation that produces local data, and agree before it starts what will be measured, by whom and when the committee will see it; the Pilot-to-Contract Planner works that back from the buyer’s budget date. Then ask each new site to introduce you to peers in its network and, in a health system, to the committee that decides for the other hospitals.

Produce the evidence buyers say they weigh. The executive survey and the review in Step 5 both put clinical evidence and cost first, so an evaluation should end with one clinical or process measure and one cost measure at the hospital’s own volume, not a satisfaction score.

Write the decision down first. Before the first patient, agree in writing: one primary measure the unit already records, the baseline, the target that means “buy”, the units and patients included, who extracts the data, the decision date and the committee meeting where results will be shown, and the price for the rest of the system. In my view, an evaluation without these ends in “let’s keep going”.

Compare the change with a unit that did not change. A committee believes a result that answers “compared with what?”. Take at least four weeks of baseline from the same unit and, where the hospital allows it, keep a similar unit on current practice over the same weeks. The effect is the change in the evaluation unit minus the change in the comparison unit; it removes seasonal swings and anything else that changed at the same time. Report process and cost measures; a single unit rarely has enough patients to show a change in clinical outcomes (Step 3). Anything you publish from it is a claim and goes through review.

Ask for the least data that proves it. Counts and averages usually prove the measure; records about individual patients rarely need to leave the hospital. Use reports the unit already produces, offer to build the extract with their analyst checking it, and send your data-handling summary and security answers before you ask. If protected health information will reach you, the hospital needs a legal basis to share it; if you handle it on the hospital’s behalf, that usually means a business associate agreement. Ask for de-identified counts instead^[36]. This is general information, not legal advice; check with a qualified professional.

Turn one unit into the system. In my view, the person who said yes to the evaluation rarely signs the rollout. Meet the system’s decision-makers (supply chain, the system value analysis committee, finance) before the evaluation ends, report the result on one page your champion can forward unchanged, and ask for a specific introduction: a name, a meeting, a date. Because the price for the other sites is already in the evaluation agreement, the committee decides on the per-dressing price for all five and on rollout, not on a new negotiation.

Track where deals slow down. Record the date each hospital reaches each step: first meeting with the champion, committee submission, committee decision, contracting and first purchase order. Report the median time for each step, not the average, and look at the slowest one first. No public source I found reports a typical committee timeline, so these medians are your own evidence for the next hospital. The Analytics & Attribution Playbook covers cycle time in more depth.

GPO and IDN contracts. Once you have early customers and evidence, apply where your category is open. Budget for the vendor’s fee: in GAO’s 2014 review (2012 data) of the five largest GPOs, each said its most frequent fee was 3 percent of the purchase price^[3]. Three percent is also the line in the federal safe harbor above which the GPO’s written agreement with its members must state the amount the GPO will be paid^[37]. GAO also found that administrative fees made up about 92% of the five GPOs’ revenue in 2012 and that nearly 70% of the roughly $2.3 billion in fees was passed on to customers or owners^[3]. Because three groups served 84.1% of hospitals in 2024 (Step 2), ask each early customer which group covers your category before you spend time on an application; if a competitor already holds the contract, plan for that.

If a hospital asks you to place or lease equipment. Work the payback for your worst likely site first (Step 5), because the filings show the trade: half of Intuitive’s 2025 placements were leased, and the company lists the usage-based offering as a risk. Put a minimum purchase and a term in the contract.

How long a contract to ask for. I know of no standard term, so test three things. The term should comfortably exceed the months it takes an account’s margin to repay your cost to win and set it up, including in-service training and any equipment placed. Renewal should land when the health system builds its budget, not after. And a longer term is something you trade for: a price held for the term, a lower price per site, or a committed rollout schedule.

Distributors. Distributor reps help when clinics already buy from them, the product needs little training to sell, and you cannot afford your own reps in that territory. They hurt when they carry competing products, cannot explain your clinical value, or keep the customer data you need to learn. When a distributor fits: clinics in your segment already order supplies through a small number of distributors; the product is simple to demonstrate and reorders on its own; your price leaves room for the distributor’s margin.

Margins: use a method, not a benchmark. I have not found a reliable public figure for the right distributor margin in any category. Work backwards (Figure 10): clinic price, minus the distributor’s margin, minus your cost of goods, freight, training and support. If what is left cannot fund your company, the channel does not work at that price.

Terms to negotiate.

• Territory and exclusivity. Grant exclusivity only for a defined territory and period, tied to minimum sales, with a way out if they miss.
• Channel conflict. Write down which accounts stay direct (for example, health systems you already sell to) and how a deal is credited when both sides touch it.
• Training. Require rep training and certification before they sell.
• Data access. Require account-level sales and reorder reports, or you cannot tell growing clinics from lost ones.

Hand the distributor a kit, not a catalogue entry. Their reps carry many products, so yours needs to be the easiest to sell: a one-page pitch built from your Step 4 lines, the questions that qualify a clinic, approved claims only, pricing and margin, and a short in-service they can run with your support. Everything the distributor shows or says about your device is promotion of your product, so it goes through the same claims review (Step 3). Train the reps live, register deals so you never compete for the same clinic, and hand them the open leads you already have in their territory so they win early.

How to evaluate. Every quarter, compare distributor accounts with direct accounts on new clinics won, reorder rate, time to first reorder and support tickets.

When to go direct, and when to hire a rep. In my view, take accounts direct when one territory justifies a rep of your own, when complex training is hurting adoption, or when the distributor’s data access is blocking learning. Work out the first of these from your own numbers: going direct keeps the distributor’s margin, and that extra margin has to pay for the rep. The same arithmetic tells you when a rep pays for themselves at all; hire only when the sale repeats, the founder’s time is the limit, and there are enough qualified accounts in the territory for the rep to succeed.

Compliance. Before you agree commissions, discounts or rebates with a distributor, or pay a clinical adviser (Step 6), read how HHS-OIG describes the federal Anti-Kickback Statute: “a criminal law that prohibits the knowing and willful payment of ‘remuneration’ to induce or reward patient referrals or the generation of business involving any item or service payable by the Federal health care programs”^[38].

Sold direct, the same dressing leaves $26 ($40 less $9, $2 and $3), so going direct keeps $12 more a dressing. A typical clinic uses about 40 dressings a month, 480 a year, so a direct clinic is worth $5,760 a year more than a distributor clinic. A third rep, for clinics, would cost Example Co. about $150,000 a year fully loaded, so a territory needs at least 27 clinics that one rep can serve before going direct beats the distributor. No territory has that yet, so the distributor stays. With the health system, Example Co. asks for a 24-month agreement covering all six hospitals with the per-dressing price held for the term, and sets renewal for the month the system builds its budget.

Approval puts your product on the list; use on every shift puts it in the reorder. In my view this is where many device companies lose ground they already won: the committee says yes, the product goes on the shelf beside the one it was meant to replace, and the night shift never hears about it.

Train every shift, not just the day team. Plan in-service sessions for nights and weekends as well as days, and recruit one or two experienced users on each unit who can show colleagues and answer questions when your team is not there. Leave a one-page guide where the product is used.

Make the switch real. Agree with the unit and supply chain what happens to the product yours replaces: whether it leaves the shelf, stays for specific cases, or is reduced. In my view, if both stay side by side, staff use what they know.

Measure use, not shipments. For hospitals, track the share of eligible cases where your product was used, by unit and shift. For clinics, track reorder rate and time to first reorder, which the distributor reports from Step 9 give you, and call any clinic that has not reordered when you expected it to.

Report value back before renewal. Every quarter, send the committee a one-page report in the measure it agreed to in Step 8, with use by unit beneath it. Send the one before renewal while the system is building its budget.

What changes by stage?

What mistakes should I avoid?

• Selling to every setting at once. Choose one primary segment and at most one secondary (Step 1).
• Pitching supply chain on price before any clinician has asked for the product. Start with a champion (Steps 2 and 6).
• Letting a copywriter “sharpen” reviewed copy. A careful claim becomes one the evidence and indication do not support; changes to meaning go back through review (Step 3).
• Writing “FDA approved” for a 510(k). Not in a headline, a quote or a post (Step 3).
• Leading with unit price. Show cost per patient, and a conservative case finance can check (Step 5).
• Running consumer-style health ads. Target roles and named hospitals, and keep ad claims inside your labeling (Step 6).
• An evaluation with no comparison and no decision date. Write the measure, the comparison, the decision date and the system price down first (Step 8).
• Granting national exclusivity on day one with no minimums. Tie it to a territory, a period and a minimum (Step 9).
• Counting approvals and shipments as success. Measure use on every shift and reorders (Step 10).