Medical Device Launch Marketing Plan: 90, 60 and 30 Days Before Clearance

A medical device launch marketing plan works backward from your expected clearance date in three steps. Ninety days out, decide who the buyers are and what you will say, and build the review process. Sixty days out, draft the website, sales materials, emails and ads with the indication left as a placeholder. Thirty days out, get everything through review so it is ready to switch on. On clearance day, four things should be ready: a product page that states the cleared indication in the clearance letter's words, reviewed sales materials, one marketing channel with a named owner, and tracking that shows which leads become sales conversations. For budget, Buzzbox Media's published ranges are $5,000 to $15,000 a month for an ongoing retainer and $10,000 to $75,000 or more for launch projects such as a website build, plus ad spend, booth and travel costs paid separately.

Build the plan backward from the clearance date

Write every task as a number of days before or after clearance, not as a calendar date. When the date moves, and it often does, the plan moves with it in one edit.

Keep a second, short list of commitments that cannot move: booth contracts, conference speaker deadlines, print runs and signed agreements with dates in them. Those do not re-date themselves, so review each one by hand whenever the clearance date changes.

One rule applies to every step below. FDA's regulation on intended use says a company's intent can be shown by "labeling claims, advertising matter, or oral or written statements" (21 CFR 801.4), so claims about what the device does wait until you have the clearance letter's language. Work on the company, the team and the buyer can start now.

90 days before expected clearance: decide and set up

• Buyer research. List who uses the device, who recommends it, who approves the purchase and who signs the contract. Write down what evidence each of them needs to see.
• Messaging. Write the positioning and the main messages with the indication left as a placeholder, to be filled in from the clearance letter.
• Claims list. Start a table of every claim you plan to make, with a column for the source document that will support each one.
• Review process. Name who reviews marketing materials, in what order, how long each review takes, and who gives final sign-off.
• Website plan. Decide which pages will exist at launch, and build the company, team and technology pages that do not depend on the indication.
• Tracking. Set up analytics, CRM stages and an agreed definition of a qualified lead with sales.
• Conferences. Decide which meetings in the first year matter, and check their exhibitor rules for devices that are not yet cleared. See the FDA conference compliance guide.

60 days before expected clearance: draft everything

• Product pages drafted with the indication as a placeholder.
• Sales materials: one presentation, one leave-behind and a list of the objections sales expects, with answers.
• Launch emails for existing contacts, written and loaded into your email platform but not scheduled.
• Paid search campaigns built in the ad account with ads in draft and campaigns paused.
• Press release drafted, with the clearance language left as a placeholder.
• Sales training outline for the field team, including what reps may and may not say before and after clearance.

30 days before expected clearance: review and stage

• Send every draft through the review process now, so only the indication wording is left to change on clearance day.
• Check every draft for the correct term. FDA's regulation says a 510(k) clearance "does not in any way denote official approval of the device" (21 CFR 807.97), so a 510(k) device is "FDA cleared," never "FDA approved."
• Load the final versions into the website, the email platform and the ad account, unpublished.
• Pick the one marketing channel you will switch on first and name the person who runs it every week.
• Agree with sales on the one number the launch will be judged on, such as qualified sales conversations in the first 90 days.

What to have ready the day clearance comes

When the clearance letter arrives, copy the indication into the claims list and replace every placeholder with that exact wording. Then check these four items before anything goes public:

1. The product page states the cleared indication in the letter's words, and every claim on it traces to a source in your claims list.
2. Sales materials are reviewed, with the reviewer's name and date recorded.
3. One channel is ready to switch on, with a named owner and a date to decide whether it is working.
4. Tracking works end to end, from the first website visit to a qualified conversation in your CRM.

The press release, launch emails and paid campaigns go out after those four are confirmed. The detailed month-by-month plan for the rest of year one is in my medical device launch plan guide.

What a first-year launch budget looks like

These figures use only the engagement ranges Buzzbox Media publishes on its homepage. They cover agency fees, not ad spend, booth space, travel or printing, which you pay separately.

Where a company falls inside those ranges depends on how many products are launching, how many channels run at once, and how much content needs regulatory review. Every engagement is scoped individually.

How I work on device launches

Buzzbox Media built the brand identity for True Digital Surgery, a B. Braun company, for its FDA-cleared robotic surgical technology, and has run marketing for INFAB, a radiation protection manufacturer, since 2014. On a launch I build the plan against your clearance date, write the pages and materials with the indication as a placeholder, run them through your review process, and switch on one channel first. Your regulatory team keeps the final say on every claim.