Regulatory approval is a significant milestone and one worth celebrating, but it’s not the finish line that guarantees commercial success. It gives a company permission to supply and, where permitted, promote a product within the conditions of that approval. It doesn’t automatically mean the business is ready to launch.

Too often, the regulatory process is treated as a series of boxes that need to be ticked to get the product across the line. The consequences of that approach are often inherited by the marketing and commercial teams later.

It might be an IFU written to satisfy the technical requirements but not the needs of the person expected to use it. Instead of reinforcing that a product is simple to use, the language can make it appear far more complex than it needs to be, creating confusion that customer education then needs to undo.

It might be product labelling with awkward wording that starts appearing in user-generated content, or internal product language that customers adopt and the business then spends years trying, often unsuccessfully, to change. Engineers may have designed packaging to withstand conditions far beyond what the end customer will ever encounter because no one had clearly defined how the product would be shipped, stored, opened or used.

These outcomes are rarely the result of carelessness. Without clear customer, market and commercial specifications, technical teams are left to fill in the gaps themselves. More often, they’ve made the best decisions they could with the information available to them.

That’s why product marketing needs to begin before regulatory approval. It’s not just about creating promotional materials once the product can legally be sold. It’s about making sure the customer, the buying process and the realities of use are understood early enough to shape the product experience, including product labelling, packaging, instructions for use, training and the commercial story.

It’s also about being ready to begin commercial activity as close as possible to the point of approval. By then, investors may have supported the business for years and will reasonably expect it to move quickly from regulatory success into revenue. Distributors may already have invested in training, warehousing, local market development and sales capability in anticipation of launch.

When approval arrives but pricing, claims, training, sales materials or onboarding processes are still being developed, momentum is lost. Distributors become frustrated, customers are left waiting and the business spends valuable post-approval time preparing to launch rather than selling.

There’s also value in creating informed anticipation before the formal launch. Word of mouth remains one of the most effective forms of advertising, particularly in healthcare, where trust, peer recommendation and professional credibility carry enormous weight.

The strongest launches often have end users already championing the product before a formal business case, purchasing process or tender begins. Their advocacy can help an organisation define the need, build internal support and sometimes shape the specifications against which solutions will be assessed. I’ve seen this work particularly well when an important safety feature became part of a tender specification because informed clinical advocates understood why it mattered. By the time procurement became involved, there were already people inside the organisation prepared to make the case for it.

Approval does not create demand

Regulatory approval confirms that a product has met the relevant requirements for the market it’s entering. It doesn’t create customer understanding, urgency or demand. The market will still want to know who the product is for, where it fits, how it compares with existing alternatives and why anyone should change what they’re already doing.

In healthcare, those questions are rarely answered by one person. A clinician may focus on evidence, patient outcomes and whether the product will improve the way they practise. Procurement may be considering cost, risk and supply, while hospital management looks at workflow, utilisation and the wider operational impact. Patients are also more informed than ever and may arrive with questions, expectations and language shaped online before they speak to a clinician.

The regulatory and technical documentation contains the evidence supporting the product’s approved indications and claims. The commercial challenge is translating that evidence into a clear, accurate and useful market story without overstating what the product can do. Without that translation, a company can have an approved product and still struggle to explain why it matters.

The commercial work should not begin on approval day

There are understandable reasons companies delay commercial preparation. Regulatory timing can be uncertain, and cash needs to be conserved. The team may be generating clinical evidence, completing design verification and validation, establishing manufacturing processes, building the quality management system and preparing the regulatory submission. For higher-risk products, this work can take years and understandably consume much of the organisation’s attention.

There can also be a reluctance to invest in marketing too early because marketing is still commonly associated with promotion, advertising and lead generation. When that’s the definition, waiting until the product can legally be promoted appears sensible.

But product marketing isn’t simply the activity that begins when advertising is allowed. Waiting until approval may leave the company trying to complete positioning, pricing, messaging, sales training, customer education and launch materials while also managing supply, logistics, manufacturing scale-up and early customer issues.

The work hasn’t been avoided; it has simply been delayed until the organisation is under the most pressure to show commercial results. The rules governing pre-approval communication vary by market and product, and companies must work within them. You cannot promote a product as generally available before it has the necessary market authorisation, but you can prepare the business and its early users to communicate about it accurately.

Product marketing should influence the product before launch

Product marketing sits between the product, the evidence, the customer and the commercial model. It asks practical questions early enough for the answers to influence decisions. Who is the priority customer and who is the actual end user? Who initiates the purchase, who approves it and who can quietly block it? What information will each person need, and what will have to change in the current workflow for the product to be adopted successfully?

This work can shape far more than a launch campaign. It can influence product labelling, instructions for use, packaging, training, service models, product configuration, data outputs and customer support. It can also expose where a technically elegant product creates unnecessary friction for the customer.

Those insights are much easier to act on before approval. Once the product, labelling and documentation are locked, even a small change can create regulatory, quality, manufacturing or inventory implications.

Early commercial input isn’t about marketers overriding engineers, clinicians or regulatory teams. It’s about marketing championing the customer and helping the wider team ensure the product has a defined market, meets a meaningful need, can be understood and adopted, and has the foundations for sustainable growth.

The first iteration of launch does not need to be perfect

The market will always teach the business something it didn’t know. Early sales conversations expose objections and show that customers don’t always use the same language as the internal team. The strongest use case may not be the one the business originally expected; pricing assumptions may be challenged, and training may need to be simplified.

That’s why I think of launch as an iteration rather than a single event. The goal isn’t perfection. It’s to have enough of the commercial foundation in place to enter the market with clarity, learn quickly and improve deliberately.

The first iteration should still have a clearly defined priority audience and use case. The business should agree on the problem being solved, why the product matters and how it’s different from the alternatives. The evidence needs to be translated into compliant messages that customers can understand, and sales teams can use, while the pricing and commercial model need to reflect how the customer buys.

The team also needs practical sales tools, clear training and a plan for what happens after the sale.

Adoption starts before the purchase

In healthcare, a signed purchase order isn’t the end of commercialisation. A product that’s bought but poorly implemented, rarely used or quietly abandoned hasn’t achieved meaningful adoption.

The launch plan needs to consider how the customer will be introduced to the product, trained and supported. The company also needs to define what good adoption looks like. Is it devices sold, clinicians trained or procedures completed? Is it repeat ordering, patient referrals or another measure of sustained use?

A difficult first experience can undo much of the enthusiasm that helped secure the purchase. The strongest advocates are usually created through successful use, not marketing claims, which is why product marketing, sales, clinical education and customer support need to operate as one connected commercial system.

Early advocates need the right foundations

Healthcare adoption is heavily influenced by trust. A small number of credible innovators, clinicians and early adopters who understand the product and genuinely believe in it can create more momentum than a large launch campaign. They refine the proposition, identify barriers, contribute to education and give others the confidence to consider adoption.

Early access programs make this even more important. Under specific regulatory pathways, selected users may gain access to products that aren’t yet approved for general commercial supply. This can generate early revenue, build clinical experience and produce real-world data before a broader launch. Just as importantly, it creates the first group of people who will discuss the product with peers, present their experience at conferences and begin shaping how the market understands where it fits.

That advocacy can be enormously valuable, but the language used matters. If an innovator or respected early user describes the product, its evidence or its role in care inaccurately, that explanation can be repeated until it becomes accepted market language. The misinformation doesn’t need to be dramatic. A slightly inaccurate description, repeated often enough by someone credible, can be very difficult to undo.

For the marketing team, correcting that language later can be miserable. The company doesn’t want to undermine the people championing its cause, but it also cannot allow inaccurate, misleading or non-compliant claims to become embedded in the market. At that point, marketing is no longer building the product story. It’s trying to reshape one that already has credibility and momentum.

This is why innovators and early users need more than clinical and regulatory oversight. They also need clear language, accessible evidence summaries, appropriate training and consistent explanations they can use confidently with colleagues and patients. Supporting them properly protects the credibility of both the advocate and the product.

When an end user understands the value and is prepared to champion the product, the purchasing process is more likely to become a conversation about how to buy rather than whether the product is wanted at all. That doesn’t bypass procurement or tender requirements; it recognises that much of the real decision may already have been shaped before the formal request arrives.

The companies that move quickly started earlier

Companies that appear to move quickly after approval rarely completed all their commercial work in the weeks that followed. They spoke to customers while the product was still being developed, understood the buying process, tested their positioning and prepared their sales story, training and launch materials within the appropriate regulatory boundaries.

They also aligned the internal organisation. Manufacturing had visibility of the forecast, customer support understood the likely questions, clinical and regulatory teams knew how the evidence would be translated, and sales knew who to approach first and what support would be needed to convert early interest into adoption.

Approval was the point at which they could begin selling, not the point at which they began working out how to sell.

A business that waits until approval may instead spend the next six months debating its value proposition, rewriting materials, identifying target customers and building basic commercial infrastructure. From the outside, the product may have launched. Inside the company, the team is still getting ready.