The FDA’s TAP Pilot Shows Why Medical-Device Commercialization Must Begin Before Clearance

The FDA’s latest expansion of its Total Product Life Cycle Advisory Program (TAP) should get the attention of more than regulatory teams. The updates also impact sales and marketing. 

As of July 1, 2026, the TAP Pilot includes 133 devices. The FDA also expanded eligibility across all Offices of Health Technologies for qualifying devices with Breakthrough Device or Safer Technologies Program (STeP) designations.

The TAP expansion reflects a broader shift in how innovative medical devices reach the market. Regulatory authorization is essential for legal market access, but the path to patient access increasingly requires earlier coordination among device developers, regulators, clinicians, payers, healthcare organizations, and, most importantly, patients.

The FDA describes TAP as a way to facilitate earlier and more strategic engagement with both FDA and non-FDA stakeholders. The stated objective is to help participating companies identify potential barriers during device development, clinical testing, and market adoption planning, rather than discovering them after authorization.

Medical-device companies should apply the same principle to commercialization. Commercial planning should not begin when the submission is nearly complete. By that point, many of the decisions that shape market performance have already been made.

The Market Pathway Requires The Same Attention As The Regulatory Pathway

Most medical device companies build a detailed regulatory pathway early on. They determine the likely: 

• Classification

• Submission type

• Testing requirements 

• Clinical evidence needs

• Quality-system obligations

• Review strategy 

These decisions affect product development from the outset because leadership understands that regulatory uncertainty poses financial and operational risks. Commercial uncertainty deserves the same treatment.

A company can obtain authorization and still lack a viable route to adoption. The device may solve a real clinical problem, but it requires more workflow change than the customer will tolerate. The clinical evidence may support authorization without answering the questions a value-analysis committee will ask. The device may appeal to physicians but fail to produce a sufficiently clear financial return for the hospital.

Clearance confirms that a company may market the device for an authorized use. It does not confirm that the market understands the value, can implement the technology, or is prepared to change established behavior. Those requirements need to be addressed before launch.

FDA’s TAP Expansion Makes This Conversation More Urgent

The original TAP Pilot was launched in 2022 as a voluntary program intended to reduce the medical-device “valley of death” through earlier and more frequent FDA interaction, strategic stakeholder input, and more proactive support during development.

The July 2026 expansion matters because TAP is no longer limited to a small group of technology offices. Eligible Breakthrough and STeP devices across all Offices of Health Technologies can now request enrollment, provided they meet the program criteria. The program’s scope also extends beyond regulatory review.

The FDA states that engagement with healthcare providers, payers, and other non-FDA stakeholders can help companies make better decisions about device design, clinical evidence, and market adoption. Further, the government is increasingly treating patient access as a multidisciplinary problem. Product development, regulatory strategy, evidence planning, reimbursement, adoption, and commercialization cannot always be handled as separate sequential functions. Instead, they must be integrated.

Commercialization Begins With Market Definition

Early commercialization does not mean promoting an unauthorized device. It means reducing market uncertainty while the company still has time to act on what it learns. Marketers need to start by defining the real market. 

The real market is the addressable commercial market, not the broad clinical population. Leadership needs to understand: 

• Which organizations can use the device

• Which facilities have the required infrastructure

• Which patient populations create the strongest economic case

• Which customer segments are most likely to adopt first

A credible market-sizing exercise should account for more than disease prevalence or procedure volume. It should consider purchasing authority, reimbursement, competitive alternatives, care settings, implementation requirements, capital cycles, clinical capacity, and the realistic rate of adoption. Otherwise, the company risks building its revenue model around theoretical demand.

Early segmentation also helps leadership prioritize the launch. The best initial market may not be the largest market. It may be the segment with the clearest unmet need, the shortest approval process, the strongest clinical champions, the most favorable economics, or the lowest implementation burden. Those are all commercialization decisions, but they should inform development and investment decisions long before clearance.

Voice-of-Customer Research Should Influence the Product

Many medical device companies conduct customer research shortly before launch so the marketing team can develop messaging and sales collateral. This market research timeline happens too late to capture the full value of the research. Instead, early voice-of-customer work reveals:

• Which product features matter most in practice

• Where the device creates workflow friction

• Who will support or resist adoption

• What evidence does each stakeholder expect

• Which economic outcomes influence purchasing

• What training will users require

• Which implementation concerns could delay rollout

These findings affect the product's development, not merely the language used to sell it. A product team cannot account for every preference, but leadership should understand the market consequences of its decisions.

For example, a surgeon may value a feature differently than the engineering team expected. A nurse may identify a usability problem that creates additional training needs. An administrator may care more about staffing efficiency than technical performance. A payer may expect evidence that was not central to the original clinical plan. Each of these stakeholders evaluates the device through a different commercial and operational lens. 

The Economic Story Must Be Built Before The Sales Story

Technical differentiation does not automatically create economic value. A device may be faster, smaller, more precise, less invasive, easier to use, or more technologically advanced than the existing standard. However, buyers still need to understand what that difference means for their organization:

• Does the device reduce procedure time?

• Does it prevent complications?

• Does it increase throughput?

• Does it reduce labor requirements?

• Does it shorten hospitalization?

• Does it replace another cost?

• Does it create a new reimbursable service?

The company needs to know which economic outcomes matter to the buyer and what evidence will support those claims.

The earlier the market research is conducted, the sooner development teams can realize commercial benefits. For example, a company might discover that its strongest value proposition depends on a workflow benefit it has not measured. Another might find that hospital buyers need a budget-impact model rather than another technical comparison. Those findings influence clinical studies, pilot programs, health-economic analysis, real-world evidence plans, and publication priorities.

Reimbursement And Coverage Are Moving Closer To Development

The April 2026 announcement of the FDA-CMS RAPID Coverage Pathway reinforces the broader shift toward earlier coordination. The pathway is intended for certain Breakthrough Devices that address unmet needs among Medicare beneficiaries. It includes eligible Class II devices participating in TAP, as well as certain Class III devices, with the goal of accelerating the path from FDA authorization to Medicare coverage.

RAPID does not remove the need for a company to develop its own reimbursement and market-access strategy. It shows that regulatory authorization and coverage planning are increasingly considered together. Device companies should make the same connection internally.

Reimbursement should not be a late-stage work assigned after the product and evidence plan have been finalized. Coverage requirements, coding pathways, and site-of-care economics all influence the device's commercial viability. A product can be clinically valuable and commercially constrained because no stakeholder has a workable way to pay for it. Developers must identify that risk before investing in a launch.

Adoption Is An Operational Problem

Medical-device adoption rarely depends on a single buyer. The purchase usually involves a buying committee with often conflicting needs. For example, a physician may support the technology while procurement objects to the cost. An administrator may approve the business case while clinical leadership remains concerned about training. The IT department may delay implementation because the device requires an integration that the commercial team did not anticipate.

Commercialization planning should map the full buying and adoption process. Teams need to know who initiates the discussion, who controls the budget, who evaluates risk, who will use the product, and who can stop implementation. The analysis will outline a successful launch roadmap.

The company may need clinical educators in addition to sales representatives. It may need an enterprise-sales model for health systems and a distributor strategy for smaller practices. It may need: 

• Implementation protocols

• Competency materials

• Reimbursement support

• IT documentation

• Patient education

• Post-installation training

For many medical devices, training and implementation are not secondary support services. They are part of the commercial offer.

Market Language Takes Time To Develop

Medical device companies usually have extensive scientific, technical, and regulatory documentation by the time they seek authorization. However, those do not define a clear market position. Regulatory language describes the device accurately within the approval framework. Commercial language must instead help different buyers understand why the device matters, where it fits, and why the purchase deserves priority. Translating the science into commercial interest requires deep market research.

The company needs to understand: 

• Which benefits resonate with which member of the buying committee

• Which differentiators buyers consider meaningful

• Which objections appear repeatedly

• Which proof points withstand scrutiny? 

Claims must remain accurate and compliant, but the message also needs to connect technical performance with clinical, operational, and financial value.

Sending the regulatory submission to a marketing team three months before launch does not produce that understanding. Strong positioning develops through market research strategies like: 

• Customer interviews

• Competitive analysis

• Claim assessment

• Message testing

• Sales input

• Repeated refinement

The market research should begin while the commercial thesis can still influence development decisions.

Clearance Should Activate The Commercial Plan

Starting commercialization earlier does not require a company to predict every market condition years in advance. It requires leadership to answer the major commercial questions before they become launch emergencies:

• Who is the priority buyer?

• What problem has enough urgency to create a budget?

• What evidence will support adoption?

• What operational changes will customers need to make?

• How will the product be paid for?

• Which channel can reach the market efficiently?

• What training and implementation support will be required?

• What can the company credibly say about the device?

FDA’s TAP expansion makes this discussion especially relevant. The program increasingly connects device development with the stakeholders and strategic considerations that influence patient access. TAP does not create a company’s commercial strategy, conduct its market research, or build its launch infrastructure. Those responsibilities remain with the company.

Medical-device leaders should treat commercialization as an integrated development discipline rather than a post-clearance marketing phase. By the time authorization arrives, the organization should already understand its: 

• Market, buyers

• Economic value

• Adoption barriers

• Evidence needs

• Channel strategy

• Training requirements

• Core market language

Clearance should be the point at which the company executes the plan, not the point at which the company begins developing one.

Build The Market Strategy Before Clearance

Borrowed Pen helps medical-device companies define the market before launch. We conduct medical device market research, including:

• Market sizing

• Voice-of-customer research

• Buyer and stakeholder analysis

• Competitive positioning

• Commercialization planning

• Launch messaging

With our market research, leadership can make stronger decisions about product, evidence, channels, and investment earlier.

Planning for clearance? Let’s build the commercial pathway now.