Medtech market access: why strategy can’t wait for regulatory approval

Emerging technology categories

Newer categories of technology add another layer of complexity to medtech reimbursement. Digital health tools that qualify as medical devices don’t always map cleanly against existing reimbursement codes. And how well a market accommodates them varies: some regions have moved faster than others to define coding pathways for these products.

Key takeaway: Understanding a market’s specific framework, rather than assuming reimbursement will follow a familiar template, is a critical part of any market access strategy.

Common barriers to medtech market access after approval

Even with strong regulatory and clinical results, devices still struggle to gain reimbursement and adoption. The following pattern is repeatedly seen:

Unclear ownership of who pays
Companies often have solid clinical evidence but haven’t identified which stakeholder – a hospital, a specific payer or a purchasing body – controls the budget for their category.

Care settings shifting
Procedures are increasingly moving from inpatient to outpatient, and outpatient to ambulatory settings. A device positioned for the wrong setting may need a completely different set of stakeholders and messaging than the ones a company originally planned for.

No established reimbursement category
New or innovative technologies, particularly digital health tools, sometimes don’t fit any existing reimbursement code. This leaves payers with no established mechanism or incentive to cover them.

Lessons learned from real-world medtech market access failures

1. Pear Therapeutics prescription digital therapeutics

Pear Therapeutics is a widely cited example of what happens when market access is treated as an afterthought. The company’s prescription digital therapeutics were clinically effective and won regulatory clearance. They were even prescribed by clinicians. But payers had no established reimbursement category or coding for the products, so there was little incentive to cover the cost.

Pear filed for Chapter 11 bankruptcy in April 2023, with its co-founder and former CEO citing challenging market conditions. Health tech analysts pointed to the lack of a well-defined reimbursement pathway as a key factor, according to Healthcare Brew. The clinical need was real, but the market access strategy came too late.

2. ReWalk Robotics exoskeleton

A similar scenario played out with exoskeleton devices designed to help patients with mobility impairments. ReWalk Robotics’ personal exoskeleton for spinal cord injury received FDA clearance in 2014. However, it took a decade of advocacy before the CMS (Centers for Medicare & Medicaid Services) finalized a Medicare payment rate for the device in April 2024, according to Mobility Management.

Only once that reimbursement pathway existed could physicians prescribe the device with confidence, knowing that patients would be covered. That’s why, when no benefit category exists, manufacturers should be aware that creating one can take a decade of evidence-building and advocacy. And this needs to start alongside the regulatory process, because it will continue long after clearance is granted.

Key takeaway: companies that treat market access as a marketing task to solve after launch, rather than a necessity at the outset, consistently experience similar failures.

Building a medtech market access strategy that works

The most cost-effective time to fix a market access problem is before the wrong evidence has been generated. In practice, that means starting to think about market access at the same time as, not after, the regulatory and clinical evidence-generation process.

What evidence do payers really want to see?

Comparative clinical evidence – how the device performs against the current standard of care, not just whether it’s safe – is the entry ticket. But clinical data alone rarely wins the reimbursement decision. Payers and hospital stakeholders are looking for a clear answer to one question: does using this device make the overall treatment pathway more cost-effective?

That typically means supplying evidence around:

• Whether the device reduces overall treatment cost (not just device cost)
• Whether it shortens the length of hospital or clinic stay
• Whether it reduces the likelihood of complications or readmissions
• Whether it improves the hospital or clinic’s operating economics (not just clinical outcomes)

Top priorities before launch

For a medtech company approaching launch without a market access plan in place, three priorities matter most:

1. Map who pays
Identify the relevant reimbursement codes, payment levels, and the two or three priority markets to focus on first.

2. Audit the evidence
Compare the clinical and economic evidence already in hand against what payers in target markets will require – and flag gaps early.

3. Engage early and equip the field
Bring evidence in front of payers and clinical champions well before launch, using advisory boards to pressure-test whether the existing dossier is strong enough, or to inform where it falls short.

Two things companies consistently underestimate: timelines, since reimbursement can take one to three years to secure per market post-approval; and the cost of generating the real-world evidence payers require, particularly across fragmented European markets where requirements vary.

Summary and next steps

To summarize what we’ve explored in this blog: medtech market access isn’t a formality that follows regulatory approval; it’s a parallel strategy that should begin during product development, not after.

Companies that map their payers early, generate the relevant evidence, and communicate value clearly to each stakeholder consistently outperform those that treat market access as a downstream sales task. This is especially true where no reimbursement category yet exists for a device: establishing one from scratch can take the better part of a decade, so that groundwork has to run in parallel with the regulatory pathway, rather than starting once the gap becomes obvious post-launch.

As the Pear Therapeutics and exoskeleton examples show, the cost of getting this wrong isn’t hypothetical – it can be the difference between commercial success and bankruptcy.

How BaseCase supports medtech market access and reimbursement

Even with the right strategy and evidence in place, communicating value effectively can be challenging. Evidence often resides across multiple slide decks, spreadsheet models, and dossiers, with different formats for global, regional, and local audiences. This makes it hard for field teams to deliver a consistent message, and even harder for a busy hospital stakeholder to get a clear answer in a 30-minute meeting.

BaseCase, Certara’s value communication platform, turns that static, fragmented material into a single interactive tool. Field teams and clinicians can adjust treatment cost, length of stay, and other parameters in real time and immediately see the financial and clinical contribution of a device – without switching between files or losing the audience’s attention.

BaseCase’s medical device reimbursement tools – including budget impact models and DRG reimbursement analyzers – put that evidence directly in front of the people who decide whether a device gets paid for.