Instead of gambling, validate your strategy with payers.
You just raised your first round of capital and your team is eager to get into the lab and develop that sophisticated prototype (or the new drug) that will change the medical industry forever. But wait, will it ever be reimbursed? You may think: "This is so far away. Let's first see if we can actually develop it and get it through the US FDA, Australia's TGA and the EU's Notified Bodies. Afterwards, we will take care of reimbursement".
Such a serial process is a recipe for joining the startup graveyard, which hosts companies that developed a great product, got it approved by the relevant regulatory entity, but have never been able to successfully commercialize it due to the lack of reimbursement.
Having worked with almost 200 different biomed companies, I still find it hard to believe that so many companies postpone the integration of reimbursement considerations into their early design and strategy decision making process, and just hope for the best. To me, this is just like gambling with other peoples' money.
This is especially surprising since payers - the entities that are in charge of making reimbursement decisions in each country - have set up specific pathways for companies to obtain their feedback in advance. Navigating these options early to build a robust medical device reimbursement strategy allows teams to secure critical guidance before making strategic decisions regarding their regulatory pathway or clinical study design.
In the following sections we detail a few such pathways. We encourage pharma and medical device companies to take advantage of these established frameworks to navigate global medical device pricing and reimbursement mechanics. Obtaining early payer feedback ensures your data matches expectations, moving you out of the medical device reimbursement casino entirely.
Medical Device Reimbursement in the USA
Here are a couple of options that may be used to obtain public and private payers' feedback on regulatory strategy and clinical study design:
- Prior to submitting a Q-Submission (Pre-Sub) to the FDA's CDRH for review, companies may obtain payers' feedback under these two pathways:
- For products that require premarket approval (PMA) or the granting of a de novo request by the FDA, companies may apply for the Parallel Review Program, which established a mechanism for FDA and CMS to simultaneously review the submitted clinical data to help decrease the time between FDA's approval of a premarket application and the subsequent CMS national coverage determination (NCD).
- Companies who may not be eligible for a Parallel Review (since, for example, they plan to get their product cleared under the 510(k) FDA process), may request CMS' input on clinical trial design and other considerations by asking for CMS' participation in a Pre-Submission meeting, or asking for private payer input on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions.
- Companies seeking Medicare coverage for Investigational Device Exemption (IDE) studies:
- Upon request, CMS can meet with study sponsors/applicants for coverage and provide feedback about favorable study protocol adjustments to help improve the likelihood of approval upon resubmission.
Medical Device Reimbursement in Germany
Companies may apply to the Federal Joint Committee (G-BA) seeking reimbursement for a 'controlled study', or leverage alternative local commercial pathways such as the NUB Germany application process for innovative hospital diagnostics and treatment methods that present a potential for improvement of care compared with the current alternatives (§137e SGB V).
As part of the process, the company may request a meeting with the G-BA to provide guidance on its clinical study protocol through the §137e Trial Regulation. This may allow innovative methods to be reimbursed while evidence is still being generated. The meeting, typically scheduled within 8 weeks, is non-binding, confidential and fee-based (€500 - €10k, depending on study complexity and company status).
As of February 2026, the G-BA has intensified the focus on "potential of improvement." For Digital Health (DiGA), new 2026 rules also require performance-based data reporting.
The G-BA is the supreme decision-making body of all the Self Governing Organizations (associations of physicians, hospitals and payers), each with its representatives at the G-BA.
Medical Device Reimbursement in France
The 'Innovation Package' (Forfait Innovation), enables the minister of health (DGOS) to provide funding for certain clinical studies designed to demonstrate the benefit of innovative devices before they can secure a permanent listing on the LPPR France medical device reimbursement index.
The company may request an 'Early Meeting' with representatives of the French National Authority for Health (HAS) to review protocol and seek guidance. The meeting is non-binding, confidential and free.
Medical Device Reimbursement in the UK
The National Institute for Health Research (NIHR) provides funding for various types of clinical studies at different stages.
As part of the process, the NIHR's clinical and delivery experts may provide the company with 'early feedback' to optimize study design for delivery in the NHS.
Summary: Avoiding Medical Device Reimbursement Failure
We have seen cases where a payer's feedback convinced the company to modify its selected comparator, changed the study's patient population and even its end points, in order to better address the requirements for reimbursement. Learning about payers' requirements early on, prior to initiating a clinical study, may save the company from having to conduct another study, post marketing clearance/approval, just to address payers' needs, significantly lowering costs and shortening the time to market.
Mediclever would be happy to guide you through these pathways in the above mentioned countries and others.
Frequently Asked Questions
You can request early meetings with CMS in the US, HAS (Innovation Package) in France, or the G-BA in Germany to obtain non-binding guidance on study design and endpoints.
Early validation ensures your product design and clinical trials align with payer requirements, reducing the risk of commercial failure despite having regulatory approval.
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Securing coverage and coding is the most critical step of your commercialization timeline. Our team maps global reimbursement pathways directly to your business goals.
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