5 Tips for the US MedTech Market Entry #11 to #15

#11: When possible, the technological characteristics of your product must be designed to optimize the FDA “Substantial Equivalence” definition to support a 501(k) application.

#12: Software is becoming an important element of every medical device. Do not forget to discuss the Level of Concern of your software and related validation and 510k documentation requirements very early in the design process.

#13: Under CLIA, laboratories performing only waived tests are subject to minimal regulation. Laboratories performing moderate or high complexity tests are subject to specific laboratory standards governing certification, personnel, proficiency testing, patient test management, quality assurance, quality control, and inspections.

#14: FDA registration fees need to be paid annually, for a September-to-September period. Foreign Small Businesses can apply for an FDA’s Small Business Certification that yields to significant (50% to 70%) “Discounts” for user fees (e.g. 510Kk) fees

#15: FDA “agents” should not be confused with “commercial agents” or Custom/export brokers. An FDA Agent is an operational liaison to FDA and can be appointed in the U.S. or retained as part of dedicated services providers for $50 to $150 per month.

Part 3: Readiness of Medical Technologies for the U.S. Markets: Designing for CMS.

US market entry plans must include a proven and documented value proposition that address the new needs of the U.S. Healthcare market – improvement of clinical and workflow related outcomes, reduction of cost, and the improvement of access to care – while optimizing the regulatory pathways (FDA ) and reimbursement plans (CMS coding,  payer’s coverage and payment), which is discussed in this Part 3.

5 Tips for the US MedTech Market Entry #6 to #10

#6: The shift to capitated reimbursement with performance incentives is inevitable. A substantiating and true economic rationale for your medical technology will be a competitive differentiator.

#7: The continuum of care between acute care and independent care is highly complex: every market segment is characterized by a specific business model and unmet needs. Do to target them all at the same time.

#8: The delivery of care for aging citizens will happen in multiple set-ups. Each of them could possibly represent multi-million opportunities for your products or services, as long as you gain an intimate knowledge of each individual segment and tailor effective go-to-market channels for each of them. Strategic Segmentation is crucial to success.

#9: Digital Health is easy. Digital Medicine is the next revolution. It will be regulated, complex and an environment ripe for breakthroughs: do not confuse them.

#10: 21CFR is the 21st chapter of the Code of Federal Regulations. It describes the rules of the Food and Drug Administration, and is in fact the perfect reference handbook. Sub-Chapter H (Part 800 to 898) deals with medical devices in several therapeutic areas (Cardiovascular, hematology and Pathology, neurological, etc...) It is updated once a year

Part 2: Readiness of Medical Technologies for the U.S. Markets: Designing for FDA

US market entry plans must include a proven and documented value proposition that address the new needs of the U.S. Healthcare market – improvement of clinical and workflow related outcomes, reduction of cost, and the improvement of access to care – while optimizing the regulatory pathways (FDA only is discussed in part 2) and reimbursement plans (CMS coding,  payer’s coverage and payment - see part 3). Because all these dimensions are interconnected, a sequential approach is often counterproductive: all need to be addressed and optimized at the same time.

What Is Clinical Utility and Why Should We Care?

Broadly speaking, utility is a measure of the personal benefit that someone has from an intervention, outcome, product, or process. “Clinical utility” is a term that is widely used in medicine to describe the relevance and usefulness of an intervention in patient care .

Who Cares? and Why ? are probably the most fundamental questions that MedNest asks to its clients from oversees, … often perceived as disturbing questions! Simply said, stakeholders in healthcare want to know the benefits offered by a novel medical technology are valid and useful in the context of the U.S. Healthcare practice.

The question of evidence generation to support clinical utility is key, as the clinical utility of a medical device or a medical software solution (for instance) is often context-dependent.

When it comes to diagnostics, “Clinical utility refers to… the value of information to the person being tested. If a test has utility, it means that the results provide information that is of the value to the person, because he or she can use the information to seek an effective treatment or preventive strategy. Even if no intervention are available to treat or prevent a disease, there may be benefits associated with knowledge of a results” [1].

There is an obvious link between clinical utility and intended use, which ties the “value proposition” with the FDA regulatory pathways. This important relationship is often misunderstood by foreign MedTech companies resulting in significant mistakes in the definition of product concepts and their related regulatory pathways. MedNest’s programs address these important questions to reduce the risk and cost of a U.S. Market entry plan.


[1] What Is Clinical Utility and Why Should We Care?Larry Lesko, I Zineh, S-M Huang December 2010 Clinical Pharmacology & Therapeutics 88(6):729-33 DOI:  10.1038/clpt.2010.229 - Weblink / ResearchGate

U.S. Reimbursement Exploration: Essential activities

Understanding Coding, Coverage and Payment options for your Medical Device is an essential activity to prepare the U.S. Market entry of Medical Technologies. We believe it is also critical at very early stages of product development.

MedNest offers a affordable “Reimbursement Exploration” program to educate companies on the U.S. Reimbursement and Payment Models and establish their optimized options for Reimbursement Coding, Payment and related product Pricing. Workflow Economic benefits will be discussed if relevant.

The program generally includes the following:

1. Audit the Company’s product and solutions, and existing pricing rationales

2. Deliver a personalized U.S. REIMBURSEMENT and PAYMENT consultation to address specific needs of each companies, with topics including

  • Present a tailored overview of the U.S. Healthcare Payer-Provider system (e.g.. what is relevant to the product at hand only)

  • Present and discuss the different insurance and payer models and segments, including HMO, PPO, POS…

  • Present and explain the MEDICARE and other federal programs

  • Discuss, if relevant, the emergence of ACOs

  • Discuss the fundamentals of reimbursement codes ( DRGs, PACs, ICD-10 Diag and Procedures, CPT, DME…)

  • Explain the coverage decision by insurance companies, and / or MEDICAIRE

  • Payment values, and how they vary from state, insurer, and federal program

  • About Economic outcomes research and trials

3. Research of most relevant codes applicable to the company‘s products

4. Research of payment values related to the selected codes (MEDICAIRE, and possibly other payers)

5. Work with Company to establish a pricing model based on reimbursement.

5. Preliminary exploration on additional economic benefits/outcomes (Workflow, Material, Labor..)

6. Preliminary recommendations on how to demonstrate/prove the additional economic benefits

7. Final report and proposed preliminary reimbursement, payment and economic value strategy.

  • Summary of most relevant reimbursement codes

  • Summary of payment values for such codes (how much $)

  • Preliminary product pricing model waterfall

  • About marketing reimbursement codes to end user

  • Recommendation on additional economic outcomes

  • Need (and preliminary recommendation if applicable) of economic studies/trials


Timing? A typical exploration project takes 2 months

Budgets? The typical budget of the exploration ranges from $5,000 to $10,000. Developing a comprehensive economic model / reimbursement plan can be scope after the exploration program

Tips for the US MedTech Market Entry #1 to 5

#1: To be successful in the U.S., your medical technology needs to address all three major pain points of the U.S. healthcare system: reduce cost of care, improve outcomes while reducing their variance, and increase access to care.

#2: If you can’t prove them, don’t talk about them (i.e. your product’s benefits)!

#3: Incorporate Value-Based Care Specifications into your new product concept proposals or upcoming product revisions.

#4: If you are a “New Entrant”, beef up your team with experts in your target healthcare segments, including physicians and experts from the payor systems.

#5: The U.S. represents 41% of European Medical Technology Exports, more than Japan, China, Russia, Canada, Brazil combined. Stay focused.

Part 1: Readiness of Medical Technologies for the U.S. Markets: Designing for the Markets

Garnering the attention of U.S. policy makers, investors and innovators, is the U.S. Medical Device market reached $160 billions in 2018 growing ~6.4% annually since 2015[i]. It represents a small fraction of the total U.S. Healthcare spend of $2.8 trillion and, as a result, is directly impacted by the evolving forces and regulations that aim to curb the cost of Healthcare in the U.S. To be relevant and competitive in this evolving market, and in order to optimize the return on capital[ii] of “MedTech” ventures or new product introductions, leadership teams need to approach the U.S. market with plans that are more targeted and comprehensive than in the past.