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Definition and Validation

At MedTech Bridge, our initial focus will always be on validation of your solution towards market needs. If something needs to change to fit market needs, or unleash a greater potential in the market you want to approach, it is far better to have that uncovered early in your go to market process.

Your most valuable validation datapoint

Your most valuable data point, when it comes to product or solution market fit, is the interest in a market test, pilot, or first paying customers.

At MedTech Bridge we will engage our network, and execute this important validation on your behalf. We understand the constraints an early-stage company is under, and we can support your initial validation efforts by use of fractional resources.

Your Representative and US Business Operator

MedTech Bridge can be your agent, your boots on the US ground, and can be the operators of your first US business. An embedded operative working on your behalf, and as a virtual part of your team, always putting efficiency first. This, both through the MedTech Bridge team, and also through our network of experienced MedTech executives.

Most likely, your US or EU  journey is not set in stone from day one, and MedTech Bridge can be engaged to follow your journey, with an adaptive approach, completing steps and obtaining data points, used as basis for validation of path and plans.

The steps we take you through

Market Assessment

The MedTech Bridge Market Assessment and Report is an important tool in your go to market strategy evaluation, in the early stages of your planning.

At MedTech Bridge, we work with the concept of "Market Sweet Spot", which we use in all aspects of our go to market investigations. The Market Sweet Spot is not necessarily the most profitable market entry point - it is the optimal market entry point, where the balance between profitability and investment needed is just perfect for a startup.

Our approach is always strategic. We will not limit our investigations to the obvious market entry point. We will look at adjacent spaces, and even markets that aren't easily identifiable as part of desk research. And we will always complete a Market Assessment with a set of recommendations and next steps to take, in your new market entry efforts.

It can provide a top-level assessment and overview of the most important aspects of the market:

  • Market fit. Where in the healthcare system does your solution have a (first) natural home.

  • Market size. Rough order of magnitude assessment of total obtainable market.

  • You most likely already know the Key Opinion Leaders within your therapeutic or diagnostic area. Just as important is knowing your early adaptors - and we can assist you in determining a strategy to locate early adopters at your target facilities.

  • Regulatory assessment. What is your classification and your most likely path to FDA approval or clearance. 

  • Reimbursement strategy (when applicable). Initial assessment of reimbursement code, coverage, and payment.  Build on that, what could be the strategy for obtaining higher value reimbursement codes with "version "2" of your product or solution. Possibly extended with a top level plan for obtaining new codes. This could be a 3-5 year endeavor, though.

Equally important, the Market Assessment Report will provide some insights into “the finer print” on going to market:

  • Are there barriers to entry.

  • Are there solid incumbents with large market share.

It will not be all-encompassing, but it will be the best assessment by the best experts available - and most importantly, it will be tailored to your needs and budget. We will always customize the Market Assessment to your needs, regardless how big a challenge you face in your market entry.

The Market Assessment Process

For us to be able to help you best, it is important we know as much about you and how your technology fits the US patients' need the best. This happens partially through our onboarding process, which happens when you sign up for (free) MedTech Bridge membership.


When you feel ready to engage deeper with MedTech Bridge, and accelerate your US journey and the gathering of US Market Intelligence, we initiate the Market Assessment process - which is very simple:

  1. We schedule a 45-60 minute meeting with our US Market Assessment and Advisory Services Partner.

  2. We create a very top level suggestion for an approach.

  3. If the approach is acceptable for you, we will create the Market Assessment Concept Design. This includes the questions that need answering in the Market Assessment, the therapeutic areas to search within, and how strategic plans (regulatory and reimbursement) can be created. This comes at a cost of USD 1000-1500, as this involves activation of our Advisory Services executives. In addition, the outcome, the Market Assessment Concept Design, can be used, as is, to approach investors and stakeholders.

  4. If you choose to execute the Market Assessment, we will project manage the execution, and you will invited for a kick-off meeting - and you will, of course, be involved from beginning to end.

Human Factors and Usability Testing

  • Conduct research in acute and clinical settings with clinicians and patients

  • Design research for qualitative and quantitative studies

  • Create protocols

  • Moderate evaluations

  • Analyze data

  • Prepare reports 

  • Perform use error and root cause analysis

  • Deliver medical device design solutions that ensure safe use

Market Research

  • KOL/physician/early adaptor consulting

  • Focus groups

  • Survey research

  • User research and testing

  • Stakeholder interviews

  • Workshops

Market Assessment and Strategy

  • Competitive landscape

  • Early adopter/KOL list

  • Proposed messaging

  • Channel strategy

  • Pricing considerations

  • Sales tools

  • Product launch plan

Fractional Marketing

  • Website development

  • Collateral/video creation

  • Conference presence

  • Earned media strategy

  • Social media strategy

Reimbursement and Healthcare Economics

  • Health economic assessment

  • Reimbursement assessment 

  • Market access strategy

  • Customer and sales training and materials

  • Code verification (when relevant and needed)

Regulatory and Clinical 

  • Regulatory assessment

  • Clinical study strategy

  • FDA market access strategy

  • CE Mark strategy and Notified Body mapping

  • Quality system development

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