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Innovate to Win In MedTech Cheat Sheet (DRAFT) by [deleted]

Innovate to Win In MedTech

This is a draft cheat sheet. It is a work in progress and is not finished yet.


When launching new med tech products succes­sfully in today’s market­place, the question is “What does it take to innovate to win in 2018?”

Whether you are a small, medium, or large entity, the ingred­ients to a successful new product launch are similar. The Top 10 factors include:

Factors 1 - 5

Clinical unmet need: Some companies start with the innova­tion, then try to find the market opport­unity. The most successful companies find clinical unmet needs first, knowing market opport­unity will follow.

Market opport­unity: Size does matter. Given the time and cost it takes to bring a med tech product to market, one needs a sizeable, addres­sable market to obtain the return on investment (ROI) necessary to justify early stage invest­ments.

Intell­ectual property (IP): Freedom to operate (FTO) is a minimum price of admission for a market. Patents can protect a market opport­unity and add value for your company.

Clinical evidence: Building a better Band-Aid used to be enough to get clinicians to try an innovative new product (espec­ially with a 510K predicate device trail). In 2018, producers must have validated clinical evidence and clinical references – known as key opinion leaders (KOLs).

Regulatory pathways: Understand and plan for the pathways to a successful regulatory clearance for each geography targeted.


Reimbu­rse­ment: Critical to market adoption is the reimbu­rsement plan for a new innova­tion. Clinical evidence must include an economic justif­ication that outlines the total cost/b­enefit of product use, in addition to proof that the product works.

Channel effici­ency: Whether taking a product directly to market or using strategic partners, leverage effici­encies existing in the channel today.

Team: The team’s capability to properly commun­icate the opport­unity and execute the plan has never been more important. Focusing on using minimal capital to get to market is essential for organi­zat­ions, large and small.

Strategic fit: For medium and large companies, the innovation needs to fit within existing markets and/or roadmap opport­uni­ties. Smaller companies often rely on the strategic fit of another company as a channel partner (distr­ibutor or strategic company).

Negoti­ation skills: For medium and large companies, have the right team capable of negoti­ating succes­sfully with large customers. On a global basis, the size of the deciding customer is becoming larger (either govern­ments or large hospital groups or even payors). Smaller companies must succes­sfully negotiate with the channel partner (distr­ibutor or strategic company) to ensure proper priori­tiz­ation of sales/­mar­keting activities for a successful launch (or even possible acquis­ition, as approp­riate).