The document provides a screener designed to guide the assessment of new medical products before their development and commercialization, emphasizing the importance of evaluating market fit and business potential. It outlines ten key issues to consider, including clinical need, upside potential, customer acceptance, downside risk, economic benefits, time to market, competition, platforms, resource needs, and intangibles. The aim is to prompt thoughtful consideration through a series of questions that can lead to more informed decision-making regarding product viability.

1. A Screener to Guide
New-Product Assessment
Should you develop and
commercialize that new
medical product?
Joe Kalinowski
Trilogy Associates
A Pathway to New-Product Success

2. Ask any product developer about their worst nightmare. Most will tell you it
involves spending countless (sometimes thankless) weeks and months
developing a wonderful innovation and having it fail miserably in the market.
Happens all the time. And, in the great majority of cases, it happens because
an appropriate assessment of that new product’s market fit and business
potential was not performed prior to its detailed development.
Don’t let this happen (again) in your business. Get that assessment done up
front. This little screener will help get you started. It consists of a series of
questions to make you think. Sometimes just being exposed to these
questions will lead you to a quick decision to kill that new-product idea.
That’s great. Sometimes these questions will encourage you to do the heavy
lifting to answer the questions accurately and honestly. Internal controversy
may ensue, but that’s great, too; a better product will result.
These 10 lists of questions could be applied to just about any product aimed at
any market. However, they fit best for the assessment of the merits of
prospective new medical products – especially medical devices.
I hope you find these reminders helpful.
JK
Trilogy Associates 2

3. Our Top-10 Issues
3
Clinical Need
Upside Potential
Customer Acceptance
Downside Risk
Economic Benefits
Time to Market
Competition
Platforms
Resource Needs
Intangibles
Trilogy Associates

4. Clinical Need
4
 Does this product address a real clinical need? Is
that need currently unmet or poorly met?
 Do we know precisely which patients will benefit and
how much?
 Does it do the job better than, or at least as well
as, existing products?
 Are we sure about these conclusions? How do we
know?
Trilogy Associates

5. Upside Potential
5
 Will this product generate a significant level of new
revenue, net of cannibalization?
 Will it contribute to an increase in profits?
 Will it improve our competitive position?
 Will it enhance our reputation among stakeholders?
 Will it raise our profile in the industry?
Trilogy Associates

6. Customer Acceptance
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 Why will customers buy? How can they be sold?
 Who will stimulate adoption? Who will resist?
 Will the product be easy and intuitive to use? Will it
save procedural time?
 Will it be more convenient to use? Will it improve
workflow and logistics?
 Will the product be disruptive to current clinical
practice? If so, is that the right outcome?
Trilogy Associates

7. Downside Risk
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 Are we reasonably sure the product will attain
regulatory approvals? When?
 Will the level of reimbursement be adequate to
stimulate adoption?
 What’s the likelihood of medical error? Adverse
clinical outcomes?
 Can our technology be readily substituted for and
commercialized by others? How soon?
Trilogy Associates

8. Economic Benefits
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 Will the product reduce healthcare expenditures
overall? How do we know?
 Will clinicians benefit financially? How?
 Will healthcare facilities benefit financially? How?
 Will payers benefit financially? How?
Trilogy Associates

9. Time to Market
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 When can we get this product to market? Are we
sure?
 How long will customer adoption take? How do we
know?
 Have our financial projections taken these realities
into account?
Trilogy Associates

10. Competition
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 Who are the major competitive suppliers in this
space?
 Will our competitive position be substantially
improved with this product? Why?
 Why will customers favor our new product over
competitive ones? Are we sure?
 How will our competitors react to this new product?
How soon?
Trilogy Associates

11. Platforms
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 Will this product serve as a technology platform for a
future new line?
 Will this product create an entirely new channel or
customer segment for us?
 If we are successful will our technology be saleable to
others?
Trilogy Associates

12. Resource Needs
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 What financial investment will be required and for
how long?
 What fraction of our critical staff resources must be
devoted to this initiative?
 What will be our opportunity cost? What other
initiatives must be sacrificed?
Trilogy Associates

13. Intangibles
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 Will this product contribute to a humanitarian
mission?
 Do we want patient recognition and access? Will this
product provide them?
 Does this product exercise our most important
strengths? Does it minimize our limitations?
 What other advantages and disadvantages are
worthy of consideration?
Trilogy Associates

14. For more insight and support contact …
14
Joe Kalinowski
Founding Principal
Trilogy Associates
(919) 533-6285
jk@trilogyassociates.com
http://trilogyassociates.com
Trilogy Associates