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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
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
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
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
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
Customer Acceptance
                              6

 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
Downside Risk
                           7

 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
Economic Benefits
                             8

 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
Time to Market
                           9

 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
Competition
                          10

 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
Platforms
                            11

 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
Resource Needs
                            12

 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
Intangibles
                           13

 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
For more insight and support contact …
                                            14




                     Joe Kalinowski
                     Founding Principal
                     Trilogy Associates
                     (919) 533-6285
                     jk@trilogyassociates.com
                     http://trilogyassociates.com




Trilogy Associates

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A Screener to Guide New-Product Assessment

  • 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 6  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 7  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 8  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 9  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 10  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 11  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 12  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 13  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