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Trilogy Tidings
January 2018
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in this issue
     No, I'm not talking about politics. And I'm not talking about world order. These are obviously important - some would say critical - challenges. Rather, I'm talking about something more mundane but of more personal import: The business you own or the business you work for. The challenge I'm talking about is the survival or growth of that business.
 
     And, although I'm not the first to suggest it, please have a Happy New Year!

Regards,
Joe

The Challenge of Enterprise Growth              
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     Can we agree on one principle that has been proven valid repeatedly - like forever? That principle is: "A business that does not grow will soon cease to exist." And one of the most reliable mechanisms of growth is to serve your customers better by continually offering them relevant, new products and services. I think few would disagree about the need for new stuff. But the immediate questions one faces are: (1) How do we determine what those new offerings should be, and (2) how do we execute to make that happen?
 
     The second question dealing with execution has been extensively covered in the literature and is beyond my scope here.
 
     The process of answering the first question is what I call opportunity assessment. It starts with understanding your positioning among customers and competitors, and it ends with a conceptual definition of a new offering that survives a rational, objective assessment of feasibility and value.
 
     I dealt with this topic from the perspective of engaging outside support in last month's Tidings. You will find more detail on the fundamentals of this process, regardless of who carries it out, in my new one-pager entitled " Dimensions of New-Product Opportunity Assessment."
 
     I've written extensively on opportunity assessment, often dealing specifically with new medical products. You can review some of this prior work dealing with screening, needs-driven innovation, and benefits assessment.

A New Pathway to FDA Clearance             
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     FDA promises more flexibility in its device approval processes by adding a new pathway to the existing 510(k) process.
 
     Quoting a recent news article:
"The U.S. Food and Drug Administration is planning to add a new voluntary, alternative pathway for medical devices, FDA Commissioner Scott Gottlieb, MD, announced Monday.

The flexible pathway will lean on more modern criteria for a reference standard and allow comparisons to standards that are more closely aligned with the particular technology FDA is being asked to evaluate.

The new framework will let device manufacturers demonstrate substantial equivalence by meeting objective performance and safety rules. Gottlieb said this will include FDA-recognized standards, guidance documents, or a combination of the two."

     This new pathway is certainly interesting and potentially advantageous to applicants. But it's not immediately obvious (to me) under what circumstances it will be applicable or how the agency staff will choose to interpret this new guidance. I refer you to your favorite FDA regulatory expert for an opinion.

The Most (and Least) Admired Professions             
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     Results of the annual Gallup survey of Americans' Ratings of Honesty and Ethical Standards in Professions are in. Drum roll: Nurses rule! Other medical professions don't do badly either.
 
     These rankings are interesting. They are largely predictable, but a few surprises are revealed. I hope your profession scored well!
Resources from our Archives 
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     Check out our Reading Room to view my published articles, presentations and white papers on a variety of topics.
 
     And, you can examine my Newsletter Archive of prior Trilogy Tidings (since February 2007).
 
What does Trilogy do? 
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     Trilogy Associates facilitates business growth and renewal through commercialization of new products, providing the following services:
  • Opportunity assessment
  • Business planning and enterprise growth strategies
  • New-product conceptualization, commercialization and marketing
  • Market research and competitive assessment
  • Business development and partnering
  • Market and technological due diligence
  • Assessment of the therapeutic and diagnostic potential of novel technologies
  • Design of efficient and effective development strategies for early-stage biomedical products
  • Business and technical writing/publishing

     Inquiries to establish whether and how we might support your business initiatives are always welcome.  Contact us.

Contact Information
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ContactInfoJoseph J. Kalinowski, Principal
919.533.6285
LinkedIn Profile: www.linkedin.com/in/trilogy
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