~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Trilogy Tidings
June 2011
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
in this issue
Needs-Driven Innovation
Industry Views on FDA Performance
Yet Another Search Tool
Resources from our Archives
What does Trilogy do?

     Innovation remains the watchword this year, so I have more to say about it -- specifically about two recognized means to achieve it.  Currently the more popular method of the two is founded on the principle that one must start by fully understanding your customers' unmet needs before launching into a discovery/invention process.

     I also address, by means of a recently published study, how the U.S. FDA is influencing the latter stages of innovation through its regulatory behaviors.

Regards,
Joe

 

 

 Change Ahead

 

Needs-Driven Innovation 
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

     This is the "year of innovation".  (What year isn't?)  So it's kind of important to be doing innovation right - to keep the competition at bay, stay on a healthy growth path, or maybe just keep your job.  There are two widely recognized approaches.  You can start with an idea, leading to ideas-driven innovation (IDI).  Or you can start with an understanding of unmet customer needs, leading to needs-driven innovation (NDI).  In my opinion, you need to be using both approaches.

     The merits of NDI are well established, and many companies claim to do this well.  Based upon my own experience in product definition/development/commercialization (good grief, almost 35 years!), I disagree.  Most companies do it poorly.  It's hard work, and it requires that a very deliberate and precise process be followed for real success.  (Real success = Every new-product introduction is a winner + No dogs survive the process.)  Our own recipe for a successful Needs-Driven Innovation approach can be found here.

     Successful NDI is much harder that most people think.  You often need to use multiple research techniques, e.g. in-depth interviews, observation, surveys, focus groups.  You need to properly frame your inquiry to get at real user needs.  ("How would you change our existing product?" will not work.)  You need to devise metrics for levels of need satisfaction.  You dare not avoid economics.  You need to separate product-feature innovations from the often more compelling business-model innovations (think Netflix).  Difficult stuff, but well worth the trouble.

     All well and good, but we cannot ignore the importance of ideas-driven innovation.  Some of the world's great problem solutions have come about by IDI.  At minimum we need fundamental research and scientific breakthroughs to arrive at product definitions that satisfy some of the most important, and most enduring, unmet societal needs.  Nevertheless, consider just one of IDI's caveats: You must avoid either immediately falling in love with any idea or dismissing it out of hand before subjecting it to full analysis and potential adjustment.

     My suggestion: Use both methods, and do them both right.  You'll be proud of your results - and you're more likely to keep your job!
Industry Views on FDA Performance 
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

     A comprehensive report disclosing industry perspectives on how FDA has managed their 510(k) approval process was issued on May 24.  The study was funded by the Institute for Health Technology Studies (InHealth) and was conducted starting in August 2010.  It's not clear to me why it took so long, but the report is a nice piece of work.  The study findings are revealing and, after discounting for the inevitable "whiner" factor, they should prove helpful to the U.S. Congress and the agency itself in finalizing the 510(k) process redesign later this year.

     You can reprise the live presentation or download the slide deck from here.
Yet Another Search Tool 
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

     I got an announcement of a new Internet search engine, called Zanran, which is touted as a means for finding data and statistics - essentially Google for data.  I tried it briefly and was moderately impressed.  Learn more about it here.  You may find it to be a nice complementary tool for web research.

Resources from our Archives 
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
     Check out our Reading Room to view my published articles, presentations and white papers on a variety of topics.

 

     And, you can examine an archive of my prior newsletters (since February 2007).

 

What does Trilogy do? 
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
     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.  And check out our partner, Innovalyst, A Catalyst for Innovation.

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