Trilogy Tidings

February 2013


in this issue
A Screener to Guide New-Product Assessment
Implants Anyone?
Go East, Young Man
Resources from our Archives
What does Trilogy do?


     This month's theme: Look before you leap! And that advice applies to each of my three topics:


  • Screening new-product ideas prior to development & commercialization
  • Entering the implanted-device arena
  • Exploiting the Far East for growth







   Change Ahead


A Screener to Guide New-Product Assessment

     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.


Assessment Checklist 


     Don't let this happen (again) in your business. Get that assessment done up front. As your luck would have it, I can help! During one recent cold January day - or as cold as it gets here in North Carolina - and with no client commitments to address, I put together "A Screener to Guide New-Product Assessment". It's nothing fancy, just a compilation of hints and memory-joggers to encourage you to touch what I think are the top-10 bases as you go about evaluating the commercial worth of your idea.


In any case, I hope you find my experience-based thoughts useful.


     Now, if you could just remember where to find these pearls of wisdom when you need them. I suppose you could put me on speed-dial or maybe paste the presentation's icon onto your desktop or smartphone. (I really need to stop overreaching!)



Implants Anyone? 


     I was struck by a recent report by Bloomberg, stating that "An internal analysis by Johnson & Johnson shows that the company has been aware of high metal hip implant failure rates since 2011. The J&J analysis concluded that approximately 37 percent of DePuy Orthopaedics' ASR metal-on-metal hip implants would require replacement at five years." (37%! Five years!) A recall of these implants led to approximately 10,000 lawsuits. According to some analysts, the final costs to the company could be as much as $1 billion in liability damages. (10,000 lawsuits!)


     Put this report in the context of another recent implant-failure story: Failure of St. Jude's Riata ST Optim and its newer Durata ICD leads owing to insulation problems. Some failures occurred in leads implanted for four years or less. More than 20 patient deaths were linked to the lead failures.


Medical Implants 


     This is scary stuff if you're a medical implant maker. Stories like these leave me with three conclusions:

  1. If you're planning to introduce an implanted product, think long and hard about that. Be sure the clinical benefits and upside potential greatly outweigh the downside risks. Be ready for a tough regulatory climate and very substantial costs prior to and after commercialization.
  2. Don't assume you know about everything that could go wrong. Don't assume you know everything about the biomaterials issues in play. Nature always will have a few surprises in store.
  3. Be prepared to test, test, and test some more - on the bench and in large numbers of animals - for a long time under worst-case conditions.


Go East, Young Man 


     Vigorous growth of Far East medical device markets seems assured. While Asia accounts for only about 18% of global healthcare spending, the growth of Asian spending is more than twice the rate of North America and Europe. So it makes perfect sense to be looking to the East for some of your medical device business expansion.


Far East 


     In a recent article by Emergo Group, observations about five Asian markets are made: Japan, China, South Korea, Southeast Asia and Malaysia. The author of the article is a well-known regulatory consulting firm, so they have a stake in their reported findings, but there's no denying that opportunity knocks in the Far East.


     As always in a new geography, do your homework first. Get to know how the healthcare system works; who decides; who buys; who pays; under what terms. And, of course, understanding the regulatory rules and climate is essential.


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
LinkedIn Profile: www.linkedin.com/in/trilogy