Trilogy Tidings
November 2009
in this issue
Three topics this month that I think you should pay attention to:
  1. Minimizing your medical product's cost-of-use
  2. Keeping a close eye on technology developments
  3. Diligently monitoring your product promotions to clinicians
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MedTech Suppliers: Leverage Cost Effectiveness Now 

Healthcare CostsAs this is written the U.S. Congress is wrestling with health care/insurance reform.  Predicting the detailed outcome is a fool's errand.  But we can be assured of one result: healthcare cost effectiveness will command much greater attention for years, and decades, to come - either because Congress will have failed to adequately constrain these costs or our esteemed legislators will have crafted a revised system that does in fact impose important cost constraints.  Either way, if you supply medical products you will need to pay more attention to the "societal costs" associated with use of those products.  You need to understand your product's cost footprint now and use that information defensively or - even better - offensively to protect or enhance your competitive position.

     I've been harping on this issue for several months now because I really believe that all the signals are pointing to an emerging  greater sensitivity to medical product cost-of-use by customers, commercial insurers and governments.  I wrote a piece on this subject which was published in this week's issue of AHC's Medical Device Daily Perspectives.  You can read an expanded version of that piece on the Reading Room page of our web site.

     It can be challenging to gather the data you'll need to demonstrate a systemic cost benefit, but I believe those efforts will pay off in spades down the road.  They may even reveal whether your contemplated new product can be successful at all.
Many Dimensions of Technology Assessment
LightbulbIf you're like most, you know what technology assessment is, but you view it through the distal end of a telescope.  In other words you see this process as one of limited scope.  That's because you and your organization probably carry out this process only sporadically and in a limited number of ways.  It's my privilege to expand your view.

Technology assessment can be many things, for example:
Competitive landscaping - What are your competitors up to?  What are their current products' characteristics?  What new technologies appear to be in their pipelines?  These investigations are best conducted on a regular basis, not only on the occasion of a competitive threat.

Due diligence - Most view technology assessment through this lens.  You're offered a technology for in-licensing or acquisition.  What are its attributes and limitations?  What is its commercial potential?  Exactly how can you adapt it for inclusion in your product line?

Supply chain advances - Few pay attention to this one.  What are your suppliers up to?  Which of them, or which other suppliers, are offering a breakthrough technology that could dramatically affect your competitive position, favorably or unfavorably?  How can you exploit that technology, and will it be worth it?

Intellectual property - This one is familiar to most.  The IP landscape must be tracked regularly for both offensive and defensive purposes.  Sometimes it's best to engage the services of an expert, such as my associate Bruce Horwitz of TechRoadmap.

New concepts and product improvements - There are two sources for these ideas, internal and external.  Most handle the internal assessments quite well, but external ideas generated by customers are often much more important.  You must have a robust system in place for gathering and responding to customer recommendations.

Opportunities for disruption - Be on the lookout for technologies that could change the face of your business - or put you out of business!  Engage an appropriate resource or internal team skilled at discovering these game-changers.

Crossovers - No, it's not an auto/truck thing.  These are technologies originally applicable to one field but potentially important in yours.  Think wireless networking suddenly essential for programming implantable medical devices.  Keep your eyes and ears, and most importantly your mind, open.

     See, it's more than you thought.  We at Trilogy Associates do all of this stuff.  And you may find my checklist of some value as you dive into the details for any of these assessment processes.
Play by the Rules - Or Else
PrisonerMost of us are guided by a moral compass of some kind.  All of us have those beliefs reinforced by certain rules and regulations imposed by arms of government.  However, a few of us are strongly tempted by business realities to violate these rules and norms of behavior.  Why this high-minded prose from a simple working stiff?  Because two remarkable announcements appeared on my desk within days of each other recently, both making it very clear that one and/or one's employer can get in major-league trouble by violating rules that apply in the medical product space.

     First, Drug Discovery News reported that the U.S. Department of Justice recently levied the largest criminal fine in U.S. history against Pfizer for bad behavior: $2.3 billion!!  Then, a day or two later, Medical Device Link reported that Stryker Biotech and several of its top managers were indicted for alleged bad behavior that could result in cumulative fines well north of $1 million and cumulative prison sentences upwards of 30 years!!  In both these cases the behavior alleged, among other charges, is unlawful promotion of medical products for uses beyond those approved by FDA.  You can read the reported details in the DDN and MDL pieces.

     Hey, these reports got my attention.  The U.S. government is clearly serious about protecting the public health against cheating suppliers.  And bureaucrats are clearly serious about protecting their prerogatives.  Physicians can use products off-label; suppliers cannot promote same.  My suggestion: Stay out of jail; it's unseemly and inconvenient.  Whatever benefit you derive from the deception, it ain't worth it.
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.

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