Trilogy Tidings
March 2017
in this issue
     Five topics this month, mostly about what comes next. What's more interesting than that?

The Medtech Crystal Ball         
     Prognosticators usually emerge in January. I took my shot two years ago, and I'm largely sticking to those predictions. However, the field of neurostimulation and its varied clinical applications have accelerated faster than I thought, so I would add that to my list today. On the other hand, EHR integration with medical devices now seems less certain, largely because EHR standardization appears to be a pipe dream; we can only hope.
Is Clinical Diagnostics Due for a Growth Spurt?         

Growth Spurt
     Some, including John Audette , think so. I'm inclined to agree. Two recent political and regulatory developments will tend to stimulate that uptick in growth.
     First, the 21st Century Cures Act passed the US Congress with overwhelming support last December. That law, among other things, provides strong support for biomarkers and associated "precision medicine." Both initiatives are likely to raise the profile of diagnostics in medical practice.
     Second, the US FDA seems to have abandoned its prior intent to regulate laboratory-developed tests (LDTs) owing to demonstrated lack of need for such regulation. LDTs are already the fastest growing segment of the diagnostics industry; now that growth is unlikely to be impeded. Thousands of laboratories have already developed and offer LDTs. 
Advice for Medtech Startups         
     Based upon my personal experience, here's the truth: All early-stage medtech enterprises need all the (good) advice they can get, and they are all tired of hearing it! Most of that "expert" advice comes free, so there's really no justification for complaint.
     In any event, I don't plan to cease offering my advice. If by any chance you care about my thoughts on the matter, here's a no-charge example. Feel free to share my views as you see fit.
Screening Ideas for New Medical Products         
     On the other hand, every medtech enterprise needs to be constantly reminded of the well-known criteria that should be applied in judging the worth of every new-product idea. (Unless you don't mind being embarrassed by a probing question from your CEO.)
     Here's my take on the subject . The questions will not change in our lifetimes.
Are Your Presentation Graphics Misleading?         
     And now for something totally different ...
     Numerical data, assuming it was accurately acquired, is always truthful; it is what it is. Graphical presentation of those data not so much. The presentation of data graphically, i.e. data visualization, has great value. It's more interesting and more apt to leave a lasting impression. But that impression is not always truthful in representing the data.
     I was impressed by a recent article by Nathan Yau of FlowingData, " How to Spot Visualization Lies." The article nicely addresses some examples of misleading data presentations. It also includes links to other topics in data visualization.
     We often have a need to present the findings of our work to clients. I'm more inclined to numbers and words than graphics. But I will now be extra vigilant with the graphics that we do present.
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 my Newsletter Archive of prior Trilogy Tidings (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