Trilogy Tidings
June 2015
in this issue

     I'm fully engaged in a typically time-crunched due diligence engagement in the orthopedics space. So allow me to disappoint my especially diligent readers with good memories by reprising a prior post dealing with advice on the important issue of deciding what new product(s) to build to support your business.


     Also, I share some views on robotic surgery. That should spark some controversy!



How do you know what to build?           

     Let's talk about new medical products, especially those which are personally used by clinicians - physicians, nurses, nurse practitioners and physician assistants - to treat patients. How does a supplier of such products, generally characterized as medical devices, determine what to develop and bring to market?


     This question is easier to answer for other kinds of medical products such as drugs and diagnostic tests because those products are quite standardized in their presentation and have minimal interaction with clinicians after they are prescribed. They are substantially easier to define after a clinical need has been established -- not a small matter but easier nonetheless.


     The simplest answer to the question is: "Ask the clinicians what they need".  Well, it ain't that easy! Here are some proven guidelines to follow in reaching a more satisfying answer to the question.


Patients come first. Goes without saying, right? Perhaps, but you do need to establish with certainty that the well being of some patient class will be improved and/or their medical risks mitigated when the product is applied by a clinician.


Just ask. A good place to start. Determine who are the likely users and ask them what they want. But who is the predominant user, and who is the predominant purchase influencer? They may be the same person or not. And you cannot simply ask "What do you need?". They may not know what they need, and they almost certainly do not know what can be delivered. But they do know precisely what job they have to do. Find that out, and make that job easier, increase their compensation, or both.


Just watch. What could be better than watching the targeted clinician perform that job? Nothing. Be there. Make yourself invisible, and learn. Watch especially for hang-ups, uncomfortable moments, complaints, time-consuming steps, error-prone activities, and such. After a procedure is done, ask what they found easy and difficult. Then go to work fixing the difficult steps. (Have you observed your physician specifying a diagnostic test to be run or a drug to be prescribed via their fancy, system-imposed EHR system? Now there's a pain point to be addressed!)


The clinician is a person. This reality is all too easy to forget. They don't generally respond only to logical arguments and fancy new products. They know what is, and what is not, in their comfort zone. They also respond emotionally just like you. Your solution cannot be too unfamiliar or too complex. Perhaps it's just the wrong color! Perhaps it will just take too long to learn. Or maybe they cannot imagine pitching your solution to the purchasing powers that be. Be prepared to react to the inevitable emotional responses. Maybe a focus group or three will do the trick.


Gather from a diverse group. Since clinicians are people, they are all different. Be sure you are covering the territory: thought leaders, early adopters, late adopters, dedicated practitioners of the art, old hands, newcomers, and everyone in between. You must ultimately sell to all so it would be prudent to hear a variety of their views.


Push your developers into the field. Encourage - force if necessary - your scientists and engineers to visit healthcare workplaces and the clinicians who work there. Let them really get the feel of the place, the stress, the disorganization, the interruptions, the distractions and resulting errors and delays. Observing any prospective product's environment of use will surely spur important questions and creativity.


Better to ask closed-ended questions.   Ask when you have something to ask about. Not so much "What would you like to have?" as "What do you think of this product concept or that product benefit, and why?" Give clinicians something concrete to ponder, something they can imagine in their workplace. Later in the process expose them to a reasonably accurate concept model. You do engage the services of human factors experts and industrial designers, right?


Consider asking patients. Self-treatment devices are becoming ever more common. In those cases it's imperative to get patient opinions and design guidance as well. The more intimate and intrusive the device, the more critical are patient inputs.


Guard your secretsYou may not much care if your competitors learn that you're conducting market research in an obvious, familiar space. But if you're up to something very different, know that your competitors will inevitably find out. In that case consider third-party support for your research.


Share the wealth smartly. Don't overlook the critical importance of sharing the knowledge that you develop with your in-house team - not just the raw data, but some carefully crafted conclusions, the analysis behind those conclusions, and the resulting influences on your internal development plans and budgets. Whether your research efforts are conducted by in-house staff or a consulting partner, its results must be widely shared, uniformly understood, and acted upon effectively throughout your organization.


Is robotic surgery a revolution or a ripoff?            

     I won't share my own views on this question, as I have not personally seen hard data on the clinical benefits and economics of robotic surgery, nor have I consulted in the field. But I will point you to a thought-provoking article by Cameron Scott in a February issue of HealthlineNews.


     Share your views in agreement or disagreement with the author's conclusions. 

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.

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).
Contact Information
Joseph J. Kalinowski, Principal