Cutting a Path Toward Product Development

January 9th, 2011
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A recent issue of The New Yorker included an interesting article by Jonah Lehrer entitled,  The Truth Wears Off—Is there something wrong with the scientific method? The article focuses on the “decline effect,” which has been observed and debated in various studies in disciplines ranging from psychology to pharmacology to biomedical research.  One of the observations is: As more trials were conducted with a given agent, the less efficacious that agent appeared.  In many cases, the agent was no better than its predecessor, even though the initial study results were significant.
 

I found Lehrer’s article interesting because it made me think about the pursuit of an idea and the development of that idea into a product – whether it becomes a medical device or test, a drug, or even a bicycle.
 
In the case of a medical device or test, the developer has a lot at stake to prove to those who hold a financial, scientific, or clinical interest that the idea is feasible.   During the clinical studies, the developer has to resist bias and maintain mental clarity in order to avoid creep of any subjectivity by not searching for results to validate the hypothesis.  A difficult pill to swallow, usually for all involved, is to let go of an idea or to go back to the design for further iteration because the data collected from a feasibility study does not support the hypothesis.  This could be due to a poor study design, lack of reproducibility from the data collected or to the fact that the device or test, in reality, would be unreliable or unsafe for patients.
 
Often a startup company may begin feasibility studies to prove that the design is equivalent and not inferior to the accepted standard.  Once proof of concept has occurred, the next step is to establish that the design is ‘equivalent’ to the standard.   In many cases, the new design is ‘better’ than the standard. “Better” can have different meanings, however.  “Better” can mean that a new technology could significantly change our lives or that a faster or easier test could be run in a laboratory or at the bedside, or it could be a “better” discriminator of positive/negative results.
 
In the realm of devices and diagnostics, limited financial support may constrict the multi-year timeline associated with moving a test design from the feasibility stage to product launch into the marketplace.  With this in mind, it is critical that the design and reproducibility of the studies are robust and can support a well-defined intended use. If a company plans to submit the product through the regulatory process by way of a 510k or PMA, it is worth reviewing the guidance documents listed on the FDA website and, in certain instances, a company may benefit from a pre-IDE meeting, which could help map out the best path to market.  A pre-IDE meeting may also help to avoid some of the common problems faced by companies (such as poor study design, a  complex test that is not well understood or an ill-defined intended use), all of which could create a critical delay in the expectations and milestones of the company.
 
Helping companies to thoughtfully develop their study plan and intended use may help to save time and costs.  Our goal at Popper and Company is to provide our clients with the best and most discriminating information with which to base their decisions as they move their ideas and products to market. If you’d like to talk on this topic or any others during the JP Morgan Healthcare Conference this week, we’d love to connect with you.  My colleagues Ken Walz, Caroline Popper, and Shane Climie will be on the ground in San Francisco. You can also contact us any time at info@popperandco.com. We’d welcome the opportunity to  talk about how we can help you map out a path that best suits your needs.


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About the Author:

I have 20 years experience in clinical research, including leading diagnostic and pharmaceutical clinical studies in disease areas ranging from cancer to infectious disease to cardiology, diabetes, and autoimmune disorders. Send me an email.

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