The current state of medical device product development has relegated clinical trials to achieving two goals: 1.) reaching a milestone for funding or exit, or 2.) supporting regulatory submissions. Unfortunately, what has been lost is the pursuit of learning that drives refinement of the device.
I have argued for many years, often to deaf ears, that clinical research provides great value when utilized to “develop” the product and not solely to confirm the adequacy of a finished product.
Especially when developing a novel product, the sooner an experimental device can be studied in the clinical environment, the greater the opportunity to impact the product design, features, and procedure. Additionally, the study protocol and case report form (CRF) design can grow in parallel to the experimental product.
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Healing Innovation Website Healing Innovation is a resource for clinician innovators. The main site - HealingInnovation.com - provides an overview of the various aspects and issues facing clinician innovators.
There is no in vitro or in vivo model that can fully duplicate the experience of medical devices interacting with human beings, both the patient and clinician. If you wait until the product design is “frozen” to perform clinical testing, the thawing-out process will be painful as the unknowns are revealed. Backtracking late in the game is never done easily and more often than not a suboptimal design is carried forward.
The high expense for clinical trials is one excuse for delaying clinical studies until the end of the development process, “let’s wait until the design is perfect before we spend a bunch of money on a trial.” The flaw in this argument is that when a large study has to be repeated due to poor study, procedure, or product design, the expense is a magnitude higher than a series of smaller pilot and feasibility studies. And, the device is guaranteed to be less than optimal if unknowns exist when the design is locked-in.
Once a prototype of a design can be manufactured in a fashion that meets the verifiable Design Inputs (especially safety), get into the clinic and learn.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Healing Innovation is a resource for clinician innovators. The main site - HealingInnovation.com - provides an overview of the various aspects and issues facing clinician innovators.
