Critical Factors in the Development Process of Diagnostics

| Stat One

The medical technology world continues to innovate and develop new products and faces new challenges every day.   The diagnostic field remains an active area and has become an area ripe for the application of AI technologies.  This broad field covers many areas from simple measurements and IVDs to real-time technologies for continuously tracking measurements or assisting in the detection of heart disease and cancer.  The need for fast, cost-effective, and accurate testing has driven home during the COVID-19 pandemic.

The development process for a technology covers more than just the performance of a test in terms of diagnostic statistics of a product.  The ability for individuals to use and understand the results; and the level of training of the users are factors to consider.  There are often issues relating to the labeled use of a product that may impact the type of pivotal study data needed,  such as does the test provides a diagnosis or simply identify an individual or tissue at risk for a disease.  Hence, diagnostic companies typically involve a team of scientists, clinical key opinion leaders (KOLs), experienced management, and an involved Scientific Advisory Board.

The following list is an example of the topics that may need to be addressed:

  • Is the diagnostic reliable and reproducible?
  • What is the product’s intended use and how will it be worded?
  • Who is the intended user and what training will be required? Is the product user-friendly?
  • How will the product affect a customer’s work environment? Does it require set-up time?  Does it have special storage requirements?  Does it require reagents or materials?
  • What are the conditions of the product in which it will be used? How may it help reduce costs or increase the testing rate?
  • Is the product feasible for all patients? Is it affected by other health diagnoses or only used as a standalone product?
  • Does the customer like the device and find it efficient and effective? What specific settings or appearance components are important?
  • Can the product be designed to make it better than the competitor’s products?

Determining these factors assist in obtaining a diagnostic product that is effective in the real world and a successful product for the company.  These will affect the class of the device and the type of pivotal study data needed to support approval and possibly reimbursement.  The benefits of a strong development process are essential to obtaining a strong product and success in the market.  Establishing this framework early on will make the process easier while optimizing performance for customers and patients.   The need for expertise and knowledge in this stage is the solution for approaching each of these aspects appropriately and accurately.

Stat One, LLC works closely with diagnostic and medical device companies to enable market success and validation of your product.   Our team has extensive experience in the diagnostic space including point-of-care products, IVDs, imaging agents, imaging devices, Computer Assisted Detection (CAD) products.  Our experience includes numerous FDA interactions in regard to diagnostic products.  We strongly advise engaging with a CRO early on in your development process to gain accurate insight and guidance to successfully bringing your product to market.  Our team is your partner in growing a better future!

To speak with our team, contact us.