Bringing Novel Health Technologies to Market:
An Important Priority for the FDA.

Is it working in the chronic disease device and diagnostics space?

By Elise Wilfinger


Alberto Gutierrez Renalytix blog


The FDA is responsible for advancing public health and its Center for Devices and Radiological Health’s (CDRH) stated goal is to “help bring innovative technologies to market and provide reasonable assurance that the medical devices already on the market continue to be safe and effective.”1

To realize this goal, the Agency’s approach is multi-pronged, including, but not limited to:

  • Providing early regulatory assistance for innovators through info-share sessions
    • Innovators can familiarize the FDA review team about their ‘device’ and share differentiating benefits vs current practice and/or
    • Innovators can request FDA’s feedback during the product development and application processes
  • Facilitating communication between innovators and payors to preempt/limit delays between FDA clearance or marketing authorization and coverage
  • Giving information re: best clinical practice in research
  • Training their own staff on new technologies and on the challenges that innovators face

Recently, I discussed the FDA’s progress in this area with none other than Alberto Gutierrez, currently a partner with NDA Partners, a ProPharma Company and a life sciences management consulting firm, where he advises companies in the device and diagnostic space. Alberto is an expert in preclinical and clinical testing of in vitro diagnostic devices, premarket notifications of devices, applications for FDA approval and post-marketing surveillance.

Notably, he also spent 25 years at the FDA in various executive roles, including, but not limited to being the Director of the Office of In Vitro Diagnostics & Radiological Health which included overseeing the Personalized Medicine Staff.



  1. Let’s start with your perspective on trends in diagnostics. Is there a growing number of innovations in the chronic disease space?

There has been a sea change in innovation if we compare today to the late 1970s, when the FDA began regulating diagnostics.

Everything has changed: what new diagnostic technologies do, how they perform, and how they can help the clinician with decisioning patient care forward. Accordingly, the regulatory system has also changed.

Unfortunately, there is less innovation in the chronic disease space. To date, most of the focus has been in genetics and with infectious diseases.

That said, there have been some very interesting diagnostic innovations that leverage biomarkers and artificial intelligence (AI). Though some individual biomarkers have been used, now multiple biomarkers can be used at the same time, and in combination with AI, for the development of better tests. These new, novel tests will allow us to identify those patients at highest risk and monitor them ongoing.

In the past, clinicians had to conduct a series of tests for each patient. Each test result would yield one piece of information, essentially providing one piece of the puzzle. Patients looked to their doctor to connect all of the dots from these individual tests into one conclusion. Now, with AI technology, we can more easily look at many pieces of patient data at once, allowing us to assess patterns and provide more accurate and reliable information for the doctors.

  1. Why is FDA review important for new diagnostics?

The FDA is known for conducting independent, unbiased assessments and making decisions based on data. Outside of the FDA, there are no comprehensive, vetting mechanisms in place for diagnostics. There are peer-reviewed studies and/or credible publications, but these entities do not have access to all of the proprietary data from the innovating company. So, it is not the same.

Of note, are the many lab-developed tests that are placed into a clinical context without review or oversight. Although some of these tests may be very good, no common standards exist. That is not the best situation for bringing new solutions to market.

  1. Understandably, an unbiased data review is critical for clinicians. What does it mean for patients?

When diagnostics or medications go through the FDA for ‘clearance’, ‘approval’ or ‘marketing authorization,’ patients understand that there has been a methodical review of the test used. I believe that this knowledge gives them added confidence in the results.

  1. Was the introduction of the FDA’s Breakthrough Device Designation a pivotal moment for new diagnostic innovations?

Yes and no.

During my tenure at the FDA, specifically at the Office of In Vitro Diagnostics & Radiological Health, we were already focused on helping innovators bring new technologies to life. So, the introduction of Breakthrough Device Designation (see Special Edition Blog (1) for details about what makes Breakthrough Device Designation mission-critical) did not necessarily increase the number of diagnostic innovations.

This Designation, however, has changed the market in three significant ways:

  1. Incentivized more innovators to submit to an FDA process (in the hopes of securing Breakthrough Device Designation)
  2. While not guaranteed, innovators have a clearer and stronger pathway for payment
  3. Payment decisions can be quicker, thereby, increasing patient access and adoption
  1. What are the greatest challenges and opportunities for stakeholders to further collaborate in the future?

Of course, the greatest and most recent challenge has been COVID-19. The FDA had to quickly pivot its focus, almost exclusively, to that area. Many In Vitro Diagnostic test reviews were put on hold and early collaboration sessions between innovators and the FDA stagnated.

Now that the Agency is moving forward from Emergency Use Authorization, the opportunity for collaboration has reemerged. Those early conversations are extremely helpful as the FDA can provide the innovating companies with specific guidance on:

  • The best language for use in the company’s submission
  • How the clinical claims must be validated
  • How to best design clinical trials to ease regulatory approval
  • How the diagnostic can be labeled in a way that payors will acknowledge
  1. Do you feel that there is more of a push or an interest in certain types of innovations at the FDA?

Recently, the Agency seems very focused on innovations that use artificial intelligence. The hope is that these testing innovations will demonstrably improve our diagnostic capabilities and patient outcomes.

  1. Is the FDA achieving its goal of promoting public health?

With new technologies, analytical and computational techniques, and knowledge on what different biomarkers can and can’t tell us, the FDA is moving in the right direction. We are better able to understand data from different disease pathways and we have more learning about the optimal techniques to leverage for each patient. Both enable improved patient care and outcomes.

  1. I know that you are aware of Renalytix’s KidneyIntelX test which was just granted De Novo Marketing Authorization from the FDA. How might this help the millions who suffer with kidney disease in the United States?

A test that can help identify the level of risk for kidney disease progression is a win. The corresponding ability for physicians to create custom treatment plans to improve patient outcomes…that’s an even bigger win.




1 https://www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-innovation

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