Expertise

Martin Culjat, PhD

Senior Vice President, Regulatory Innovation and Digital Medicine

EVERSANA

Martin Culjat, PhD

Marty is an innovator at the cross section of product development and regulatory affairs in the medical device and digital medicine sectors. In recent years, he led the effort to obtain the first ever breakthrough device designation from the FDA for a DTx monotherapy at Dthera Sciences, launched a DTx that incorporates AI and telehealth coaching to manage and treat the symptoms of autoimmune disease while at Mymee, launched clinical decision support software using precision oncology and AI algorithms to rank millions of drug combinations at CureMatch, and developed a DTx for asthma self-management that tracks lung function, triggers, and medication use at an early stage startup.

As an industry leader on regulatory affairs in digital therapeutics, Marty has spoken at numerous conferences including DTxWest, DTxEast, and Clinically-Validated Digital Therapeutics Summit. And, he has served as a strategic advisor to a wide range of digital therapeutic, digital medicine, medical device, and pharmaceutical companies.

Marty holds a PhD in biomedical engineering from the University of California Los Angeles (UCLA), and a Bachelor’s degree in bioengineering from the University of California San Diego.

Expertise:

Digital Health, Digital Medicine, Medical Devices, Regulatory

Articles by Martin Culjat, PhD

CMS Announces Medicare Coverage for FDA-Designated Breakthrough Devices. What Does This Mean?

On August 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule change that would automatically provide national Medicare coverage for FDA-designated Breakthrough Devices for a four-year period immediately upon FDA approval. This is big news for patients, health care providers and medical device manufacturers. When the Breakthrough Devices program was […]

5 Trends in Digital Medicine to Watch For

  We Are Uniquely Positioned To Deliver EVERSANA is uniquely positioned to follow the trends and introduce new models and strategies to maximize the value of pharmaceutical products through Digital Medicine Solutions and Execution. Digital Solutions can be deployed to impact the entire life cycle of a product in unprecedented ways. Schedule a 30-minute call […]

What does the new FDA Guidance for DTx Products Treating Psychiatric Disorders actually mean?

On April 14, 2020, FDA posted new guidance that eases regulatory enforcement of Digital Therapeutics to improve patient access to psychiatric care during the COVID-19 public health emergency. FDA should be praised for this decision, as there are countless individuals with a variety of mental health conditions who are stuck at home during the COVID-19 […]

What kind of clinical data is required for FDA clearance of a Digital Medicine?

What kind of clinical data is required for FDA clearance of a Digital Medicine? It depends. Digital therapeutics and digital medicines that are subject to FDA regulation are considered medical devices. The amount of clinical data required by FDA generally depends on risk. Many moderate risk (class II) medical devices seeking 510(k) clearance are required […]

What specifically triggers FDA regulation of a digital medicine?

I often meet with Digital Health or Pharmaceutical clients to discuss their commercialization journey, and they ask me the same question. What specifically triggers FDA regulation of a digital medicine? Some of these products require FDA clearance and some do not. Regulatory oversight of digital medicines depends primarily on intended use, which is generally captured […]

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