Browsing “Digital TherapeuticsDigital Therapeutics | EVERSANA”

Sharpening The Value And Definitions Of Digital And RWD: An Exchange Between Two Industry Leaders

The following is a exchange between Brigham Hyde and Ed Cox, two health tech experts and coworkers on a quest to educate each other and their teams. Note: An inquiry from a colleague who interchanged terminology initiated this exchange. Download the PDF Version  

Ask the Expert: Digital in Pharma | The Critical Questions

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. In a “digital tell-all” conversation, Ed Cox addresses four critical questions […]

Podcast: The Future of Digital Therapeutics

The Digital Therapeutics market continues to evolve at a rapid pace. In this podcast, hosted by Erica Sosnowski, host of the podcast series “The Platform”, we discuss current trends in the life sciences industry and the future of digital therapeutics with Edward Cox, the Global Head of Digital Medicine and Executive VP of Strategic Alliances […]

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 […]

Healthcare Pivot: Digital Medicine Delivers During A Global Crisis – Reviewing Commercial Pathways

In February 2020, healthcare as we knew it changed. The industry began waging an aggressive war with an unknown virus beginning to overwhelm hospitals on a global scale. We immediately recognized that we needed to do things differently. Virtual healthcare began to rise, and disruptive advancements in medical technology began breaking down siloed healthcare delivery […]

PharmaVOICE Showcase on Connected Health and IoT

The Growing Potential of Connected IoT In PharmaVOICE’s Showcase on Connected Health and IoT, Ed Cox offers executive viewpoints on the challenges of integrating the Internet of Medical Things (IoMT) into pharma processes. “Breaking down siloes by supporting technology that provides value across the patient care ecosystem and investing in IoMT that generates data and […]

[Infographic] Defining the Digital Space

Despite the increased popularity of Digital Therapeutics and Digital Medicines, there is still ambiguity around their definitions. This infographic provides clarity and defines the Digital Healthcare Space. Digital Therapeutics (DTx) Evidence-based digital solutions making direct therapeutic (and frequently drug-like) claims and regulated by the FDA, usually as Software-as-a-Medical Device (SaMD). Digital Medicine A broader category […]

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 […]