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In Case You Missed It: Highlights | When Digital and Life Sciences Intersect

In this session, panelists discussed common pitfalls that life sciences companies face as they explore ways to incorporate digital-health strategies into product and service offerings, as well as approaches for successful integration and launch. Seasoned veterans in developing and deploying digital-health solutions from within the life sciences ecosystem, the panelists shared lessons learned and offered practical suggestions for listeners addressing similar projects.

Session panelists:

  • David S. Klimstra, MD, Founder and Chief Medical Officer, Paige.AI, Inc.
  • Suhas Krishna, Vice President, Head of Product Management, Digital Health, Bristol Myers Squibb
  • Betsy McSheffrey, Head Counsel, Data, Technology and Innovation, Takeda
  • John Rootenberg, MD, Principal Director, Digital Safety and Decision Support, Genentech (Roche)
  • Ryan Sysko, Chief Executive Officer, Amalgam RX
  • Moderator: Jennifer Geetter, Partner, McDermott Will & Emery

Top takeaways included:


  1. Last-mile conundrum. Panelists observed that for typical products manufactured by life sciences companies, a disproportionate amount of the hard work occurs prior to regulatory approval. Once the product is approved (by, for example, the Clinical Laboratory Improvement Amendments (CLIA) or the US Food & Drug Administration (FDA), the company’s most difficult work is done. For digital-health solutions, the inverse is often true. Even sophisticated digital-health products and services typically have a shorter development timeline, but once released in the market, challenges around adoption, adherence, persistence and integration must be addressed. In addition, customers will expect regular software updates. Life sciences companies are not always adequately prepared for this reverse last mile—i.e., the longest mile—of the development and marketing lifecycle.
  2. Risk appetite. Panelists noted that the life sciences industry is typically risk averse. This is in sharp contrast, for example, to the software industry, which is attuned to software innovations and is designed to anticipate missteps and optimize, when necessary, the “fast fail.”
  3. Blurry strategic vision. The panelists discussed “digital-health FOMO” (fear of missing out). Life sciences companies want to offer digital-health products and services because they recognize the strategic value of participating in the market explosion at the intersection of healthcare and data/computing. Sometimes this enthusiasm outpaces the speed with which life sciences companies can develop dedicated digital-health strategies, either as companions to existing products or as complimentary clinical services. Having a clear strategic objective governing the development of a product and realistic investment goals are critical.
  4. Deployment. The panelists emphasized that once a digital health tool is developed, companies should ensure physicians and patients actually adopt and continue to use the tool. Specifically, one panelist stated, “The one who wins is the one who has the right deployment [of the tool].”


  1. Hidden value. Digital-health strategies, such as using the data obtained from digital-health tools to promote research, offer hidden value for life science companies. As a component of development and marketing strategy, life sciences companies need to be prepared to articulate these benefits, especially those that may not be readily apparent or may be ancillary benefits. The successful deployment of a digital-health tool—for example, a patient- or consumer-facing app—is predicated on the persistent adoption of [...]

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McDermott Partners Recognized As Digital Health Power Players

Washington (August 11, 2021)McDermott Will & Emery partners Jennifer Geetter and Vernessa Pollard have been recognized within an Insider profile on the “9 behind-the-scenes players who can make or break your digital-health startup.” The pair discussed advising young companies on the regulatory hurdles they have to clear before tackling the healthcare market.

As part of the Firm’s industry-leading health practice, Jennifer advises digital health companies on the development, delivery and implementation of innovative healthcare solutions. Vernessa leads medical device and technology companies through US Food and Drug Administration (FDA) regulations to bring products to market.

Vernessa explored with Insider how more tech companies are spreading into healthcare. These companies need assistance discussing the FDA’s newest regulations, including machine learning oversights or health-data privacy rules. If businesses are not knowledgeable about their regulatory requirements, it can make or break their investments.

“We have a number of what we’d consider to be nontraditionally FDA regulated entities, such as the large tech companies and even hospitals and healthcare providers, that are entering this space because they’re developing new tools or technology that may trigger FDA requirements,” Vernessa noted.

Jennifer explained that it’s not always clear if decade old FDA laws apply, so she advises her clients to prioritize building trust with patients through an emphasis of privacy and cybersecurity protection.

“There’s something about the intimacy of the standard doctor-patient relationship when you’re sitting across the room from your doctor that breeds trust,” Jennifer said. “When you’re in a digital healthcare system with distance, you don’t necessarily have that.”

McDermott Will & Emery is the nation’s leading health law firm. The Health Industry Advisory group is the only health practice to receive top national rankings from U.S. News – Best Lawyers “Best Law Firms,” Chambers USA, The Legal 500 US and Law360. The practice was also recognized by Chambers as “Health Team of the Year” in 2010, 2013, 2017 and 2019. McDermott has also held the top spot in PitchBook’s League Tables as the most active firm for healthcare private equity since 2017.

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FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers

As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. In December 2018, FDA issued a guidance document describing policies FDA intends to use to implement the Program.

There are two criteria for inclusion in the Breakthrough Device Program:

  1. The device must provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition; and
  2. The device must (i) represent breakthrough technology, (ii) have no approved or cleared alternatives, (iii) offer significant advantages over existing approved or cleared alternatives, or (iv) demonstrate that its availability is in the best interest of patients.


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UPCOMING WEBINAR | Digital Health: The New Dynamics — Big Data Part I: Data-Driven Life Sciences Innovation, Personalized Medicine and Research

Health care and life sciences companies increasingly operate in a digital environment. McDermott Will & Emery is hosting a complimentary four-part webinar series to explore the practical business considerations and to simplify the regulatory complexity of digital health, including health information technology (IT), big data, mobile health and telehealth.


Big Data Part I: Data-Driven Life Sciences Innovation, Personalized Medicine and Research

Date:  Tuesday, December 9
Time: 12:00 – 1:30 pm EST

Data-driven solutions are a powerful tool for the life sciences sector and research community. This program will explore how life sciences companies, research institutions, providers and informatics businesses can successfully navigate the regulatory landscape for big data to develop, introduce and differentiate products. The following key questions, among others, will be addressed:

  • Overview of Regulatory Framework — How can big data initiatives be structured to comply with key federal laws?
  • Data Registry Creation and Management — What are the data stewardship and data governance considerations?
  • Emerging Partnerships — What is the role of the government and industry for data initiatives in the life sciences?
  • Personalized Medicine — How is data used to deliver personalized medicine at the bedside?
  • Biospecimens — How does the introduction of annotated biospecimens affect the big data landscape?
  • Genomic Age – What does it mean to engage in big data initiatives in an age of genomic medicine?


Amy Hooper Kearbey, Partner, McDermott Will & Emery LLP

Matthew Hawryluk, Ph.D., Senior Director, Corporate & Business Development, Foundation Medicine, Inc.

Jennifer C. King, Ph.D., Director of Data Governance for CancerLinQ, American Society of Clinical Oncologists

Sari Heller Ratican, Chief Privacy Officer, Amgen


Jennifer S. Geetter, Partner, McDermott Will & Emery LLP


  • WEBINAR THREE: Big Data Part 2: Data-Driven Changes to Payment Models, January 13, 2015
  • WEBINAR FOUR: Mobile Health & Telehealth: Mobile and Telehealth Technology Create New Business Opportunities, February 10, 2015

Click here to view WEBINAR ONE: Health IT: Collection, analysis and sharing of health information

For more information, please contact McDermott Events.

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