The digital health era is well underway. Since its beginnings at the turn of the millennium, the industry’s digital transformation has spawned the development of computerized and artificial intelligence-based tools for disease diagnosis, treatment, and management. With virtual and telehealth opportunities bolstered by the pandemic, the pace of healthcare’s digital transformation is only expected to accelerate over the next decade as digitally connected technologies change the paradigm of deliverable care.

The definition of “digital health,” however, can vary widely. There are many categories that fall under this umbrella, including:

Wearables: Some of the current trendy items in this category include watches, patches, rings, necklaces, and textiles.

Digital Therapeutics: Defined by Wikipedia as “evidence-based therapeutic interventions driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.”

Software as a Medical Device (SaMD): The International Medical Device Regulators Forum specifies SaMD as software intended to be used for one or more medical purposes that perform these functions without being part of medical device hardware.

Artificial Intelligence (AI) and Machine Learning (ML) in SaMD: AI is the science, engineering, and development of intelligent machines, especially intelligent computer programs. ML is an AI technique used to design and train software algorithms to learn and act on data. Current deployment of AI/ML in medtech include imaging systems, monitoring solutions, and surgical planning software.

Cybersecurity: The use of technology to manage and mitigate risks for medical devices that are exposed to threats through the internet or other forms of connectivity.

Digital mHealth: Not every medical app is considered a SaMD. There are many apps that seek to improve overall well-being by providing patients and clinicians important health information.

Digital Health Information IT: The framework used to manage health information across multiple electronic systems and devices, as defined by the U.S. Food and Drug Administration (FDA).

Medical Device Data Systems (MDDS): Hardware or software products intended to transfer, store, convert formats, and display medical device data, according to the FDA.

Medical Device Interoperability: The ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems (per the FDA).

Telehealth and Telemedicine: The American Academy of Family Physicians broadly defines telehealth as electronic and telecommunications technologies and services used to provide care and services at a distance. Telemedicine is the practice of medicine using technology to deliver care at a distance. A physician in one location uses a telecommunication infrastructure to deliver care to a patient at a distant site. Telehealth is different from telemedicine in that it refers to a broader scope of remote healthcare services than telemedicine. Telemedicine refers specifically to remote clinical services, while telehealth can refer to remote non-clinical services.

Personalized Medicine: Wikipedia’s definition is “a medical model that separates people into different groups—with medical decisions, practices, interventions and/or products being tailored to the individual patient based on their predicted response or risk of disease.”

Digital Health Communities: Online platforms that enable consumers, caregivers, and clinicians to share stories and develop solutions across the healthcare system.

Many of these categories did not exist (at least in a meaningful way) 20 years ago. The development of digital health shows the medtech industry continues to evolve and change in ways that have yet to be fully understood. Nevertheless, digital health has had a significant influence on the medtech sector. Its impact on businesses can vary, though, depending on the category. A detailed look at the specific entrepreneurial effects and best practices for some of these categories follows.

Wearables: Patient monitoring companies are now most likely a remote patient monitoring (RPM) organization as well. RPM providers must be particularly vigilant about technological performance, consumer adoption, clinical workflow integration, and reimbursement challenges.

Digital Therapeutics (DTx): Establishing a foothold in this newer category of patient solutions can be tricky. Start with funding—there are huge amounts of money being invested in this category. Last year’s $18.5 billion acquisition of Livongo (a chronic condition management platform) by Teladoc has certainly highlighted the attractiveness of this space. Some current examples of competitive companies in this area include Omada, Virta Health, Biofourmis, and Pear Therapeutics. Even though these companies tackle different patient issues, most of the common DTx solutions involve patient education, data tracking and analytics, coaching, and some type of sensor.

AI/ML: Companies in the robotics space (or considering entering it) should “up their game” with some type of AI or ML component. AI/ML is now rapidly growing within many medical segments, including imaging, endoscopy, diagnostics, and digital surgery. This is a capability that can be developed alone or with a partner. There are many non-medtech companies with AI/ML capabilities that would make ideal partners.

Cybersecurity: Devices containing software have already been impacted by this issue. And many a C-suite executive has lost sleep over this matter. Earlier this year, the FDA appointed its first cybersecurity chief to help build out the Center for Devices and Radiological Health’s (CDRH) cybersecurity programs, public-private partnerships, and premarket vulnerability assessments. The director will service a one year term as an expert-in-residence at the CDRH as well as at the nascent Digital Health Center of Excellence, which launched last fall. No company can eliminate every threat but the best efforts should be made to minimize or reduce cybersecurity risks.

Digital Health IT: Historically, this was an area left for HIS (hospital information systems) or RIS (radiology information systems). In today’s drive for interoperability, digital health IT is nearly every company’s business. Finding a way for products to drive data into a hospital or clinic’s EMR system has evolved from being a competitive advantage to a customer expectation. Finding solutions to ensure products can provide data across platforms will continue to be increasingly important in the future. Companies not already working on this issue will have to quickly make up for lost time, as it’s clear the healthcare industry will continue its momentum to move into the 21st century.

Telehealth and Telemedicine: Not every medical device company participates in this area today but thanks to the global pandemic, more may be willing to venture into this area. Telehealth/telemedicine allows patients to seek treatment without exposing themselves to hospital- or clinical environment-based pathogens. For clinicians, the technology helps improve efficiency and allows them to care for more patients. Institutions that adopt telehealth/telemedicine solutions are securing their financial futures. Thus, medical device companies would be wise to rethink their “clinical use” stories for current products. Solutions meant for the hospital or clinic may now be better marketed directly to the patient (consumer). Such a switch would require different sales techniques and an emphasis on patient education.

Digital Health Communities: Like it or not, these online platform communities are here to stay. Patients, care givers, and clinicians use these platforms to discuss products, therapies, and other solutions in an open environment. The question is, will medtech firms embrace it or ignore it? These online forums will undoubtedly impact companies, even those whose products are used only in hospitals. Smart companies with hospital or home-based products that will benefit patients suffering from diabetes, atrial fibrillation, cancer, and other conditions are finding ways to become involved in these community discussions. An informed consumer can be a great advocate. Therefore, medtech companies should think about products that ultimately benefit patients and ways to constructively inform them about these solutions. Educating patients without insulting them or selling to them will create immense value in both the product offerings and future business.

Certainly, there are many different aspects to digital health that can affect medtech businesses in various ways. And while it is still evolving, the industry’s digital transformation will create opportunities for companies as patients demand instant access and in-depth, real-time data on their health. In the decades ahead, healthcare will need to adopt digital technologies that streamline and enhance connectivity, and foster communication and engagement between patients, providers and payers. The path ahead is clear—medtech companies just have to be brave enough to follow it. 

---

Florence Joffroy-Black, CM&AA, is a longtime marketing and M&A expert with significant experience in the medical technology industry, including working for multi-national corporations based in the United States, Germany, and Israel. She currently is CEO at MedWorld Advisors and can be reached at florencejblack@medworldadvisors.com or at www.medworldadvisors.com

Dave Sheppard, CM&AA, is a former medical technology Fortune 500 executive and is now focused on M&A as a managing director at MedWorld Advisors. He can be reached at davesheppard@medworldadvisors.com