bio + tech meet the delivery of care

Integration? oil and water? bio + tech interface with the delivery of healthcare

By Yuri A. Maricich, M.D., M.B.A.

Idea in Brief

Delivery + Tech

Digital technologies convergence with biopharmaceuticals, as well as software-as-medicine (SaMD), must all be delivered to patients through our health care delivery infrastructure and ecosystem, if they are to achieve impact. Healthcare, historically, a laggard in digitization, has experienced COVID’s forcing mechanism, accelerating technology, particularly, digital tech adoption. User-unfriendly EHRs have been consolidated by Epic, Cerner, AthenaHealth, and a handful of others. Until COVID, the use and acceptance of telemedicine was slowly plodding along, gated by slow reimbursement coverage and clinician adoption.

In the space of months in 2020, we witnessed an explosion in the use of telehealth at the height of the COVID pandemic with that number remaining elevated at approximately 35-40% for mental health and SUD (and around 5% for other outpatient visits) according to KFF and the growth of companies like Teladoc (now Livongo), AmWell, plus broad adoption of consumer and enterprise video call systems by provider organizations (IDNs, community, and AMCs). Telemedicine offers increased access, convenience, reduced cycle-time to diagnosis, treatment, or getting to the right clinician. Telemedicine and virtual care (VC) , while major positive steps, are far from panaceas for our ailing health system as tele/VC is limited given the requirement for synchronicity between clinician and patient and the inability for certain clinical assessments to be performed (e.g. labs, accurate vital signs, physical exam, etc).

Organizations pioneering hybrid, synchronous, and asynchronous, virtual and live, care delivery, such as OneMedical (Iora, Medicare Advantage, now part of OneMedical), Firefly, Oak Street Health, as well as more traditional providers like IDNs such as Kaiser, Community Providers, and Academic Medical Centers (AMCs) in outpatient care may help determine the optimal virtual/life and synchronous/asynchronous care models. Hospital-at-home firms like MedicallyHome and Contessa Health are similarly innovating higher acuity, inpatient care. The integration of telemedicine/virtual as well as remote patient monitoring alongside home-based diagnostics and treatments like continuous glucose monitors (CGM), inhalers with internet connected sensors, or prescription digital therapeutics (PDTs) are poised to open new models of care that can improve access as well as deliver clinical and economic outcomes and efficiency.

Further convergence examples can be found in specialty treatment clinics like Bright HeartHealth, PursueCare, and Ophelia which provide fully virtual addiction care, Cerebral (mental health), Maven (maternity), PillPack (now Amazon Pharmacy), Artificial Intelligence such as imaging augmented by AI (see FDA cleared AI-medical devices), digital passports associated with negative CoVID test (i.e. Abvie’s antigen test), or COVID vaccination status, Test-and-Treat Paxlovid, and 98point6, which is digital primary care, including means to text with a clinician. The expanding integration of sensors in consumer products which are emerging medical grade assessments devices, diagnostic, or monitoring, while many are not yet sufficient to facilitate independent, remote, medical decision-making, are near-term catalysts[1]. Apple Watch, FitBit, AliveCor EKG and many others are examples of sensors and/or even imaging (Butterfly IQ ultrasound via handheld probe connected to iPhone), which are expanding access and integration. Use of telemedicine/virtual care, software-based treatments (like PDTs), and home based/self-testing, are being adopted at scale and starting to become familiar to patients and to us all.

Tech is rapidly integrating into development of therapeutic products. Clinical trial platforms and models are being re-invented with decentralized study platforms such as Meddable, Science37, TrialSpark, and many others, including the leading CROs bringing their own decentralized solutions to market. The CRO industry is thus being remade, and the distinction between decentralized clinical trial providers and therapeutic developers is blurring (TrialSpark licenses a drug candidate and Pear builds their own virtual trial platform (VSP) as part of PearCreate to conduct DREAM Study). Digital endpoints, sensors, and wearables are becoming a more common part of studies. Platforms like HumanFirst (formerly Elektra Labs) and FDA public-private partnership MDIC’s NESTcc study of the PDT Somryst are including digital endpoints and wearables into clinical trials.

[insert a montage of diagram from one of the examples above: TeleHealth Window, show Abbvie antigen test from MediaKit, AppleWatch Pulse Ox, AliveCor, Paxlovid Therapeutic ]

Delivery + Bio

Just as the delivery of care and digital are converging and creating new opportunities and challenges together, so to is the evolving delivery system and therapeutics. Patient experience of consumer tech’s convenience and seamless integrations is helping drive a higher bar for healthcare. At present, it highlights, however, the magnitude of the gap which exists between the experience of consumer tech and delivering/obtaining healthcare (e.g. visits with clinician, navigating care, diagnostic testing, imaging, pharmacotherapy,etc).

Digital tech in healthcare, in general, lags to a greater or smaller degree, in convenience and seamless experience, than consumer. In some areas, like EHRs, scheduling or navigating healthcare provider organizations, the gap remains great. In other areas like hardware medical device or software-based therapeutics it may be small or even equivalent to common consumer experiences. (Mainstream experience by patients is that there gaps, despite the existence of some outliers). Much opportunity exists to bring “design” thinking and user-experience approaches deployed well (and compliantly) in consumer tech to healthcare. Barriers such as reimbursement, fragmentation, and complexity, make this journey not straightforward, as a “seamless” experience can be rapidly interrupted when a clinician diagnosis, test interpretation, or insurance reimbursement is needed.

Therapeutics, particularly biopharmaceuticals, have historically had their integration with the delivery system and clinical workflow, as a “late-thought” in development and/or go-to-market planning. This has caused the failure of some safe and effective drugs and reduced time to scale, or impact of others (such as extended-release naltrexone for alcohol use disorder and Sage’s treatment brexanolone which is both an innovative breakthrough as the first and only treatment approved for Post-Partum Depression (PPD) yet requires healthcare facility continuous infusion over 60 hours, a “suboptimal” workflow for a new mother).

COVID, in-particular, has laid bare the shortcomings of delivery, therapeutics, (not to mention testing). The roll-out of COVID vaccines, monoclonal antibody infusions, and now antviral medications highlight that even when we have achieved monumental scientific breakthroughs, we limit impact at best, create public health catastrophes at worst, without integration, scale, and flexibility, for the integration of bio into delivery. Going forward delivery, workflow, not to mention reimbursement, considerations must be considered much earlier.

Care is fundamentally a human act

Biology and its organized, goal-oriented, regenerative complexity is incredible. Digital technology is transforming and “eating the world” with its capabilities. Biology and digital technology, however, are only as valuable and only able to deliver good, or ill, based on their application by the human beings who wield them.

At some point – all of us are patients. At some point – all of us will need a clinician to help us with a diagnosis, evaluation/tests, and treatment. At some point – all of us will come into contact with biopharmaceuticals, digital technology, and the delivery ecosystem.

We, the developers, clinicians, scientists, engineers, product managers, investors, researchers, policymakers, regulators - all of us - eventually being patients, but perhaps at present holding one of the roles above must make decisions how to evaluate, safeguard, and apply these tools, which will create the legacy of their ultimate impact.

The many topics above will be further elucidated and explored in subsequent posts by guest authors and myself.

[1] Sensitivity and Specificity of many of these sensors and their applications remain sufficiently low to result in need for confirmation as well as raise situations of false positives and false negatives resulting in downstream negative sequelae.