By Hakim Yadi, co-founder and CEO of Closed Loop Medicine\n\n\n\nThe traditional healthcare delivery model is designed to cater to the masses, rather than the individual. \n\n\n\nAdministering treatments based on the overall safety and efficacy demonstrated in large-scale clinical trials, and not taking into consideration individual responses to such treatments, is resulting in poorer outcomes for patients, higher healthcare costs for payors and lost revenue for pharmaceutical companies.\n\n\n\nNeglecting to consider how a drug’s efficacy and tolerability may vary from one person to the next puts a patient at risk of receiving sub-optimal care and experiencing adverse effects. In turn, this could lead to medication non-compliance and contribute to the rising burden of chronic illnesses. \n\n\n\nIn 2016, the U.S. annual cost of drug-related morbidity and mortality resulting from non-optimized medication was estimated to be $528.4 billion, demonstrating the devastating effect treatment mismanagement can have on both society and the economy.\n\n\n\nPrecision medicine for hypertension\n\n\n\nUsing hypertension as an example, a disease that affects around a third of adults in Western countries and the single biggest reversible factor for death, it is costing the U.S. $131 to $198 billion a year. Managing high-blood pressure through medication and lifestyle modifications can significantly reduce associated health risks and improve quality of life. This could in turn prevent up to 91,900 heart attacks, 139,000 strokes, and 115,400 cardiovascular deaths in five years, which. according to the Center for Disease Control, could save the U.S. healthcare system hundreds of millions of dollars every year.\n\n\n\nTaking a patient-centric approach to managing hypertension, breakthrough data published in 2022 in the Journal of the American College of Cardiology demonstrated how a drug plus software-as-a-medical-device (SaMD) combination product can facilitate personalized drug dose optimization by integrating real-time patient feedback and closed loop models of care with traditional therapeutics.\n\n\n\nThe study evidences how one size does not fit all when it comes to medicine – a degree of personalization can lead to better outcomes for patients by finding the balance between efficacy and unwanted effects, ensuring maintenance of blood pressure control. Therefore, a move toward developing modern healthcare solutions depends on comprehensive understanding of an individual’s response to medication.\n\n\n\nBreakthrough designation\n\n\n\nGround-breaking advances in digital therapeutics (DTx), cloud-based platforms and intelligent medical devices have facilitated the decentralization of data acquisition and real-time data processing. Combining software with medical devices and prescribed therapeutics has the potential to accelerate the movement from the traditional paradigm of taking an umbrella approach to healthcare, toward accessible personalized treatment. \n\n\n\nIdentifying the capabilities of combination prescription products and medical devices for the treatment and diagnosis of life-threatening or irreversibly debilitating conditions, in 2018 the U.S Food and Drug Administration (FDA) launched the “Breakthrough Devices Program” to expedite product development, assessment and review. \n\n\n\nSince then, a total of 728 products have been granted a “breakthrough designation,” with 129 designations being granted by mid-2022 — maintaining that pace of approvals put 2022 on course to break the previous year’s record of 206. \n\n\n\nIn 2021, the FDA also launched the voluntary “Safer Technologies Program (STeP),” modeled after the “Breakthrough Devices Program” and aimed toward products that treat or diagnose non-life threatening or reversible conditions. Considering how both programs are designed to fast-track approval of such innovations, 2023 has the potential to be a record year for FDA authorizations of combination products and medical devices that could benefit public health.\n\n\n\nThe undeniable potential of digitization in healthcare is driven by this industry’s capacity to recognize the worldwide demand for more advanced and personalized care. In the Global Strategy on Digital Health 2020-2025 report, the World Health Organization acknowledges “that the strategic and innovative use of digital and cutting-edge information and communications technologies will be an essential enabling factor towards ensuring that 1 billion more people benefit from universal health coverage, that 1 billion more people are better protected from health emergencies, and that 1 billion more people enjoy better health and well-being.” \n\n\n\nCombination products\n\n\n\nIn 2022, key opinion leaders from academia, pharma, and healthcare have become more engaged in advocating for the use combination products, with involvement in key reports demonstrating how such products could be of benefit to patients, healthcare providers, and payors.\n\n\n\nIn addition to deploying a better standard of care across the globe, innovations in digital health tools are fueling economic growth. Investments in digital products supporting disease treatment grew 2.6x between 2020 and 2021 as insurance coverage pathways for prescription DTx widened. Digital health startup investment exceeded the total amount of money raised in that category in the whole of 2020, by mid-2021, with around $15 billion, while the US DTx market is projected to see a compound annual growth rate of 26.1% from 2022-2030, to over $32.5 billion. \n\n\n\nThere is still much to prove in the digital delivery of care, with many companies still searching for sustainable business models. As we enter 2023, we are on the cusp of realizing a new and hopefully better way to provide healthcare by using software to integrate care modalities and deliver better outcomes for patients.