There is a paradigm shift in how tech giants perceive the healthcare environment as they move into medtech. Companies such as Verily, Apple, Samsung, and IBM are at the forefront venturing into the healthcare space. These companies are entering the space with key solutions to multifaceted unmet needs within the health industry, from cloud-based platforms for patient records to patient engagement technologies and wearable health devices. These tech giants have taken the necessary steps to entering the medtech market, with support from the FDA.

The FDA rolled out its Digital Health Innovation Action Plan (DHAIP) which focuses on the quality, safety and efficacy of digital health products. Within the DHIAP, the FDA initiated a volunteer pilot program to regulate the digital health software industry. The main issue with regulation is that software-based health programs cannot follow traditional medical device timelines. The Software Precertification Pilot Program focuses on higher-risk devices and programs based on their functionality and attributes.

The main goal of the pilot program is to enable a modern approach that allows for newer software iterations to be rolled out in a timely fashion. The FDA would also like companies to demonstrate their Culture of Quality and Organization Excellence (CQOE), which means engaging in ongoing efforts to establish internal frameworks and processes pertaining to digital software. The precertification program is a huge step toward solidifying major companies foraying into the healthcare space. The volunteers chosen for this initiative include Verily, Apple, Samsung and Fitbit, along with traditional medical device manufacturers such as Roche and Johnson and Johnson.

Studying clinical benefits

There will also be a focus on the efficacy of the products, which can only be determined by clinical trials. Recently, Apple launched a study with researchers from the University of Stanford to test if the Apple Watch could detect cardiac abnormalities, specifically atrial fibrillation. Similarly, Fitbit is focusing on atrial fibrillation with its wearables, as well as shining a light on sleep apnea. Further studies need to be conducted on the efficacy of these wearables in a clinical setting in addition to their ability to diagnose medical ailments.

Similar to wearables, the need for cloud-based solutions for patient health records is of utmost importance as innovation within the medtech products becomes readily available. Verily, a subsidiary of Alphabet, focuses on health data integration through cloud-based solutions, enabling health practitioners to make clearer clinical decisions and streamline data processes.

IBM Watson Health drives not only cloud-based solutions but enables physicians to make treatment decisions by searching through evidence-based literature. IBM also has cloud-based data management programs where it provides its expert data scientists to help healthcare organisations gain patient insights with analytics and engage with patients’ needs.

Regulatory compliance

The only issue with cloud-based programs is they must be compliant with regional protections to protect patient data. These regional protections include the Health Insurance Portability and Accountability Act (HIPPA) in the US, while Canada has the Personal Information Protection and Electronic Documents Act (PIPEDA). Difficulties can arise once these programs need to comply across varying regions, and that is something of which each company will need to be aware.

The potential for these tech giants within the medtech industry is immense, and these companies are taking advantage of each portion of the market they carve out for themselves. The involvement of the FDA is a move in the right direction, as the Precertification Pilot Program creates an initial framework which will enable some sort of regulation for the programs and devices released by these companies.

Moreover, additional clinical trials are necessary to demonstrate the efficacy and safety of new devices as well as security and feasibility of cloud based patient data software. The moves each player makes in the next five years will distinguish the market leaders and differentiate between effective and ineffective digital health products.