Big Tech Companies Move into Medical Technology and Healthcare

What are the challenges and opportunities?

There has been a lot of interest in health care and medical technology from big technology companies covered in business publications, such as Forbes and The Economist, and the medical device trade press. Attention from companies like Apple, Alphabet (the parent of Google), Amazon, Facebook and Microsoft is not surprising; the overall healthcare market today estimated at $ 7 trillion and the medical technology market element of this has been forecast to grow to $ 0.5 trillion by 2021.

Areas in which some or all of these companies have been reported in being interested are adjacent to their current core businesses; data analysis, mobile applications, artificial intelligence and product delivery channels. This interest is providing sources for multiple areas of innovation in the medical technology sector. But these areas could just be the start. Some of the reported developments include:

• Mobile devices as platforms for applications in diagnosis for conditions such as Parkinson’s Disease, diabetes and cardiac arrhythmia;
• Platforms for portable individual health records and integrating data from wearable sensors;
• Analysis of the mass of data held across heath records to predict when interventions are needed to prevent deterioration in health or adverse outcomes;
• Connecting groups of patients with researchers for clinical research and post-market feedback;
• Development of enhanced robotic surgery;
• Application of algorithms and artificial intelligence to improve the consistency of diagnosis;
• Provision of healthcare services – doing business with hospitals and healthcare companies or creating new channels to deliver healthcare, initially targeted at providing new methods of care for their own employees using technology.

Some, but not all, of these areas are covered by the regulation of medical devices. Medical device regulation has been evolving to address challenges of software, particularly when software is the medical devices rather than controlling medical device hardware. The International Medical Devices Regulators Forum (IMDRF) has published a number of guidance documents on software as a medical device. However, the philosophy in some big technology companies to ‘go fast and break things’ is challenging to the measured development familiar in the regulated environment. In particular:

• The challenges introduced by machine learning where the product evolves and changes based on the inputs received over time. This conflicts with the way that the regulation of medical devices look at product approval and control of changes.
• The distribution of responsibilities between multiple parties who are accountable for separate elements that ultimately comprise the product offering. This is a challenge to the traditional understanding of the ‘legal manufacturer’ with complete accountability and responsibility.
• The need to protect privacy and include requirements for cybersecurity.

Medical technology is faced with a wave of rapid innovation that has the potential to be transformational. Regulatory requirements will need to evolve along with the technology.