Across the globe, adverse events associated with medical devices are on the rise. Here are the top five reasons why:
Medical device volumes are exploding globally. According to KPMG, the global medical device market will grow from US$483 billion in 2020 to US$795 billion in 2030, a 5.2 per cent CAGR. The major growth drivers are healthcare spending, ageing populations, chronic disease and technological development. More devices and more patients in developed and developing countries mean increased numbers of adverse events – more injuries, more complications and more deaths.
For medical device manufacturers, the costs of quality events are sizeable. According to McKinsey, it is as much as 7 per cent of revenues annually, or over US$35 billion globally.
According to KPMG, the global medical device market will grow from US$483 billion in 2020 to US$795 billion in 2030, a 5.2 per cent CAGR.
The double-edged sword of innovation
Technology advances also introduce risks. The pace of innovation in medical devices is breath-taking – novel in-vitro diagnostics, drug-device combinations, next generation materials such as graphene and bio-substrates, 3D and 4D printed instruments and implants, nano-scale robotics, IOT sensors, and software as a medical device. With such dramatic innovation in diagnostics and therapeutics comes uncertainty and risk.
Industry sources estimate 15 per cent of devices are connected. These devices are also increasingly interoperable, software-enabled and algorithmically controlled. The result is a huge jump in cybersecurity risks.
Last year, the chief information security officer of a leading U.S. research hospital told regulators his organisation has 25,000 connected devices in its facilities. These comprise 6,000 makes, models and versions with over 15 operating systems. Many of these devices operate as families or clusters of inter-operable devices and equipment. Every device is a snowflake. Keeping up with routine patches and upgrades is tough, not to mention urgent vulnerability mitigation.
Worryingly, some white hat hackers have observed that device-specific cyber-vulnerabilities could provide an entry point for lateral movement into a hospital’s IT systems, making real the possibility that a trauma centre could become a centre of trauma.
Regulators are keenly aware of the trade-off between these emerging technologies and the risks they present. For its part, the FDA now insists that medical device manufacturers step up their games when it comes to post-market surveillance and adverse event management. Under the EU MDR, heightened vigilance will be demanded from device manufacturers and distributors.
Overwhelmed and underfunded
Clinical engineers and medical technology specialists face huge challenges. They must track, monitor, and maintain growing volumes of increasingly complex medical devices and equipment across multiple delivery locations (e.g. acute care, community facilities and outpatient clinics, and home-based settings).
From beds, hoists and mattresses, infusion pumps, ventilators, flexible endoscopes, surgical instruments, radiation therapy and imaging equipment in an acute care setting to implants, closed-loop diabetes management systems and sensor-enabled asthma inhalers, the challenges in ensuring devices are safe and in good order at the point of care are huge.
Standoff over servicing
OEMs, hospital systems and third-party service firms disagree about who’s accountable. On a day to day basis, this standoff about qualifications, competence and contractual obligations for medical device servicing further complicates an exceedingly difficult operating environment.
Data, system and organisational silos
Silos reduce transparency and delay action when it matters most. Without necessary visibility and traceability, it’s difficult for hospital staff to assure that medical devices and equipment are safe and in good order.
Under-reporting of incidents and long supply chains delay action. It can take months or years for manufacturers to recognise and attribute adverse events to their devices. Even then, root cause investigations (e.g. design, production, component failure, training protocols) create further delays, leaving patients vulnerable to preventable injuries, complications and deaths.