Here we are one-third of the way through 2022, with COVID restrictions lifting (or returning), a war in Ukraine dominating headlines, and fuel prices having worldwide downstream effects. During all of this, the medical device and healthcare industries continue to operate in an environment of ever-changing regulations and requirements, new (and sometimes conflicting) requirements, emerging technologies, and economic volatility. Through it all, we keep a constant eye open for the next crisis and what that might bring.
Amongst this uncertainty, the demand is constant for safe and effective medical devices and reliable, affordable healthcare. The year 2022 is not going to calmly sit back in the shadows of the last three years and pass quietly on. So, what could the next several months possibly have in store for us?
Instead of preparing for the EU Medical Device Regulation (MDR) deadline, attention is on in vitro diagnostic medical devices and the EU IVDR, with an almost 70% increase in the number of device manufacturers needing Notified Body review of their products. These NB reviews are currently taking 9 to 11 months, but could take as long as 18 months, growing exponentially to demand much the way global gasoline prices are increasing.
Added to this are the many sustainability objectives made as a result of the climate pledges at last year’s COP26 Climate Summit in Glasgow, Scotland. Notably among these is the UK National Health Service’s (NHS) Net Zero program, with the aim of being the world’s first net zero national health service. To this end, the NHS have set two targets:
- Reach net zero by 2040, with an ambition to reach an 80% reduction by 2028 to 2032 for the emissions controlled directly by NHS (the NHS Carbon Footprint)
- Reach net zero by 2045, with an ambition to reach an 80% reduction by 2036 to 2039, for the emissions NHS can influence (the NHS Carbon Footprint Plus)
Then, we have growing security threats to our healthcare information systems by
- Bot-network operators that control vulnerable system access and illegally trade it for monetary gains
- Cybercrime groups carrying out targeted campaigns to commit identity frauds
- Espionage at the industrial, staff, or nation-state level to gain a competitive edge
- Foreign intelligence agencies that have offensive security capabilities and may use them to compromise healthcare information systems and exfiltrate research data
- Insider threats coming both deliberately and unintentionally from employees
- Phishing attacks utilising phishing and spam emails aimed at stealing sensitive patient information
Lastly, and what will likely have a significant immediate impact on the health and wellbeing of the global society, is the resilience of the healthcare supply chain amidst all of what has happened and what surprises 2022 still has waiting for us. The global supply chain is being hit hard by sanctions imposed on Russia after their invasion of Ukraine, new pandemic-related shutdowns in China, and the move by some companies in the West to reduce reliance on China for components and products and on Russia for transportation and raw materials. But this could also prove beneficial in strengthening localized, or regional, sourcing strategies. Despite so many known current challenges and concerns, we must make time to look forward, contributing to multi-stakeholder dialogues, and develop a collective regulatory intelligence for the industry.
Lena Cordie-Bancroft is sector lead, medical devices, at BSI.