AI in MedTech: We need to strike the right balance between innovation and regulation
- 4 September 2024
Stricter regulation is inevitable, so how should MedTech companies respond? By Cognizant’s Rohit Alimchandani
The MedTech industry stands at a pivotal point, torn between fully embracing technological advancements, particularly in AI, and the demands of strict regulation. Our report, published with Microsoft, found that whilst the majority of decision-makers in the MedTech space feel they operate in a tightly-regulated environment, stakeholders are split on whether these guidelines help to facilitate innovation or act as a barrier. For the sector to thrive, innovation and compliance must coexist; they cannot threaten each other.
Does regulation support or stifle innovation?
The report on the state of the industry, and the opportunities and challenges presented by AI, reveals the findings of a quantitative survey of 200 MedTech decision makers across Europe and the USA.
More than half (52%) of MedTech leaders feel the current regulatory framework supports innovation in the sector, suggesting well-designed guidelines can enhance public safety as well as encourage progress simultaneously. Some think that AI can aid in complying with these regulations by detecting issues early, spotting patterns that humans might miss and adhering to protocols consistently, reducing human error. In this regard, AI can be viewed as a tool that can strengthen regulatory compliance.
On the other hand, nearly a third (31%) of MedTech leaders argue that current regulations inhibit innovation in the space. This is a popular view among companies dealing with implantable devices, who face challenges such as differing rules across markets (45%), slow approval processes (31%), and the difficulty of adapting AI to new risk classifications (21%).
Regulatory priorities
For all of its benefits, the implementation of AI still brings concerns around ethics, bias prevention, and trust. A flaw in the technology that must be addressed is that it often pulls information from inaccurate sources of data, damaging the reliability of its output. Research from Pew found that this is a significant area of focus for regulators who are working to ensure that healthcare data used to train AI is of the highest possible quality to avoid any biases and protect patient privacy.
AI models must be trained on diverse datasets that accurately reflect real populations, otherwise algorithms will simply not be as effective. These more intricate data sources will likely require an increased level of investment from MedTech companies. Stakeholders will also have to confront complex discussions about personal health data ownership.
Setting a global standard
The EU AI Act represents a significant move towards creating a standardised approach to AI regulation. It aims to set a global example by ensuring public safety without stifling technological advancement. The Act’s introduction is a crucial moment for the MedTech industry, balancing AI’s potential with necessary safety precautions.
However, some stakeholders argue that the Act will be harmful for creativity and ingenuity across the MedTech sector, with our research spotlighting a regional divide that mirrors this sentiment: nearly a fifth (17%) of MedTech leaders in Europe feel that regulation significantly hampers their innovative efforts, compared to only 5% of their US counterparts.
Although the UK’s new Labour government has just shelved £1.3bn of funding that was promised by the Conservatives for technology and AI projects, increased regulation is inevitable. Other global markets are already beginning to follow the EU’s example and setting out plans for stricter guidelines around the technology’s use.
MedTech firms must learn to adapt to variations in regulation across different jurisdictions – ongoing dialogue between regulators and the industry to refine guidelines and address any unintended consequences, as well as ensuring companies have the right teams in place to support these efforts, will be pivotal to achieving this.
The right people to do the job
To confidently navigate obstacles presented by new and varying regulation, MedTech companies need to find the right talent for the job, with the skills and experience necessary for meeting the standards required for regulatory compliance, data quality and fostering innovation.
However, the industry faces fierce competition for digital talent, particularly in AI and automation, where there is a significant gap between supply and demand. MedTechs may therefore consider investing in training programmes to upskill existing members of staff to plug gaps from within, explore novel collaboration agreements with tech/AI firms, as well as scouting out new talent.
Equilibrium
Innovation and regulation are equally important pillars of success for the MedTech sector. A stricter regulatory environment is essential for patient safety and protecting personal data, but this should not stifle the creativity and innovation that drives technological progress.
Developing effective strategies for data quality and privacy and attracting the right talent are key to harnessing AI’s full potential. These efforts will help companies demonstrate that they are using technology responsibly and in compliance with regulations. Moving forward, a balanced regulatory approach that encourages innovation while safeguarding public health is vital. Collaboration among manufacturers, regulators, healthcare providers, and tech/AI partners will be crucial to achieving this balance.
As the MedTech industry navigates this crossroads, the collaborative efforts of all stakeholders will be key. By fostering innovation within a robust regulatory framework, the industry can ensure both technological advancement and public safety, paving the way for a healthier, more advanced future.
