Medtech regulation

Medtech – Reconciling Regulation and Innovation Efforts

Medtech is one of the fastest-growing technology fields, and also one of the most regulated. In the past two years alone, it has grown by 235 percent, developing a broad range of innovations and technologies – in the areas of personalized medicine, algorithm-aided diagnostics, augmented reality, and self-driven healthcare – aimed at improving health and ensuring more equitable, easy, and distributed access to patient care. This proliferation of medical technology has been accompanied by regulatory measures, standards, requirements, and processes to ensure that patients’ safety always remains at the forefront.

According to AND Technology Research CEO Nicole Thorn, the tension between agile technology development and stringent regulation will continue to grow in the future unless a new approach is developed. On the one hand, iterative and dynamic approaches to development are proven to result in better technology. On the other hand, however, a lack of strict regulation in medtech can open the door for under-tested and under-managed systems, devices, and products that can be dangerous and harm patients.

Thorn suggests that regulatory compliance geared toward patient safety could be better aligned with the aim of agile medical innovation by focusing on three areas. The first is to ensure that auditing bodies and regulatory consultants are given better guidance to enable engineering teams to easily combine compliance standards and agile development processes. This would help reduce innovators’ confusion when faced with a cascade of regulations and long lists of product requirements, and allow them to proceed smoothly through all stages of development.

The second suggested area of focus is to leverage technologies to help innovators better understand the requirements. To this end, electronic quality management systems can be employed, although they can be expensive and require special expertise. Decision support algorithms, classification algorithms, natural processing language, and visualization tools are some of the technologies that can support companies in generating documentation, tracking testing, and assembling evidence of compliance.

Finally, Thorn suggests consolidating information sources in one place, as far as possible, to help innovators find information such as relevant contacts of bodies and authorities, submission requirements, ethical approvals, and so on more quickly.

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