Compliance and the growth of the medical industry, does it collaborate? This question is highly relevant because the growth in the medical device industry is significant. And also, this will continue to be the case for the foreseeable future. Does this jeopardize regulatory compliance? And do the regulations themselves still meet the new developments in the sector? This article is published on April 5, 2022. What will the regulatory landscape for medical devices in, e.g. 2025 look like?
The time of the pandemic seems, at least for the time being, to be behind us. We now see that the period behind has forever changed the way we work and live. This is also a fact for the medical device and related artificial intelligence industry. A digital transformation took place for several reasons. There is the assurance of product quality, but also the conformity to the currently applicable regulations regarding the safety of the equipment.
Artificial Intelligence’s Influence in Medical Regulations
There is a clear trend: the medical industry is struggling with the growing demand for their services. Added to this is the fact that some of the personnel involved are struggling to meet the changing needs of patients. After all, the medical device industry is improving at a rapid pace. This is due to the ever-increasing group of patients with changing motivations. All parties involved have to keep up. So do the regulations and their enforcement.
Huge expenses and operational inefficiencies are forcing companies to rethink their entire life cycle. The role that artificial intelligence will play in this is also becoming increasingly important. It is the science of equipping a machine to make human decisions and mimic human behaviour. Partly due to the impact of the pandemic, artificial intelligence has long since ceased to be science fiction and has become a daily reality. So when we take a look at the development of medical devices, then what does the future hold for compliance?
Strict Regulatory Standards can Provide Reasonable Safety
Very strict regulatory standards apply to the safety of medical devices. Artificial intelligence provides meaningful insights. For example, it can discover (small) patterns in gigantically large data sets and make advanced analyses of how different systems work. It also has predictive abilities with regard to reading texts and symbols. For humans, these are often laborious procedures that take a lot of time. Artificial intelligence allows this to be done in a fraction of the (human) time. It can also significantly improve error handling and performance management.
Digital Innovation is the Key to Conformity and Growth of the Medical Industry
The medical industry faces many operational challenges. One is that they must maintain ongoing compliance with then-current safety policies. New standards are created and the industry is facing deadlines to meet them. New technologies are going to help with that. Think artificial intelligence, 3D printing, and cloud-based services. They will not replace human interaction and intelligence, however, they will play a major role in reducing the risk of errors and increasing efficiency in various areas.
Compliance and the Growth of the Medical Industry, does it Collaborate?
We must ask this is order to continue the growth and innovation on one hand and keep the market safe on the other. There is already a noticeable shift in where the industry’s prioritized approval lies: The US-based FDA is now top-ranked, above EU authority. According to a study from the Boston Consulting Group the shift is being driven by the EU’s “complex and unpredictable” Medical Device Regulation (MDR). In our post EU No Longer Priority Market For Medical Device Manufacturers we commented on this shift.
This raises even more questions about the route to take for safe medical devices in the future without interfering with new developments…
Links & Downloads
- Boston Consulting Group
- Source of this article: Elizabeth Engler Modic from Today’s Medical Developments