Let's Chat: Software as a Medical Device

Let's Chat: Software as a Medical Device

Flashback.

It's January 2020. We just finished celebrating the new year. Companies are preparing their "2020 Plans", how they will make their product the best it will ever be. To finish manufacturing, get it to market and celebrate in style when Summer comes along. Unfortunately, COVID-19 was never a factor in those January plans. Sending your staff to work remotely from March for the foreseeable future was not in anyone's Business plan.

Kal Patel, CEO + Founder of Digital Health firm BrightInsight, outlined in an article (1) how this unexpected turn of events has opened up the eyes of thousands on how a more digital strategy can be the most efficient way forward, and now more than ever, we are seeing a sharp rise in the need for Software as a Medical Device because of how COVID has caused companies to delay (or even altogether stop) product launches etc. which has led to the need to look more into Software and a Digital strategy to ensure success.

Patel states that "When it comes to long-range planning, biopharma companies are saying, ‘How do we actually prioritize and, in some cases, severely limit investment in certain areas?’ That’s where digital becomes an interesting topic because we’re starting to see folks take a differential view to how they’re thinking about digital investment.”

2020 has seen more and more Biopharma and Medical Device companies beginning to shift their focus to developing Class II and Class III Software as a Medical Device.

More so, because of these developments, it is crystal clear that this market is going to shoot up over the coming months and years. A recent article predicted that the European Software as a Medical Device market is expected to reach US$25 million by 2027, a sharp rise in Market value from US$5 million (2).

It is a fascinating market. So complex, interesting, dynamic and critically important as the digital age takes shape within the Medical sector.

Do you work within the SaMD market? What's your vision for the future of Software in this field?

Thank you for reading, please do share your thoughts in the comments.

Keen to hear some viewpoints, opinions and experiences people have had working on Software as a Medical Device products.



  1. https://www.globenewswire.com/news-release/2020/09/23/2098175/0/en/The-Europe-software-as-a-medical-devices-market-is-expected-to-reach-US-24-898-07-million-by-2027-from-US-5-430-19-million-in-2019.html
  2. https://medcitynews.com/2020/10/covid-19s-digital-imperative-for-biopharma-and-medtech/



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