SaMD or Software as a Medical Device is NOT a new concept. It was first introduced in 2013 by the International Medical Device Regulators Forum, which means the actual movement towards using digital solutions in healthcare is much older than that. Despite the slow pace of change in the healthcare industry, 10 years after the official introduction of the term, the adoption rate of medical software has dramatically increased as did the capabilities of each solution. 

This post is to share the little knowledge that I’ve learned recently about SaMD. One disclaimer for those who may be interested, is that I won’t be listing any particular companies or solutions in this post. 

Like many other things in the digital realm today, SaMD is also an area heavily influenced by AI. The core value proposition for these solutions are focused on reducing the human care provider’s workload and/or enhancing their productivity. Here are some key themes of 2025’s SaMD trends. 

Helping clinicians as well as patients with understanding the symptoms and deriving the diagnostics seems to be a key area of interest for solution providers. Solutions vary from a GPT based Q&A services to narrow down a diagnosis based on a systematic questionnaire to those that interpret medical images for quick interpretation as well as capturing abnormalities that might be missed by a human eye simply because it was at the peripheries of focus area. 

Remote monitoring has been widely experimented since the pandemic to improve care efficiency and also address the staffing shortages to some degree. These solutions will track patient vitals through wearable devices, attached sensors, and even video and audio inputs. These solutions opened the doors for patients to continue their care at the comfort of their homes and simultaneously opening up the hospital resources for the sicker patients. 

Taking one step away from patient care, there are solutions that aim to provide support for the administrative workflow. Solutions in this realm support a wide variety of activities, some in the care setting and some behind the curtains: Dictation services for providers to minimize documentation needs, coding support to optimize billing, and other facilitative solutions that link payers and/or post-discharge care facilities. 

If the solution has a direct impact in the diagnosing or the care of the patient, then it must go through a series of approvals by the FDA. Here are 3 approval pathways. 

Key consideration factors are whether there is a similar device already available in the market that can be used for reference and the risk level. As you might imagine, a solution with a predicative solution that is has minimal impact on the patient’s care will have a short journey through approval while the opposite case might have to brace for a more arduous path for approval. 

Even after the approval, the solutions will be periodically reviewed and be subjected to reevaluations. The FDA places a lot of emphasis on continued assessment of the solutions on their safety, efficacy, and efficiency. So adverse outcomes or continued negative reports of the solutions will trigger a new round of scrutiny. Additionally, if a major update or modification was made to the tool that alters its nature from the original scope will also kick up some dust. 

However, if you’re a consumer of these products, this is all good news as it implies that the government is providing an additional layer of safety and quality assurance for these solutions. Keep in mind though, actually adopting and operating any solution would require a whole new set of prep work and careful execution, which we will talk about in another post. 

With a little over a decade of formal introduction in the US, SaMD is still a field that is being actively developed. This is especially true if you count in the latest iterations with generative or predictive AI solutions. It’s no secret that healthcare is relatively slow in adopting new technology compared to other industries but there are a LOT of players across the globe, knocking on those doors of opportunity. 

The US has a rapidly growing market for SaMD solutions; in 2025 the market is estimated to be about $3 billion dollars, which is projected to grow to over $12 billion dollars in 2034. Being the home to global tech titans like Google and Amazon, it’s also drawing a lot of solution developers as well as investment from all over the world. FDA and HIPAA regulations control the solutions that are being introduced into the market but this is not hindering the innovators from exploring the frontiers of the next chapter of healthcare innovation. 

Europe’s SaMD market is expected to reach $6.1 billion by 2034 and there are active private and public initiatives that are nurturing new ideas and new companies. The regulatory landscape is a little more complex to navigate than the US as each country has slightly different policies that are not necessarily unified. However, the centralized efforts led by government agencies are providing support to lay the ground work for creating digitized data sets. 

Japan, Korea, and China all have major players in the SaMD market, which is expected to reach $1.4 billion by 2034. The regulatory landscape varies with Korea and Japan alluding to a tighter set of regulation around the development and approval of novel solutions. Nonetheless, there are several innovative companies developing solutions for healthcare providers as well as patients, leveraging wearable or mobile devices. 

South Asia has one of the fastest growing markets overall, which implies increasing investments flowing into the healthcare and SaMD market. With a huge population, it also has the greatest potential to benefit from novel solutions that will decrease of care while expanding its reach. The regulatory landscape is actively evolving and new regulations around the use of healthcare data is being introduced as we speak, so there is some volatility that should be embraced. 

If you grew up in the 90s and early 2000s watching sci-fi films or novels that illustrate some near-magic level of care, today is an exciting time to be alive as parts of that future that was once fiction is unraveling into reality. Of course, developing and actually leveraging these solutions in real life to tangibly benefit patients is no easy task but I find gratitude and meaning in being able to be a part of this greater tide. I hope you found this post to be valuable and would welcome you to share your thoughts and observations in the comments. 

Thanks for reading!