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Business model strategies to harness in the software as a medical device market


SaMD companies have taken off during the past years, helping create more accessible, personalized and effective healthcare. There is so much potential that the software as a medical device market is projected to continue growing at a CAGR of 70% through 2026—second only to pharma and drug development. 

SaMD comprises technology across diagnosis, treatment, prevention and more and provides a wide array of benefits to patients, providers, payers, healthcare businesses and investors. Software as a medical device development is an immense opportunity that every company should be looking into right now. 

Start your journey and get a preview of the business models and future trends reshaping healthcare delivery. 

Supporting evidence-based care and improved outcomes

SaMD isn’t fueling the rise of evidence-based care. But it’s playing a key role in its proliferation. 

Evidence or value-based care shifts away from the fee-for-service model. 

Payers are strong proponents of it and are now turning to SaMD to help enable it. Hospitals are incredibly expensive. We’re seeing the expansion of services across telehealth, urgent care and community health clinics to deliver value at lower costs. 

SaMD is critical for this shift because it is helping capture vast amounts of valuable data, shifting care into the home and boosting patient engagement. 

Preventative care and your business model

The adage that prevention is the best medicine has never been more true. Yet, 90% of the $3.5 trillion in US annual healthcare spending is for people with chronic and mental health conditions. 

SaMD can help people manage their conditions and receive care before a costly visit to the emergency room. That’s why we’ve seen a rapid spread of MedTech and SaMD products targeted at every stage of the care cycle. 

By focusing on preventative and holistic care, we cannot only drive overall healthcare costs down, but healthcare businesses can also capture more value while improving outcomes. 

Remember, the device itself, however, is just a tool. You have to think beyond the traditional point of care for your business model. It’s essential to embrace organizational changes that reflect service-based offerings. 

Think ecosystem, not just product

3.2 million IOMT products have already been deployed in hospitals worldwide. This will double in just a few years. It is essential to remember that healthcare devices do not exist in a silo. They must connect and securely exchange data with others which is why healthcare systems leaders and top SaMD consultants continuously identify interoperability as a priority.  

This is a business model game changer. As a result, organizations can help better coordinate care, improve workflows and efficiencies and help generate higher quality outcomes to outperform competitors. 

You don’t have to build the ecosystem, but you want to be a key participant in it. Focus on the relationships you can create between payers, pharma, health organizations, investors and providers. 

Importantly think about how you can work together to harness synergies by: 

  • Aligning incentives and operations
  • Sharing resources and data 
  • Enhancing connectivity 
  • Developing compatible tech strategies 

These ecosystems have already begun forming. Now is the time to find the right fit for your business. 

Embrace regulatory opportunities

Medical device development requires additional time and investment compared to creating consumer healthcare products. But this is a key opportunity to find your niche and secure a reimbursement pathway. 

Software as a medical device is still relatively new. To win provider and payer support, you truly need validation from the FDA or other regulatory agencies. This is a perfect moment to get ahead of other players and build lasting relationships and brand recognition. 

Pear Therapeutics is an excellent example. They set the stage as the first FDA-approved for substance abuse treatment. Not only has this been incredibly helpful for patients, but this has formed the foundation of their now extensive product line that includes opioid use disorder, insomnia, PTSD, pain management and many other conditions. 

Moreover, this has helped them win academic partners like Dartmouth and the University of Virginia and broader support in the healthcare community. Leverage the same approach to improve your SaMD product development process.  

Gear up for the future of software as a medical device

We are at the beginning of the software as a medical device area. As technologies like AI, blockchain and computing help push advancement, we will see even further growth and transformation over the next decade. 
How do you start uncovering the right opportunities for your business? The place to start is with Healthtech consulting services. They’re critical for helping you understand the right technologies and approaches to streamline product innovation, navigate regulatory complexity and deliver breakthrough products on time and within budget. Lead healthcare evolution. Leverage SaMD to fuel your growth with Star technology consulting.

Photo by Tima Miroshnichenko from Pexels


The editorial staff of Medical News Bulletin had no role in the preparation of this post. The views and opinions expressed in this sponsored post are those of the advertiser and do not reflect those of Medical News Bulletin. Medical News Bulletin does not accept liability for any loss or damages caused by the use of any products or services, nor do we endorse any products, services, or links in our Sponsored Articles.





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