Successful modern healthcare companies are obliged to keep their fingers on the pulse of a rapidly changing technology ecosystem. One developing manifestation of that ecosystem is medical device software; you’ve likely heard at least something about it if you’re in the healthcare space. And if your organization isn’t already actively dealing with medical device software, the likelihood is that you will be soon.
Understanding what it is and how it might fit into your organization is important if you want to stay on the cutting edge. Here, we give you a guide to everything you need to know about medical device software and how it’s developed.
What is Medical Device Software
Medical device software, otherwise known as software as a medical device (SaMD), is software that is designed to perform some medical function but that does so without any attendant hardware. In a nutshell, it’s software that is itself a medical product. Medical device software can refer to any application that is designed for medical use, including prevention, diagnosis, monitoring, and disease treatment.
SaMD is very often used in conjunction with other databases or computational platforms that are not specifically designed for medical use. A good example to think about is the increasing use of mobile technology, particularly apps. These days there are apps that perform all manner of medical services, from fertility tracking to the analysis of MRI images. That kind of functionality is possible because of the ubiquity of mobile devices and the ability of SaMD to piggyback off of existing network architecture.
SaMD is increasingly focused on the analysis of data using machine learning (ML) algorithms. Since medical device software isn’t yoked to any particular hardware device, it is particularly susceptible to iterative development and improvement, a hallmark of ML. And since the use of data-producing medical technologies is exploding, a particularly salient use case for SaMD is to harness that data using ML for better disease prevention, streamlining of business practices, and an overall improvement in patient care.
SaMD Development Process
The development process for cutting-edge SaMD should itself be as modern and flexible as possible. Increasingly, companies in the healthcare sector are embracing Agile techniques. That sort of methodology is clearly appropriate for the development of SaMD.
There are several considerations that any development team needs to be aware of when creating medical device software.
Every successful medical product, whether hardware or software, must be guided by those who will ultimately be using the product: end-users. It is essential for any development team to have a detailed understanding of and to be guided by use cases. Who will use the product? How will the product interact with the larger computational landscape? A successful development process requires answers to these questions.
One aspect of medical devices that is distinctive is that they must cross several (understandably) onerous regulatory hurdles before they can go to market. Regulatory constraints do not only apply to hardware devices but to SaMD too.
Another thing that makes SaMD development unique is that user experience and user interface play an outsize role in a good product. SaMD, after all, is software, and that means that it needs to be pleasant and intuitive to use. As can be seen in other parts of the software industry, UX/UI considerations are important, if not determinative, for a product’s success.
SaMD is just one aspect of an overall larger trend toward the digitization of the medical industry writ large. Medical device software will continue to play an important role as that inevitable future unfolds. And that’s because SaMD fits synergistically with other technology trends occurring concomitantly in the medical industry.
- Remote Patient Monitoring and Care: SaMD will interface with these practices by providing platforms that use, store, and analyze data generated from wearable devices.
- IOT and Connected Devices: SaMD offers opportunities for understanding data derived from connected devices to improve care, streamline business practices, and reduce costs.
- AI and ML: SaMD can be software that is capable of understanding patterns in extremely large and complex data sets, which every expert in the industry now sees as an important innovation in how patient care and clinical practice will improve as the industry moves forward.
When it comes to the development and deployment of innovative software like SaMD, companies have a suite of possibilities available. One cost-saving option that often initially seems attractive is to work with off-the-shelf software solutions that perform the needed functionality and that are able to interact with existing systems within an organization.
The problem is that off-the-shelf solutions aren’t flexible. They’re not responsive to your particular business needs. They’re not designed to respond to the very specific problems you face, but some (perhaps) similar set of problems.
Additionally, off-the-shelf software solutions can’t grow with your company. They don’t necessarily scale in ways appropriate to your business needs. They’re rigid. Many companies are forced to ultimately invest in additional platforms and link them together, creating a convoluted mess that is difficult for employees and patients alike.
Custom SaMD Development
The better option is to embrace custom software development for your SaMD needs. There are many benefits to custom software solutions:
- Holistic software integration across your business
- Improved patient care
- Streamlined business practices that save money
- Enhanced security
- Room for growth in quickly changing industry
At illumisoft, we understand custom software consulting and development. We specialize in integrating development teams into your business to generate and act upon a full understanding of your needs, the needs of your stakeholders, and most importantly the needs of your patients. illumisoft works with clients over the long term to maximize successful product launches and to ensure customer satisfaction–viewing ourselves as an extension of the team.
If you’re interested in exploring the possibilities of medical device software for your business, we’re here to help.