The medical technology industry is evolving rapidly. For companies interested in creating software and devices for this field, these rapid changes come with a lot of promise. Promise for innovation, opportunity, and new markets.
But any industry evolving this quickly also poses a lot of risks. After all, it does no good to come up with the next life-saving technology if, during the years it takes you to build it, the platform you planned to launch it on or the AI your tech is reliant on becomes obsolete.
As fast as the technology landscape is changing, these risks aren’t just theoretical. Every day, companies who have invested millions in a new product wake up to find they’ve been backing technologies that no longer exist.
To avoid such a costly fate, you must build your product so it is ready for a pivot from day one. Agile software that can adapt as technology adapts, will never be left in the past. While there are many factors that determine how agile a piece of medical tech is, it is the framework of the software that determines if it can keep up with industry advancements.
Specifically, your SaMD needs to be built using a componentized architecture that can be quickly and easily updated, replaced, expanded, and reused to adjust to every change the industry throws at it.
What Is Componentized Architecture?
Component architecture is a framework for building software that relies on independent, modular components that communicate to form a whole but can easily be replaced, repurposed, and rebuilt as needs change.
Each component within this framework encapsulates well-defined functionality within a binary unit that can be stored and used as needed without requiring any changes to other components. Think of the concept of Legos; think about how easy it is to add wings to a car with just a few new blocks and now, hypothetically, you have a car that can drive down the road and also fly. There is a lot to be said in terms of the ability to create new products for new markets with compenentized architecture.
As needs evolve, software built using component architecture can be updated without recoding the entire project. Those pieces affected by industry changes can be rewritten and subbed out. In the same vein, as changes in software capabilities open the doors to new processes and functionality, new components can be created and added to the core product to keep it relevant and functional within evolving markets.
Why Is Component Architecture a Must for SaMD?
Software across all sectors requires the flexibility and adaptability of component architecture. But it is especially important when building Software as a Medical Device (SaMD).
Here, creators are battling not just an ever-changing field of technology possibilities, but a market where innovation is the standard. Innovation is a very important aspect of garnering market share. New products come out every day to help doctors, patients, and everyone in between better monitor and care for their health. As we discussed in our article on software development kits, this kind of market saturation requires every company to put interoperability and inter-device connectivity front and center when designing new SaMD.
But even beyond these standard considerations, component architecture is highly beneficial, allowing for the expansion of finished products across different applications, simple and affordable implementation of software updates, and quicker, cheaper certifications for updates and changes. Componentized architecture, by definition, is highly scalable and adaptable to whatever future needs your company or the market may have.
Provides Effortless Interoperability
As we’ve looked at before, interoperability within diabetes technology is a must. No matter what a device is meant to do, the user will want the information it provides to sync effortlessly with the rest of the data, devices, and software they use to manage their condition. Component architecture lends itself perfectly to interoperability and other-device connectivity.
Components can be readily added to the core kernel to allow the software to communicate and exchange data with other devices and programs. These additions can be made at any point during the creation of the software. This means that if you have a partner program in mind before development, you can build that connectivity into the original architecture. If that partner falls through before launching the product, you can easily remove that component and replace it with the necessary software to connect to your new partner(s).
Once the product is on the market, creating connections with new devices and software is as simple as replacing or adding components. None of this requires rewriting code or slowing progress.
Allows for Reusability Across Applications and Evolving Technologies
Just as component architecture allows for seamless connectivity between devices, your software can be made to interact with various platforms and applications by replacing and adding components.
This means that if technology changes dramatically within the months or years it takes you to create your product, you don’t have to scrap your progress and start again. Instead, you simply add new components and replace those that have become obsolete. Neither will require you to touch the core code of your software, meaning you won’t need to worry about introducing bugs or affecting the performance of the device itself.
Additionally, adding your technology to new or existing applications can be facilitated by your reusable components, which can be plugged into existing architecture and integrated seamlessly. This kind of effortless scalability is what will keep your product profitable long after its initial release date.
Allows for Safe and Affordable Updates
Once your medical software is on the market your component architecture will remain agile to changes in technology, requirements, and user needs. Adjusting functionality to meet these changes is as simple as building a new component and adding it to the existing architecture.
These updates are not full rebuilds that take years to create and require careful sleuthing and testing to get the bugs out. Instead, they build on all the work you have already done, which saves you money and time. And most importantly when it comes to medical software and devices, these kinds of simple updates keep the tech safe and reliable.
Creates the Potential for Incremental Certification
Another major benefit to building software with component architecture in the diabetes technology field is the potential for incremental certification. Getting new SaMD certified and approved by governing bodies is a long and expensive process. If you have to rebuild your software for every update and repurposing you undertake, then you’ll have to go through this same time-intensive and expensive process over and over.
According to J. W. S. Liu, et al, a system designed for compositional verification and validation will be incrementally certifiable. Meaning that if you build your software using separate components that can be independently tested and verified, you won’t have to go through the same process of certification for your entire software product each time you make changes or additions. Only the affected components will require recertification in these cases.
Necessary for the Future, Necessary for Now
Diabetes technology that is built using component architecture today will be ready for anything advancements in technology can throw at it tomorrow. As a device company looking to create SaMD, the principles of component architecture can be hard to wrap your head around. After all, unless the physical devices you’ve built are made of legos, they cannot be changed and adjusted as easily as software can be.
This is why it is so important for diabetes device companies looking to create SaMD to partner with a software company that understands how to build agile, componentized software. This investment upfront will pay off not just at the launch of your completed product, but for years after as it continues to grow and adapt in response to evolving technologies.