The medical technology industry is evolving at a rapid pace, presenting both opportunities and risks. For companies developing software as a medical device (SaMD), innovation is exciting—but building on platforms or AI tools that quickly become obsolete can be disastrous.
To stay competitive, products must be designed for flexibility from day one. The key is adopting a component architecture for SaMD, which allows software elements to be updated, replaced, or expanded without disrupting the entire system. With component architecture for SaMD, companies gain the agility to pivot as technologies shift, ensuring their solutions remain relevant and future-proof in a rapidly changing market.
What Is Component Architecture for SaMD?
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 about this in terms of Legos. How easy is it to add wings to a car with just a few new blocks? And just like that, you have a car that is still functional in a world where roads have become obsolete. This is the type of flexibility that component architecture for SaMD offers.
As needs evolve, software built using component architecture for SaMD can be updated without recoding the entire project. Those pieces affected by industry changes can be rewritten and substituted. 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.
Even beyond these standard considerations, component architecture for SaMD is highly beneficial, enabling the expansion of finished products across various applications, the simple and affordable implementation of software updates, and quicker, more cost-effective 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 discussed before, interoperability within diabetes technology is a must. Regardless of a device’s intended purpose, the user will want the information it provides to integrate seamlessly with the rest of the data, devices, and software they use to manage their condition. Component architecture for SaMD 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 for SaMD 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 for SaMD 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 for SaMD 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 built using component architecture for SaMD today will be ready for any advancements in technology that may be thrown at it tomorrow. As a device company looking to create SaMD, the principles of component architecture can be challenging to grasp. 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 crucial for diabetes device companies seeking to develop 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.
