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Software as medical device

HTD has experience designing and building FDA-regulated companion software applications to extend the impact of medical hardware devices.

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our focus

Engaging software for next-generation medical devices

Medical devices are no longer standalone pieces of hardware with a singular medical function. They are part of an increasingly connected ecosystem of healthcare technology.

Rapid innovation has made devices smaller and more mobile and a new class of Software as Medical Device (SaMD) has extended devices into comprehensive patient care platforms. Whether reserved for clinical settings or available for patient use at home, device companion software can help doctors and patients alike understand best practices, analyze data results, and integrate device function into broader care plans and patient health goals.

Our deep expertise in adjacent areas including health IT integrations and design for behavior change ensure these SaMD systems will be effective and successful. The HTD team has experience designing software applications that support medical device use among both patient and clinical audiences:

  • Onboarding is key to set expectations for users and provide clear guidelines for device use. Compelling onboarding experiences immediately build trust with the audience and encourage high rates of adoption.

  • It is important to provide education around how to use the device properly and how to interpret readings or results. However, it is also important to educate users about what results mean in the context of a particular condition or health area. As more and more devices enter patients’ homes, broader health education becomes crucial.

  • Software serves not only as a means to display device information, but it can also provide additional features including data tracking, trend reporting, virtual imaging and image analysis, medication dosing information, and more.

  • Software systems also offer the ability to manage user and team permissions and monitor devices for potential malfunction or available updates.

FDA regulated software design and development

Any companion software serving a medical or device function is subject to FDA regulation. Like the hardware device components, software must also be rigorously documented throughout all phases of design and development. This helps ensure ease of FDA 510(k) application and De Novo classification request for class I and class II medical devices, and FDA approval for class III devices. Our internal Quality Management System (eQMS) Greenlight Guru helps the team manage the entire medical device software lifecycle.

The client perspective

Brian Howe, Format Health

HTD has met or exceeded all of our high expectations. They are excellent communicators who constantly find new ways to create value. In addition to delivering superb work on time and within budget, they've become trusted advisors on a range of critical issues. We could not be more pleased with our relationship and highly recommend HTD for any healthcare vendor or provider.

Brian Howe

Chief Executive Officer
Format Health

client work

Next-generation devices

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