Who We Work With

We Achieve SaMD Success

From startups to healthcare giants, Orthogonal works with companies of all shapes and sizes to build, evolve and scale Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems.

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Meet funding deadlines, hit clinical milestones, build a great product.

You have a proof-of-concept for your device, and you’ve secured funding for your next milestone. Now you have your next looming deadline. Orthogonal helps you apply quality processes designed for SaMD, manage validation for a BYOD environment and tackle integration between hardware and software – while keeping development on time and on track.

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A Quality DevOps approach to product evolution.

Medical device companies can use connected technologies to extend their products. You need an experienced partner who can continuously evolve products faster than your competitors. With our Quality DevOps process, Orthogonal helps medical device companies make medical device software with valuable differentiators that drive patient adoption and adherence.

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Therapy specialists know that innovations in how to treat patients are essential for success.

SaMD and DTx can create “sticky” treatments that promote patient adherence, improve outcomes and create new revenue streams. Orthogonal’s proven process for developing SaMD takes advantage of Agile methods while staying compliant. We streamline the process of creating unique software components that meet the needs of specific patient profiles. 

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We’ll show you the ropes in this
highly regulated industry.

You have a successful product development process that is iterative, user-centric and scalable. But you’ve come up against an industry with a standard way of working that is not what you’re used to. Orthogonal has the expertise to tailor modern software development methods to the constraints of medical device regulations and standards.

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What Our Clients Say

“Orthogonal brought us the expertise we needed to ensure our technology platform met the high standards of the FDA. Through their involvement, we absolutely accelerated our pace through the regulatory process. ” Gary Conkright CEO of PhysIQ
“We needed a SaMD partner equally versed in medical device software development and modern software engineering. Orthogonal clearly crosses that bar, and has been an invaluable asset for Boehringer Ingelheim Digital.” janet maldonado headshot Janet Maldonado Head of Engineering, Boehringer Ingelheim Digital
“Applying modern engineering techniques to the development of SaMD is no easy feat. Orthogonal’s approach to blending these domains helped Tandem accelerate our product innovation cycle and outputs” Larkin Lowrey, Senior Director of Software Engineering for Digital Health, Tandem Diabetes Larkin Lowrey Senior Director of Software Engineering, Tandem Diabetes Care