Orthogonal

Medical Device Software
That Fits Into Patients’ Lives

Orthogonal’s approach combines Agile methods and regulatory compliance to build, evolve and scale powerful SaMD and connected device systems that fit into patients’ day-to-day lives.

Orthogonal - female with phone and glucose

Build, Evolve, Scale

Orthogonal is uniquely qualified to help you take advantage of the rapidly expanding opportunities presented by digital technologies. We enable you to not just build the right products faster, but to evolve faster and scale faster than your competitors.

build evolve scale mockup 4

Who We Work With

Venture-Backed Startups

Leverage our deep SaMD and connected device experience to build game-changing medical device systems.

Medical Device Companies

We’ve set the standard on how to continually evolve your product to deepen patient engagement and stay ahead of the competition.

Pharmaceutical Companies

Rapidly scale your product pipeline of SaMD and Digital Therapeutics that engage patients and demonstrably improve outcomes.

Consumer Enterprises

You create awesome products. We enable you to bring that success into a highly regulated world.

Some of Our Customers

Google Logo Roche Logo Eli Lily Logo Novo Nordisk Logo Medtronic Logo Tandem Diabetes Logo Nanowear Logo Boehringer Ingelheim Logo physIQ Logo

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 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, Tandem Diabetes

Case Studies

Case Study

Continuous ECG Monitoring with Nanosensors

Case Study

PhysIQ: Ambulatory Patient Monitoring

Case Study

Diabetes Management System

Case Study

Percutaneous Tibial Nerve Stimulation

Bluetooth. Mobile apps. Machine Learning.
FHIR & EMR Integration.

These technologies are our bread and butter. We have over 10 years of experience in SaMD and connected devices, so when an issue arises, there’s a good chance we’ve faced it before – and know exactly how to handle it.

Hand holding smartphone

White Papers

White Paper

Agile in an FDA Regulated Environment

White Paper

AI and the Design of Medical Devices: It’s Getting Better All The Time

White Paper

Software as a Medical Device (SaMD): What It Is & Why It Matters

White Paper

Accelerating the Creation of Software as a Medical Device (SaMD) with Product Analytics

Compliance to Global Standards

Orthogonal’s Quality Management System is certified by BSI to ISO 13485:2016. Our Agile processes are compliant with IEC 62304, AAMI TIR:45, and ISO 14971, as well as FDA QSR, EU MDR, GDPR and HIPAA.

BSI certified logo home page padding