Orthogonal
Chicago software firm that builds Software as a Medical Device and connected-device apps
Founded 1998 | Chicago, IL, USA | 11–60 employees
samdconnected-iotregulatoryverificationcybersecurity
What is Orthogonal?
Orthogonal is a Chicago software company founded in 1998 and led by founder and CEO Bernhard Kappe, with its office in the Merchandise Mart. It builds Software as a Medical Device (SaMD), digital therapeutics and the mobile and cloud software that connects to medical devices, working with venture-backed startups as well as established medtech and pharma companies. Directory listings describe ISO 13485 and HIPAA compliance and Class I–III experience. Team size estimates vary widely, from about 11 to 60 people.
Orthogonal works primarily with clients in Digital health, Wearables & remote monitoring, Diagnostics & lab devices sectors. Its primary differentiator is: Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices.
Orthogonal tech stack and services
iOSAndroidCloud (AWS/Azure)BLEIEC 62304ISO 14971
| Service area |
|---|
| Software as a Medical Device |
| Connected Devices & IoT |
| Regulatory & QMS Support |
| Verification & Validation |
| Device Cybersecurity |
Orthogonal pricing
Short answer: Orthogonal uses a time and materials, dedicated team pricing approach. Minimum engagement is not publicly disclosed; a discovery call is required.
| Engagement model | Typical range | Best for |
|---|---|---|
| Dedicated team | Variable; depends on team size | Large programmes or team augmentation |
| Time & materials | Variable; depends on team size | Large programmes or team augmentation |
Orthogonal does not publish a public rate card. Contact them directly via their website to get project-specific pricing.
Orthogonal pros and cons
| Advantages | Things to consider |
|---|---|
| +Focused on regulated medical software for more than a decade | -No hardware or firmware design |
| +Publishes practical guidance on agile methods under FDA rules, a sign of real process experience | -Small team limits how many parallel workstreams it can staff |
| +Strong on mobile apps that talk to devices over BLE | -Team size data is inconsistent across sources |
| +Small enough for direct access to senior people |
Orthogonal vs alternatives
How Orthogonal compares to the other top Medical Device Development companies.
| Company | Best for | Key difference | Rating | Compare |
|---|---|---|---|---|
| Lemberg Solutions | Connected and smart medical devices, one engineering team. | Owns PCB design, firmware, embedded Linux, IoT backend and edge AI under one roof, so device and cloud are designed together | 4.8 | Full comparison |
| StarFish Medical | Startups needing design plus pilot manufacturing. | Medtech-only practice that can build clinical and early commercial units in its own certified clean room | 4.6 | Full comparison |
| Sunrise Labs | Electromechanical devices, fluidics and infusion. | Three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled | 4.5 | Full comparison |
| Velentium | Implantables and FDA cybersecurity submissions. | Combines active-implantable engineering with a dedicated device cybersecurity team that prepares FDA premarket security documentation | 4.5 | Full comparison |
| Cambridge Consultants | Novel technology with high technical risk. | Physicists, chemists and engineers working in one building on problems no off-the-shelf design can solve | 4.4 | Full comparison |
| TTP | Pharma device programs, inhalers and injectors. | Employee ownership plus long-running drug delivery and surgical device work for large pharma and medtech clients | 4.4 | Full comparison |
| Zühlke | European medtech firms modernizing device software. | A device engineering practice and a large digital practice under one owner, useful when a device program is really a platform program | 4.4 | Full comparison |
| MedAcuity | Device makers with hardware but no software team. | US-based, ISO 13485 certified team that does nothing but regulated device software | 4.3 | Full comparison |
| Key Tech | IVD instruments with consumables. | Designs the diagnostic instrument and its cartridge together, with human factors in the same studio | 4.3 | Full comparison |
| Team Consulting | Inhalers, injectors and human-factors-heavy devices. | Three decades of medical-only industrial design and human factors, especially for drug delivery | 4.3 | Full comparison |
| Minnetronix Medical | Electronic devices from design into US production. | Develops and then manufactures electronic medical devices in the same Minnesota medtech cluster | 4.3 | Full comparison |
| Planet Innovation | Diagnostics companies in Asia-Pacific and the US. | Diagnostics roots plus product and commercialization experience in Australia and the US | 4.2 | Full comparison |
| S3 Connected Health | Pharma companies adding connectivity to drug delivery. | Combines embedded wireless engineering with patient-facing apps and data platforms for pharma programs | 4.2 | Full comparison |
| Veranex | Device design plus clinical trials and reimbursement. | One contract can cover engineering, clinical studies, regulatory strategy and reimbursement | 4.2 | Full comparison |
| Sagentia Innovation | Surgical robotics and combination products. | Medical development backed by a listed science group that also runs a regulatory consultancy | 4.1 | Full comparison |
| Bluefruit Software | UK device makers outsourcing firmware and testing. | Small, employee-owned embedded team with medical devices as its largest market and a strong testing culture | 4.1 | Full comparison |
| Promenade Software | Small device makers needing software and security. | Pairs contract device software with its own medical cybersecurity tooling and information-sharing service | 4.1 | Full comparison |
| Integrated Computer Solutions (ICS) | Touchscreen user interfaces on medical devices. | Qt and embedded UI depth applied to regulated device software, including on QNX | 4.0 | Full comparison |
| Delve | User research and industrial design for medtech. | Design research and industrial design depth from two long-established US studios | 4.0 | Full comparison |
| Kaleidoscope Innovation | Enterprises already working with Infosys. | US medical design studio with access to Infosys engineering and digital capacity | 4.0 | Full comparison |
| Product Creation Studio | Pacific Northwest startups and lab instruments. | Small ISO 13485 studio that can follow its own quality system or the client's | 4.0 | Full comparison |
| Simbex | Sensor wearables and biomechanics research. | Biomechanics and sensor research background applied to wearable health devices | 3.9 | Full comparison |
| Softeq | Connected devices needing hardware plus apps. | Hardware, firmware, mobile and cloud teams in one company, with ISO 13485 in place | 3.9 | Full comparison |
| ScienceSoft | SaMD and device software on a budget. | Large, ISO 13485 certified software team with healthcare analytics and testing services | 3.9 | Full comparison |
| Tata Elxsi | Large medtech firms offshoring sustaining engineering. | Offshore scale for verification, documentation and sustaining work on existing device portfolios | 3.9 | Full comparison |
| Phillips-Medisize | Drug delivery devices needing high-volume production. | Design, molding and assembly of drug delivery devices under one global quality system | 3.9 | Full comparison |
| Jabil Healthcare | Global production capacity for cleared devices. | Global scale, supply chain and FDA-registered production for established medical device brands | 3.8 | Full comparison |
| Flex Health Solutions | Design transfer into global contract manufacturing. | Dedicated NPI center and design sites that feed directly into Flex's medical manufacturing network | 3.8 | Full comparison |
| Plexus | Complex capital equipment needing build and sustaining. | Engineering, NPI and sustaining services for low-to-mid volume, high-complexity medical equipment | 3.8 | Full comparison |
Orthogonal FAQ
What is Orthogonal?
Chicago software firm that builds Software as a Medical Device and connected-device apps
How much does Orthogonal charge?
Orthogonal uses time and materials, dedicated team pricing. Minimum engagement is not publicly disclosed. A discovery call is required to get project-specific quotes.
What tech stack does Orthogonal use?
Orthogonal works with iOS, Android, Cloud (AWS/Azure), BLE, IEC 62304, ISO 14971. Primary industries served include Digital health, Wearables & remote monitoring, Diagnostics & lab devices.
Is Orthogonal right for enterprise?
SaMD and device companion apps. 11–60 team size. Key consideration: No hardware or firmware design.
What are the best Orthogonal alternatives?
The best alternatives to Orthogonal depend on your use case. Top options are:
- Lemberg Solutions: owns pcb design, firmware, embedded linux, iot backend and edge ai under one roof, so device and cloud are designed together
- StarFish Medical: medtech-only practice that can build clinical and early commercial units in its own certified clean room
- Sunrise Labs: three decades of work on pumps, fluidics and motion-heavy medical systems where mechanics and firmware are tightly coupled
Compare Orthogonal with other Medical Device Development companies
Orthogonal vs Lemberg Solutions Orthogonal vs StarFish Medical Orthogonal vs Sunrise Labs Orthogonal vs Velentium Orthogonal vs Cambridge Consultants Orthogonal vs TTP Orthogonal vs Zühlke Orthogonal vs MedAcuity Orthogonal vs Key Tech Orthogonal vs Team Consulting Orthogonal vs Minnetronix Medical Orthogonal vs Planet Innovation Orthogonal vs S3 Connected Health Orthogonal vs Veranex Orthogonal vs Sagentia Innovation Orthogonal vs Bluefruit Software Orthogonal vs Promenade Software Orthogonal vs Integrated Computer Solutions (ICS) Orthogonal vs Delve Orthogonal vs Kaleidoscope Innovation Orthogonal vs Product Creation Studio Orthogonal vs Simbex Orthogonal vs Softeq Orthogonal vs ScienceSoft Orthogonal vs Tata Elxsi Orthogonal vs Phillips-Medisize Orthogonal vs Jabil Healthcare Orthogonal vs Flex Health Solutions Orthogonal vs Plexus
Verify all details directly with Orthogonal before making a decision.