MedAcuity
Massachusetts firm that only writes medical device software, from embedded code to cloud
Founded 2007 | Westford, MA, USA | 100–130 employees
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What is MedAcuity?
MedAcuity was founded in 2007 by software engineers and is based in Westford, Massachusetts. It concentrates on medical technology software: architecture, embedded and application development, risk management and the technical documentation behind FDA submissions, with experience across Class I, II and III and PMA devices. It is ISO 13485:2016 certified, and listings put its team at about 119 people. In 2021 it partnered with Fathom Consulting to add human factors engineering.
MedAcuity works primarily with clients in Surgical & robotics, Diagnostics & lab devices, Digital health, Implantables & neuromodulation sectors. Its primary differentiator is: US-based, ISO 13485 certified team that does nothing but regulated device software.
MedAcuity tech stack and services
Embedded C/C++C#/.NETQtIEC 62304ISO 14971Cloud (AWS/Azure)
| Service area |
|---|
| Firmware & Embedded Software |
| Software as a Medical Device |
| Verification & Validation |
| Regulatory & QMS Support |
| Device Cybersecurity |
MedAcuity pricing
Short answer: MedAcuity uses a time and materials, fixed project pricing approach. Minimum engagement is not publicly disclosed; a discovery call is required.
| Engagement model | Typical range | Best for |
|---|---|---|
| Fixed project | From not disclosed | Well-defined scope |
| Time & materials | Variable; depends on team size | Large programmes or team augmentation |
MedAcuity does not publish a public rate card. Contact them directly via their website to get project-specific pricing.
MedAcuity pros and cons
| Advantages | Things to consider |
|---|---|
| +Software-only focus means IEC 62304 documentation and traceability are part of every project | -Does not design hardware, so you need another partner for electronics and mechanics |
| +Experience with PMA-level Class III software | -US onshore rates are higher than nearshore software teams |
| +US onshore team helps with data access and IP-sensitive programs | -Human factors work is handled through the Fathom partnership instead of an in-house group |
| +Secure lab space for testing with client hardware |
MedAcuity vs alternatives
How MedAcuity 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 |
| 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 |
| Orthogonal | SaMD and device companion apps. | Agile delivery adapted to FDA-regulated software, focused on the app and cloud side of connected devices | 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 |
MedAcuity FAQ
What is MedAcuity?
Massachusetts firm that only writes medical device software, from embedded code to cloud
How much does MedAcuity charge?
MedAcuity uses time and materials, fixed project pricing. Minimum engagement is not publicly disclosed. A discovery call is required to get project-specific quotes.
What tech stack does MedAcuity use?
MedAcuity works with Embedded C/C++, C#/.NET, Qt, IEC 62304, ISO 14971, Cloud (AWS/Azure). Primary industries served include Surgical & robotics, Diagnostics & lab devices, Digital health, Implantables & neuromodulation.
Is MedAcuity right for enterprise?
Device makers with hardware but no software team. 100–130 team size. Key consideration: Does not design hardware, so you need another partner for electronics and mechanics.
What are the best MedAcuity alternatives?
The best alternatives to MedAcuity 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 MedAcuity with other Medical Device Development companies
MedAcuity vs Lemberg Solutions MedAcuity vs StarFish Medical MedAcuity vs Sunrise Labs MedAcuity vs Velentium MedAcuity vs Cambridge Consultants MedAcuity vs TTP MedAcuity vs Zühlke MedAcuity vs Key Tech MedAcuity vs Team Consulting MedAcuity vs Minnetronix Medical MedAcuity vs Planet Innovation MedAcuity vs Orthogonal MedAcuity vs S3 Connected Health MedAcuity vs Veranex MedAcuity vs Sagentia Innovation MedAcuity vs Bluefruit Software MedAcuity vs Promenade Software MedAcuity vs Integrated Computer Solutions (ICS) MedAcuity vs Delve MedAcuity vs Kaleidoscope Innovation MedAcuity vs Product Creation Studio MedAcuity vs Simbex MedAcuity vs Softeq MedAcuity vs ScienceSoft MedAcuity vs Tata Elxsi MedAcuity vs Phillips-Medisize MedAcuity vs Jabil Healthcare MedAcuity vs Flex Health Solutions MedAcuity vs Plexus
Verify all details directly with MedAcuity before making a decision.