Medical Device Engineering and Biomedical Product Development
The medical device industry requires a rigorous design process that complies with stringent requirements set by the Food and Drug Administration (FDA). Sparx Engineering is a medical product development firm that has a long history of bringing medical device designs to market. Our team of engineers can make your new product a reality or create the next generation of your existing medical designs.
Medical product development firm
We will help you establish a clear plan for your product, guiding you from the initial design phase through prototyping, testing, verification & validation (V&V), qualification, and into production. With the support of our contract manufacturing partners, Sparx ensures your medical device technology is produced in compliance with ISO 13485 and other applicable standards.
With Sparx Engineering, transparent proposals and step-by-step project phases keep you informed throughout the process. We routinely work with businesses of all sizes – from startups to large corporations – to produce medical devices that are of the highest caliber and comply with the relevant requirements, such as FDA regulations, military standards, and EMS requirements.
We also have a full-service team that offers a significant breadth of skills in more than just one specific niche:
Life Support and Critical Safety Systems
Sparx has a history of developing fault‑tolerant, redundant designs for life‑critical medical devices, including pre‑hospital transport equipment, critical care monitors, fluid pumps, and airway management systems such as aspirators and ventilators. By focusing on these critical concepts and incorporating rigorous risk analysis from the outset, we help our clients ensure compliance with FDA regulations and contribute to safer patient outcomes. Since our founding in 2009, we have helped bring to market products that not only meet the standards of FDA medical devices, but also a variety of MIL standards including MIL STD 810F, MIL STD 461F, MIL STD 1275F, and can achieve U.S. Army Airworthiness Release (AWR) certification for use on fixed and rotary wing military aircraft.
Biological Compatibility
Medical devices that come in contact with humans must be evaluated for biological compatibility and must comply with FDA and OSHA regulations. We work with clinicians and prospective patients or users early in the design process to determine the industrial design of the device and the chemical products used in the creation of the device to ensure that safety guidelines are satisfied. With expertise at Sparx including chemists, chemical engineers, and biomedical engineers, we understand how to make sure the materials used in your product can meet the regulatory standards as well as hold up to the environment your users need, which may include high temperatures and cleaning chemicals.
Fitness and Health Wearables
Our skilled team of electrical and software engineers have dealt with a diverse landscape of common wearable wireless protocols like ANT+ and Bluetooth Low Energy (BLE). This skillset allows us to take hardware from initial characterization and implementation up through FCC testing and certification. Our team can also provide you with accelerometer-based motion sensors and analysis, as well as non-invasive optical tissue analytics which are essential for many fitness and health wearable applications.
Biological Data Acquisition
Taking biological data and converting it to a form that is more easily analyzed is key for medical devices. Our team has the digital signal processing expertise to understand how to take these sensor inputs, apply filters to increase the signal-to-noise ratio, and perform real time analysis to isolate the clean data you need for your application. We have vast experience with biological signal collection and analysis, so whether you are measuring impedance changes, absorption/transmission of specific optical wavelengths, RF signal attenuation, gas/liquid pressure or temperature changes, or any number of other methods, our team can help accelerate your signal acquisition designs and analysis algorithms.
Lab Services
Sparx Engineering has its own chemistry laboratory with a complement of chemists and chemical engineers that can assist with services such as:
- Infrared analysis: comprehensive material identification and product purity analysis
- Optical spectroscopy: concentration quantification or characterization
- Separation and analysis with automated flash chromatography
- Plastic blending: iteration of plastic blends for mechanical properties
- Materials assessment and customization for biocompatibility and antimicrobial performance
- Comprehensive formulation to meet performance specifications
Medical Device Software Services
Sparx Engineering’s software team brings deep expertise in developing smart, connected systems that bridge hardware and software seamlessly. Our engineers specialize in sensor measurement and data acquisition, fluid control systems, and secure networking—collecting, packaging, and presenting data from multiple devices with precision. Beyond integration, we create intuitive dashboard interfaces for real-time medical analysis, advanced algorithm development, and closed-loop control systems that enable smarter, more responsive performance across applications.
Medical Device Safety and Reliability
Our design team will work alongside your quality and regulatory compliance teams to design hardware that safely and reliably conforms to key medical device standards such as IEC 60601 for electrical safety, ISO 14971 for risk management, IEC 62304 for software lifecycle processes, and ISO 10993 for biocompatibility. We also align with ISO 13485 and FDA 21 CFR Part 820 to ensure robust quality management. Sparx integrates seamlessly with your team to work within your existing quality system, supporting compliance across the full product lifecycle.
spark engineering — a medical device engineering firm
Our engineering firm consists of a team of licensed engineers, skilled in electronics, mechanical, software, chemical, automation, and safety-critical systems. With an immense amount of combined engineering experience, our industry knowledge is far greater than any single competitor.
This breadth of expertise gives us the interdisciplinary capacity to take on complex medical device development problems. This is our edge, and how we can bring our customers exactly what they need, when they need it.
Where many competitors focus solely on design or prototyping, we provide a full suite of services, and a comprehensive approach that streamlines the development process and ensures continuity from problem definition to requirements, design, integration, and verification.
With in-house 3D printing, CNC machining, and a network of FDA-compliant manufacturing contacts, Sparx can rapidly prototype and iterate designs. Our teams are centrally located in the United States, and we never outsource projects.
Whatever the project, from health wearables to life support equipment—Sparx can help.