Boost Design Develops Medical Devices for Startups & Established Businesses
Our Team research and develop new complex technologies, from theoretical concepts through to manufacturable commercial products.
Contact us to discuss how we can help with your medical device development project.
Experts in Medical Device Design & Development
With staff that have previously worked at leading medical device technology companies (e.g. Cochlear, Resmed, Nanosonics, Saluda, Imaxeon, and others), our team have a deep understanding of medical device development. We also have post-doctorate medical research and biomedical engineering research experience ready to apply to your project.
Our team also have a wide range of experience across multiple industries and engineering disciplines beyond medical products, which we combine together to take an integrated approach to medical device development. We have far greater capability than our team itself; we expand our network as needed to include subject-matter experts from universities and industry, maximising success factors in complex medical device development projects.
We can develop products based on ideas conceived by a doctor or clinician, based on a University PHD thesis or whitepaper, or by making improvements to existing products. The team also specialize in early-stage R&D for complex new technologies.
For more mature designs, we can apply our electronics, mechanical and software engineering capabilities to design a completed prototype ready for verification testing, as well as take it further through design-for-manufacture in preparation for commercial product launch.
Examples of some of our previous medical device and diagnostics product development experience:
- Eye diagnostics camera system
- Audiometer (hearing tests)
- Portable injector
- Electroacoustic gut screening device
- Thermal skin measurement device
- Brain-machine interface R&D
- Anaesthesia device PC software application
- Radiotherapy device accessory
- Diagnostics sample control system
- Cannula accessory
- Glue-ear treatment portable wireless device
- Touch sensing & diagnostics
- Disinfection (UV & Chemical)
- Wearable ultrasound phased arrays for therapeutic treatment
- Wireless medical device monitoring devices
- Portable battery-operated device to assist with clinical evaluation
- Spinal load sensor
- Laryngoscope prototype development
- Sensor design and algorithm development
Quality and Regulatory – ISO13485 & FDA Compliance
The Boost Design Team has significant experience in the development of medical devices to meet appropriate industry standards.
For new medical device startups, we can take a lean approach to medical device development. This is where regulatory requirements are considered up-front, but overheads are kept low until product design is matured and ready to undergo more restrictive design process controls.
For established medical device companies, we can work within your existing quality management system and certifications.
Boost Design can provide ISO13485 & FDA compliant design documentation, including:
- Design descriptions
- Design architecture documentation
- DFMEAs (design failure mode effects analysis) to ISO14971
- SRS (system requirements specifications / traceability matrix)
- For software and firmware, additional design documentation required to be compliant with IEC62304 verification protocols and test reports
Designs and documentation may be included as a part of device regulatory submissions.
Product Development Capability
Boost Design can provide comprehensive product design and development services as part of any medical device development. This includes:
- Electronic design
- Mechanical and industrial design
- Software and firmware development
- Design for manufacture
- Verification protocol design and testing
- Design documentation (compliant with FDA, ISO13485, IEC62304, ISO14971 etc)
- Assistance with product validation and certification
- Production setup and support
Contact Us to discuss how we can assist you with your medical device development project.