Medical Device Design & Development – IoMT

Laboratory Machine Designed and DEveloped by Boost Design

Boost Design Develops Medical Devices for Startups & Established Businesses

The Boost Design Team researches and develops complex new technologies, from theoretical concepts through to manufacturable commercial products.

 

Internet of Medical Things – IoMT

We specialise in the development of wireless products, such as IoMT (Internet of Medical Things). These devices are often point-of-care and home-care based physical devices, that may collect data to a smartphone App, and/or send data to the cloud. This enables simplified remote monitoring, automated alerts, and the collection of large datasets that help to provide insights on health conditions and appropriate treatments. These devices are the future of healthcare.

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 are highly-skilled in early-stage R&D for complex new technologies, including for startup companies.

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.

Previous Projects

Examples of some of our previous medical device and diagnostics product development experience:

  • Eye diagnostics camera system
  • Audiometer (hearing tests)
  • Portable injector
  • IoMT Electroacoustic gut screening device
  • IoMT Thermal skin measurement device
  • Brain-machine interface R&D
  • Anaesthesia device PC software application
  • Radiotherapy device accessory
  • Diagnostics sample control system
  • Cannula accessory
  • IoMT Glue-ear treatment portable wireless device
  • Touch sensing & diagnostics
  • Disinfection (UV & Chemical)
  • Wearable ultrasound phased arrays for therapeutic treatment
  • IoMT wireless medical device monitoring devices
  • Portable IoMT 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 medical device regulatory submissions.

SureVis Thermal Camera with Software development

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
  • Smartphone Apps
  • Cloud Servers and Portals (AWS)
  • Proof-of-Concepts
  • Prototyping
  • Design for manufacture
  • Tooling
  • 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.