Medical Device Development.

Developing innovative medical products can be a complex and daunting task, particularly for start-up companies and new inventors. Achieving your desired project goals, such as improving patient outcomes, clinician workflows, and improving health economics, requires a team of experienced medical device developers that can help navigate you through the process and the challenges.

We are here to help bring your medical device idea into reality. Our team comprises experts who specialize in medical device development, including in all relevant fields of engineering, and also have an extensive network of expert partners on-hand to support nearly any type of project.

Our services cover a range of product development stages, from early-stage R&D and design to prototyping and manufacturing. We take an integrated approach to medical device development, leveraging our background in bringing new technology products to market, experience across multiple industries and engineering disciplines, in order to plan and execute an optimal project for your needs. We also work with a network of ISO13485-certified manufacturing partners to ensure that your product is made to the highest standards in addition to meeting all appropriate regulatory requirements.

Our team considers regulatory pathways and project funding requirements when developing a customized plan for your project, tailoring the plan to achieve your specific desired outcomes. These outcomes may include testing a proof of concept to assess the device’s efficacy, conducting a field trial, testing the market demand for the product, developing technology tom achieve a patent, testing and verifying a design, or documenting a design in preparation for a regulatory submission.

We act as your partner throughout the entire process, providing the expertise and support needed to achieve your desired outcomes. Whether you need assistance with early-stage R&D or require help with design-for-manufacture, our team has the skills and expertise to guide you through.

IoMT technology has been revolutionising modern healthcare, enhancing the ability for the deployment on-mass of remote healthcare services. IoMT devices are often point-of-care and home-care based physical devices, that may collect data to a smartphone App, a desktop application, 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 will play a big role in the future of healthcare, and Boost Design is here to help you bring your IoMT product from concept to market launch.

Contact us to discuss how we can help with your medical device development project.

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

• Eye diagnostics camera system
• Medical image processing software
• Audiometer
• Portable injector
• Electrosurgery device
• 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 system
• Portable IoMT battery-operated device to assist with clinical evaluation
• Spinal load sensor
• Mechanical syringe system
• Laryngoscope prototype development
• Medical temperature controller
• Sensor design and algorithm development

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.

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.