Projects

Projects

Current and prior projects worked on by Boost Design team members

Medical Device Disinfector

The trophon EPR is a Class IIb medical device designed for the disinfection of ultrasound probes.  This product is the market leader, and there are currently 1000s in operation in hospitals and clinics around the world.  Activities completed included:

  • Foundation and leadership of the engineering teams, comprising mechanical, electronics, software and firmware specialities
  • Development of the product family from functional proof-of-concept to successful global product
  • Technology research program leadership
  • Customer needs assessments and next-generation product requirements development, up-stream marketing
  • Input into commercialisation strategy, including sales and marketing programs, tradeshows etc.
  • Input into service and support strategies, and ongoing engineering support of the product in the field and in production
  • IP protection strategy development and implementation (five patents and one design registration)
  • Regulatory activities, including writing critical sections of the successful FDA submission, and ownership of all design and validation documentation required to support the product
  • Compliance with ISO13485 medical device quality system (with numerous audits from major compliance bodies), and many other appropriate standards

A video describing the technology and operation of the product is shown below:

 

Linesaver Medical Device

This Class I medical device is designed to externally protect cannulas, the thin tubes inserted into a vein that administer fluids and medication to hospitalised patients.  The Linesaver device is strapped to the arm or hand, and protects the patient from injury if the cannula is accidentally bumped or the IV line pulled. Activities included:

  • Matching product requirements with design and technology feasibility
  • Design reviews and design management consultation
  • Medical Device quality and regulatory consultation, including regulatory strategy development, and creation of appropriate documentation and company processes to support device registration and approval for sale
  • General technology startup company commercialisation advice and support

Electronic Motion Sensor

High-performance sensor electronics were designed from scratch for the purposes of detecting human motion.  This product was to be used as a research platform for algorithm development and testing.  Design activities included:

  • Determination of business needs, and development of project scope and product requirements
  • Systems and architectural design of electronics, software, and hardware
  • Design, development, and management of the project utilising a combination of internal and external teams
  • Provided on-going support and improvements to prior product versions
  • Provided on-going manufacture of the sensor systems
  • Development of design and manufacturing tests

Retro Recording Equipment

This project was to research, design and build a prototype of a unique audio recording device based on proven circuitry used in classic studio equipment popularised in the 1970s. This device comprises a preamplifer circuit combined with a FET limiter circuit. Activities included:

  • Research classic studio audio equipment and usage
  • Define product requirements and specification, and design
  • Source components (including vintage-reproduction components)
  • Prototype and test

Cancer Therapy Assistive Device

Breathe Well is a Class I device designed to assist cancer radiation patients better control their breathing in order to achieve improved treatment. Key activities undertaken by Boost Design include:

  • Review of regulatory strategy and existing TGA/FDA documentation prior to submission
  • Translation of product features into testable requirements
  • Development of basic verification and validation test procedures
  • Development of single-fault risk assessments and mitigations
  • Manufacturing strategy planning
  • Engineering support
  • General start-up guidance and advice

Technology-to-Market Strategy

Our client had an existing technology but were unsure how to best bring it to market. Boost Design conducted the following activities:

  • Review of technology and possible roadmaps
  • Identification of potential products and markets
  • Market segmentation and market opportunity assessment
  • Competitive analysis
  • Identification of, and interviews with future users and key stakeholders (including key opinion leaders)
  • Identification and development of product requirements
  • Creation of R&D plan and commercialisation strategy