What is our process?
The strength of the Waterfall Commercialisation Group is the use of an end to end, systematic and concurrent process to commercialisation that can be applied to innovative technologies, that mitigates market and commercial risk.
The process is driven by a team of specialists with extensive experience and complementary skills and knowledge. The commercialisation of a medical device can be summarised in the following diagram (please click to enlarge):
The Waterfall Process
We call this the Waterfall Process as a metaphor for a cascading waterfall. The diagram shows there are 3 key areas, all of which we can perform. Note that a key process in each of these steps is to perform a thorough risk analysis including risk mitigation.
- The Waterfall Product Definition Process is the first time where all areas of medical device commercialisation come together. This is a critical process where a promising technology is analysed in the context of commercial viability, what it offers the end user and the patent landscape. A product development, clincial trial, regulatory, quality and manufacturing analysis is also performed. These are all intertwined, as changes in direction for one area can affect strategies for the other areas. A common problem with medical device companies is not getting the User Needs defined well at an early stage
- The Waterfall Business Planning Process is where all the information used in forming the User Needs document is combined with the people, infrastructure and financial requirements of the company/technology into a business plan which can be then be used for capital raising.
- The Waterfall Product Design Process is based on the FDA Design Control Guidance for Medical Device Manufacturers (FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001). The design proceeds in a logical sequence of phases or stages where the User Needs is the start of the process. Basically, requirements are
developed, and a device is designed to meet those requirements. The design is then evaluated, transferred to production, and the device is manufactured. In practice, feedback paths would be required between each phase of the process and previous phases, representing the iterative nature of product development.
- An excellent overview of this process can be found in Dr Andre Routh’s (BSI) presentation on Medical Device Design and Development. Please note that the ISO 13485: 2003 standard for CE marking (and Australian approvals) requires a similar process. A comparison between each standard is shown in Ed Kimmelman’s presentation on ISO 9001:2000 and ISO 13485:2003 and the FDA 21 CFR 820 system.