Winning Strategies

Complex Diagnostic Instruments

Successful Strategies for Developing Breakthrough Medical Devices


27 September 2012

Invetech has used the following strategies to develop breakthrough products for companies around the world. The strategies are advanced and require a very experienced team, supported by effective product development and program management processes.

At a Glance: Strategies to Create Breakthrough Products

  1. Use structured system definition processes to identify the key requirements of the device.
  2. Perform risk analysis to address the hardest challenges first and prove feasibility.
  3. Shorten the time to market with rapid product development techniques.
  4. Focus on user interaction.
  5. Involve the manufacturer early.

1. Use structured system definition processes to identify the key requirements of the device.

In the early stages of a new product development the end user requirements may be unclear.

It is common for different teams involved in the product development, such as technical and marketing, to have different perceptions of which features the market will value most. To ensure the device is a success, it is critical that the initial system definition is right, yet maintains a level of flexibility. By using proven system definition processes, both the stated and unstated requirements can be identified. It is important that these requirements are captured in a comprehensive and unbiaised requirements document.

2. Perform risk analysis to address the hardest challenges first and prove feasibility

By adopting a risk-based development approach and using a range of risk analysis tools it is possible to significantly increase the likelihood of product success.

This approach identifies and tests high risk elements of the product design early in the development to ensure product practicality and speed progress of the development. Risk-based development involves iterative prototyping and testing to reduce risk and avoid costly and time consuming course corrections.

3. Shorten the time to market with rapid product development techniques

Extra close involvement of the client team with the contract development team, perhaps even co-locating for a period of time, can facilitate rapid high quality development.

Complementing this close interaction, a global development team can leverage different time zones to extend the working day. While one team sleeps, the other team can be advancing the project ready for hand over the following day. On critical developments two or more development approaches can be run in parallel. This strategy can be used to mature multiple device concepts in parallel, thus compressing the development schedule.

In some cases, after carefully evaluating the risks and maturity of the product design, the decision can be made to skip a prototype iteration in order to reduce time to market. For example, if a product concept has been thoroughly tested and evaluated for risks, it could be taken direct to Beta prototype from a stable and mature test bed.

4. Focus on user interaction

Adopting a user-centred design philosophy will help develop a better and safer product.

Human Factors Engineering (HFE), the study of how people use technology, is integral to a product's design and development and pivotal to achieve product acceptance by the user. Usability should be a crucial consideration from the beginning of a project and there should also be constant usability checks and evaluations throughout the development process. This integration ensures the technical team receives direct and continuous input, allowing them to make critical design changes.

5. Involve the manufacturer early

Much value can be gained by involving the selected manufacturer early. Production and sustaining engineers from the manufacturer can provide valuable input to design for manufacturing, design for reliability, simplified device calibration and ease of service. The manufacturer can also promote the use of standard parts or modules and provide advice on supplier selection to drive down transfer cost.