Tailored to Medical Devices
New product development efforts are a significant investment. Whether it is an established company that is acquiring new technology or a startup with a new product concept hoping to move to commercialization; decisions should be made regarding what needs to be de-risked before moving to formal product development.
Integrating technology readiness reviews into the product development process enables actionable processes that reduce project risk. This helps to avoid project delays, potential budgetary concerns, or the pressure to make design/feature compromises.
To determine whether a potential product has adequate technical maturity to effectively launch formal product development, the following steps should be considered:
- Determine the stage of maturity of the current technology
- Understand the implications of technology and project risks
- Model, take measurements, and analyze to decide whether core technology is capable of meeting the product requirements
- Demonstrate that the device can provide adequate performance over the expected range of conditions
- Determine whether the technology can scale to volume manufacturing and distribution
Evaluations begin with an objective review of each core technology critical to the operability of the device that may delay or prohibit market introduction.
This may involve proving whether core technology is adequate for use in a particular application. For example, does the new sensor being developed operate over the variety of conditions needed? Will environmental effects cause problems? Are measurements and control mechanisms adequate to provide safe and effective outcomes? Are there manufacturing difficulties in achieving the needed tolerances? These and other questions are explored, and appropriate efforts are made to bring the technology readiness level to the point that justifies moving the project to its subsequent phases.
Technology Readiness Assessment Tailored to Medical Devices
At Sunrise Labs, we implement a rigorous Technology Readiness Assessment customized specifically for medical devices. By analyzing the maturity of the technologies and the risk that each stage incurs, our assessment determines what challenges must be overcome in order for a device to be successfully engineered and commercialized.
We then improve the Technology Readiness through our feasibility Phase 0 process to prepare for a successful development effort.
To learn more about our process, check out our whitepaper on Technology Readiness.