Tailored to Medical Devices
New medical device 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.
Does your product meet the following requirements to be considered for formal product development? Follow these steps to find out:
- 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, you might wan to consider the following questions:
- 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 successful medical device engineering and commercialization.
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.
FAQ’s
1. What is a Technology Readiness Assessment (TRA)?
A TRA is a process used to evaluate the maturity of a technology and the associated risks of incorporating it into a product. This helps to identify potential problems early in the development process and avoid costly delays or compromises.
2. Why are TRAs important for medical devices?
Medical devices are subject to strict safety and regulatory requirements. TRAs help to ensure that the technologies used in these devices are sufficiently mature and well-understood to minimize risks to patients.
3. What are the benefits of conducting a TRA?
- Reduces project risk by identifying potential problems early
- Helps to avoid project delays and budgetary concerns
- Prevents the need for design/feature compromises later in development
4. What are some of the things considered during a TRA for a medical device?
- Maturity of the core technologies
- Potential risks associated with the technology and the project
- Capability of the technology to meet product requirements
- Performance of the device under various conditions
- Scalability of the technology for mass production
5. How does Sunrise Labs approach TRAs for medical devices?
Sunrise Labs offers a customized TRA process specifically tailored to medical devices. This process involves:
- Reviewing each core technology critical to the device’s operation.
- Identifying potential issues such as sensor performance, environmental effects, and manufacturing challenges.
- Developing a plan to mitigate these risks and improve the technology readiness level.
- Completing a feasibility study (Phase 0) to prepare for a successful development effort.
6. What is the role of Sunrise Labs’ Phase 0 process?
The Phase 0 process helps to improve the Technology Readiness Level (TRL) of a medical device concept. This involves addressing the challenges identified during the TRA and ensuring the technology is ready for further development.
