In addition to demonstrating that your product is efficacious and safe, in many territories there is also an expectation that the technology has been constructed and tested in fashion that is consistent with the guidelines designed to ensure that those processes are robust and consistent. This is achieved through the implementation of quality management systems.
There is usually no requirement to introduce or adhere to formal quality management systems in an academic research environment. Implementing a quality system in a research lab may help accelerate the translation of technologies but comes with a significant burden in time, resources and flexibility. As such, this is only likely to be appropriate in research centres with a significant translational focus. However, familiarising yourself with parts of these quality systems will allow you to consider implementing elements within your normal research work flow that will make it significantly easier to transition the technology’s development to a quality managed environment in the future. For example, by understanding the standards relating to the sterilisation of medical devices, you can consider using materials and constructive methods compatible with cheaper and easier methods of sterilisation, resulting in overall reduced production costs.
Questions to Consider
- Do you have an understanding of the testing and manufacturing requirements of your technology?
- Do you intend to produce medical technologies ready for clinical evaluation within your research centre?
Resources to Request:
As part of your proposal you should consider requesting resources to:
- Undertake relevant training in Quality Management Systems, ISO13485, Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Process.
- Employ people with relevant expertise on the project.
- For Large Investments only, resources may be requested for the design and implementation of a formal quality management system.
- Engage with professional Technology Consultants
- Engage with NHS Medical Physics and QPs (Qualified Persons)
- MHRA Good Practice Guidance: Guidance on topics including Good Laboratory Practice, Good Manufacturing Practice etc. from the UK regulator.
- FDA Quality System Regulations: An introduction to US Quality system regulations.
- ISO13485 Medical devices: Link to the ISO standard for medical devices.