Medical device manufacturers must conduct clinical evaluation to compare a new device to standard of care practice. This section includes considerations needed here for market approval and adoption.
STUDY DESIGN/PATIENT & PUBLIC INVOLVEMENT (PPI)
Medical device manufacturers are required to conduct clinical evaluation (incl. literature review, trials) to compare a new device to standard of care practice, or established similar devices, for (pre-)market approval and adoption
- Undertake risk-benefit assessment of the new device under actual clinical conditions of use
- ISO 14155 Clinical Investigation of Medical Devices for Human Subjects - Good clinical practice. An international standard for studies carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes
There’s also a great guidance document from the International Medical Device Regulators Forum (IMDRF) that would be useful to include:
Important PPI considerations:
- Understanding the patient and clinician needs – Does your TPP meet all of the essential requirements expressed by frontline clinical care providers, patient and public contributors (PPI)?
- Research is carried out ‘with’ or ‘by’ members of the public or potential patients etc. – Advisory members of a project steering group
Further information on PPI can be found via INVOLVE:Ìý
¹û¶³Ó°Ôº Support:Ìý
The ¹û¶³Ó°Ôº Translational Research Office (TRO) can help with the timely identification of future needs or opportunities for diversifying, as well as advising on appropriateÌýpatient groups and charities to consider.Ìý
DOCUMENTATION:
Although resource-intensive from the start, the development of a comprehensive Device master file unquestionably increases commercial attractiveness and value of a product to a potential buyer, since it avoids the need to ‘back-fill’ the history and results of the Device design, manufacture & testing.Ìý
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Regardless of altruistic drivers, clinical evaluation of devices has significant costs that must be met.
¹û¶³Ó°Ôº Support:
The Translational Research Office (TRO)Ìýsupports ¹û¶³Ó°Ôº device developers in attracting and managing public, commercial, investor and philanthropic funding for clinical studies of devices, appropriately costed in partnership with the JRO.Ìý
REGULATORY APPROVALS:Ìý
Medical device developers requireÌýlocal, national & international approvals for device evaluations in hospital(s)Ìýand must engage with regulators in advance to identify and address potential hurdles to authorisations.Ìý
¹û¶³Ó°Ôº Support:Ìý
The Joint Research Office (JRO) and Translational Research Office (TRO) support device developers in the above points, as well as ensuring rigorous compliance of ¹û¶³Ó°Ôº researchers and contractors with international standards.Ìý