Clinical investigations for software medical devices
Conducting safe and effective clinical investigations provides an opportunity to prove all the clinical claims you want to make for your technology.
Clinical investigations are a pivotal step in your clinical evaluation process. These investigations must be designed in line with current gold standards and use independent data that is representative of your intended population. The necessity for and nature of your clinical investigations will depend on your specific software as well as your intended use and related risk level.
The importance of this step in the process cannot be overstated as not only is it the evidence you will need to prove your clinical validity to the regulators, but it is also key information that will be reviewed when assessing your device for use in healthcare settings. Once again here, planning is crucial. You must undertake a thorough Clinical Investigation Plan (CIP) before embarking on any clinical investigations.
You Clinical Investigation Plan (CIP) should:
Evaluate and document the risks and benefits of proceeding to investigate an experimental technology.
Justify the design of the clinical investigation.
Document the Investigator’s Brochure, Case Report Forms and Informed Consent procedures.
Document a monitoring plan for adverse events.
Once you have completed your Clinical Investigations, documentation must be completed in your Clinical investigations Report (CIR). Detailed, traceable and accountable documentation is vital. Regulators care about safety and risk as much as performance so ensure you include documentation of adverse events and risks as well as performance.
Best Practices
Align with internationally recognised standards
Before embarking on your clinical investigations there are a number of standards designed to ensure safety and quality that you will need to get familiar with. Firstly, you will need to purchase the international standard (ISO 14155:2020) for clinical investigation of medical devices for human subjects. Next, read the standard. Unfortunately, there is no way around this, and auditors will check!
Additionally, before you start planning any clinical investigations you will need to complete NIHR Good Clinical Practice (GCP) or hire someone who is experienced in designing studies in line with GCP. These are the standards that must be complied with while conducting a clinical investigation and are an essential foundation for ensuring safe practices.
In the UK, the NHS provides guidance to help you decide whether your device needs a clinical investigation, as well as detailing the level of evidence required by NICE and NHS adopters for digital technologies.
You will also need to consider the need for ethics approval. In some jurisdictions, you will be required to notify the appropriate regulatory bodies about Investigational Device Exemption (IDE), for example, the FDA (US) and MHRA (UK).
Case Study
How Hardian solves the problem.
Hardian has worked with multiple clients in developing and designing clinical studies that align aims across multiple verticals including regulatory submissions, health economic activities and market strategies.
A well-designed study that accounts for multiple stakeholders can save significant long-term costs, and Hardian’s multidisciplinary team is here to make sure that your studies are aligned with your product and long-term strategy.
Get in touch
Get in touch to see how Hardian can help you streamline your Clinical Investigations process.