Aderico Medical are proud to announce their involvement in helping a global market leader of continence care products obtain regulatory approval for a new male intermittent catheter (IC) device.
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Aderico Medical are proud to announce their involvement in helping a global market leader of continence care products obtain regulatory approval for a new male intermittent catheter (IC) device. This was a great example of where we successfully delivered on time and on budget for our client, a leading UK Human Factors consultancy, whose responsibility was to ensure the product was safe and effective to use. The new device will help improve the lives of male IC users by helping reduce the risk of urinary tract infections.
Aderico were required to recruit a number of participants, to ensure a broad section of user groups were supplied for this summative study. This included healthcare professionals, carers, current and prospective patients (both with and without experience of using similar IC devices on a day to day level). The participants were selected using a very specific criteria profile ranging from age, ethnicity, gender, condition, experience levels and qualification. In general, device evaluation studies require different mixes and volumes of users and user groups depending on the stage in the approval process and the reach of the device in the market. Each study has a set number of participants and user group requirements, if these quotas are not met then this can delay approval and add significant cost to the device manufacturers - sometimes costs that run into the £ms.
All medical devices are required to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before they are accepted into the Great Britain market. The same applies for the European Union through the The European Union Medical Device Regulation (EU MDR) and the United States through the Food and Drug Administration (FDA). As part of the approval process manufacturers are required to submit qualitative data from their human factors and usability studies to demonstrate that the medical device is safe and effective to use.
Medical device evaluation studies are usually conducted by specially trained Human Factors Engineers who have a unique skill mix of clinical, psychology and engineering, which allows them to understand how people interact and use medical devices. The studies are often conducted in spaces where the environment reflects that of the end users, for example a room that has been converted into a Doctors surgery or the living room set up of a house. Simulated equipment use is often required such as realistic mannequins, skin pads or blood and fluid loss simulators, to ensure detailed and accurate results. Researchers can also monitor participants safely through a viewing gallery window to ensure results reflect purely those of the individual involved.
Aderico's core business is to assist medical device manufacturers and healthcare professionals to improve lives by connecting ideal participants for human factors and usability market research studies. Our responsibility as a participant recruitment company is to ensure the correct quota of exact participant matches is met. Through our extensive network of charities, recruiting partners, social media connections, healthcare professionals, and our comprehensive CRM database we can source and arrange for participants to attend studies against your specific requirements. If you'd like to understand more about what we do please call us on 01264 334239 or visit our website at www.adericomedical.com.
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