INNOVAT ION
Overall, the trial showed that biopsies taken using CamProbe are safe and produce high diagnostic yields. The procedure is also well tolerated by patients and is especially suited to the local anaesthetic outpatient setting. With this in mind, there is a high chance that transperineal biopsies taken using CamProbe will directly replace transrectal ultrasound guided biopsies.
Development pipeline The development of the device has been completed using a structured approach, engaging with individuals and companies to bring the appropriate skill sets to the table. Development for this type of medical device can usually be separated out into areas of expertise with various work packages to ensure a complete product at the end. In addition to the design and development work and clinical trial, there has been lots of work completed on the device in parallel to ensure it is market ready. One example of this is the requirement for medical devices to adhere to EU and UK medical device regulations before they can be sold. To ensure adherence to these regulations, data and evidence has been gathered under the appropriate standards for inclusion into a technical file for CE and UK CA marking. This will ensure that the device is safe to use and, therefore, will be CE marked in 2021, ready for market launch.
HEE has been leading the ongoing work to ensure that the underlying intellectual property is protected. Patent protection for the device is now in force in the UK with other countries due to follow shortly. In addition to the technical and commercial development, it was important that a product was made that will benefit both patients and clinicians alike. Therefore, there has been extensive input from patients and the general public throughout the development
About the Author
Dr. Alice Green is the innovation manager at Health Enterprise East (HEE), where she supports a diverse range of innovators to turn ideas into products and services that will benefit patients, the NHS and the wider economy. Alice has experienced how innovation can impact healthcare and ultimately benefit patients within the NHS, and with HEE having the largest network of NHS organisations in its field, there is ample opportunity to connect healthcare experts and establish successful partnerships. Alice has a BSc in Biochemistry from the University of York and a PhD in Breast Cancer Research from the University of Manchester. She previously worked at UMIP
of CamProbe to help ensure the device is as patient-friendly as possible. Ultimately, patients will be able to benefit from this fast biopsy procedure without the higher risk of infections associated with other techniques. At a time when we are all too aware of the need to relieve pressure on health care services, the fact that more procedures can be carried out in the out-patient setting, is welcome news to both patients and the healthcare establishments alike.
CSJ
– The University of Manchester’s agent for Intellectual Property commercialisation, as well at start-up biotech companies in both the UK and US.
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