New technology network for colorectal, hepatobiliary and vascular surgery
In January 2018, the Colorectal Therapies HTC became the NIHR Surgical MedTech Co-operative - one of a national network of 11 NIHR MICs announced as part the government’s Life Science Industrial Strategy in 2017.
The NIHR Surgical MedTech Co-operative will provide support for companies developing new medical devices for use across colorectal, vascular and hepatopancreaticobiliary diseases – areas of surgery which all face substantial challenges, and which will benefit from technological innovation.
Expertise available to industrial partners will include engineering support for medical device and robotic technology development, nanotechnology development and biosensor development, support for designing and running clinical evaluations and health economic assessments of innovative devices.
Surgery plays a central role in the management of many medical conditions and whilst there is no shortage of surgical innovations only a few make it to clinical practice. Early clinical involvement has been identified as the biggest obstacle to successful translation and by working with our key stakeholders, the NIHR Surgical MedTech Cooperative will address many of the important unmet surgical needs and provide the expertise and resource needed to translate new technologies into patient benefit.
There are important challenges that cut across General Surgery. “Safer Surgery” is a priority area of national (UK National Patient Safety Agency) and international (WHO Safer Surgery Saves Lives) importance. 30% – 50% of patients undergoing major abdominal surgery suffer a complication, inflating the cost of care by ~6-fold and causing long-term physical, psychological, and financial consequences. Surgical site infection and anti- microbial resistance are high on the national agenda, and there is a real need to improve outcomes for the most vulnerable patients undergoing emergency surgery.
One of the most significant advances in surgical practice has been the introduction of minimally invasive therapies (laparoscopic and endoluminal), with benefits for patients in terms of quicker recovery, and healthcare providers in terms of efficiency savings. Although there is no shortage of surgical innovation, few devices make it into clinical practice; only 9.8% of surgical innovations are translated to first-in-man studies, with ~1% being widely adopted.
To achieve its goals, the Surgical MedTech Co-operative will be supported by expertise in:
The Physics and Engineering work stream jointly led by Prof Steve Evans (Physics), Assoc Prof Pete Culmer (Engineering), and Prof Pietro Valdastri (Robotics). Engineering benefits from access to the Centre for Innovative Manufacturing in Medical Devices, and EPSRC- funded National Facility for Innovative Robotic Systems.
Prof Evans has an international reputation for nanotechnology-related research in theranostic materials for cancer treatment and microfluidics for high throughput single cell phenotyping. He is supported by expertise in antibody-mimetic technologies (Prof P Millner, Prof M MacPhearson), and Biomolecular systems research (P Beales).
Assoc Prof Culmer runs a surgical technologies engineering programme, including next generation instruments, haptic feedback systems, and devices for incontinence through the EPSRC-funded IMPRESS network.
Prof Valdastri is Chair of Robotics and Autonomous Systems with research focusing on medical capsule robots for endoscopy, including a magnetic platform for painless colonoscopy, and an ultra-low-cost Hydrojet gastroscope.
The Pathology work stream boasts the largest clinical academic pathology department in the UK, with sector-leading digital pathology, state of the art molecular biology facilities, access to HTA-accredited human tissue banks, a GI microbiome research programme, new measures of response to neoadjuvant therapy, and an international reputation for pathological assessment of surgical quality through 30 NIHR and international clinical trials. This is led by Dr N West, academic consultant histopathologist, supported by Prof P Quirke, Dr D Treanor, and NIHR Academic Clinical Fellows (ACF’s).
Dr N West and Prof P Quirke are world leaders in pathological assessment of surgical quality, including quality improvement programmes embedding total mesorectal excision, complete mesocolic resection, and extra-levator abdominoperineal excision into clinical practice with demonstrable improvements in cancer outcomes.
The Clinical Trials work stream is led by the Leeds Clinical Trials Research Unit, under the Directorship of Prof J Brown. It is a National Cancer Research Institute (NCRI) accredited and UKCRC Registered Clinical Trials Unit. It has an international reputation for the design and delivery of innovative early to late phase clinical trials. In 2015, the CTRU became a RCS Engl. Surgical Trials Centre (RCS-STC) with clinical themes in colorectal, vascular, HPB, and urological surgery.
The CTRU has contributed to improved surgical outcomes and healthcare efficiency through its clinical trials research in minimally invasive surgery, including the MRC/NIHR CLASICC and MRC/NIHR ROLARR trials, which have been instrumental in changing surgical practice and informing healthcare decision-making across the globe.
The Health Economics work stream is led by Dr. B. Shinkins, lead of Test Evaluation Group, Academic Unit of Health Economics (AUHE). She is lead health economist for the Surgical Med Tech Co-operative with particular expertise in health economic evaluations of tests and devices. She is supported by D Meads, A Vargas- Palacios, and Prof C Hulme.
AUHE collaborates closely with the CTRU on a large portfolio of economic evaluations of surgical technologies. Early economic modelling informed the development of our intra-abdominal platform for laparoscopic surgery (NIHR i4i), including market headroom analysis and commercialisation strategy.
To ensure that new innovations have a realistic chance of progressing into clinical practice we have added Business Development and Commercialisation as an additional work stream.
Medical imaging cuts across our clinical themes, and the Surgical MedTech Co-operative is keen to identify opportunities for medical imaging in surgery, and to explore ideas that can be adapted across clinical themes.