Title: Colorectal
Funder: Department of Health and Social Care

Abstract: with academia, patients and public, industry, and other related NIHR and MedTech partners, to form a dynamic network focused on the development and translation of new surgical technologies to treat colorectal disease. The MIC 5-step approach to innovation will be used as a model to progress unmet needs through to clinical translation. Short term objectives (Year 1): Objective 1: to embed colorectal surgery as a theme within MIC Surgical Technologies with national reach and impact. The colorectal theme lead will work closely with the MIC central office to develop colorectal surgery as one of the 3 clinical themes. To facilitate this, strong links will be fostered with national professional associations, including our strategic partner (RCS Engl.) and its relevant subspecialty organisations (Association of Coloproctology GB&I, the Pelvic Floor Society (PFS), and Association of Laparoscopic Surgeons of GB&I). The ACPGBI is the national society for over 1,000 UK colorectal surgeons, with specialist interest groups in cancer, inflammatory bowel disease, and pelvic floor surgery. It is the channel for communication to other national and government bodies for policy development and dissemination of information. It is organised into 19 regional Chapters, providing a structured framework to align to the MIC “Hub and Spoke” model. We will establish a strong national identity by working closely with national associations facilitated through joint hosting of events, contribution to newsletters, and reciprocal links to websites. Previous events have included an HTC/Roy. Soc. Medicine “Robotics” Day, and HTC/KTN “Biosensing” and “Nanotechnology” workshop. In keeping with MIC philosophy of engaging with the younger innovation community, we will engage with national trainee forums, including the Duke’s Club - the national society for trainee colorectal surgeons - and the RCS National Research Collaborative, a national network for surgical trainees undertaking collaborative research. In 2015 an audit was undertaken with the National Research Collaborative and collated data from 107 centres and over 2000 patients suffering from acute diverticulitis to identify unmet clinical needs. We will promote the MIC Young Innovators programme and its links to the NHS Clinical Entrepreneurs Training Programme (combined workshop in 2017) to create a dynamic national network. Objective 2: stimulate research and innovation through MIC Surgical Technology networking events. Through our programme of networking events we will bring together partners from colorectal surgery, engineering, academia, industry, and PPI to identify new areas for technological development (Innovation cycle: step 1). We will build on the 20 unmet clinical needs identified through our HTC workshops. We will focus on areas of strength, developing projects with our MIC supporting work streams in physics and engineering, clinical trials, health economics research, pathology, and business development and commercialisation. We will replicate previous successful HTC strategies, including industry “show and tell” workshops, academic sandpits, and PPI events (e.g. “Gutted” – an emotive play about coping with Ulcerative Coliti Objective 3: accelerating the pull through of early technologies into clinical practice. We will use the expertise in our supporting workstreams, in conjunction with our extensive network of academic and industry partners, to progress projects smoothly through the innovation cycle towards commercialisation and adoption. We will use our Surgical Test Bed (Innovation cycle: step 3) to provide the infrastructure for rapid and affordable early clinical evaluation. Examples of technologies to be evaluated in the Surgical Test Bed include: Ostom-i (device to prevent leaks from stomas);ClearView (smoke elimination system for laparoscopic surgery); and LapKit (low cost simulator for laparoscopic surgery). We will facilitate clinical evaluation studies (Innovation cycle: step 4) through our Leeds RCS-STC, with wider links to the RCS STEPS and RCS National Research Collaborative, providing expertise in clinical trials methodology, design, and evaluation and assisting in grant writing. On going HTC collaborations include HTA/NIHR SaFaRI: magnetic anal sphincter for incontinence, and MRC/NIHR IntAct: intraoperative fluorescence perfusion imaging to prevent anastomotic leak. Key deliverables: i) colorectal surgery as a MIC theme with strong links to professional associations ii) networking events to identify unmet clinical needs in colorectal disease, iii) Young Innovators programme linking to colorectal organisations, iv) recruitment of colorectal patients to the MIC Surgical Test Bed. Measures of success: i) identification of 10 unmet clinical needs iii) contribution to 4 networking events and 1 MIC National meeting, iii) 4 new projects, 2 with pumppriming, iv) 100 colorectal patients recruited to phase I and II clinical studies. Medium term objectives (years 2 & 3) Objective 1: growing the MIC as the premier national network for Surgical Technologies We will continue to engage with other NIHR infrastructure (MIC Diagnostic Evaluation Leeds, NOCRI, other MICs) and MedTech organisations (ASHNs, Medilink, KTN) to mutual advantage. RCS Engl. and the specialist societies (ACPGBI, PFS, ALSGBI) will be key partners in establishing national identity and engaging with the wider colorectal and allied professional communities. Objective 2: stimulate research and innovation through MIC Surgical Technology networking events. We will continue to engage with research networks, including the EPSRC IMPRESS and IMPRESS Plus (incontinence) and EPSRC MeDIAN and MeDIAN Plus (GI imaging) networks – collaborations that have yielded successful projects in the past e.g. biosensing for incontinence, novel meshes for pelvic floor suspension (Innovation cycle: step 2). We will develop links through our contacts in Advanced Manufacturing, tapping into expertise available through the Innovate UK Centre for Process and Innovation (CPI) and its Centre for Healthcare Photonics, with whom we have co-hosted a “Photonics for Medicine” workshop. We will encourage health economics evaluation early in technology development to inform commercialisation. Design for Manufacture will be represented by Pd-m International, with previous successful projects including an intra-abdominal platform for laparoscopic surgery (NIHR i4i), and a disposable surgical headlight. We will work with the Bowel Disease Research Foundation to align technologies to identified areas of clinical and research need. We will develop our Young Innovators programme and incentivise activity through international exchange programmes (Baylor University, Houston, TX, and STORM Lab, Vanderbilt University, Nashville, TN, USA) and industry placements (Olympus Medical, Xiros Medical) in collaboration with the Industry Academy (UoL). Objective 3: accelerating pull through of surgical technologies into clinical practice. We will continue to develop our Surgical Test Bed on a regional level, linking with SMEs and multi-national companies to provide access to early clinical evaluation within the NHS (Innovation cycle: step 3). We will work closely with Leeds RCS STC, surgical specialist societies, and other clinical networks (NIHR CRN) to develop multicentre clinical evaluation studies and facilitate patient recruitment (Innovation cycle: step 4). Key deliverables: i) colorectal MIC theme with national profile and strong links to RCS Engl., ACPGBI, and ALSGBI, ii) generation of new technologies to areas of unmet clinical need in colorectal surgery, iii) expansion of MIC Young Innovators programme with international exchange programmes and industry placements, iv) recruitment of colorectal patients to the MIC Surgical Test Bed. Measures of success: i) contribution to >10 networking events and 3 MIC National meetings, ii) >12 projects initiated or completed, iii) 5 new technologies evaluated, iv) >500 patients recruited to clinical trials, vi) >£2 million in external research income and >£6 million leveraged income. Long term objectives (year 4) Objective 1: consolidation of a mature MIC infrastructure Year 4 will see the colorectal theme fully contributing to the MIC network, providing a pipeline of new technologies through its academic collaborations and industry partnerships, and contributing to the recruitment of patients to clinical efficacy and validation studies. We will use our patients and public groups, and links to professional and allied health associations, to showcase the achievements of the MIC and foster awareness of the new technologies developed and evaluated MIC Competition 2016 Reference: MIC-2016-004 Date submitted: 25 January 2017 Page 23 of 51 (Innovation cycle: step 5). The colorectal theme will make a full contribution to the sustainability of the MIC network to ensure its viability beyond the 4-years of funding. Colorectal surgery will be a key component of the MIC’s engagement strategy with the wider NHS through its links to its strategic partner (Colostomy Association), other PPI groups (Bowel Cancer UK, Bowel and Cancer Research), commissioners (LAHP) and the MedTech community (YH-ASHN, Medilink). Key deliverables: i) mature MIC colorectal theme with national reach and impact, ii) portfolio of innovative research projects iii) pipeline of new colorectal technologies for clinical evaluation, iv) established lines of communication to colorectal PPI, Professional Associations, and NHS Commissioning Groups for wider dissemination and adoption. Measures of success: i) engagement with 100 SMEs and multinational companies, ii) 20 active or completed projects,


Research activity codes: 8.5 RESOURCES AND INFRASTRUCTURE (HEALTH SERVICES)
Health categories: GENERIC HEALTH RELEVANCE