Internal Reference Number: FOI_9535
Date Request Received: 09/07/2026 00:00:00
Date Request Replied To: 17/07/2026 00:00:00
This response was sent via: By Email
Request Summary: adoption and business case process for new and innovative medical technologies
Request Category: Private Individuals
| Question Number 1: I am writing to make a request for recorded information under the Freedom of Information Act 2000. Scope of this request (please read first, to avoid misdirection) This request concerns the Trust's governance and business case process for adopting new and innovative clinical technologies. To be precise about what I mean: In scope: technologies that are novel to the Trust; implantable devices; high-cost or specialised devices; novel diagnostics; digital health or Software as a Medical Device; and, in particular, technologies that are subject to, or recommended by, NICE guidance (for example Medical Technologies Guidance, Diagnostics Guidance, Interventional Procedures Guidance, Technology Appraisals, or an Early Value Assessment). Also in scope is significant clinical capital equipment introduced through a business case, such as robotic surgical systems, theatre tables, imaging systems, and higher-value ward equipment where it forms part of a service change or investment case. Not the primary focus: the routine replacement, medical equipment library, clinical engineering, or general estates and facilities procurement of established, commodity equipment on a like-for-like basis (for example standard beds or blood pressure monitors purchased as replacements). Please provide that process only if the same committee, template, or route also governs the introduction of the novel and innovative technologies described above, in which case please say so explicitly. Where responsibility for the above is split across more than one committee or group (for example a medical devices or new products committee, a new interventional procedures committee, a capital investment group, and a digital or NICE-implementation route), please provide the information for each relevant committee and identify which one owns which category. Request for recorded information 1. A copy of the current business case or application template(s) used to seek approval for the introduction of a new or innovative clinical technology as defined above, including implantable, high-cost, and specialised devices. | |
| Answer To Question 1: Please see attached To accompany this answer to question 1 please also see the documents listed below:  FOI Q1.pdf | |
| Question Number 2: A copy of the capital business case template(s) used for significant clinical capital equipment (for example the Strategic Outline Case, Outline Business Case, and Full Business Case, or equivalent staged templates), where these are distinct from the template at (1). | |
| Answer To Question 2: This form is used for Capital bids in conjunction with Business case form from Q1. To accompany this answer to question 2 please also see the documents listed below: FOI Q2.pdf | |
| Question Number 3: The name of the committee(s) or group(s) responsible for approving each of the following, and confirmation of which committee owns each: (a) new and innovative medical devices, including implantables and high-cost or specialised devices; (b) novel interventional procedures or techniques; (c) significant clinical capital equipment such as robotic systems and theatre tables; and ( d) digital health or Software as a Medical Device. | |
| Answer To Question 3: (a) new and innovative medical devices, including implantables and high-cost or specialised devices; In part Medical Devices Committee for equipment but not sure for implants etc (b) Please find attached the Policy for the Introduction of new procedures, and the appendices. Please note the policy is currently being reviewed. New procedures need to go through Divisional Governance / sign off, and then come to Clinical Effectiveness Steering Group (CESG) for further clinical approval. If they have any financial requirements, they would also need to go to the Trust Investment Group (TIG) for approval. Once they have been through all these, they then go to a further Committee for final approval (this was TMC, but with the governance changes this is still being decided). I have attached the CESG TOR, which includes the members on page 2 and mentions new procedures on page 3, (c) significant clinical capital equipment such as robotic systems and theatre tables - This would be Medical Devices Committee d) digital health or Software as a Medical Device -This would be Medical Devices Committee To accompany this answer to question 3 please also see the documents listed below: Appendix B - Proforma for business cases.pdf CESG TOR - 2026.pdf introduction-of-new-procedures-policy-v25-Aug 24-appendix-a-application-form.pdf Policy for the Introduction of New Procedures_.pdf | |
| Question Number 4: The Terms of Reference for each relevant committee. | |
| Answer To Question 4: Please see the attached To accompany this answer to question 4 please also see the documents listed below: FOI Q4.pdf | |
| Question Number 5: The membership of each relevant committee by role or job title, and the name or job title of the chair or responsible officer. | |
| Answer To Question 5: This is listed in the ToR for MDC. The current chair is Duncan Murray, Chief Medical Officer | |
| Question Number 6: The meeting frequency of each relevant committee, the scheduled meeting dates for the current and forthcoming year, and the deadline for submission of papers ahead of each meeting. | |
| Answer To Question 6: MDC meets quarterly with July, October, January, April planned, Submissions are the week before hand. | |
| Question Number 7: Any additional standard submission forms associated with the process (for example a new product or device request form, clinical evaluation form, risk assessment template). | |
| Answer To Question 7: The capital bid form encompasses the Risk. Additional forms such as new product and evaluation forms are via Procurement To accompany this answer to question 7 please also see the documents listed below: FOI a.pdf FOI b.pdf | |
| Question Number 8: Any evaluation or scoring criteria used to assess submissions, and any financial thresholds or delegated authority limits that determine escalation to executive or Board approval, including the point at which a case moves between the revenue and capital routes. | |
| Answer To Question 8: The Capital threshold is 拢5K at which point it comes to the attention of MDC. MDC report to CapCG and then to SCC and then to Board. (Finance can provide thresholds and reporting if required perhaps Simon Bruce) | |
| Question Number 9: The policy or standard operating procedure governing the introduction of new medical devices and innovative technologies | |
| Answer To Question 9: Please see attached To accompany this answer to question 9 please also see the documents listed below: FOI 9.pdf | |
| Please see Attachments: | |
| To return to the list of all the FOI requests please click here | |
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