A useful guide providing details on various aspect to consider for bringing a medical device to market.

This online guide is designed for academics and researchers and will be useful for anyone with an interest in medical technologies innovation and translation, with a focus for innovators based in higher education or research institutions.

An overview of the relevant regulations to support the development and widespread adoption of safe, innovative, value-adding technologies in health and social care. It provides guidance on how to identify, pilot and rollout AI and digital health medical devices at scale.

This tool was created for health tech innovators and developers in England to help them navigate the different stages to get new technology adopted into the NHS. It includes useful information on commissioning and adoption.

This toolkit provides an overview of some of the barriers research may face when applying their research to solve challenges in human health and wellbeing.

Literature on the application of the Technology Readiness Level framework for assessing the maturity of scientific discoveries/innovations along the translational pipeline

This blog post provides a useful summary of ISO and IEC standards related to software and medical devices.

This resource provides a comprehensive list of ISO standards related to medical devices.

British Standards Online (BSOL) is a comprehensive database providing access to over 55,000 British and adopted European and international standards. Access to BSOL is available through institutional subscription.

An NHS support service to provide advice on how to navigate the regulatory and evaluation pathway for AI and digital innovations in health and social care.

Together with the NIHR Manchester Biomedical Research Centre (BRC), Translation Manchester has developed an online training portal to upskill academics in key skills needed to translate their findings into healthcare interventions and new pathways to the benefit of patients and society. The portal features courses focusing on non-traditional skills and topics such as developing an entrepreneurial mindset, securing translational funding, collaborating with industry, creating impact from healthcare research and much more. The content of the training portal is continuously updated with new materials/modules.

Lucid Innovation is offering an initial free consultation to support academics in developing successful digital or other medical technology.

Medtechtomarket is offering free consultations to help academics and researchers navigate the journey from concept to market, including advice on meeting strict medical device and IVD development requirements in order to comply with regulatory standards. With extensive experience in product commercialisation, they can help to support your innovation’s potential. For projects requiring additional support, they can also serve as an industry partner, leveraging translational funding to provide a complete, end-to-end development solution.

The Pankhurst Presents: Health Tech Matters (HTM) is a podcast about technology and healthcare. It is hosted by Videha Sharma and Lamiece Hassan. In each episode, leading researchers, innovators and healthcare professionals linked with the Christabel Pankhurst Institute are interviewed about how advances in areas such as digital health, advanced materials and artificial intelligence are shaping the future of healthcare.

This a special edition podcast series produced by The Scientist’s Creative Services Team where translational scientists discuss their experiences in taking preclinical concepts to the market.

Discover how digital technologies are transforming healthcare through interviews with leading digital health experts. Presented by Dr Annabelle Painter.

This template can be used to gather your early thoughts by concentrating on important questions such as what is the unmet need that you are trying to address, how your research might solve it, who you may wish to work with and how, and what resources you might need. It includes full guidance notes on how to complete it and four worked examples from diverse FBMH research and impacts. 

Your School's Research Impact Officer can help you complete it and/or review a draft: SBS Deborah Bentley, SMS Emma Hatton, SHS Denise Davidson. 

The UK standards body and global certification body, BSI Group, have developed guidance on medical device usability. This guidance includes an overview of what usability is, its importance, regulatory requirements, the usability engineering process, and notified body expectations.

The MHRA has developed guidance on the importance of applying human factors to medical devices, so that they are designed and optimised to minimise patient and user safety risks. This guidance applies to the design of future products and changes in user interfaces of existing products, rather than those already on the market. It is primarily aimed at manufacturers of all device classes and developers of medical devices and drug-device combination products, and UK Approved Bodies responsible for assuring the quality of those devices.

EPSRC have published a framework for researchers to follow to demonstrate awareness and commitment to the principles of responsible innovation. They also detail how the EPSRC supports the approach outlined, EPSRC’s expectations of the research community, and additional resources.

The UK standards body and global certification body, BSI Group, have developed guidance on responsible innovation (PAS 440). The practical guidelines in PAS 440 will help innovators to work through the demands of innovating in a responsible manner.

The University of Manchester’s Digital Health Software and Platforms team co-designs and co-produce smartphone apps, databases and web-based clinician interfaces for research into a wide range of different health conditions, including multiple co-morbidities.

Matt offers a free introductory call for any researchers looking for advice relating to the development of physical products. He typically provides support at the early stages of product development but has experience taking medical products through from concept design through to manufacture.

A 1:1, designer-led accelerator program taking you from an innovative product idea to an evidence-based concept solution ready for technical development and investment. Fees apply.

A well designed target product profile (TPP) provides a structure to ensure the company embarks on a product development program that is efficient and defines a listing of all relevant medical, technical and scientific information required to reach the desired commercial outcome.

The National Institute for Health and Care Excellence (NICE) provides guidance to the NHS in England on clinical and cost effectiveness of selected new and established technologies. NICE carries out appraisals of health technologies at the request of the Department of health and Social Care. Guidance from NICE is also applied selectively in Northern Ireland and Wales.

This guide describes the methods and processes, including expected timescales, that NICE follows when carrying out health technology evaluations. The methods and processes are designed to produce robust guidance for the NHS in an open, transparent and timely way, with appropriate contribution from stakeholders.

The medical technologies advisory committee (MTAC) makes recommendations on medical devices with the potential to improve: patient outcomes, patient experience of treatment and recovery, efficient use of resources.

The META Tool supports and informs a face to face discussion between you, the medical technology developer, and a trained adviser to identify the gaps in your product’s development and evidence generation plans.

The Diagnostics Assessment Programme evaluates diagnostic technologies. It is responsible for evaluating diagnostic tests and technologies when such evaluation is complex, for example, if recommendations can only be made on the basis of clinical utility and cost-effectiveness analysis or if meaningful assessment requires the consideration of multiple technologies or indications. This programme manual describes how the NICE Diagnostics Assessment Programme develops guidance.

NICE selects and evaluates medical technologies to determine whether evidence supports the case for adoption in the health and social care system. This methods guide describes how NICE selects medical technologies for development of NICE guidance.

A support service for pharmaceutical and healthtech companies seeking to enter the NHS market. The NICE Advice service can help to prepare for a NICE evaluation, or engagement with NHS payers or commissioners. This includes advice on understanding the market, identifying routes into the NHS, preparing for market access, building evidence and refining an economic model. Fees apply.

This is the team based in the Directorate of Research and Business Engagement responsible for developing and monitoring University policy and providing guidance and support to researchers in the area of research governance, integrity and ethics.

An information pack for researchers undertaking Health and Social Care research and applying for NHS REC ethical approval and/or HRA approval.

Government guidance on what you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.

This Government guidance covers what you need to know before you can place a medical device on the Great Britain market with a UKCA mark.

This resource by the Department of Health & Social Care provides useful information on the classification of medical devices in the UK.

The European Commission and the Medical Device Coordination Group provide guidelines relating to the classification of medical devices for use in the EU.

This guide from the Food and Drug Administration (FDA) provides useful information on the classification of medical devices in the US.

This guidance summarises best practices for preparing and submitting medical device regulation documentation.

BSI’s medical device resources include white papers, infographics and more to better understand regulatory and technological changes.

The terms efficacy, effectiveness and efficiency are sometimes used interchangeably but have a clear distinguishable meaning in the context of assessing healthcare innovations. This article sheds some light on the ambiguity.

Proper definition of the intended purpose of a medical device is key to properly evidencing the benefits of a device and to not impair any subsequent efforts to comply with medical device regulation. 

Artificial intelligence (AI) based health innovations need to be thoroughly assessed to make sure they meet sufficient quality, safety, and ethical standards. BS 30440:2023 is a new British Standard that provides a framework for the evidence required to assess and validate AI in healthcare products.

This guide from the Food and Drug Administration (FDA) outlines the regulatory framework for Clinical Decision Support (CDS) software in the US.

This guide from the Food and Drug Administration (FDA) provides comprehensive guidance on Software as a Medical Device (SaMD)—software intended for medical purposes without being part of a physical device. It covers aspects like risk classification, clinical evaluation, and regulatory requirements, offering clarity on how SaMD is assessed for safety, effectiveness, and performance in the US market.

This guide from the Food and Drug Administration (FDA) outlines the principles and practices necessary for validating software used in medical devices and in the production of medical devices. It highlights key areas such as risk analysis, software development lifecycle, and verification and validation activities, ensuring that software performs as intended and complies with regulatory requirements.

The 510(k) Premarket Notification is the most common pathway for bringing medical devices to the US market. This guide from the Food and Drug Administration (FDA) explains how to determine whether a 510(k) submission is required, how to prepare one, and the substantial equivalence criteria needed for clearance.

This guidance provides information on when software applications are considered to be a medical device and how they are regulated. It is applicable to standalone software and apps placed on the Great Britain market.

RegMetrics is an interactive web tool that provides personalised regulatory support to help innovators navigate the world of medical device regulation.

Hardian Health offers a free self-assessment tool aligned with ISO/TS 82304-2, enabling developers to evaluate their health apps against these international standards. The tool assists in identifying areas for improvement, ensuring that apps are safe, reliable, and fit for purpose. By utilising this self-assessment, developers can proactively address potential issues, facilitating smoother integration into healthcare systems and building trust with users.

Advanced Therapeutics Translation Workshop: Regulatory Pathways for Advanced Materials in Medical Devices by Michael Kipping, 5th July 2022.

Demystifying regulation and commercialisation mini-series: Digital Health Technologies Regulatory Event by Richard Hall, QMS Consultancy Ltd, 1st July 2021.

Demystifying regulation and commercialisation mini-series: Digital Health Medical Technology Regulatory Event by Kyun Thibaut, COVARTIM, 2nd September 2021.

The FBMH Research Governance Team holds Research Governance Clinics for 20 minutes every Thursday (between 1-2pm) & Friday (between 10-11am). These are a fantastic opportunity for those who have a complex study and/or have a number of issues, which all the available forms of online help can’t assist with.

Before booking a clinic slot, it is expected that you have reviewed all sections of the FBMH Research Governance Pack (link below), have discussed the issues/queries with supervisors and/or senior members of staff and to have completed the IRAS tutorial and accessed all available IRAS guidance.

If, after the above, you feel that you would benefit from a clinic appointment then please read the guidance in document 5. RG Clinic Information from the FBMH Research Governance Pack and then contact the Research Governance Team with the required information.

To ensure better understanding of medical device regulations and to support medical devices getting to market, Richard offers 1:1 sessions to train, coach and mentor individuals and start-up companies within Accelerator Hubs, Universities and Hospitals.

A 2-day course to learn about medical device regulation requirements and to define the design inputs for your health technology innovation. The course will cover the intended use specification, user requirements, risk management and a traceability matrix to link your design outputs to your design inputs. The workshop will result in a number of documents for your technical file (and are designed to support your regulatory approval). Fees apply.

The course covers what medical devices are, how they are categorised, and how they are regulated. It is a free online bite-size course that is aimed at anyone interested in understanding the medical devices market better.

The MHRA Innovation Office is open to queries relating to products or technologies that challenge the current regulatory framework. They offer free and confidential expert regulatory information, advice and guidance to organisations of all backgrounds and sizes based nationally or internationally.

This is the official NHS England guidance on the Digital Technology Assessment Criteria (DTAC), outlining the core requirements that digital health technologies must meet to be adopted within NHS systems. It covers key areas such as clinical safety (DCB0129), cybersecurity (Cyber Essentials), data protection, usability, and interoperability, ensuring that digital solutions are safe, effective, and compatible with NHS infrastructure.

The Organisation for the Review of Care and Health Apps (ORCHA) provides an assessment of digital health technologies and guidance on how to comply with DTAC.

Medical Device Cybersecurity is critical to ensuring patient safety, data privacy, and regulatory compliance in an increasingly connected healthcare ecosystem. This guide from StarFish Medical provides insights into best practices for incorporating robust cybersecurity measures throughout the medical device lifecycle, from design and development to post-market surveillance.

Guidance and advice on intellectual property provided by the UK’s Intellectual Property Office.

The University of Manchester’s Library has a service to support employees and students with IP advice relating to copyright.

Advice from UoM Research and Business Engagement on the do's and don’ts for external collaborations.

This resource is helpful in explaining how patentability of software is assessed by patent attorneys in the UK and Europe.

Nature Communications has asked Prof Frank Tietze questions on the interplay between publishing and patenting research findings. From the perspective of academic researchers, he talks about when an intervention is patentable, what to disclose at a conference and how the patenting process works.

This guide aims to provide an overview of the key issues relating to Intellectual Property (IP) which are likely to arise during your academic/research career. It explains the nature of IP, how you may create it, and how to protect it; how to use IP belonging to others safely; how IP can be commercialised; and the importance of confidentiality.

This IP Workbook contains practical examples, questions and scenarios which you might encounter in your academic/research life. Its goal is to increase your learning in, and awareness of, the areas covered, by working through given situations which should reflect the reality of your day to day work. This IP Workbook is designed to assist you in thinking ahead about issues and problems that might arise or need to be dealt with in your work and perhaps try to prevent problems arising in work undertaken by you.

This guide aims to give you some helpful tips and an overview of the key issues which you may need to consider when dealing with academic materials or when looking to publish. This guide explains what IP is relevant when dealing with academic materials and publishing, what key issues you should be aware of when looking to publish, how to get clearance to use others’ IP, and what matters you should be aware of when using and/or commercialising academic materials or engaging in publishing.

Confidentiality Agreements, also known as ‘Confidentiality Disclosure Agreements’ (“CDAs”) or as ‘Non-Disclosure Agreements’ (“NDAs”) are used between two or more parties to protect the exchange of confidential information which is not in the public domain/already published.

A Material Transfer Agreement (MTA) is required for the transfer of materials and/or data between the University and a third party. Find out when it is needed and what to include.

This guide aims to give some general pointers as to the issues, including intellectual property rights, one should be thinking about when considering entering into and/or supervising a research project contract.

Consultancy is an important and effective way for staff to share their expertise and knowledge with external clients across public, private and charitable sectors, while increasing their experience and involvement in real-world challenges. This is a quick guide on the UoM consultancy process.

This is a practical guide about consulting. There is a checklist for you in the pocket on the inside of the back cover. This Guide is written for anyone who wishes to begin consulting or for those who wish to refresh their existing activity. Its purpose is to show you how to work as an expert for industry and commerce as an individual research consultant and in certain specialist roles, such as an expert witness. It aims to: classify the types of consultancy and relate them to you; propose how consultancy assignments might be won and carried out; and suggest what you should check from intellectual property, contract and potential conflict perspectives.

The setting up and running of any spin-out company from a research institution involves similar principles and steps. This Guide is intended to help you by providing an overview of the entire process. It aims to: in Inform you about the process and several types of documents, terminology, issues, people, and organisations that you will encounter; alert you to the role and responsibilities of a director of a company; and set your expectations regarding the level and nature of your involvement and influence.

This Guide aims to increase your awareness of licensing as a possibility for transferring your intellectual property (IP) into a business/industrial context and to encourage you to be as engaged as much in the licensing process as is appropriate. It explains: what a licence of IP is and why you may want to license IP; the different ways in which IP can be licensed; what types of licence there are and what terms a licence should typically contain; and what you should be doing after a licence agreement has been signed.

This blog provides guidance and discussion on how to create a business model for a  digital health start-up, covering topics such as value proposition, revenue streams and costs of a start-up.

This guidance introduces the Business Model Canvas (BMC) and provides an overview of how to structure and use it.

This resource portal, provided by the Masood Entrepreneurship Centre, offers a whole range of resources and guidance for starting a business.

The drop-in sessions offer advice and support on potential start-up ideas and activities and how they can be supported by the Masood Entrepreneurship Centre (MEC) and other initiatives at the University. The sessions are open to all current students, members of staff and University of Manchester graduates (up to two years post-graduation date).

NICE provides a support service that helps health technology companies to engage with both NICE and the healthcare system to speed up access to the NHS market. The support includes accurate and reliable scientific and strategic advice, education, and NHS insights.

The Innovation Factory works to support UoM’s academics, researchers and postgraduate students to commercialise their innovations. It offers advice and an early assessment of innovations. Enquiries should be for the attention of the ‘Innovation Discovery Team’.

The university has a dedicated Consultancy Services Team within the Business Engagement and Knowledge Exchange team to discuss any consultancy related questions and support consultancy projects.

The Clinical Trials Team at the University of Manchester provides sponsorship for clinical trials when the chief investigator (CI) who runs them is an employee of UoM.

The MHRA provides detailed guidance around the requirements for a clinical investigation as part of the process to obtain medical device approval.

The ESF is a set of evidence standards for a wide range of Digital Health Technologies (DHTs). Evaluators and decision makers in the health and care system can consistently use to help them identify DHT’s that are likely to offer benefits to users and to the health and care system.

This is a one-stop resource for anyone within The University of Manchester looking for clear, concise and easy to understand guidance on how to plan, undertake and achieve policy engagement and impact.

This session took place in November 2021 and focussed on giving health researchers the tools that they need to engage with policymakers confidently and effectively. It covers how to identify different potential policy audiences for your area of research, and how to design the policy briefings and other content that will get their attention.

This article discusses the scope of postmarket surveillance activities within the European Union (EU) as set out in Medical Devices Regulation (MDR 2017/745).1 The author explains the difference between postmarket surveillance (PMS) versus market surveillance regarding regulatory compliance, discusses PMS plan minimum technical content, persons responsible for regulatory compliance, PMS reporting, types of reports, postmarket clinical follow-up and transparency, accountability and documentation burden.

By Dr Saira G. from Prova Health, September 2024.