Article by our partner BSI
Contact lenses, wound dressings and pacemakers - commonly used medical devices that would not be safe and available to patients without standards. Standards provide peace of mind in an ever-changing landscape grappling with technological advancements and complex regulations. Through the evaluation of evolving products and processes, standards help any business to achieve safety and sustainability goals while simultaneously protecting patients and people.
What is a standard?
Standards are a valuable tool to enable best practice and ensure trust of products, systems and services. They impact on almost all aspects of our lives. From health and safety to the quality of your tea, standards are there to provide a reliable basis for people to share the same expectations about a product or service.
Promoting innovation, trade and productivity, standards have a significant impact on the industry and the economy. They underpin our existing trading relationships, facilitating international trade by reducing technical barriers and providing a signal of quality. International standards create a common language for trading partners to enable compatibility of products and services. Through this, standards enhance efficiency, reduce costs and boost revenue by opening up new markets, consequently promoting productivity across sectors. Through compliance of a British Standard, businesses and systems are demonstrating their conformity to regulations. The government often draws on standards when putting together legislation or guidance documents (although it is worth noting that standards are not the same as regulations and following a standard does not guarantee that you are within the relevant law).
Decisions on best practice are made by people who share an interest in how things are done. BSI’s role as the UK’s National Standards Body is to convene and facilitate conversations with these experts, from regulators and customers to suppliers and academics. With the power of consensus, this collaboration makes the world a safer and better place. Partnerships with universities and innovation hubs are vital to this process – not only are we spreading the word about the value of standards in day-to-day life, we are also building bridges with the next generation of standards makers and standards users – this could be you!
How can standards pave the way for health technology innovation?
In the aftermath of a global pandemic, healthcare services and technologies have never been more important. Standards promote innovation as a critical part of commercialisation of emerging technology and supporting creation of new markets at home and abroad. In the context of standards, there are typically two types of innovation. The first is incremental innovation, the idea of creating something similar to an existing technology and using the existing standards in place to help with regulatory approval, good design and manufacturing practices.
The second type of innovation is radical innovation and this is where BSI seeks to strengthen its relationships with universities. Radical innovation means working with emerging technology and agreeing on new rules for this to become commonplace. By defining a common language, standards ensure everyone is talking about areas of innovation in the same way, providing a tried and tested framework for taking new ideas from the drawing board all the way to commercial production. Standards can also provide a platform upon which further innovations can be built. Consequently, the pace of innovation is accelerated, and commercial success is more likely. There are many examples of standards that support innovation across all sectors. In the case of healthcare innovation, there are two initiatives in particular to highlight. The first is a joint project undertaken by BSI and Innovate UK to create quality criteria across the life cycle for Health and Wellness Apps. The guidance sets out quality criteria for the development, testing and releasing of health and wellness apps, covering the full app project life cycle from development through to updating. It allows app developers to come up with innovative ways of providing solutions that may be adopted by health care professionals and the public. The second initiative is joint work with the Association for Advancement of Medical Instrumentation (AAMI), based in the USA. Together BSI and AAMI have created guidance on the application of ISO 14971 (the application of risk management to medical devices) specifically for Artificial Intelligence (AI) and Machine Learning (ML) medical devices. The guidance covers consideration for AI/ML-based solutions in relation to the general requirements for the risk management system, risk analysis, risk evaluation, risk control and the evaluation of the overall residual risk. It focuses on the risks that are elevated or unique to AI-based medical devices.
How can you get involved?
There are three ways you can get involved:
BSI’s Student Research Programme aims to enrich understanding into the standards development process, including research at postgraduate level. Each year the programme offers practical support to a limited number of postgraduate projects on topics relevant to standards or standardisation.
Invite BSI to partner with your university – this can be through delivering a guest talk for your course on standards in healthcare technologies or joining a research proposal in an area of radical innovation that would benefit from standards expertise.
Become a standards maker and play a vital part in the creation of standards. Use your knowledge and insight to effect real change and benefit future society.
Through partnerships with universities and research centres, BSI can be up-to-the-minute on new areas of innovation and potential standardisation. Researchers and innovators play a vital role in this process. BSI is delighted to be in partnership with the NIHR MedTech Foundation and to be collaborating on a host of activities in the coming year. This is an excellent opportunity for you to share your views on how we can shape this partnership and support the MedTech Foundation. Bring your thoughts and ideas to the upcoming Hackathon at the University of Leeds - we look forward to seeing you there!
Contact University Partnerships Manager: emma.glass@bsigroup.com for further information.
Useful resources:
BSI is the UK’s national standard’s body (NSB) and the first national standards body to be created. We represent UK economic and social interests across all European and international standards organisations and in the development of business information solutions for British organisations of all sizes and sectors. Our role is to help improve the quality and safety of products, services and systems by enabling the creation of standards and encouraging their use. At BSI, our mission is to share knowledge, innovation and best practice to help people and organisations make excellence a habit.
Check out the Standards Show, a podcast all about the stories behind the standards:
The Power of Standards: free online course available to everyone.
Authors
Emma Glass
University Partnerships Manager for Healthcare Technologies, BSI
Emma Glass is the University Partnerships Manager for Healthcare Technologies in the Knowledge Solutions division. She is responsible for engaging with universities in healthcare technology research and innovation to promote participation and raise awareness of standards and standards development. Recent work has included co-creating university curriculum on the value of standards in healthcare and collaborating with universities on innovative research projects in the sector. Prior to working at BSI, Emma launched new open-access science journals in digital health, nuclear medicine, oral health and radiology. She also authored CBP’s Big Data Focus Report in 2016 and 2017. Emma has a degree in English Literature from the University of Exeter.
Edward Mbanasor
Editor
Edward is an intercalating fourth-year medical student at the University of Leeds currently studying MSc Enterprise and Entrepreneurship. He has a strong interest in healthcare entrepreneurship, digital healthcare and digital transformation. Edward is the National Content Director at MedTech Foundation.