InnoScot Health and Heriot-Watt University are set to further solidify their partnership with representatives from both organisations set to perform a joint presentation explaining the classification of medical devices and related regulations to a range of businesses.
The two organisations recently signed a five-year agreement which will see Heriot-Watt University’s Medical Device Manufacturing Centre (MDMC) collaborate with InnoScot Health to help bring new ideas and innovations from healthcare professionals to life.
In a further step in the organisation’s relationship, InnoScot Health’s Head of Regulatory Affairs Elaine Gemmell and Prof. Marc Desmulliez, Manager of the MDMC will help to lead a free online event entitled ‘‘What is a medical device?’ which is taking place on Thursday 22 September at 10am.
The combined technical seminar will feature Elaine, Marc, and also Ms Melissa Siah, Director of Syntacog.
Together, the trio will be presenting on:
The legal definition of a medical device
The classification of a medical device and its impact on the regulations that need to be satisfied by this device
Case studies of devices which lie at the boundaries between classes of devices
The presentation of a software that automatically provides information on the classification of a medical device and lists the regulation documents to be filled in. A live demonstration of the software will also be provided
Elaine said: “We expect this combined technical seminar to be of interest to manufacturers with little prior knowledge and experience of medical devices, as well as established businesses seeking more information on the automation of classification of medical devices.
“Joining the event will allow you to better understand the definition of a medical device, its classification, and the resulting medical device regulations for which the device needs to comply to.
“Before the pandemic, there was already movement towards increased governance around medical device innovation. Now, however, far-reaching new regulations are having a significant impact on everyone involved with medical devices – from their manufacture to their use.
“A strong understanding of regulatory compliance must therefore be intertwined with the development process early on when attempting to harness the true potential of new innovations.
Elaine joined InnoScot Health, formally Scottish Health Innovations, in 2002 and helped establish the organisation. With more than twenty years’ experience in medical device development, she is a certified ISO 13485 /ISO 9001 Lead Auditor and has experience of regulatory approval and CE, UKCA marking for medical devices.
Joining SHIL spinout company, Clear Surgical, as a Director, Head of Regulatory Compliance and laterally Chief Operating Officer, she has helped to establish the company with ISO 13485 accreditation and launch two innovative devices onto the market.
Prof. Marc Desmulliez has been involved in medical devices manufacturing for over 15 years. From his previous research interests in Microelectromechanical Systems (MEMS), and in collaboration with his former PhD student, Dr. Suzanne Costello, he developed some in situ sensors to look at the gas and moisture ingress in encapsulated packages.
The work culminated in a monograph (“Hermeticity Testing of MEMS and Microelectronic Packages, Artech House Pub.). His current research interests include microwave sensing and nature inspired engineering.
Melissa Siah co-founded Syntacog, a regulatory startup in mid-2020. The company subsequently won the regulatory challenge in the 2021 Singapore Airlines AppChallenge and more than £500k in Innovate UK grant funding to develop its regulatory compliance technology.
Melissa’s passion for making regulations easier to understand comes from a decade in regulatory law and policy with the Australian government, and seven years leading the development of legal tech and AI products in the UK and Australia.
The webinar will be hosted on Zoom, with a link provided to attendees following registration here.
Research by James Hutton Institute and Heriot-Watt University scientists has carried out the first review of antimicrobial resistance (AMR) in Scotland’s waters.
Antibiotic-resistant bacteria, such as Staphylococcus aureus and Escherichia coli, are a major source of concern for public health. According to the World Health Organisation, new resistance mechanisms continue to emerge and spread globally, threatening our ability to treat common infectious diseases and endangering the achievement of the Sustainable Development Goals set by the United Nations.
Work by Hutton and Heriot-Watt researchers, funded by Scotland’s Centre of Expertise for Waters, considered the available information on antimicrobial resistance in Scotland’s waters and identified emerging monitoring approaches and potential technological solutions for detecting and tackling antimicrobial resistance.
Findings will help policymakers develop solutions for detecting, monitoring and reducing antimicrobial resistance in Scottish waters.
Dr Lisa Avery, a senior environmental microbiologist at the James Hutton Institute’s Environmental and Biochemical Sciences department and co-author of the study, said: “So far, there has not been enough monitoring of antimicrobial resistance in Scotland’s waters to know how widespread or how concentrated the levels of resistant microbes, genes and resistance-driving chemicals are.
“Globally, lots of different methods are used for detecting resistance. The most common ones are to detect antibiotic resistant bacteria by culturing (growing) them and using polymerase chain reaction (PCR) – based methods to detect specific resistance genes. Our study found no consensus on the best detection method.”
Dr Helen Bridle, Associate Professor at the Institute of Biological Chemistry, Biophysics and Bioengineering of Heriot-Watt University added: “A diversity of approaches is needed for research purposes.
“However, if we can develop some guidelines so that those researching or monitoring resistance in waters are encouraged to use at least one or two of the same approaches across all of the different studies, this would help in understanding antimicrobial resistance and how it is linked across humans, animals and the environment.”
At a recent meeting of the Scottish Parliament, Maree Todd MSP, Minister for Public Health, Women’s Health and Sport, said: “We need to recognise that antimicrobial resistance does not affect only humans.
“Bacteria with the potential to become resistant to antibiotics exist in animals and in the environment. For that reason, we require a one health approach to the threat that recognises that the health of people is closely connected to the health of animals and our shared environment.”
The researchers conclude that agreement across methodological approaches and guidance would support technology developers to develop and validate new approaches for detecting antimicrobial resistance, as most current methods are developed for the clinical, rather than environmental field.
It’s hoped that treatment technologies can remove antimicrobial resistance, but cost-benefit analyses are needed to compare different treatment and mitigation strategies.
A spokesperson from SEPA commented: “SEPA welcomes the publication of the Centre of Expertise for Waters’ (CREW) policy briefing, which provides valuable insights to better understanding the risks of AMR in Scotland’s water environment.
“There are many sectors and activities we regulate that have the potential to exacerbate the spread of AMR through the environment, and we are committed to playing our role in understanding and helping to address the issue.
“Through research and multi-agency collaboration we are working to ensure that interventions are developed and implemented in a way that recognises how the health of people is closely and inextricably linked to the health of animals and our shared environment. This includes our involvement in key groups such as the One Heath Breakthrough Partnership and the Scottish One Health National AMR Action Plan Group.”
The policy outputs, including a policy note (Antimicrobial resistance in Scotland’s waters) and policy brief (Technologies for monitoring and treatment of antimicrobial resistance in water), are both available from the CREW website [https://www.crew.ac.uk/publications].
Researchers at Heriot-Watt and Strathclyde team up with international partners to develop quantum technologies for medical imaging and new materials for better medicines
Researchers at Heriot-Watt and Strathclyde universities team up with international partners to develop technologies of tomorrow
Teams at Heriot-Watt will work on developing quantum technologies capable of measuring single light particles that could be used for medical imaging or detecting objects behind barriers
A team from Strathclyde will develop new materials which could improve the processing and performance of drugs such as tablets and capsules
Leading UK researchers from Heriot-Watt and Strathclyde universities will work with international collaborators to develop the technologies of tomorrow, including quantum technologies for medical imaging and new materials for better medicines.
They are among 12 projects announced today bringing together UK and international researchers to develop cutting-edge new technologies, funded through a £17 million investment from the Engineering and Physical Sciences Research Council (EPSRC), part of UK Research and Innovation (UKRI).
One team at Heriot-Watt, led by Professor Gerald Buller, has been awarded a £1.3 million grant to advance quantum technologies capable of measuring single light particles.
Detectors that are capable of measuring the single quantum of light – the photon – are critical to many quantum technologies.
These technologies include quantum communications systems which connect remote quantum processors, and quantum-enhanced imaging approaches for uses such as medical imaging, detecting objects that are faint or behind barriers and satellite communication networks.
The team will work with collaborators at the Jet Propulsion Laboratory and California Institute of Technology in the US.
Professor Buller said: “The impact of this project will be found in both advancing the emerging applications of quantum technology, as well as in more ‘blue-sky’ quantum research.
“Accessing the state-of-the-art detect single-photon detectors from this project will enable a range of advances in emerging quantum technologies such as quantum communications and quantum-enhanced imaging.
“In parallel, this project will allow examination of more fundamental studies of quantum entanglement in ultra-high dimensional quantum imaging and communications.”
A team of researchers at Strathclyde, led by Professor Alastair Florence, has been awarded a £1.2 million grant to work with collaborators in the USA, advance the development of amorphous materials, which are rigid and can hold their shape like solids but have disordered atomic structures like liquids.
They have huge potential in medicines manufacturing where they could be used to improve the processing and overall performance of drugs, in particular treatments which are taken orally such as tablets and capsules.
The team will work with collaborators at the University of Copenhagen in Denmark and Ghent University in Belgium.
Professor Florence said: “This ambitious new international collaboration will develop new science and digital technologies to de-risk the use of amorphous solid forms, reduce the timescale and cost of their development, deliver innovation in their design and manufacture, and help drive the adoption of this versatile and important class of materials across pharmaceutical industry.
“Crucially, the project will also help to develop the talent pipeline and future research leaders for industry as well as academia.”
UK Science Minister George Freeman said: “From improving cancer treatment and generating clean growth to designing the communication networks of tomorrow, UK science, technology and innovation is developing pioneering solutions to the some of the world’s greatest challenges.
“These 12 international projects will harness the expertise of the UK’s world-leading researchers and global collaborators, helping us accelerate our path to an innovation nation and underline our position as a science superpower.”
EPSRC Executive Chair Professor Dame Lynn Gladden said: ““From better, cheaper medicines to powerful quantum computers and next-generation communications networks, these new technologies have the potential to transform the way we live.
“By bringing together world-leading researchers to deliver ground-breaking science and engineering solutions, these projects will generate impact that will be felt across all of society.”
The projects are:
A project led by Durham University aims to develop molecular quantum technologies for use in powerful quantum computers. They aim to use ultracold molecules cooled to within a millionth of a degree of absolute zero as the building blocks of new computing platforms, exploiting the rich internal structure of molecules to unlock the enormous processing power of quantum computation.
Partners: Imperial College London, University of Oxford, Harvard University (USA), JILA at the University of Colorado Boulder (USA)
Led by the University of Birmingham, researchers intend to develop robust and transportable optical clocks which use light to provide an unparalleled precision in timekeeping. They have a wide range of potential uses, from helping planes and ships to navigate to underpinning ultra-high broadband networks.
Partners: University of Nottingham, NPL, Riken (Japan), University of Tokyo (Japan), the University of Düsseldorf (Germany), PTB (Physikalisch Technische Bundesanstalt) (Germany), Technical University Munich (Germany)
Researchers at Heriot-Watt University will work with US collaborators to advance quantum technologies capable of measuring single light particles. These have a wide range of applications, including medical imaging, detecting objects behind barriers and satellite communication networks.
Partners: Jet Propulsion Laboratory (JPL) (USA), California Institute of Technology (Caltech) (USA)
Partners: Max Planck Institute of Molecular Physiology (Germany) and Rosalind Franklin Institute
Working with collaborators in the USA, a team led by the University of Sheffield aims to develop the technology needed to fabricate ultimate visible light communication (VLC) systems and micro-displays. Using lasers on tiny chips in our devices, VLC could potentially offer bandwidth more than three orders of magnitude larger than conventional Wi-Fi or 5G.
Partners: University of Strathclyde, University of Bath, Harvard University (USA), Massachusetts Institute of Technology (USA)
Researchers led by Newcastle University aim to ensure that electric vehicles using the Internet of Things to optimise energy usage are cyber-secure. They will test the vulnerability of electric vehicles, national grids and charging infrastructure while developing the approaches needed to protect them against cyberattacks including the zero-day attacks.
Partners: Cardiff University, University of Sydney (Australia), Commonwealth Scientific and Industrial Research Organisation (CSIRO) (Australia)
A project led by The University of Manchester intends to increase, by up to a million-fold, the volume of manufactured materials that can be X-ray imaged to identify defects. Focusing on battery, composite materials and additive (3D printed) manufacturing, this will guide the manufacturing of new products and improve their performance.
Partner: European Synchrotron Radiation Facility (France)
Partners: National Science Foundation Industry-University Cooperative Research Center for Metamaterials (USA), Airbus, BAE Systems, Ball Aerospace (USA), Bodkin Design, British Telecommunications, The City University of New York (USA), Dstl, Metamaterial Technologies, M.Ventures (Merck) (Netherlands), NASA (USA), Oxford Instruments, Phoebus Optoelectronics (USA), QinetiQ, Thales, Transense Technologies, Wave Optics
A team led by the University of Strathclyde will advance the development of amorphous materials, which are rigid and can hold their shape like solids but have disordered atomic structures like liquids. They have huge potential in medicines manufacturing where they could be used to improve the processing and overall performance of drugs, in particular treatments which are taken orally such as tablets and capsules.
Partners: University of Copenhagen (Denmark), Ghent University (Belgium)
A project led by the University of Leeds aims to improve the outcomes of surgical treatments for osteoarthritis, a condition affecting more than 8 million people in the UK and costing the NHS more than £10 billion a year. Researchers intend to use personalised approaches to evaluate devices such as hip and knee replacements so they can be matched to individual patients’ needs, reducing the risk of complications.
Partner: The Center for Orthopaedic Biomechanics, University of Denver (USA)
A project led by the Imperial College London and UCL aims to develop sophisticated mathematical optimisation algorithms that can guarantee finding the best possible designs and operational strategies in industrial processes and their supply chains. These algorithms will be designed and implemented to facilitate use by decision makers across the process industries to balance economic performance, safety and environmental impacts and handle uncertainty
Partner: RWTH Aachen University (Germany)
A project led by Aston University aims to advance frequency comb technology, which allows light to be measured and controlled and has potential in areas such as telecommunications, gas sensing and sensing for the food industry. Researchers aim to design and develop a new family of light sources with improved robustness, performance and versatility to allow for practical applications in a wide range of different fields.
Partners: University of Nice Sophia Antipolis (France), University of Lille (France)
