Multi-modal Manufacturing of Medical Devices (4MD)

Lead Research Organisation: Heriot-Watt University
Department Name: Sch of Engineering and Physical Science

Abstract

Medical device technologies are vital for the detection and treatment of a great number of diseases and healthcare problems. Increasingly, micro-devices are being developed for minimally-invasive measurement and therapy, for example in cancer detection and drug delivery. To enable broad-based takeup of such devices it is vital to provide low-cost and reliable manufacturing solutions.

The group at Heriot-Watt has significant experience in developing manufacturing solutions for a wide range of applications, with a particular focus in recent years on medical devices e.g. for cancer detection and treatment. Particular challenges include: miniaturisation to enable minimally invasive application; the low-cost integration of optical, chemical and electronic technologies; and hermetic sealing to prevent unwanted ingress of fluids, whilst allowing appropriate interaction e.g. measurement of cell stiffness, measurement of pH, laser ablation/treatment of cancerous tissue. Our manufacturing expertise (spanning laser techniques such as ablation, sintering, bonding and inscription; also additive and subtractive microfabrication processes based on mechanical, chemical, evaporative and microwave techniques), coupled with our highly supportive and growing base of clinical and industrial partners means that we are ideally placed to provide appropriate manufacturing solutions, and to enable rigorous testing and a route to commercialisation and ultimate application.

The Platform will allow us to retain key staff, and to deploy them in ways that are not possible with standard proposals. In particular, we will be able to accelerate our ability to grasp immediate opportunities based on our existing collaborations, both within the group and with external partners, by carrying out critical proof-of-concept studies.

The PDRAs employed will benefit greatly from the enhanced career development under the Platform. We will broaden their experience through research exchanges; engage them in proposals to win new funding; support them in applications for personal fellowships; provide them with dedicated funds for their own short proof-of-concept projects (10% of budget allocated to PDRA-led 'seedcorn' projects); provide a mentoring programme using industrial and academic members of our Advisory Board; and involve them in management of the Platform.

We will organise facilitated workshops to bring together a broader group of academics and medics and to identify new collaborative activity and application areas. We will also employ targeted dissemination activity to inform current and potential industrial and clinical partners of the full range of our medical device manufacturing research activity.

Planned Impact

The overall motivation for, and ultimate impact of, this Platform is to provide improved procedures and outcomes for healthcare patients, by developing and applying manufacturing techniques to enable minimally-invasive solutions for detection and treatment.

Additional impacts can be divided into 4 different categories: (i) economic benefits for medical device companies that will deliver the commercial products resulting from this research; (ii) manufacturing technology advances that can be exploited in other areas of manufacturing; (iii) the output of skilled personnel; and (iv) public awareness and understanding of engineering and science.

In the course of our research and importantly in follow-on projects we will work closely with a range of industrial partners including Renishaw plc, Optoscribe, SPI Lasers, Merlin Circuit Technology, Edinburgh Molecular Imaging and PA Consulting. Their development of the manufacturing systems (e.g. M-Solv, Oxford Lasers) and medical device commercial products (e.g. Renishaw) will result in direct economic benefit for these companies, with broader benefits for their supply chain partners.

The investigators are all involved in a range of other manufacturing applications, e.g. in aerospace, optical systems, and security; and are well-linked into the manufacturing community in the UK, e.g. via the Association of Industrial Laser Users (AILU) and the International Microelectronics Assembly and Packaging Society (IMAPS). Hence they are perfectly placed to identify other applications that would benefit from the technological approaches developed for medical devices.

Absolutely central to the philosophy of the Platform Grant scheme is the output of highly trained personnel skilled in the use of modern manufacturing techniques, and who thrive on working in a multidisciplinary environment. An integral part of our programme is to engage in research exchanges of personnel, in both directions, with existing and proposed new collaborators. Involvement in these interactions, and in the wider group under the Platform, will enhance the skills and experience of the PDRAs. They will be ideally suited to contribute to the growth or creation of high-technology companies, enhancing innovative capacity and consequently increasing business revenues.

We will also continue to enhance public awareness of engineering and science. We will involve the PDRAs in the dissemination of the aims and results of this work to the wider public, at a suitable level, extending our group's on-going contributions to Open Days, careers events, and external events such as Science and the Parliament and the Edinburgh Science Festival.

Publications

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Bitharas I (2018) Visualisation of optimisation of shielding gas coverage during gas metal arc welding in Journal of Materials Processing Technology

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Kossenas K (2022) A Methodology for Remote Microwave Sterilization Applicable to the Coronavirus and Other Pathogens Using Retrodirective Antenna Arrays. in IEEE journal of electromagnetics, RF and microwaves in medicine and biology

 
Description This project is set up to fund a series of short research projects. To date outcomes from these include: (i) a laboratory prototype of a micro-gripper that can be delivered through the working channel of a medical endoscope for measuring the stiffness of tissue (ii) the development of techniques for manufacturing a miniature ultrasound system to aid placement of an epidural needle; (iii) improved fundamental knowledge of additive manufacturing of medically-relevant materials; (iv) manufacturing of micro-optics for minimally invasive laser surgery applications; (v) demonstration of micro-needle manufacture for sensing in the skin; (vi) feasibility demonstration of Tacrolimus drug monitoring sensor (important to prevent rejection after organ transplants); demonstration of feasibility of ultrashort pulsed laser resection for brain cancer treatment; (vii) development of ultrafast laser modification in combination with selective chemical etching, to develop novel distal end microsystems for minimally invasive medical devices; (viii) proof-of-concept results for the high precision laser ablation of brain tissue by means of ultrashort laser pulses; (ix) production of fibre optic sub-millimetre oxygen measurement probe for measurement of hypoxia sensing during hysteroscopy; (x) demsontrate feasibility of wearable Piezoresistive Fibre Sensors for Mobility and Gait Analysis of People with Lipoedema; (xi) Manufacture of custom Ti6Al4V structures with 3D multiscale controlled porosity; (xii) PressureCap, a novel ingestible motility capsule; (xiii) Feasibility of microwave induced inactivation of SARS-CoV-2 method for the safe and rapid sterilisation of ambulances and medical gear; (xiii) feasibility of electromagnetic actuators for anterior magnetic stimulation of the human body.
Exploitation Route We are working with a range of different clinical partners to take forwards the projects funded by 4MD and in many cases have obtained larger scale funding in order to take the next step on the translational pathway. We plan to do this also with the remaining projects.
Sectors Healthcare,Manufacturing, including Industrial Biotechology

URL https://4md.hw.ac.uk/
 
Description The 4MD project to develop miniature palpation devices for detection and diagnosis of prostate cancer has been taken forward with the incorporation of start-up company Intellipalp Dx on 30 March 2020. The 4MD project helped lead to the creation of the Medical Device Manufacturing Centre, which has provided direct assistance to 7 Scottish SMEs to date.
First Year Of Impact 2020
Sector Healthcare,Manufacturing, including Industrial Biotechology
 
Description "The Sixth Princess Royal Tenovus Scotland Medical Research Scholarship"
Amount £90,410 (GBP)
Organisation Tenovus Cancer Care 
Department Tenovus Scotland
Sector Charity/Non Profit
Country United Kingdom
Start 10/2019 
End 09/2022
 
Description ''Mechanically-intelligent'' Intra-operative Tissue Assessment for Robot-Assisted Surgery (MIRAS)
Amount £1,245,292 (GBP)
Funding ID EP/V047612/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 08/2021 
End 08/2024
 
Description Advancing Manufacture Challenge Fund
Amount £1,587,903 (GBP)
Organisation European Commission 
Department European Regional Development Fund (ERDF)
Sector Public
Country Belgium
Start 04/2020 
End 12/2022
 
Description Contribution in cash from from Tommy's (Charity) towards Andrew Brown and Claudia Ferreira
Amount £56,000 (GBP)
Organisation Tommy's 
Sector Charity/Non Profit
Country United Kingdom
Start 03/2018 
 
Description EPSRC Adventurous Manufacturing
Amount £250,000 (GBP)
Funding ID EP/T005076/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 07/2019 
End 06/2021
 
Description Impact Acceleration Account EPSRC
Amount £50,000 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 01/2020 
End 12/2020
 
Description Industry Doctorate Programme in Advanced Manufacturing (NMIS-IDP)
Amount £40,000 (GBP)
Funding ID NMIS-IDP/035 
Organisation Scottish Research Partnership in Engineering 
Sector Academic/University
Country United Kingdom
Start 01/2020 
End 12/2023
 
Description Industry Doctorate Programme in Advanced Manufacturing (NMIS-IDP) - Industrial contrbution
Amount £39,928 (GBP)
Organisation Renishaw PLC 
Sector Private
Country United Kingdom
Start 01/2020 
End 12/2023
 
Description JSPS Summer Programme
Amount £6,000 (GBP)
Organisation British Council 
Sector Charity/Non Profit
Country United Kingdom
Start 07/2020 
End 08/2020
 
Description U-care: Deep ultraviolet light therapies
Amount £6,132,366 (GBP)
Funding ID EP/T020903/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 01/2021 
End 12/2025
 
Description A Platform for Electrical, Optical and Mechanical Sensing - collaboration with NHS 
Organisation National Health Service
Country United Kingdom 
Sector Hospitals 
PI Contribution Led by an expert in microneedles and tissue mechanics together with his team who have vast experience in laser fabrication and electronics microfabrication. This will take place from May to October at HWU.
Collaborator Contribution This project creates a new collaboration with NHS Scotland and Edinburgh University, and an expert in neurophysiology.
Impact Project not started yet
Start Year 2019
 
Description A Platform for Electrical, Optical and Mechanical Sensing - collaboration with NHS 
Organisation University of Edinburgh
Country United Kingdom 
Sector Academic/University 
PI Contribution Led by an expert in microneedles and tissue mechanics together with his team who have vast experience in laser fabrication and electronics microfabrication. This will take place from May to October at HWU.
Collaborator Contribution This project creates a new collaboration with NHS Scotland and Edinburgh University, and an expert in neurophysiology.
Impact Project not started yet
Start Year 2019
 
Description Dr. Andrew Brown who is a part-time (2 years) medical student working on a Master of Medicine in collaboration with the University of Edinburgh and HWU. He is therefore seconded with us 
Organisation University of Edinburgh
Country United Kingdom 
Sector Academic/University 
PI Contribution Dr. Andrew Brown who is a part-time (2 years) medical student working on a Master of Medicine in collaboration with the University of Edinburgh and HWU. He is therefore seconded with us
Collaborator Contribution Dr. Andrew Brown who is a part-time (2 years) medical student working on a Master of Medicine in collaboration with the University of Edinburgh and HWU. He is therefore seconded with us
Impact n/a as yet
Start Year 2018
 
Description Fibre optic probes for endoscopic measurement of uterine hypoxia - collaboration with MRC centre for reproductive health 
Organisation University of Edinburgh
Department MRC Centre for Reproductive Health
Country United Kingdom 
Sector Academic/University 
PI Contribution We are leading this new proposal with our expertise and leadership in fibre optics. The project is from June to October.
Collaborator Contribution Our researchers working with a Doctor from MRC Centre for Reproductive Health, QMRI, University of Edinburgh
Impact Project not yet started
Start Year 2019
 
Description Post-transplant drug dosage detection - collaboration with NHS, Edinburgh University and Glasgow University 
Organisation NHS Scotland
Country United Kingdom 
Sector Public 
PI Contribution The project is led by HWU and their experts in fibre optics, laser processes and fibre sensors.
Collaborator Contribution One partner is from NHS/Edinburgh University and the other from NHS/Glasgow University, they have a range of expertise including dialysis and transplantation knowledge.
Impact Not started yet
Start Year 2019
 
Description Post-transplant drug dosage detection - collaboration with NHS, Edinburgh University and Glasgow University 
Organisation University of Edinburgh
Country United Kingdom 
Sector Academic/University 
PI Contribution The project is led by HWU and their experts in fibre optics, laser processes and fibre sensors.
Collaborator Contribution One partner is from NHS/Edinburgh University and the other from NHS/Glasgow University, they have a range of expertise including dialysis and transplantation knowledge.
Impact Not started yet
Start Year 2019
 
Description Post-transplant drug dosage detection - collaboration with NHS, Edinburgh University and Glasgow University 
Organisation University of Glasgow
Country United Kingdom 
Sector Academic/University 
PI Contribution The project is led by HWU and their experts in fibre optics, laser processes and fibre sensors.
Collaborator Contribution One partner is from NHS/Edinburgh University and the other from NHS/Glasgow University, they have a range of expertise including dialysis and transplantation knowledge.
Impact Not started yet
Start Year 2019
 
Description Secondment for Regulatory Approval - collaboration with NHS Lothian and Medical Physics 
Organisation NHS Lothian
Country United Kingdom 
Sector Public 
PI Contribution HWU have the experts leading this project who have the technical and engineering experience to have brought the device this far. The team are now working on the regulation and legislation needed to commercialise and manufacture the probe.
Collaborator Contribution The collaboration allows our team to work with clinicians and researchers at medical physics and within the NHS to help us to understand the regulatory requirements and to begin this preparation process.
Impact No feedback yet as project only just started
Start Year 2019
 
Description Secondment for Regulatory Approval - collaboration with NHS Lothian and Medical Physics 
Organisation University of Edinburgh
Country United Kingdom 
Sector Academic/University 
PI Contribution HWU have the experts leading this project who have the technical and engineering experience to have brought the device this far. The team are now working on the regulation and legislation needed to commercialise and manufacture the probe.
Collaborator Contribution The collaboration allows our team to work with clinicians and researchers at medical physics and within the NHS to help us to understand the regulatory requirements and to begin this preparation process.
Impact No feedback yet as project only just started
Start Year 2019
 
Description Ultrashort pulsed laser resection for brain cancer treatment - collaboration with Leeds Institute of Medical Research, University of Leeds 
Organisation University of Leeds
Country United Kingdom 
Sector Academic/University 
PI Contribution HWU leads this project with the PI who has experience in this area of research. The project is for 3 months.
Collaborator Contribution The medical research institute at the University of Leeds will support from a clinical perspective and will supply the tissue samples for use in this project.
Impact Project not yet started
Start Year 2019
 
Description Wearable Piezoresistive Fiber Sensors for Mobility and Gait Analysis of People with Lipoedema - collaboration with a QMU clinical researcher 
Organisation Queen Margaret University
Country United Kingdom 
Sector Academic/University 
PI Contribution Our academics have the knowledge and expertise to lead and develop the technology leading to a successful outcome. The project will run from May to December 2020.
Collaborator Contribution A clinical researcher at QMU is our clinical adviser for the project with a wealth of experience in many areas of healthcare including the challenges of living with lipoedema.
Impact Project not yet started
Start Year 2019
 
Description 4MD Inaugural Workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Medical device technologies are vital for the detection and treatment of a great number of diseases and healthcare problems. Increasingly, micro-devices are being developed for minimally-invasive measurement and therapy, for example in cancer detection and drug delivery. To enable broad-based take-up of such devices it is vital to provide low-cost and highly repeatable manufacturing solutions.

This workshops will be where academics and clinicians will be given the opportunity to share ideas for both future collaborations and new projects that can be undertaken during the life of the 4MD platform and beyond.
Year(s) Of Engagement Activity 2018
 
Description Attending Conference SRPe Scottish Research Partnership in Engineering 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact We attended an informative, interactive conference in Glasgow (13th November 2019) showcasing the impact of world-class engineering research in Scotland's universities. This created an opportunity to network with the delegates from across academia, industry and government/public sector reflecting the triple-helix collaboration.
Year(s) Of Engagement Activity 2019
URL https://www.srpe.ac.uk/conference
 
Description BBC Radio Scotland Interview 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Live interview on BBC Radio Scotland to discuss the latest results and describe the potential impact on the treatment of cancers (BBC Radio Scotland: Good Morning Scotland, 25/01/21)
Year(s) Of Engagement Activity 2021
 
Description Information Session to raise awareness within Heriot Watt University/new academics 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other audiences
Results and Impact Information session held at HWU to raise awareness of 4MD where new academics learned of the platform grant and potential funding opportunities. There were presentations given on the current projects and a workshop planned to help to develop new ideas.
Year(s) Of Engagement Activity 2019
 
Description Public lecture hosted by the Royal Scottish Society of Arts 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Public lecture hosted by the Royal Scottish Society for the Arts, on 26 March 2018
Year(s) Of Engagement Activity 2018
URL https://www.rssa.org.uk/20180326.shtml
 
Description The Evening Standard Tech and Science Daily Podcast 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Interview on The Evening Standard Tech & Science Daily Podcast (Jan 21) about the latest results from our grant and the future perspectives.
Year(s) Of Engagement Activity 2021
 
Description Workshop and collaboration between academics and medical practitioners 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Successful workshop held bringing together academics from HWU and medical practitioners who presented real problems within the NHS. All attendees worked in group to discuss the problems and to look at solutions. Finally all ideas were gathered and a deadline set for the proposals to be submitted for consideration. There were 10 proposals received by the deadline which resulted in 4 new proposals being funded from 4MD and 1 seedcorn project. This is a positive result and brings new academics and new exciting collaborations from different areas of the NHS.
Year(s) Of Engagement Activity 2019