Accelerating innovation in the healthcare and wellness sectors

Overview

• Who we are

• Our strategic focus on healthcare

• Medical devices

• Medicines

• Disease prevention and wellness

• Digitalisation and Healthcare 4.0

• Engagement model

High-Value Manufacturing Catapult (HVMC)

Supporting the growth and developmentof advanced manufacturing in the UK…

…as part of a wider catapultand innovation network in the UK

AFRC-NMIS

Nuclear AMRC

MTC

NCC

CPI

AMRC

WMG

2017-18 performance in numbers

We help UK companies, SMEs and start-ups to innovate and grow their business.

Our Customers:

• Rapidly extend their innovation capacity by gaining access to our state-of-the-art facilities, expertise, know-how, innovation networks and contacts

• Accelerate the development of new innovative materials, products, manufacturing processes and digital services

• Reduce the their risk and cost of developing and adopting new disruptive technologies; and/or addressing global societal, environmental and industrial challenges

Total value of our assets

£683mUp 11% from 2016-17

Private sector clients

3,763Size of order book

£234mOf which £170m is CR&D

Number of projects

1,555

SME clients

2,03254% of total number of private sector clients

54%

2,482Number of employees (FTE)

Advanced Assembly Automation Biologics Biotechnology Casting Composites Design Digital Manufacturing Electronics

Flexible Manufacturing Formulation High Temperature Processing

Joining Machining Polymers Materials Characterisation

Metal Formingand Forging

Metrology

Modeling and Simulation

Netshape and Additive Manufacturing

Powder Technology Power andEnergy Storage

Resource Efficientand Sustainable Manufacturing

Printable Electronics Surface Engineering Toolings and Fixtures VR and Virtualisation

HVMC technological capabilities and expertise

HVMC strategic objectives

Increase the uptake of digitaland automation technologies.

Establishing the UK as a global leaderin Additive Manufacturing.

Develop world leading capabilities & differentiating technologies to

secure the future of air transport manufacture in the UK.

To increase the uptake oftechnology to create a more

productive food and drinks sector.

Accelerate the enabling capabilitiesand technologies for electrification

in support of Low EmissionsMobility (LEM).

Shaping and influencing theUK’s Nuclear Energy policy.

Transition the constructionand infrastructure sectorfrom a project focus to

a process focus.

Accelerate growth in the UK Healthcare Manufacturing Sectorby delivering technical innovation

to healthcare organisations.

Accelerate resource efficient manufacturing that enables a

global circular economy, which drives UK prosperity.

Increase the UK’s share of thethrough-life services market by

better integrating design, manufacturing and through-life

performance.

Develop and commercialise thetechnology for vehicle autonomy.

Improve the competitiveness& position the UK as a global

defence manufacturing nation, maximising value to the UK

taxpayer.

Our strategic objective for healthcare

• Promote growth in the UK in Healthcare andrelated sectors

• Help UK businesses to innovate new productsand processes that will simultaneously reduce healthcare costs and improve patient outcomes

• Strengthen UK’s associated manufacturing industries and supply chain

Cross-fertilise our deep expertise in new product development, manufacturing and Industry 4.0 into the pharmaceutical,medical devices and healthcare sectors.

Key healthcare societal factors, trends and drivers

Rising Populations and Ageing

Rising Levels of Chronic Diseases and Multi-Morbidity

Unsustainable and Rising Healthcare Costs

Advanced Digital Technologies

Predicative, Prevention, Lifestyle Intervention and Nutrition

Advanced Targeted Medications

Personalisation, Self-Management and Remote Monitoring

Servitisation and PatientOutcome Based Models

Risks of Pandemics and Antibiotics Resistance

Societal Factors Emerging New Healthcare Models

Innovative Enabling Technologies

The global healthcare sector is now worth $10 Trillion

Our state-of-the-art facilities for healthcare

Implants, Product realisation, DigitalMedicines Manufacturing Innovation Centre

Microelectronics

Composites

Institute of Digital Healthcare

Biologics, Healthcare Photonics, Printed Electronics, Formulation, Industrial Biotechnology

Medical Device Design,Manufacturing, Digital

Title tbc

• Product Development

• Automation and Smart Factories

• Smart Connected Supply Chains

• Healthcare 4.0

Digital• Manufacturing process development

for biotherapeutics, including recombinant proteins, viral vectors and microbial therapeutics

• Drug formulation and delivery

• Small molecule medicines

Medicines• Diagnostics

• Rehabilitation devices

• Implants

• Sensors and monitoring devices

• Light and heat therapy devices

Medical devices• Product Development

• Automation and Smart Factories

• Smart Connected Supply Chains

• Healthcare 4.0

Disease prevention & wellness

Medical devices

Medical devices

• The medical device market is expected to reach an estimated $432.6 billion by 2025, and it is forecast to grow at a CAGR of 4.1%.

• The major drivers for market growth are increasing healthcare expenditure, technological development, growing aging population and chronic diseases.

• We can help you to realise your new medical device idea frominitial design through materials development, device prototyping, pre-clinical validation to establishing the associated manufacturing processes.

• HVMC has strong links with NHS Trusts and the Medical Research Community across the UK.

Medical devices for diagnosis, treatment and rehabilitation

• Optimise product design for ease of use and manufacturability

• Apply state-of-the-art technologies and modelling

• Quality management system to develop high-grade products and compliance to all relevant legislation

• New materials development and characterisation

New device design and development

• Support for the design, manufacture, scale-up

• Product prototyping and testing

• Innovative materials manufacturing

Manufacture and scale up

• Pre-compliance testing to meet medical device regulations

• Product validation

• ISO 13485 for Medical Devices

Access to pre-clinical validation and trails

Case Study

Developing next generationpatient monitoring devicesThe creation of wearable, wireless medical devices for the remote monitoring of patient health with advanced photonic diagnostic capabilities.

Outcomes and impact

• Enabling new product development that improves patient monitoring.

Click here to find out more

Case Study

ACL ScrewCollaborative R&D with an SME to develop a novel ACL screw design, turning initial concepts into a production ready device.

Outcomes and impact• Development work carried out under ISO 13485.

• Screw thread design optimised through 3D printing and fixation trials.

• Established manufacturing machining conditions using STAR Lathe.

• Introduced customer to supply chain for device manufacture.

• Manufacturer purchased additional STAR Lathe to generate parts.

• ACL Screws received regulatory approval, devices have been successfully implanted into humans.

• Whole process (drawing to implanted product) less than 2 years.

• Screw reduces repetitive strain on surgeon, has lower insertion torque and low cost.

• IP created and Design Registration for company.


Case Study

Victor Mobility Device – Conquering HorizonsSpearheaded by a Former Royal Marine veteran, Victor is a unique compact, high-performance, all-terrain, indoor/outdoor mobility device that avoids any stereotyping or stigmatization of users as “disabled” which typical electric wheelchairs and invalid carriages can do. It can bring the user up to “social height” or down to sit at a table, turn on the spot, climb kerbs and slopes, overcoming existing mobility device shortfalls. Funding was provided by the Royal Marines Charity and later through Crowcube.

Outcomes and impact• AMRC developed the device from a blank sheet,

including user research, creating industrial design concepts, building lash-up prototypes, mechanical prototypes and look-alike/work-alike prototypes.

• Support with funding applications was provided.

• Victor Mobility was formed following the AMRC concept stage and the device is being productionised in the UK.

• AMRC & Victor Mobility won the 2018 Institute for Engineering Designers Alex Moulton Award for Product Innovation.


Case Study

Forging of ultrafine grained commercial purity titanium orthopaedic implants

Outcomes and impact

• Significant savings of up to 50% on material costs, the forging temperature was reduced, the tool life was extended and chemical etching after forging was avoided


Investigation into reducing the cost of manufacturing orthopaedic implants with a commercial partner company.

Innovative approach: replacing titanium alloy Ti-6Al-4V ELI with the more cost effective pure titanium.

Process used: the AFRC’s patented severe plastic deformation process to produce ultrafine grained commercial purity titanium for implants.

Case Study

Cranial Plates

Outcomes and impact

• A faster, higher quality method of manufacturing titanium cranial implants.

• The commercial partner now intends to supply implants to maxillofacial units inthe UK.


Challenge: reduction of the manufacturing cycle time for cranial implants without compromising fit.

Solution: Application of incremental sheet forming method was applied on titanium sheet. The design required a method of stretching titanium sheet to fit individual needs without tearing.

Medicines

Supporting innovation in medicines manufacture

The pharmaceutical industry is constantly evolving and there is an increased demand for lower cost drugs, rapid manufacturing and a more patient-centric approach.

As experts in pharmaceutical innovation, we are able to accelerate the development of your ideas through to market.

The facilities available across the HVMC can support process development and manufacturing innovation for a range of medicines, including:

• Biotherapeutics

• Complex medicines and nanomedicines

• Small molecule pharmaceuticals

Biopharmaceuticals

• Manufacturing solutions for biopharmaceuticals including monoclonal antibodies, recombinant proteins, viral vectors, microbiome therapeutics and complex medicines

• Rapid process optimisation and scale up for microbial and mammalian expression systems

• Advanced analytics for product and process characterisation

• Fill, finish and lyophilisation

• Formulation and stability testing

Innovative Manufacture

• Next generation manufacturing processes such as cell free synthesis and continuous processing

• Advanced process control and integrated online analytics

• Data diagnostics and modelling for process optimisation

• Bioinformatics expertise to support integrative omics data analysis

Smart Factory

• Smart packaging technology to enable global supply chain traceability

• Product track and trace capabilities

• Product security measures

• Patient adherence tracking

• Environmental monitoring

Supply Chain

Small molecules

• GMP capable solutions in small molecule andfine chemical manufacturing

• Oral solid dose and parenteral dose pharmaceutical manufacture

• Continuous direct compression

• Rapid formulation development for multiple dosage forms, including solid dosage, parenteral, inhalation, suspension formulation and encapsulation

Innovative Manufacture

• Advanced process control through digital design and integrated process analytics

• Data diagnostics and modelling for process optimisation

• Flexible and modular manufacturing for stratified medicine production

• Just in Time (JIT) manufacture and supply capabilities

• Real-time release

Smart Factory

• Smart packaging technology to enable global supply chain traceability

• Product track and trace capabilities

• Product security measures

• Patient adherence tracking

• Environmental monitoring

Supply Chain

Case Study

MMIC Initiatives: small molecule medicines

Outcomes and impact

• Enhanced particle models andCDC Digital twin

• Material Property Database(API and excipients)

• Equipment configurator including process analytical technology (PAT) selection, equipment interfaces, control strategy and data workflows


Grand Challenge 1 –Continuous direct compression (CDC) for oral solid dose manufacture.

Developing an integrated, multi-step continuous process demonstrator platform that is aligned to the principles of portable, continuous, modular and digital manufacturing.

Case Study

MMIC Initiatives: small molecule medicines

Outcomes and impact

• Develop and deliver a GMP compliant Just-in-Time, automated pharmacy using a modular automation system with software connectivity to achieve real time material release by a partner organisation.


Grand Challenge 2 –Just-in-Time clinical material supply.

Enabling a clinical supply chain that can rapidly and responsively process material on an ‘actual or short-term’ demand driven basis reducing materials waste.

Case Study

Developing a scalable viral vector manufacturing solution

Outcomes and impact• Development of a scalable manufacturing process

to support the advancement of viral vector based treatments into the clinic

• Optimised transfection and cell growth to achieve high titre vector production in both 2D and 3D cultures

• Designed and optimised novel work flows to support the downstream processing of AAV vectors

• Development of an advanced analytical tool kit consisting of conventional and high throughput techniques to support AAV in-process development and final product quality assessment


Gene therapy is a rapidly growing therapeutic area, with viral vectors as one of the main platforms being developed for commercialisation. The challenges facing the viral vector industry include producing enough material to meet the rising demand of these therapies. Scalable, robust processes for viral vector manufacture that meet regulatory requirements are essential and this project focussed on the development of an industrial manufacturing platform for adeno-associated virus (AAV) production to support the supply of gene therapy products.

Case Study

Continuous integrated biologics manufacturing

Outcomes and impact• Key delivery partner supporting the rapid

development of a prototype integrated system sited in a dedicated continuous processing laboratory

• Developed technical knowledge around the challenges of implementing PAT approaches on a continuous process

• Supported the conversion of established batch biologics manufacturing processes to continuous and the development of control strategies for flexible continuous manufacturing


Continuous manufacturing offers the potential for higher efficiencies, reduced cost and improved product quality over batch processes currently implemented within biomanufacturing.

This IUK funded project focused on merging multiple downstream processing unit operations to operate as one uninterrupted unit, integrated with process analytical technologies for automated control.

Case Study

Smart Supply Chains for Pharmaceutical IndustryRE-configuring MEDIcines End-to-end Supply (REMEDIES) was a £23M AMSCI project, which developed smart packaging technologies that enabled product tracking, condition & compliance monitoring and patient engagement.

Outcomes and impact


• End - End Smart Pharma Supply Chain

• Real World Performance

Case Study

Smart Connected Supply ChainsSupply Chain Opportunity for Printable Electronics (SCOPE) was a £10M AMSCI project.

Outcomes and impact

• Developed new processes, equipment and applications in order to meet the growing demand for high volume (billions or even trillions) units incorporating various components, at low cost.

• Provided a technology platform to develop new, innovative and ultimately more complex

and novel functionalities and applications, build skills and capabilities and strengthen the UK supply-chain.

• Targeted multiple market verticals including smart packaging, logistics, pharmaceuticals, personal care consumer goods, smart credit cards/tickets, and homecare products.


Disease preventionand wellness

Wellness remains one of the world’s biggest and fast-growing industriesThe global wellness industry grew 12.8%from a $3.7 trillion market in 2015to $4.2 trillion in 2017.

Source: Global Wellness Institute

Disease prevention and wellness

• Rising costs of healthcare is placing burden on government budgets

• People living longer with a reduced health span

• Chronic diseases that could have been prevented through healthier lifestyle choices

• Disease prevention and healthier living is of greater importance

We can help you to realise your new products idea:

• Smart devices with embedded sensors and flexible electronics

• Self monitoring devices, lightweight wearables, smart clothing and devices for everyday assisted living

• Supplements, probiotics, ointments and nutraceuticals

Smart devices and nutraceuticals

• Design for Manufacturing, Product Prototyping, Wireless Connectivity, Testing, and Manufacturing Processes

• Integration of Flexible Electronics, microelectronics and physical, biological and biochemical sensors

Wellness devices and wearables

• Design, Development and Scale-Up of Manufacturing Processes for Supplements

• Optimisation of Product Formulation

Supplements and nutraceuticals

• Automation, Robotics, Digital Twin, AR/VR for Plant Operations and Connected Digital Supply Chains

Smart factory and supply chain

Case Study

Printed biosensors for urine dietary and disease analysisDevelopment of reproducible, point-of-care sensor systems. Using techniques that can be scaled-up to commercial manufacturing volumes

Outcomes and impact

• Developed ink formulations and high-throughput printing processes for four sensor systems, enabling new product development

• Produced ‘multiplexed’ sensors that permit analysis of complex, biological fluids

• Improved sensor signal intensity, reproducibility and clarity of signal, meeting the requirements of the technology and taking the product closer to market


Case Study

Behavioural Change

Outcomes and impact• Evidence helped Sweatcoin to be part of 2019

NHS Accelerator scheme.• Now have over 30m users worldwide.


Evaluating the impact of an incentives for exercise app.Sweatcoin converts smartphone recorded step count into a virtual currency which can be used to buy real products on the in-app marketplace.

Analysed 6000 users, 3-months prior to app usage and 6-months post.

Mean 19% increase in step-count linked to app use.

Case Study

Novel Sensor Development

Outcomes and impact

• We have shown that it is possible to detect and monitor glucose in sweat using enzyme based (glucose oxidase in our case) amperometric sensing.


mPatch: a wearable sensor for healthy living.mPatch: novel development of a device and assays of higher sensitivity and robustness.

We have demonstrated together with Industry, for the first time (patents pending), that it is possible to measure metabolites from sweat without any active sweat extraction mechanism.

Our device tested for glucose monitoring (BSREC) compares well with the semi-invasive commercial device Abbott Libre.

Digital manufacturing and Healthcare 4.0

Help you navigate and harness opportunities offered by digital technologies

In particular for:

• Design, prototyping, integration, validation, of smart wellness and medical devices, instruments and tools

• Automation of production lines and deployment of smart factory and operator solutions

• Development of solutions to enable connected supply chains

• Development of digital services and platforms for Healthcare 4.0

Healthcare 4.0 = Integrated Personalised Healthcare

Last Decade Current Decade Next Decade

Valu

e fo

r Cus

tom

er

Time

Services+ Medical Products

Differentiation by providing services to key stakeholders such as physicians,

patients and payers

Intelligence+ Services + Medical Products

Differentiation via intelligent solutionsfor evidence / outcome based health benefits

to demonstrate value to end users

Historic / Evidence Based Care• Sell Parts & Hardware• Consumables & Upgrades• Repairs & Maintenance Support• Leasing & Buying Support

Real-time Outcome Based Care• Product as a Service• Data as a Service• Platform as a Service• Managed Services

Predictive & Preventive Care• Insight as a Service• Automation as a Service• Robotics as a Service

Medical Platforms Medical Solutions

Artificial Intelligence

Augmented Reality

Robotics

Wearables / Biosensors

Big Data and Health Analytics

Medical ProductsDifferentiation solely through

product innovation

Internet of Medical Things

Parts, Hardware & Consumables

Repairs & Maintenance

Leasing & Buying Support

Digital Manufacturing and Healthcare Services

• Digital Design of Devices and Products

• Predictive Modelling, Simulation, Analytics and AI

• Digital Product Twin

• High-throughput Testing for product and process optimisation

Product Development

• Smart Connected Equipment andAsset Management

• Digital Twin

• Factory in a Box

• Automation, AI, Robotics

• AR/VR for Operations, Operator Training

• Predictive Maintenance

• Additive Manufacturing

• Advanced Process Control

Smart Factory

• Smart Tags

• Smart Packaging

• Real-time tracking

• Condition and Environmental Monitoring

• Product Security and Anti-tamperand Anti-Counterfeit

Connected Supply Chains

• Smart Devices/Tools for the Internet of Medical Thing, smart clinics and remote monitoring

• Cloud-based Platforms with Data Analytics and AI

• Safety and cyber-security

Healthcare 4.0

Case Study

Augmented making an impactFuturistic headsets programmed to enable skilled aerospace and automotive production line operatives to rapidly switch to the manufacture of 10,000 life-saving medical ventilators were rushed from the University of Sheffield Advanced Manufacturing Research Centre (AMRC) in Rotherham to sites across the UK last week at the same time as its recently opened R&D facility in North Wales was turned into a production facility for the devices.

Outcomes and impact

• Microsoft HoloLens headsets & PTC Expert Capture combined to deliver operator instructions.

• Ability to create and share training content with real time hands free communication to team leaders.

• System was scalable to allow for training & qualifying large numbers of operators across multiple sites.


https://www.amrc.co.uk/news/rising-to-the-challenge

Case Study

Automating social distancing Two fast-moving, agile robots named Madge and Bob have been racing around the Mercedes powertrain technology centre delivering every component to the Mercedes Formula 1 team manufacturing 10,000 breathing aid devices for Covid-19 patients, thanks to the University of Sheffield Advanced Manufacturing Research Centre (AMRC).

Outcomes and impact

• Social distancing through the removal of unnecessary operator travel and interaction.


https://www.amrc.co.uk/news/madge-and-bob-turn-on-the-speed-for-f1-team

Case Study

Simulating Safety – Airbus & AMRC CymruSix months after being hailed a ‘game changer’ for the North Wales economy, the University of Sheffield Advanced Manufacturing Research Centre (AMRC) Cymru is playing an essential role in an unfamiliar game, helping save lives as a production facility for thousands of vital medical ventilators.

Outcomes and impact

• Discrete Event Simulation (DES) set-up to simulating safe distancing of the workforce.

• What if scenarios to define the shift patterns and safe factory layout for ventilator production.

• Airbus/Siemens pop up factory was defined in advance to establish the most efficient use of equipment.


https://www.amrc.co.uk/news/from-game-changer-to-life-saver

Case Study Click here to find out more

Prime

Consortium

Enablers & support

Case Study

Smart Factory DemonstratorA Smart Factory demonstrator where visitors can experience the integration of digital technologies in a real factory setting.

Outcomes and impact

• Provides a fully operational representative manufacturing environment which creates a Digital Thread of data across key technologies such as PLM, ERP, MES, IoT and Analytics capabilities leveraging Cloud and On-Premise OT and IT software.

• Helps to de-risk technology by providing a test facility prior to deployment.

• An innovation sandpit to promote new solutions development and provides a learning environment to promote skills development.


Case Study

Digital Theatre DemonstratorA fully immersive augmented Operating Theatre environment with real-time 3D digital twin.

Outcomes and impact

The Digital Theatre consists of a physical (real) and virtual (digital twin) and focuses on:


• People and asset tracking

• Recording of clinical procedures

• Development of smart surgical tools and devices

• Advanced data visualization (AR/VR)

• Medical device prototyping

• Digital workflow

• Artificial Intelligence (AI) analysis

• Machine Learning (ML) analysis

Case Study

C3-Cloud: Managing Chronic Diseases

Outcomes and impact• Deployment of personalised care systems to primary and secondary care of pilot sites

in the UK, Sweden and Spain


Integrated Collaborative Care and Cure Cloud Architecture, addressing the needs of multi-morbidity and managing poly-pharmacy.Collaborative creation and execution of personalised care plans for multi-morbid patients through systematic and semi-automatic reconciliation of clinical guidelines.

Decision Support for risk prediction and stratification, recommendation reconciliation,poly-pharmacy management and goal setting.

Fusion of multimodal patient and provider data and seamless integration of existing information systems.

Active patient involvement and treatment adherence evaluation.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 689181

Case Study

Total Hip Arthroplasty Optimisation

Outcomes and impact

• Prototype device that can rapidly screen for high pelvic mobility in THR patients.

• 90% correlation with x-ray measures.


Personalised planning for Total Hip Replacement surgery.Total hip replacement (THR) is one of the most common and successful surgical procedure. But significant complications in 10%, often related to implant malposition.

Patients with a highly mobile pelvis increased risk of implant dislocation and excessive wear resulting in early failure.

Measuring functional pelvic tilt is a challenge and currently requires multiple x-ray images. This project has developed a portable, wearable sensor for measuring pelvic tilt in patients.

How you canwork with us

• Collaboration with one or more HVMC Centre, together with a larger consortium

• Projects initiate after completion of a detailed funding protocol

• We offer a bespoke service forbid development and grant landscape navigation

Fee forservice

Funded SME support

• Smaller projects may qualify for total funding status from regional programmes

• Regional and State-Aid limitations can apply to supporting SMEs

• Engagement via commercial assignment with one or more HVMC Centres

• Flexible scope and project size

• Rapid initiation of projects

• Can encompass a range of services including business and innovation support, consultancy, and lab-based projects

Collaborativeprojects

Offers flexibilityand speed

Best option for highly innovative projects you can’t fully fund yourself

Great mechanism for an initial engagement with us

Contact usTo discuss how we can work together to help your business, please contact:

A Name

[email protected]

0123 4567 8910

Accelerating innovation in the healthcare and wellness sectors

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