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Case Study

MTC support BG Research’s manufacturing development journey, helping to save lives with rapid “At Patient Testing” MedTech device

Business challenge

  • Growth & Scaling

  • Product Innovation

Sector

  • SME

Technology or capability

  • Product Design

  • Additive Manufacturing

  • Industrial Transformation

BG research have developed a unique technology process that enables their device “CENOS” to carry out high sensitivity RT-qPCR diagnostic testing direct from almost any crude sample medium (including whole unprocessed blood) anywhere in the world without the need for expert personnel, lab facilities or equipment in under 30 minutes. The system is designed to be portable with the ability to rapidly diagnose patients and enable early detection to identify the correct treatment. Pandemic preparedness can be done through a proactive approach by monitoring and identifying dangerous diseases before they escalate into epidemics and pandemics.

The West Midlands Health Tech Innovation Accelerator programme has enabled our team to provide a really impactful bespoke support package for BG Research while also impacting the region’s supply chain. BG Research openness and willingness to utilise our expertise enabled our engineers to become part of the team and work collaboratively in an accelerated manner. We are looking forward to nurture accelerated growth for BG Research and the very capable supply chain companies in the West Midlands.

Miguel Fernandez-Vicente, WMHTIA programme technical lead – MTC
 

Project Challenges

On their journey to market, BG research had the technology defined but needed engineering experience to develop critical components and subsystems of their product for scaling up manufacturing. They needed a design that could be produced initially at low volumes for usability testing, but that would be suitable with minimal amends to scale up to higher volumes in the future. They requested support to address this challenge to the West Midlands HealthTech Innovation Accelerator (WMHTIA), a regional programme uniting 21 partners across academia, industry and NHS to provide specialist support in developing tomorrow’s ground-breaking Health Tech solutions. The WMHTIA is funded by DSIT, Innovate UK and the West Midlands Combined Authority.  MTC’s skills and expertise were identified as the most suitable within the WMHTIA consortium to address those challenges and help BG Research accelerate their development.

As a consortium partner of the WMHTIA, MTC were approached to review the existing design and identify areas that require amends to make them suitable for injection moulding and laser cutting, due to the ability of these processes to produce parts at a faster rate and lower cost, as well as help reduce the volume of material within the parts.

A major challenge was the different design mindset required as the current prototype was designed with additive manufacturing in mind, allowing for complex structures and design freedom. The redesign focused on injection moulding and laser cutting as the main manufacturing methods, for which complexity should be reduced to ensure manufacturability and cost reduction.

Due to the complexity of the compact CENOS device, MTC was required to understand the device thoroughly, to interpret the parts intended functionality and ensure any amends to make the part more appropriate for mass manufacture did not affect its functionality.

For the amended parts, an overview of the UK supply chain to identify manufacturers and suppliers was also required to create a pathway to manufacture for BG research, identifying a supply chain local to their West Midlands, in line with the WMHTIA objectives.

MTC's Solution

MTC put together a dedicated delivery team, which followed MTC’s design for X structured approach to tackle this challenge, starting by holding a design discovery workshop to discuss and understand the current design challenges of the existing CENOS system. This workshop enables a holistic identification of technical, business and user requirements and opportunities.

The MTC team reviewed the existing bill of materials (BoM) for the CENOS, identifying 36 parts that required review. After the data gathering and definition, the team moved to the Analyse and Improve step of the design for X approach, highlighting amendments required and identifying opportunities for injection moulding and laser cutting. MTC then took these amendments and redesigned many of the internal and external polymer components to reflect these, implementing or recommending changes covering considerations such as draft angle, chamfers/fillets, tool design, material reduction, ribs, bosses and other best practices. The changes were verified both digitally through tools like draft analysis and physically via prototype parts, ensuring suitability for the manufacturing method identified and fit with the other assembly components. For this purpose, a systematic analysis and description of the assembly steps was performed to identify the quality of finish & fit, identification of interferences and ease of assembly assessment. To enable user perception testing by BG research, the MTC team extended the scope producing two external cases of different colour schemes to display different aesthetics.  

Alongside the component re-design a supply chain study was created to define a pathway for the CENOS device to be manufactured in the UK. The system was broken down into material composition and methods of manufacture to establish the supply chain needs. From this, several UK-based suppliers were evaluated using criteria to help establish a secure supply chain for the medical application. Evaluating the capability, production volume and lead times of suppliers were a critical part of the project as this influenced the design in terms of what is possible. 

After engaging with the staff at MTC it became clear that the deep expertise that is embedded within MTC (knowledge, staff and processes/equipment) would be critical to BG Research’s journey to release of a qualified product at scale. We have since worked together to begin to realise the objectives and the MTC’s willingness to engage and work with us proactively has been a critical factor in getting product to release far sooner than originally hoped for

Nelson Nazareth – Managing Director, BG Research 
 

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The Outcome

With the support of BG Research, MTC created new CAD models containing the necessary detail to allow for injection moulding and laser cutting and to demonstrate the feasibility of manufacture. In total, 104 changes to the CAD model were made or recommended, with 10 external and 26 internal parts impacted by these changes.

From the supply chain exercise, the top three suppliers for each method of manufacture were ranked based on the criteria and a production timeline was outlined for both veterinary and human applications of the CENOS.

Following the work completed within this project, BG Research and MTC are looking forward to repeated feasibility testing of the parts which will confirm if the design changes impact the performance or function of the CENOS. Also looking to the future, a number of parts have been identified that would require further work to be optimised for mass manufacture, including a complete redesign for the casing solution as opposed to the current frame and panel design.

Benefits to the Client

This project has helped BG Research have several components of their device ready for mass manufacture while identifying opportunities to further evolution. Many of these modifications can be made easily without large changes to the component, enabling an easy adoption of the improvements by BG Research.

From the supply chain exercise, prioritising a UK-based supply chain will help to reduce expected lead times for production, as well as introducing BG Research to potential suppliers and development opportunities locally.

In summary, this project developed under the WMTHIA has helped BG research derisk and accelerate their journey to market, setting the groundwork for their growth, as well as impacting positively the West Midlands manufacturing supply chain. MTC and BG research are keen to continue the collaboration, fostering the region’s Health Tech sector.

It has been incredible to support BG Research throughout their journey from discovery to the creation of new prototype designs, knowing the significant impact this product will have. Collaborating with Nelson and witnessing his ambition and aspirations for the CENOS-1 system has been a privilege. Observing its progression towards market readiness has been exciting. The CENOS-1 will introduce new capabilities to the medical field. Leveraging our expert knowledge and understanding of Design for Manufacture and Supply Chain research, we’ve been able to dig deep into the intricacies of their design and deliver a comprehensive project.

Matthew Wood, Project technical Lead – MTC
 

100
Design changes made to improve the fit, function and assembly of the devic
30 mins
From sample to receive a test result
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