The future of women’s health is in collaboration

Abingdon’s Health’s manufacturing manager, Jessica Aird, takes a look at all things women’s health with a particular focus on how the organisation in which she operates so effectively – an expert lateral flow CRO & CDMO business –  works together to deliver innovation and change in this area on a daily basis.

On March 8, 2021, the government launched a call for evidence to inform the development of England’s first Women’s Health Strategy, with two main aims:

1. First, to improve the way in which the health and care system listens to women, and to reset our approach to women’s health by placing women’s voices at the centre of this work.
2. Second, to improve women’s health outcomes.

As part of this launch, the government called for organisations with expertise in women’s health to submit written evidence into the following:

• Current medicines and medical devices.
• Geographical differences in women’s life expectancy and access to services.

Women’s specific health can be categorised in two main stems of health needs: general and reproductive specific. The diagram below explores these two stems and how these needs change during the course of a woman’s life.

Two main stems of women’s health needs (Department of Health and Social Care, 2021)

Abingdon Health’s vision is to become the leading rapid test business globally and share our mission – to improve life by making rapid testing accessible to all – with all industries. This includes improvement to current women’s health testing solutions through the development and manufacture of new, innovative, and creative medical devices.

The role of Abingdon Health in the improvement of women’s health strategy does not just lie within the manufacturing process.

There are many supporting departments working in unison to ensure any devices which successfully enter the market are the best solution available for women to further improve their knowledge and understanding of their health and wellbeing.

R&D

Abingdon’s R&D team are either approached by commercial on behalf of a customer with a bespoke women’s health testing solution, or the idea comes from within the organisation.

The process of progressing the idea from a concept to small scale manufacture relies heavily on R&D. The team must develop the device with key focuses on:

• Selecting the most efficient and appreciate materials
• Testing for cross-reactivity
• Optimisation and repeatability of performance
• Scalability considerations are also considered at this stage.

Technical transfer

The key role of the technical transfer department is to take each R&D-proven small-scale manufacturable assay to a full-scale production batch; this could be up to 30,000 devices per batch run. This is achieved through the following processes:

• Understanding potential failure modes, risk to assay performance and what current controls are in place in order to mitigate the risks. This is done predominantly by the technical transfer team, but also reviewed and adjusted collaboratively through input of many departments, including production, quality control, quality assurance and technical specialists.
• Transferring the processes from small scale equipment to large production equipment within the production laboratories whilst understanding the how the process parameters must change to keep product performance optimised and results, sensitivity and specificity within range at scale.
• Robustness testing of assay capacity and the assay performance in terms of scaling up the batches. This is done in order to understand the limitations of an assay. Robustness testing typically includes studies of treated materials, stability on part-processed components and stacked tolerances to determine optimal performance going forward.

Regulatory

Product regulatory compliance plays a significant role in bringing the concept of a new product in women’s health to reality and onto the market as fully reproducible manufactured product.

The regulatory team are part of development of the new assay from the very beginning; this is crucial as it helps the team to understand the regulatory requirements and anticipate where potential Quality Assurance and Regulatory Affairs (QARA) issues may arise.

The implications of a non-conformance at any stage of product development can cause significant timing delays, product redesign requirements and increased costs, so it is essential for QARA functions to have input at all stages of development of a new product.

Regulatory approvals are the last step before product launch to market. Obtaining official approval for a product to go to market, particularly in the case of a medical device, requires immense planning with manufacturing, quality assurance and commercial to ensure the product to be launched is viable and has the best chance of success in its newly obtained distribution regions and channels.

Customer services and commercial

Keeping the customer intimately involved in the product development process is essential to successful project and product performance and launch onto market.

The commercial team and customer services functions work hand in hand with both the new product development internal project team members and customer stakeholders to ensure direct interaction between both parties is maintained and expectations are managed.

Ensuring customers sign off at project stage gates, review quality control data and approve operating procedures and product process parameters all require commercial and customer service organisation.

Production and shipping

Once the product is ready for launch, customer service work closely with our quality, regulatory and warehousing teams to ship products to customer on time and in full. This can involve booking shipments with couriers, completing the product release process, and managing customer expectations of timelines.

In summary, the future of women’s health is indeed in collaboration: working closely cross-departmentally to take a concept or idea through to developing a product ready for marketing which can improve women’s access to healthcare, all the way through the research and development to technical transfer and production, is critical to success.

Working collaboratively will ensure better access to healthcare for women and inspire others to come forward with innovative solutions to everyday issues in women’s healthcare today and throughout the course of our lives.

To find out more, visit abingdonhealth.com.