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Could 3D technology replace breast reconstruction post-mastectomy?

A growing number of women are choosing to wear prosthetics rather than undergoing an additional surgery to reconstruct their breasts after a mastectomy.

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At the end of 2020, 7.9 million women had been diagnosed with breast cancer over the previous five years, making it the most prevalent cancer globally.

About one in eight women are diagnosed with breast cancer during their lifetime. 

The best chance for a positive outcome in the case of breast cancer is a mastectomy, which is a surgical removal of one or both breasts.

For many women, the loss of one or both breasts to cancer can cause feelings of hopelessness, body incompleteness, social inconvenience, a lack of confidence and a loss of sensuality. 

A growing number of women are choosing to wear prosthetics rather than undergoing an additional surgery to reconstruct their breasts. This is where new technologies come in to help post-mastectomy cancer women.

Julien Montenero, a French prosthetist, created a personalised breast prothesis, identifying 3D technologies as the best to do so. 

A year ago Julien started working with Boreal, a technical consultancy service that introduced him to 3D scanners from Artec 3D.

Florian Goussu, sales technician at Boreal, explained: “With the use of 3d technology in reconstructive surgery, epithetists now have a range of digital tools such as Artec 3D scanners that allow them to quickly and efficiently duplicate limbs or organs. These operations give patients the courage and strength to face the world around them.”

More and more medical companies are putting high hopes in 3D scanning for prosthetics. Seen as the next revolution in medicine, 3D devices bring the next-gen practices and technologies to underprivileged families, those who suffered in conflict, or – like in this case – cancer survivors.

Montenero’s usual workflow with 3D scanners involves scanning a breast before the mastectomy, processing the 3D scan data to prepare a 3D model, and 3D printing a mold. From the mold, a prototype is created with the use of special medical silicone. 

After the mastectomy, the patient can use this prototype while waiting for the final prothesis to be designed, with the nipple (or freckles and birthmarks if needed) made to match the second breast. 

“The goal is to reach the same density as the other breast, to avoid any discomfort and imbalance,” said Montenero.

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The future of women’s health is in collaboration

By Jessica Aird, manufacturing manager at Abingdon Health

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Jessica Aird, manufacturing manager at Abingdon Health

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.

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The femtech founder’s stress toolkit: how to make wellbeing a non-negotiable

By Kate Hesk, founder and CPO at Cognomie

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Stress – as anyone in femtech will know – manifests in many forms. As humans, each of us has different triggers, vulnerabilities and tolerances to it.

And while many of us will claim to “thrive under stress” (hi A-types, I see you), we know that too much will flood our nervous systems, accelerate burnout, and ultimately, lead to longer-term health issues if left unchecked.

Recent HSE figures found that 51 per cent of the 1.8 million work-related illnesses in Great Britain are a result of stress, depression or anxiety. An estimated 17 million working days were lost due to work-related stress, depression, or anxiety in 2021/22.

As female founders, we’re excellent at investing our time and energy in the vital work of supporting our teams, building our businesses, keeping investors happy. Often taking on more stress as a result.

You know the saying “You can’t pour from an empty cup?” How can you manage stress levels as a female founder, doing All The Things, while staying replenished and in touch with your own wellbeing?

Perspective as a superpower

Harnessing your perspective as issues arise can help you create distance from stress – or stressful situations. Notice when it’s happening, pause and try to delineate your thoughts and response.

When you step back, and look inwards, you can acknowledge the situation rather than be consumed by it. Know you are not your thoughts.

Connection plays a huge part in perspective. Invest in connections with peers and likeminded founders to build community, support and accountability. The femtech community is a hugely supportive one – reach out, build those links.

Understand your stress

Where does your stress come from? Is it environmental – the expected pressures of building a business and all that comes with it? Or could it be physiological? For instance, could it be the reality of peri/ menopausal symptoms adding another layer of stress?

While femtech is a brilliant example of the strides made in the menopause conversation, we can’t underestimate how it impacts our emotional, mental and physical health. Investing in coaching and wellbeing support to create a personal plan is a powerful way to navigate this transitional time.

Seeking support as radical courage

You know the deal. As women, there’s a legacy of nurturing others while putting our own needs to the bottom of the list. Between team check-ins, investor updates, and life admin, it can feel uncomfortable to ask for something for yourself.

Years of coaching has taught me that overwhelm is a fast-track to burnout. And because it’s cumulative, it compounds everything we’re dealing with – breaking points can happen in the boardroom or the playground.

Stress is not a failing, it’s a normal part of a full life. Take courage in asking for help.

Build your own trusted support team. Engage coach or a thinking partner who is committed to holding space for quality conversations helping you support and expand your own self-awareness, understanding and personal development.

Come back to your values

Reconnecting with values is a huge part of the resilience work I do with clients. When stress escalates, we need to get back to our why, and refocus on our sense of purpose.

Start small, perhaps by setting a daily intention aligned to your values. Then build this into your working day. Ask: what do I want from this meeting? What can I bring to this conversation? What’s the one thing I need to accomplish today?

Break it down into micro-steps. What’s the next positive step I can take to bring me back to my goals?

Anchor into your own wellbeing

Making wellbeing a non-negotiable can be one of the most powerful things you can do – especially as a femtech founder.

Identify your personal wellbeing pillars – hydration, meditation, 10k steps, a weekly yoga class, 9pm bedtimes – with the knowledge these will vary from season to season.

Heading into summer, I’m committing to more white space in my day, building in thinking and creative time. Choose what works for you. Attend to it daily.

Embodying wellbeing as a femtech founder shouldn’t be considered a privilege; it’s neither frivolous or a nice to have. It’s how we shape new possibilities for what we’re building with our companies, helping us all to be more authentic and whole in our work.

This isn’t about adding yet another “to do” to the list. It’s how you access powerful resources to support you through the sticky, stressful moments that come with the founder territory.

A bonus is that modelling this behaviour for your team means you can give the people around you permission to do the same, and reset the culture around stress at work.

Kate Hesk is the founder and CPO at the HRtech platform Cognomie. Prior to Cognomie, Kate’s career spanned 15 years in leadership development and coaching consultancy after 12 years in management and leadership roles in the pharmaceutical and healthcare industry.

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Women’s health diagnostics: a market in the midst of transformation

By Nina Garrett, R&D director of Abingdon Health

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Nina Garrett, R&D director of Abingdon Health

The women’s health diagnostics market is huge. Recent estimates suggest it is worth over US$27b and is expected to grow to over US$50b by 2029.

A number of factors are driving this change notably innovation but also a growing demand for empowerment and the ability for women to manage their own health proactively.

As a contract developer and contract manufacturer of lateral flow rapid tests, Abingdon Health is at the forefront of these changes and Nina Garrett, R&D director of Abingdon Health plc, offers her insight into the female health lateral flow market and what is driving this change.

Did you know?

The first ever lateral flow tests launched commercially were pregnancy tests. They were urine tests that were launched in the late-80s by Unipath in the UK. What is interesting is that it has taken 30 years for the first ever saliva pregnancy test to be launched.

Abingdon Health is proud to be launching SalistickTM in the UK and Ireland on behalf of its Israeli health-tech partner Salignostics Limited.

SalistickTM is far more convenient and offers women an improved user-experience, with high accuracy for early pregnancy detection, by way of its revolutionary and patented saliva technology which allows for saliva to be used as a sample rather than the traditional urine tests. The simple saliva sample collection method enables the testing experience to be shared with a partner.

Pregnancy testing seems a hot bed of innovation currently with for example a number of companies developing reusable or recyclable pregnancy tests to reduce the environmental footprint.

One example is UK-based female-founded fertility wellness brand OVUM which has launched the UK’s first fully recyclable pregnancy test to reduce environmental impact.

It’s not just pregnancy. Innovation is happening across a range of female health areas

It’s not only the pregnancy test market that is seeing transformation. We are also seeing new innovative products being developed in a range of other areas of female health. For example, there are a range of diagnostic technology products being developed to support women through the menopause.

Innovative Swedish/UK female-led company Hormona’s mission is to provide women with the tools and information they need to take control of their hormone health.

Hormona is developing a first-of-its-kind system for weekly hormone monitoring to enable women to gain a greater understanding of their hormone health.

US-based Mira Care has also launched the Ovum Wand that “provides lab-accurate detection of the follicle-stimulating hormone (FSH) to predict menopause, evaluate fertility and assist in ovulation prediction”.

What is driving this change?

Within the lateral flow market the barriers to adoption of the technology have reduced significantly following the mass-use of lateral flow tests during COVID-19. Everyone is familiar with the technology and how to use it. This is now driving investment in innovation and female health diagnostics is seeing more that it’s fair share of this focus.

Also, the traditional healthcare models are no longer seen as “fit for purpose” (weeks for a GP appointment in the UK) and these models of care are increasingly being replaced by innovative technology-driven approaches which allow women to manage their health in their own time and in their own way.

We’re also seeing major retailers driving this change, within the UK leading retailers Boots and Superdrug both offering online menopause consultations and HRT treatment and monitoring and support.

Female empowerment is a major catalyst of change

However, within women’s health, there are other factors at play. One of the key drivers is the female empowerment which is driving change and a demand for more improved female health products.

This is being driven in part by female entrepreneurs looking to drive change, and it is encouraging to see these ventures being supported by a venture capital industry looking to support and invest in female-led companies. In addition, influencers are playing a key role in demanding change.

A great example is the work TV celebrity Davina McCall has done in helping women receive evidence-based information and treatment for their perimenopause and menopause.

In addition, female consumers are demanding better products that fit with their lifestyles and their needs. The gender health gap is now recognised as a key issue with both governments and NGOs looking to support innovation and products that close this gap with female health issues being brought to the top of the agenda.

A great start, but a long way to go

It is really encouraging to see the transformation of female diagnostics underway and within the lateral flow segment of the market we at Abingdon Health are actively involved in supporting the development and manufacturing of these products.

We are at the start of this paradigm shift, driven in part by innovation, lower barriers to adoption of this technology and female empowerment, and we believe this will see women increasingly proactive in taking greater control of their own health and wellbeing through the use of new diagnostic products.

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