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Can period trackers support better healthcare?

By Amanda Shea, head of science at Clue

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When the pain and health concerns of women and people with cycles are still so often normalised or brushed off as imagined, period tracking is becoming an increasingly powerful tool for better, more personalised healthcare support.

Clue, together with the Bill and Melinda Gates Foundation, recently conducted a study looking into how self-tracked data in period tracking apps can support more accurate diagnoses and individualised management of conditions like heavy menstrual bleeding (HMB).

Estimated to impact around 30 per cent of women, HMB has long been difficult to diagnose, often going under-recognised.

This is thanks, at least in part, to the normalisation of pain and problem periods as something you “just have to live with”.

Different people may have vastly different understandings of what constitutes a heavy period – with personal bias and cultural norms coming into play.

Consider, for example, the perception of someone who comes from a family where heavy periods are considered the norm and complaints are considered an overreaction.

Such people may downplay their own experience and not be likely to seek help, or to even acknowledge their period as being heavy, despite having the clinical symptoms.

Where HMB was previously clinically defined as the loss of more than 80mL of blood in one menstrual period diagnostics have recently shifted toward a more holistic understanding of what makes a period “heavy”. And it’s much more than blood loss alone.

Many clinical organisations now define HMB as excessive menstrual blood loss that interferes with a person’s physical, social, emotional, or material quality of life.

This shift in definition was both necessary (anyone measured their menstrual blood loss lately?) and long overdue.

In one study, only 26 per cent of people who described their period as “heavy”, actually had blood loss higher than the 80 mL clinical norm.

Removing standardised clinical criteria for diagnosing conditions like HMB increases the need to more thoroughly understand individual experiences.

As a period tracking app with a large, diverse user base and unprecedented dataset, at Clue, we were interested in how self-tracked data could support more accurate diagnoses and personalised healthcare by informing individual assessments of HMB.

Our study compared the de-identified real-time tracked data of over 6500 consenting Clue users, to their responses to an online questionnaire which asked them about their last period.

We found that for those who reported having a heavy or very heavy period in the questionnaire, actual flow heaviness was not always the most influential factor.

Instead of just days of heavy flow, period “heaviness” was associated with a variety of additional factors including increased app-tracked period length, increased pain and other physical symptoms such as fatigue and digestive issues, as well as greater disruption of daily activities such as the ability to participate in sexual activity, social and leisure activities, school or work.

Notably, almost 20 per cent of respondents who stated that they had heavy or very heavy periods had not tracked any days of heavy flow, but did track period length and quality of life indicators such as pain and disruptions to daily life similar to those who had tracked heavy flow.

This reinforces why a personalised approach is needed for healthcare support, as the characteristics of individual definitions of “heavy menstrual bleeding” – while sharing some similarities – can vary considerably from person to person.

To support those who are experiencing disruptive menstrual periods or other reproductive health challenges, a holistic approach to care is essential.

Apps like Clue can facilitate quick and simple tracking of a variety of cycle-related experiences in real-time, including things like pain, sleep, mood, and energy.

Our study also found that those who experienced long periods were more likely to underestimate their number of bleeding days, even in their most recent periods, underlying another challenge for accurate diagnoses.

By removing the burden of having to accurately recall previous periods or subtle changes over time, one’s tracked period data can become a powerful, detailed health record – and the basis for more confidently self-advocating with your healthcare provider, through having a deeper understanding of your unique patterns and concerns.

User centric, personalised, digital healthcare is the next frontier. We’re just beginning to see what’s possible when self-tracking can help give women and people with cycles the self-knowledge, insight, and data to back up and validate experiences that have otherwise been invisible and hard to communicate and quantify to their healthcare providers.

 

Amanda Shea is the head of science at the Berlin-based period tracker app Clue.

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Could femtech tackle period poverty? Here’s what campaigners think

Women’s health campaigners have their say on period poverty after study unveils lack of access to menstrual products

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Period poverty, defined as a lack of access to menstrual products, hygiene facilities and education, affects more than 500 million women and girls globally every month.

While it impacts many on low income, researchers from the University of Southampton have looked at an often-forgotten group: homeless women.

The research, published last month, showed that homeless women experience practical challenges in managing menstruation, alongside feelings of embarrassment and shame, with many “making do” due to inadequate provision.

The review, the first to explore homeless women’s experiences of menstruation, concluded that it’s time to address the provision of menstrual health resources as a basic human right.

Femtech World sat down with charities and women’s health organisations to find out how policymakers and femtech organisations could tackle the issue.

Jennifer Gaines, manager of national engagement at Alliance for Period Supplies

Homeless individuals face unique challenges when it comes to managing their periods, including limited access to period supplies, adequate restroom facilities and stigma associated with managing menstruation.

The femtech industry has a significant role to play in addressing the menstrual needs of the most vulnerable populations, including homeless individuals, and developing unique solutions to the challenges faced, such as lack of access to clean facilities and products.

The industry could address the issue by educating the general public and policymakers, establishing donation initiatives to local organisations that distribute period products to homeless populations and investing in research initiatives to better understand the specific challenges faced by homeless individuals regarding menstruation and the lack of access to period products.

Organisations can also advocate for policy reform on local, state and national levels to address period poverty and homelessness.

In the United States, there are more than 70 million individuals, girls and people who menstruate between the ages of 12 to 44. Of these more than 70 million, one in six lives below the federal poverty line. That means there are millions of people who menstruate in our country who live in poverty and are unable to afford the material basic necessities they need to thrive.

People who live in poverty often face food insecurity, housing insecurity, transportation issues and other struggles every day. Period poverty is yet another obstacle that prevents people who menstruate from reaching their full potential.

Petchara Newson, business development coordinator at the period poverty charity Freedom4Girls

We wholeheartedly agree with the findings of the University of Southampton, which shed light on the urgent issue of period poverty among homeless women. This research reaffirms the observations we’ve made at Freedom4Girls, especially as the period poverty crisis escalates amidst the current recession.

To support homeless women effectively, it’s imperative to ensure they have access to safe and clean spaces where they can use menstrual products. Menstrual hygiene should be prioritised not only in spaces traditionally targeted towards women, like women’s refuges, but also in places where women experiencing poverty exist, such as homeless organisations or food banks.

Increasing representation of menstruators on the boards of diverse organisations and providing training to non-menstruators can help identify gaps in support for menstrual hygiene.

Organisations serving those in poverty should ensure they have clean and safe restrooms equipped with a range of free period products and proper waste disposal facilities.

Furthermore, when supporting homeless menstruators, it’s essential to provide a variety of free period products, including heavier flow options, as many experience heavy periods.

Manjit Gill, founder and CEO of the period charity Binti

In the femtech space, we have some amazing products to manage menstrual health but how much funding is provided for “women’s health?”

Menstrual matters have to include all facets of health which include options of products best suited to the needs of women be it disposable or reusable pads or tampons cups or pants.

The cost of living crisis means people can’t afford food but how many address the unaffordable cost of period products for women?

Period products mandated as essential products in everyday life and menstruation becoming a word that is not shrouded in shame is the only way we can create a world where all women have menstrual dignity.

Terri Harris, education and communication manager at Bloody Good Period

Nearly one and a half million people in the UK can’t currently afford period products, and for those who are unhoused or in unstable accommodation, the additional barriers to accessing and using period products are far worse.

Periods aren’t a luxury, they’re a necessity. Everyone should be able to access period products whenever they need them, for free.

At Bloody Good Period, we’re campaigning for period products to be freely available and accompanied by education, normalisation, and practical support. Without this, we cannot hope to achieve menstrual equity.

Laura Rathbone, founder of Sisters on the Streets

We witness first-hand how the lack of access to menstrual supplies among individuals experiencing homelessness perpetuates a cycle of disadvantage. Without adequate period products, people are not only forced to endure physical discomfort and health risks but also face significant barriers in accessing opportunities crucial for escaping homelessness.

Imagine someone missing out on housing, employment, or education opportunities simply because they bled through their only pair of pants just before a crucial job interview or apartment viewing, rendering them unable to attend.

Addressing menstrual equity is not just about hygiene; it’s about dignity, access to basic rights, and creating pathways to stability and independence for those most vulnerable in our society.

To receive the Femtech World newsletter, sign up here.

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The slippery slope of presumed consent in post-humous reproductive health cases

By Bethany Corbin, healthcare innovation and femtech attorney

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It sounds like something out of a sci-fi film: A young man, on the cusp of starting a family with his wife, suffers a serious accident that renders him brain dead.

His wife, longing for the family they never started, requests access to his post-humous sperm to become pregnant and build the family she was denied.

After a long and arduous battle with the court system, the wife is granted permission to use her dead husband’s sperm to create her family, even though her husband never stated his family-building preferences in a will or otherwise provided consent to the use of his sperm.

If the situation seems fantastical (and a bit scary), beware: This is a true and landmark case that has shifted the consent paradigm for reproductive health on its head in the UK.

While the Human Fertilisation and Embryology Act of 1990 (as amended in 2008) requires written, informed consent to the use of a person’s reproductive materials, the case of Y v A Healthcare NHS Trust [2018] EWCOP18 (affirmed by the Court of Protection in Re X (Catastrophic Injury: Collection and Storage of Sper) [2022] EWCOP 48) departed significantly from this requirement to allow “presumed consent” as an alternative to informed consent.

This trend by the UK courts does not align with the strict letter of the law and is more akin to an opt-out organ donation framework for reproductive health. It begs two questions: (1) What is really in the best interests of a patient who lacks capacity to procreate? (2) Should gametes be treated the same as all other organs?

These are heavy questions that have sparked global debate. On one end of the spectrum, a 2016 article published in the journal Reproductive Biomedicine & Society Online argues that gametes, similar to organs, are resources that should be considered for use after death, given their life-creating properties.

The authors contend that once an individual is dead, they no longer have a meaningful interest in the use of their reproductive material and post-humous conception should follow a framework of presumed consent.

The authors base their argument in large part on studies conducted showing that the majority of men support their partners accessing their sperm for post-humous conception.

On the other end of the spectrum, however, is the fundamental need to protect the best interests of the patient, who is no longer capable of understanding or consenting to the creation of life.

Numerous situations may arise where a partner seeks to exploit a vulnerable individual for their reproductive materials. For example, imagine the situation where a husband has repeatedly said “no” to creating a family. If he then suffers a life-threatening accident, his spouse could claim that he had agreed to start a family and that his consent should be presumed.

The same rationale could apply to an abusive boyfriend seeking to exploit his girlfriend’s reproductive materials and demanding the post-humous harvesting of her eggs to be used in the future. This creates an environment that can easily result in exploitation of incapacitated individuals who do not have the ability to defend their own interests.

The rights and wishes of the deceased must have meaning if we are to respect human autonomy. These individuals are vulnerable, unable to protect their own interests, and at the mercy of others who may try to exploit them.

This becomes particularly concerning when we add in the scenarios of abusive relationships, suicide, and reproductive coercion. If the law does not protect the rights of the vulnerable, who will? In essence, the trending case law prioritises the interests of the living over the rights of the dead.

Presumed consent for post-humous conception is an incredibly slippery slope. Reproductive material is fundamentally different from other organs in that it is not lifesaving, but rather life-creating. If we allow an individual’s partner or family to make their post-humous reproductive choices, where do we draw the line?

In the case of Y v A Healthcare NHS Trust, the court relied on circumstantial evidence to presume the husband’s consent – such as the early fertility treatments undertaken by the husband. But what about cases in which such evidence is fabricated or in which consent has been withdrawn prior to the accident?

The fact of the matter is, there will always be factual permutations and attempts by individuals to manipulate existing legal frameworks to obtain the outcome they want. It won’t always be clear what the deceased wanted or whether the evidence of their desires has been forged.

As a society, our laws have historically protected the most vulnerable. Any decision to depart from this history should be made by a body of elected representatives that can carefully consider the broader ethical implications of this decision and its downstream impacts, not the courts.

Bethany Corbin is a healthcare innovation and femtech attorney on a mission to help thought-leading companies revolutionise women’s health. Through her company, FemInnovation, Corbin partners with emerging companies at the forefront of healthcare transformation to ensure they are building robust, scalable, and legally compliant businesses focused on enhancing health equity. 

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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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