Features
How digital twins are making clinical trials more inclusive

For decades, women have been excluded from clinical research, but AI-powered digital twinning is helping make trials safer, more inclusive, and more representative of real patients.
For Karen Yeo, innovation is not just about technology, but how it is used to change things for the better.
Yeo (pictured top left) is senior vice president of client and regulatory strategy at Certara, a biosimulation company focused on “transforming drug development for good”, which since 2014, has supported 90 per cent of novel FDA drug approvals.
Yeo and her team are using AI to make scientific research more inclusive by creating digital twins, matching the characteristics of a real patient with their digital counterpart to predict optimal dosing.
Women, particularly pregnant women, have typically been excluded from clinical trials for decades.
In 1977, following the thalidomide crisis of the 1950s and 1960s, the US FDA introduced guidelines preventing women of childbearing age from participating in many studies to avoid possible risks to pregnancies.
This was eventually lifted by the FDA in 1993, and the same year, the National Institutes of Health issued its Revitalisation Act, which required the inclusion of women and minorities in federally funded clinical research.
But while these changes opened the door to more representative trials, pregnant women continued to be excluded due to safety and ethical concerns.
“[Researchers] fear that exposing expectant mothers and their babies to experimental medicines could cause harm, so the default has been to leave them out,” Yeo tells Femtech World.
While “well-intentioned”, policies which prevented them from participating in clinical trials have contributed to “major gaps” in our understanding of how treatments work in women, and slowed down access to potentially life-saving treatments, leaving them facing “more risk, not less”, says Yeo.
“The result is a healthcare system where women are underserved,” she adds. “And both mothers and infants miss out on advances that could have been better supported through careful, inclusive trial design.”
The evidence gap
Excluding women from trials has delayed access to lifesaving therapies, and without the right evidence, clinicians often prescribe medications off-label during pregnancy with little understanding of how those drugs behave in women’s bodies.
For years, drug dosing was determined largely from small studies in men, even though women may metabolise and respond to drugs differently, Yeo explains.
“This gap has contributed to higher rates of adverse drug reactions in women and less clarity about the effectiveness of medicines in conditions unique to them, such as pregnancy and postpartum care,” she says.
Yeo points to the example of the antimalarial drug primaquine.
Pregnant and lactating women have typically been excluded from primaquine studies, leaving physicians without the right guidance.
Using biosimulation, Yeo and her team took the findings from a small clinical study conducted in breastfeeding women and were able to predict infant and newborn drug exposures through breast milk.
“The results provided evidence of safe dosing of primaquine in mothers, showing how model-informed methods can begin to close those gaps,” she adds.
Digital twins
By creating virtual representations of women’s physiology, including during pregnancy, biosimulation can predict how a drug will behave in these populations without exposing patients to any unnecessary risk.
This allows regulators and clinicians to access insights early and encourages trial sponsors to include women more confidently.
“Models can estimate how a drug transfers through breast milk, giving trial designers a foundation for guidance before patients are enrolled,” Yeo explains.
“This reduces ethical concerns by minimising direct risk while still advancing inclusive research.
“Over time, it shifts the approach from protecting women from research to protecting them through research.”
These digital twins start as virtual populations, representing typical physiological scenarios. But as more personalised clinical data become available in pregnant women, these can be replaced by digital twins.
These are digital replicas of individual patients reflecting real-time individual physiology.
Yeo says these AI-powered digital twins can provide a safe way to generate evidence in individuals that are difficult to study directly, such as pregnant women with preeclampsia.
While no model has yet perfectly captured human biology, Yeo says biosimulation has advanced to a point where it can reflect many of the complexities of women’s health.
“Virtual populations can account for physiological changes during pregnancy, such as altered metabolism, which can affect the exposure of the drug across each of the trimesters,” she says.
“Rather than oversimplifying, they provide a framework that can help inform decision-making for clinicians.
“As real-world and clinical trial results with personalised data become increasingly available, virtual populations can evolve into more complex digital twins.”
“Safeguards start with data”
But as with any AI-driven technology, poorly designed models or those that rely on narrow datasets risk reinforcing existing biases, rather than correcting them.
Yeo says “safeguards start with data”.
Certara emphasises reproducibility and clear documentation, allowing every assumption to be reviewed, and works closely with regulators, clinicians, and patient advocates.
“Trust grows through representation and openness,” she continues.
“Patients need to see that the data behind digital twins includes people like them, and that models continue to be refined with clinical and real-world evidence.
“Clear communication about how the models work and why they matter helps show that these tools are designed with patients in mind.
“By involving women directly, researchers can ensure the models address concerns that matter most, from pregnancy safety to postpartum care.
“When women see that their priorities influence science, they are more likely to trust and benefit from it.”
Accelerating innovation
Having more inclusive datasets will also accelerate innovation in femtech, ensuring developers design new diagnostic tools and therapies for women’s health based on representative science, while data and insights collected through biosimulation can potentially shorten the timeline to regulatory approval.
“Femtech innovation depends on evidence that reflects women’s realities,” says Yeo.
“Digital twins make this possible by generating early data where traditional studies fall short.”
According to Yeo, AI is already having an impact on diversity in clinical trials, with regulators encouraging trial designs that use biosimulation to fill data gaps.
She believes digital twins could become a standard part of trial planning to ensure underrepresented groups are included within the next five years.
“Inclusivity will take time, but the momentum is here. Each step toward more representative datasets and more confident dosing guidance brings us closer to equitable clinical research.”
So what does success look like? That depends on the stakeholder, says Yeo.
For Yeo and her team, it’s being able to generate virtual subjects that reflect the characteristics of the patients receiving the medicine, giving a more realistic view of how therapies perform in practice.
For regulators, it’s the ability to approve drugs with confidence that dosing and safety information work across diverse groups.
And for patients, it is the assurance that the evidence was generated with their needs in mind.
“Success is not about technology alone,” adds Yeo.
“But about the trust and outcomes it creates for people who were once excluded.”
Features
Gender gap in treatment persists even when men and women have same condition

Women with the same medical conditions as men were less likely to receive the same treatment across several specialties, a global research review found.
The review found differences in care for conditions including cardiovascular disease, kidney disease and Parkinson’s, with women less likely to receive some active treatments.
Of 38 studies analysed, 33 found women were less likely than men to be offered active treatment.
Researchers at the University of St Andrews found women with myocardial infarction, heart failure or an irregular heartbeat were more likely to receive medication, while men were more likely to undergo coronary bypass surgery, stenting or other surgical treatment.
Women were also less likely to be prescribed statins.
Men with Parkinson’s were more likely to be referred for deep brain stimulation.
Men with liver failure were more likely to receive a transplant, while women with kidney disease requiring dialysis were less likely to receive permanent access and spent longer using a catheter.
Women were also less likely to receive opioids for pain management.
The researchers found no significant difference between women and men in treatment for stroke or diabetes, while women were more likely to receive treatment for dementia.
None of the studies identified clinical guidelines recommending different treatment based on sex.
Researchers said this suggested the differences could not be explained by the need for different clinical approaches to women’s health.
Dr Andrew O’Malley, who co-led the study, said: “For clinicians, the findings are a prompt to check whether treatment is being offered on clinical grounds rather than assumption.”
He said studies showed doctors more often attributed women’s symptoms to anxiety and made more diagnostic errors with female patients, even when test results were positive.
Dr Miriam Veenhuizen, honorary lecturer in the School of Medicine at St Andrews, said: “While the direction of the findings was not a surprise, the consistency was. The same pattern appeared in cardiology, surgery, transplant medicine and emergency care, and it survived statistical adjustment in most studies.”
News
Far from ‘boxed in’: The innovative design transforming at-home testing

Alexander Parker is head of wellness at packaging design and manufacturing company, Burgopak.
Burgopak is a world leader in design innovation, with a 25-year-history spanning entertainment, consumer tech and now health diagnostics, including an expanding range of at-home hormone and fertility testing kits.
We speak to Alexander to discover what goes into designing robust, functional but engaging packaging and the sometimes surprising considerations that can make or break a product.
Hi Alexander. Please tell us about your role at Burgopak.
My role is about driving our growth and direction in the healthcare and wellness space, which in practice means everything from packaging to client engagement, to partnerships, to developing the team.
I also sit on the company management committee and help manage our IP portfolio.
Before stepping into this role, I spent 20 years as a designer, 15 of them as head of design – so I bring a hands-on understanding of what it takes to deliver great packaging.
At-home test kits require the user to perform a medical procedure alone, without professional support.
How does that inform your design approach?
It’s a key pillar of a project, heavily influenced by the product and its intended use.
In the case of a test kit being used to collect a sample specimen and return it to a lab, there’s often plenty of opportunity for packaging to help or hinder the process and experience.
There are layers to effective packaging.
● Structure – Physical interventions through the packaging.
● Artwork – The visual identity, messaging and instructions across the pack and instructions for use.
● Signalling – Sometimes-undervalued but what signals are communicated through the packaging – how this makes the user feel about the product, the company behind it and the task at hand.
Careful design of the instructions for use is universally appreciated and often a regulatory requirement.
However, the pack structure and artwork should also work together to communicate a clear user journey.
This could include presenting components in the order they’re used, aligning the pack layout with the IFU steps (Prepare>Test>Return), making the IFU immediately visible as a hero component.
We can also introduce physical aids, like collection tube stands, to help during the sampling process.
The packaging is often used in the return of the sample to a lab so this needs to be considered and intuitively designed.
The structure, materials and artwork are all communicating something to the user.
You want to reassure the user by signalling care, efficacy, trust and in the case of a paid product, value.
In your mind, compare these two pack examples.
One a simple carton with a sea of components loosely filled and rattling around inside. Poor quality print and seemingly damaged in the post.
Contrast that with a suitably robust piece of packaging, with the components arranged and labelled into steps 1, 2, 3.
They might both work, but you can imagine the second building a reassured user experience.
How often do you encounter brands that haven’t thought about the emotional and potentially anxiety-inducing moment of opening a testing kit, and what’s the first thing you fix?
Thankfully it’s not too often, in our case at least.
I think we tend to attract customers who sense there’s more to packaging than just being a container or functionally driven.
The start of a project for us is building a brief with the customer and aligning on values for the packaging – what we want people to feel when opening or using it – as well as defining the technical requirements.
So, if there’s going to be an early fix it’ll probably be here, establishing the emotional intent.
How has the rise in social media ‘unboxing’ videos and product reviews changed what you do?
Is there a tension between designing for social media shareability and designing for the privacy women often want around health testing?
I don’t think there has to be a tension, provided everyone is clear on what the goals of the packaging are, and they are aligned with the product type and its use.
We can’t influence the results of a test or the positive or negative emotional significance it has in someone’s life.
What we can do is design packaging that offers the best possible user experience.
If there’s a shareable moment at the end, packaging might be a prop within a photo or video. But equally it might be a very private experience.
If it’s a test offering a diagnosis or insights into a health condition – you can conceive of a range of emotional outcomes. As you could imagine for certain fertility products too.
The design needs to acknowledge all these possibilities in its structural design, visual identity and the signals they communicate.
For women using a fertility or hormone test, perceived quality signals trust.
How do you stop sustainable choices from reading as cheap?
Do the essentials well, look for small interventions that add value and use attention to detail to signal that the care taken over the packaging, and sustainability, extends to the user.
Material choice is incredibly important.
In the case of paperboard quality can be a spectrum so it’s important to take the time to find and qualify the right one.
One that offers the necessary performance characteristics, is verifiably from responsibly managed forests such as through FSC/PEFC, and from a mill whose activities are aligned with your sustainability targets.
Take care over the design of each touch point and detail. A fitment that holds a device should neatly cradle it. A closure should be intuitive to open and work every time.
If the pack is meant to stand up, then the proportions should be optimised to facilitate that. It’s attention to the details that’s important.
Print quality will have a big impact on perception, not just the messaging or visual identity it renders. If the print quality is poor, then it devalues the product.
Doing it well doesn’t mean using material resources – it’s careful vendor selection and quality assurance.
For some responsible premiumisation you can introduce embossing or debossing details to the artwork, a tactile three-dimensional finish.
This details-led approach is valuable across all packaging but if sustainability is driving a reduction to the essentials, then there is a heightened importance to the execution of what is left.
As at-home health testing moves into NHS and public health contexts, what does good packaging look like when the brief is scale and cost rather than aspiration?
Scale and cost often feature very heavily in the success of projects outside of these settings, so there are parallels between the public and private, but with greater imperative to strip things back.
What is important to understand is success is not a piece of packaging in isolation. It’s efficiency, kitting, quality, distribution, tracking, data management across all activities and partners. Packaging is one part of the bigger picture.
Central to all of this is the need for it to reliably and consistently encourage the correct use of the kit through structure, artwork and instructions.
It is materially efficient and from a robust agile supply chain.
Assembly and kitting might be automated so it will be designed for those production lines or in conjunction with the equipment development.
It is compliant with all transport regulations and the most cost-efficient postal streams to the patient and from them back to the lab.
So, what does good packaging look like? It’s the design that efficiently offers the best patient user experience through a robust, reliable, scalable supply chain.
How do you make the business case for investing in packaging design before the product itself is ready to market?
There’s an opportunity cost.
Packaging has the potential to be a valuable asset when someone invests time and resources into coherent design and development. By starting too late or under resourcing the process you risk having packaging that’s a commercial pain point.
At the earliest opportunity, you at least want to be selecting your packaging partners and have a clear understanding of the development timeline and milestones – structural design, prototyping, stakeholder feedback, artwork/labelling development, regulatory milestones, transit testing, stability testing, wetproofing, manufacturing, delivery.
You must complete these steps before your product can go to market.
What’s the cost to you of delaying launch because you didn’t get packaging underway sooner?
You need to spend time creating packaging that elevates your brand and is a marketing asset that works across ecommerce, retail, advertising, social media.
Engage with the other supply chain stakeholders.
One example would be involving kitting partners in the process to validate and input on packaging improvements. If it’s expensive to kit, your cost of goods go up and if it’s slow to kit you might not have a scalable solution.
You may also find packaging insights influence product decisions.
If you are defining components for a test kit, factor in that larger devices might in turn increase pack size and eventually incur higher shipping costs.
You might work with a device manufacturer on how a USB cable is wound so the packaging volume can be decreased – another potential packaging and shipping cost reduction.
Transit testing and design improvements ensure that products arrive in acceptable condition – reducing costs associated with replacements, damaged reputation and potentially the loss of repeat purchases.
Packaging done well is that opportunity realised – it’s value demonstrated across sales, marketing and operations.
For a founding team approaching a packaging partner for the first time, what does a genuinely useful brief contain, what do most brands leave out, and how much does coming in underprepared add to the timeline and cost?
At Burgopak we build a brief together with the customer and that usually happens in a few stages.
The initial conversation is a chance to learn more about each other, make sure we’re a good fit for one another and the project.
We like to learn more about you, your product, how it’s used and some headline information around timelines, volumes, budget, your packaging ambitions and likes/dislikes.
We explain what we do and how we typically work. This really is the kick-off point – the goal at the end of this stage is being excited to be working together on a project that looks technically and commercially feasible.
In the next stage we build-out a brief capturing the technical and brand-led requirements of the packaging.
It will cover product details, brand & experience, sales & delivery channels, fulfilment and distribution, budget and timelines, compliance and regulations.
The exact questions will vary by product and project, but they span those areas.
From this we can build the project plan – and this might involve working towards answers that aren’t yet defined.
It seems obvious, but knowing exactly what needs to be packaged is fundamental – the product, peripherals – and this can be one of the common missing puzzle pieces.
You can design a container to hold ‘something’.
But when you know exactly what the product is – its size, shape, weight, how it’s used – you can design a piece of packaging that is maximally efficient and effective in elevating the total product experience.
The risk to a successful project is not so much under preparedness at the start – we’re here to help build the brief and a realistic project plan – it’s a loss of momentum through the process.
The packager and the client must work together.
We can be very efficient and agile in doing the work but there’s also the responsibility from the client to keep momentum through rounds of feedback, coordinating product samples or technical drawings and so on.
If there’s a finite timeline and repeated delays within it there can come a crunch point – when delivery dates are pushed out or potentially avoidable compromises made.
Come prepared to collaborate on the brief – but know that the founding teams who get the best outcomes are the ones who stay engaged and keep momentum through the whole process, not just the kick-off.
Learn more about Burgopak at burgopak.com
Features
Elation Health acquires EHR startup Aster

Elation Health has acquired Aster, a women’s health EHR startup created by sisters Fifi Kara and Dr Lailah Kara-Newton.
The deal, announced on 3 June 2026, will see Aster’s team join Elation Health as the company expands development of what it describes as the first agentic operating system for primary care.
An EHR, or electronic health record, is a digital system used by healthcare providers to store and manage patient information.
Aster was founded by Kara and Kara-Newton as an AI-native EHR platform for women’s health providers.
Elation Health said the acquisition would allow Aster to learn from its expertise in AI agents and support development of its agentic operating system for primary care.
Kyna Fong, co-founder and chief executive of Elation Health, said: “The Aster team impressed us with their vision and creative inventions to support independent practices.”
Fong said Elation, like Aster, was founded by siblings who wanted to change the healthcare system.
She added: “That shared north star means they understand what we’re building and why it matters. It was clear right away they would significantly add to our capabilities.”
Kara has spent 10 years creating consumer and business-to-business products across the UK, Europe and the US, and recently supported Meta’s Health & Fitness team, according to Aster’s website.
Kara-Newton previously worked as a hospital doctor in the NHS across medical and surgical specialties, including breast surgery, general surgery, emergency medicine and obstetrics and gynaecology.
Aster launched in 2023 after raising US$2.8m from Zeal Capital Partners, Cornerstone Ventures, Octopus Ventures and others.
Kara, Kara-Newton and Aster’s chief technology officer, Nacho Vazquez, will all join Elation.
Kara said: “From the moment we met Kyna Fong, Ashley Rogers, and the Elation leadership team, it was clear we were aligned on what matters most: that clinicians deserve truly incredible software that brings joy back to their practice. Together, we can now bring that vision to millions of primary care patients across the country.”
The sisters said their work was shaped by Kara-Newton’s first pregnancy, when undiagnosed pre-eclampsia led to an emergency caesarean section and neonatal intensive care admission for her son.
The founders said they wanted to build technology that could help prevent similar outcomes for other women.
The acquisition comes amid continued concern over maternal health inequalities in the US.
In the US, Black maternal mortality remains alarmingly high, with rates nearly double those of white women, and experts point to unequal access to care, implicit bias and fragmented approaches to care.
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