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IVF in transition: 2025 realities and what device manufacturers must do now

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FinDBest IVF is a global B2B platform that connects manufacturers of fertility and reproductive health devices with IVF-specialist distributors in over 150 countries. We simplify global expansion, regulatory pathway planning, and distributor onboarding.

Each year, the European Society of Human Reproduction and Embryology (ESHRE) Congress reveals not just clinical updates, but also clear signals about where the IVF market is heading.

In 2025, Circular Communications compiled a focused commercial and product roadmap briefing from the event, kindly shared recently by Dr Georg Griesinger on Linkedin.

What follows is a practical breakdown of their insights—designed for medical device manufacturers and clinical users who need to make fast, evidence-based business and product decisions:

The Six Shifts Reshaping IVF

The IVF landscape in 2025 is not simply evolving—it is undergoing structural change.

Six key forces are reshaping how medical devices are adopted, evaluated, and purchased. Manufacturers who adapt early will find more predictable paths to market.

Those who do not risk falling behind as clinics tighten their criteria.

Cost pressures are now the central constraint

IVF remains financially inaccessible for large segments of the population.

In many countries, patients are still paying out of pocket.

The result is a growing preference for solutions designed around total cost of ownership (TCO).

That means not just upfront purchasing price/cost, but reusability, reliability, throughput, maintenance needs, and training time.

Products that align with capital expenditure (CAPEX) models and flexible subscriptions—especially those matched to clinic cash flow—are more likely to be adopted.

Growth in mature markets has flatlined

In many high-income countries, the number of IVF cycles per capita has plateaued.

For manufacturers, that means growth must now come from share gain or geographic expansion, particularly into fast-growing regions like Southeast Asia, the Middle East and North Africa (MENA), and Latin America.

But entering these markets successfully requires localising value propositions and working with distributors who understand IVF workflows and regulatory constraints.

Legal and ethical oversight is tightening

Questions about embryo selection, long-term storage, and artificial intelligence (AI) in diagnostics are under increased scrutiny.

For manufacturers, this raises the bar on traceability, audit readiness, and labeling compliance.

Products now need to include support for standard operating procedures (SOPs), as well as detailed logging and audit trails.

These are no longer differentiators—they are minimum requirements.

Patient experience has become a key decision factor

Clinics are under pressure to not only deliver outcomes but also reduce the emotional and cognitive burden on patients.

Devices that simplify communication, reduce the number of steps in a procedure, and help patients understand “what’s next” are increasingly favored.

Clear interfaces, intuitive indicators, and minimal user intervention all contribute to better adoption.

Clinic consolidation is shifting how buying decisions are made

Independent clinics are being replaced or absorbed by multi-site groups (Eg. US Fertility or IVIRMA, owned by KKR).

These groups prioritise enterprise-style purchasing: standardised protocols, centralised training, measurable return on investment (ROI), and clear service levels.

Manufacturers that can offer SOP kits, multi-site onboarding, and enterprise-level value metrics will have a distinct advantage.

Technology alone no longer drives differentiation

Automation, AI, microfluidics, smart incubation systems, and digital integration are becoming standard.

The key to winning adoption now lies in reproducibility, data quality, interoperability, and auditability—not just product specifications.

Clinics expect devices that integrate easily with their digital systems and produce consistent results across different settings.

Each of these shifts presents a challenge, but also a roadmap.

Cost, regulation, technology, and buyer behavior are all converging toward a more structured and evidence-driven IVF market.

Manufacturers who address these realities in their design, pricing, and commercial execution will be best positioned to scale.

Clinical and Technological Frontiers Highlighted at ESHRE 2025

Beyond the market dynamics, ESHRE 2025 spotlighted several areas of clinical innovation that are directly shaping device and diagnostics development.

These themes are not theoretical—they are influencing purchasing, adoption, and regulatory expectations now.

Ovarian stimulation protocols are being rethought As clinics aim for personalisation and patient comfort, the need for smarter diagnostics and more flexible drug delivery systems is growing.

Biomarkers that can predict ovarian reserve and treatment response are informing stimulation protocols, making room for devices that adapt to individual profiles.

At the same time, there is a clear trend toward mild stimulation protocols, which create demand for less-invasive monitoring tools and delivery systems that are intuitive, reliable, and easy to train on.

The ongoing refinement of protocols using gonadotropin-releasing hormone (GnRH) antagonists reinforces the need for workflow-agnostic solutions—those that can fit into varying cycles without adding complexity.

Embryo selection is moving well beyond morphology

Objective, evidence-backed methods are replacing subjective scoring.

One major area of interest is AI-supported time-lapse imaging, which offers the potential to assess embryo viability in a more standardised and reproducible way.

However, clinics are demanding validated tools—classified appropriately as software as a medical device (SaMD), with integration capabilities and clean clinical evidence.

In parallel, non-invasive preimplantation genetic testing (niPGT) is gaining momentum.

Media capable of capturing cell-free DNA (cfDNA), paired with ultra-sensitive genetic testing platforms, could redefine embryo selection workflows.

This is not a future trend—it’s a present R&D priority.

Manufacturers need to plan both the evidence and regulatory strategy from the outset.

Metabolomics and biomarker analysis of culture media are also being explored, particularly where kits can offer clear utility and fit easily into existing lab infrastructure.

Implantation remains a key bottleneck

Even with viable embryos, successful transfer remains challenging.

There is growing interest in non-invasive endometrial diagnostics that can assess uterine receptivity without disrupting workflow.

The market demands tools that are specific, reproducible, and easy to use.

Meanwhile, catheter design continues to influence both outcomes and patient experience.

Ergonomics, atraumatic placement, and consistent delivery are still core drivers of successful transfers.

While less discussed in marketing, this area remains a top priority for clinical users and therefore deserves more innovation attention.

Taken together, these frontiers point toward a product development path that favors integration over novelty, reproducibility over experimentation, and real-world usability over theoretical performance.

It is not just what your device does—it is how it fits into the day-to-day life of clinics under pressure.

Regulatory and Market Access: Build It In, Not On

Global regulatory expectations are rising, and shortcuts are closing.

Product teams can no longer afford to treat compliance as a post-development task. It must be embedded from Day 0.

For software and AI-based tools, classification is tightening across the United States, European Union, and China.

This means developers must create full validation plans early, align endpoints with regulatory expectations, and document cybersecurity and data governance practices before launch.

Post-market surveillance and post-market clinical follow-up are not optional; they need to be built into the development process.

Culture media and reagent products are under increased scrutiny from regulations like the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Manufacturers must establish robust quality systems, ensure all labeling is complete and language-appropriate, and be ready to implement unique device identification requirements in every target market.

For connected lab devices, regulatory bodies expect more than just functionality.

They now require detailed documentation of data interoperability, security protocols, and integration capabilities.

Manufacturers should design clean application programming interfaces (APIs) and seamless connectors for hospital and laboratory data systems to make compliance easier—not harder—for clinics.

A practical checklist for manufacturers:

  • Confirm software classification and plan validation early for each market.
  • Create templates for traceability, labeling, audit logs, and PMS/PMCF.
  • Implement cybersecurity and data protection frameworks from Day 0.
  • Ensure unique device identification (UDI) compliance for each geography.
  • Offer clear integration documents for lab systems (no assumptions).

Strategic Focus Areas for IVF Device and Diagnostics Manufacturers

  • Balance cost and innovation
    Demonstrate lower total cost of ownership through real-world data. Show how your product reduces maintenance, training time, or consumable use.
  • Support with evidence, not claims
    Build prospective, multi-site clinical studies. Prepare audit-ready documentation: instructions for use, labeling, traceability, and surveillance templates.
  • Integrate digital and physical
    Provide open, secure APIs. Ensure fast and simple onboarding for embryologists and nurses. Focus on reducing clicks, errors, and delays.
  • Refine embryo selection strategy
    Align product claims with validated inputs—whether AI models, cfDNA media, or metabolomic markers. Monitor data drift and revalidate regularly.
  • Improve uterine receptivity and transfer tools
    Support claims with performance data (e.g. time to placement, consistency). Offer quick training modules to accelerate adoption.
  • Embed regulatory design
    Maintain a live matrix of requirements per SKU and market. Don’t delay planning for UDI, cybersecurity, PMS/PMCF.
  • Sell to enterprise buyers
    Offer group-level SOP kits, ROI calculators, and centralised onboarding. Provide remote diagnostics and clear SLAs to reduce downtime.
  • Speed up market entry through smarter distribution
    Use IVF-experienced distributors with proven regulatory capabilities. Shorten time to first order by removing the guesswork.

Key Takeaways

  • Total cost of ownership is now the key metric—design around it.
  • Patient workflows and clinic processes must be simplified.
  • Reproducibility and integration matter more than specs.
  • Plan evidence generation around the claims you want to make.
  • Prepare for audits with full traceability and post-market tools.
  • Offer group-ready commercial packages for multi-site chains.
  • Match each market with a localised regulatory strategy.
  • Choose distributors who understand both IVF and compliance.

FinDBest IVF: Your Partner in Global Expansion

These insights from ESHRE 2025, as compiled by Circular Communications, offer a compelling glimpse into the future of fertility treatment.

For medical device manufacturers, these trends are direct signals for where to focus R&D, innovation, and market entry efforts.

At FinDBest IVF, we specialise in helping medical device manufacturers navigate the complex global regulatory landscape.

Whether you’re developing cutting-edge AI for embryo selection, next-generation culture media, or advanced cryopreservation devices, we can help you:

  • Find regulatory-savvy distributors and license holders.
  • Identify partners who understand country-specific timelines and dossier formats.
  • Expand globally, faster — with fewer surprises.

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UK reviews surrogacy firm over rejected insurance claims

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The UK government is reviewing a surrogacy firm after complaints that medical insurance claims involving surrogates in Mexico were rejected.

The Department of Health and Social Care (DHSC) is considering whether UK-based provider My Surrogacy Journey should remain listed on gov.uk as one of four domestic surrogacy agencies available to intended parents.

The review follows allegations concerning its Mexican sister company, where surrogates are based.

Health minister Diana Johnson said: “The department is looking into the allegations about My Surrogacy Journey.

“As part of that assessment, the department will consider whether it is appropriate for that company to remain on the gov.uk list of agencies.”

Emails sent by My Surrogacy Journey chief executive Michael Johnson-Ellis and seen by the Guardian suggest multiple surrogate women in Mexico had their insurance claims rejected.

The emails also suggest 300 couples using the company were moved to a new insurance provider because of the increased risk of claims being rejected.

Commercial surrogacy is banned in the UK, where only altruistic arrangements are permitted.

My Surrogacy Journey operates a not-for-profit UK branch alongside for-profit sister companies in Mexico and the US. All three companies have the same owners and chief executives.

The reported insurance issues relate to surrogacy arrangements in Mexico.

One couple told the Guardian they paid tens of thousands of pounds to cover medical costs after their surrogate had a hysterectomy during childbirth and an insurance claim was refused.

The Guardian said it understood that at least five sets of parents said they had to cover medical costs after insurance claims were rejected.

In an email to the couple whose surrogate underwent a hysterectomy, Johnson-Ellis wrote: “We have already told you that the insurance companies have been declining some of the claims and we are actively working with the broker to get this issue resolved but you should also consider that they may not be paid out and there is nothing we are able to do to change this …

“We appreciate this is not an insignificant sum but this genuinely is out of our control.”

Johnson-Ellis also said the company had switched insurance providers, writing: “We’re also managing this for 300 other journeys, which is a complex position to be in.”

Lawyers acting for My Surrogacy Journey said the company did not comment on individual cases, but that existing insurance policies were in place and claims continued to be accepted and processed.

They said the company understood that a small number of claims had been rejected and was supporting people seeking to resolve those claims with an insurer.

Under the surrogacy arrangements, intended parents are understood to be contractually required to cover medical costs not paid by an insurer.

The couple said they had been recommended the company’s Mexico option. Its website advertises that intended parents using the route can have a baby in “under 18 months”.

They said they were told the UK route could take up to five years and that the US option was much more expensive.

Lawyers for My Surrogacy Journey said prospective parents are given information about typical timelines, costs, legal frameworks and practical considerations, and that the 18-month timeframe is indicative only.

The couple said their surrogate developed placenta accreta, a serious condition in which the placenta attaches to the wall of the uterus.

Emails from Johnson-Ellis acknowledged that the insurance provider investigated the birth after the surrogate experienced health complications.

The parents are considering legal action, while the Guardian said it understood at least four other couples were reviewing their options.

Phil Brickell, MP for Bolton West, raised concerns in parliament about a separate couple who had used My Surrogacy Journey.

He said: “Two of my constituents recently travelled to Mexico, where their children were born by surrogacy.

“Those births were facilitated by a company called My Surrogacy Journey, which is listed on gov.uk.

“While in Mexico, they had repeated traumatic experiences with the company relating to issues including insurance for their children, accusations of bullying towards staff and repeated efforts to silence any constructive criticism.

“I understand that other members of this house have received similar complaints.”

Brickell called for My Surrogacy Journey to be removed from gov.uk pending a review by the Human Fertilisation and Embryology Authority.

Lawyers acting for My Surrogacy Journey said the company was communicating with DHSC and was confident any issues could be resolved.

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Spain football federation partnership to offer players egg-freezing and fertility treatment

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Spain’s football federation will offer national team players egg-freezing and fertility treatment through a clinic partnership running until 2029.

The agreement with the Tambre clinic in Madrid will give Spain’s World Cup winners more options to pursue motherhood when they feel the time is right.

The Royal Spanish Football Federation (RFEF) said the agreement covers all national team players, including the futsal team, as well as Primera Division referees and assistants and all other federation employees.

It is the latest policy introduced by the RFEF as it seeks to lead the way in work-life balance and maternity protection.

The federation has also introduced measures allowing players to travel with their children during major tournaments. The scheme was extended to the men’s team during their successful World Cup campaign in North America this past summer.

RFEF president Rafael Louzán said: “If Spain and its national teams are the best in the world on the pitch, they must also be the best in matters such as work-life balance.

“This is a new, comprehensive and pioneering benefit that extends to all federation employees. Today is a great day for the entire Spanish football family.”

The agreement followed a direct request from players after discussions with national team captains, including London City Lionesses midfielder Alexia Putellas.

Putellas told Spanish outlet El País: “As a group of captains, we had a concern — because experiencing a World Cup is vital for a player — regarding the difficulty of reconciling that with the desire to become a mother.”

“It’s a desire I didn’t originally have but developed some time ago.

“Thanks to the incredible work done by the federation, an agreement has been reached with a clinic allowing us to freeze our eggs while we are still active players, for as long as we wish.

“For me, this is a huge step forward; the federation understands that you are serving your country in a way that runs counter to your biological clock — that you can’t simply pause your career to become a mother because you need your body to do your job.”

The announcement follows Chelsea becoming the first Women’s Super League club to offer similar fertility treatment options to its players.

The move has also drawn criticism.

Spanish triple jumper Ana Peleteiro-Compaoré Brión said on Instagram: “The problem obviously isn’t freezing eggs.

“The problem is: why does the institution these women work for have an interest in financing them to delay their motherhood?

“And here there’s a problem that for me changes absolutely everything.

“Is this measure intended to make it easier for women to be mothers or is it intended to make it easier for them not to be while they’re playing?”

Spain are the current world champions in both the women’s and men’s games.

The women will attempt to defend their title at the 2027 World Cup in Brazil next summer.

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Paracetamol use may impact future fertility, studies suggest

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Paracetamol use in pregnancy was not linked to autism or ADHD, while separate research found reproductive differences in girls exposed before birth.

One study analysed health records from more than 120,000 children and found no increased risk of autism following prenatal paracetamol exposure.

A separate analysis of nearly 100,000 children also found no increased risk of ADHD among those born to mothers who used the painkiller during pregnancy.

Researchers from the Hong Kong Hospital Authority examined electronic health records covering pregnancies between January 2001 and December 2023.

The autism analysis included 124,333 children, who were nine years old on average and split almost evenly between males and females. There were 3,445 autism diagnoses, representing 2.8 per cent of the group.

The ADHD analysis involved 97,285 children, who were seven years old on average and also split evenly between males and females. There were 5,168 ADHD diagnoses, representing 5.3 per cent.

Women prescribed paracetamol during pregnancy were more likely to be older and have pre-existing conditions including psychiatric disorders, as well as reasons for taking the drug such as infection, fever or chronic pain.

No association was found between prenatal paracetamol exposure and either autism or ADHD.

The findings did not differ according to the trimester in which paracetamol was taken or whether use was intermittent or daily. Advanced maternal age, defined as pregnancy in women over 35, did not alter the findings.

The researchers wrote: “Paracetamol remains a safe and essential analgesic [pain reliever] and antipyretic [fever reducer] during pregnancy, whereas alternatives, such as NSAIDs and opioids carry well-documented risks.

“Unwarranted reluctance to use paracetamol could lead to undertreatment of pain and fever, or the use of more harmful alternatives, both posing risks to the pregnancy and developing fetus.”

The authors said women should assess paracetamol use with guidance from their doctor.

A separate study involving 685 pregnant women without pre-existing conditions and 302 infant daughters found associations between prenatal paracetamol exposure and differences in reproductive organs and hormone levels.

Researchers from Copenhagen University Hospital enrolled the women during their first trimester and assessed them during the first trimester, third trimester and again when their babies were three months old.

At around three months, infants experience a temporary rise in reproductive hormones sometimes called mini-puberty.

Pregnant participants completed questionnaires every two weeks about their use of pain medicines including paracetamol. Infant girls underwent ultrasound scans of their reproductive organs and blood tests to measure hormone levels.

Researchers also examined a separate group of 1,210 girls followed from infancy to adolescence whose mothers reported paracetamol use during the third trimester.

Three-month-old girls exposed to paracetamol before birth had an average 40 per cent smaller ovarian volume, 13 per cent smaller uterine volume and 23 per cent fewer ovarian follicles.

Girls exposed during the first trimester also had lower levels of Anti-Müllerian hormone, a marker of ovarian function.

Among the older girls, those exposed before birth were more likely to have smaller uteruses at puberty and smaller ovaries during their teenage years.

Dr Margit Bistrup Fischer, lead study author and postdoctoral researcher in the Department of Growth and Reproduction at Rigshospitalet hospital in Denmark, said: “Animal studies have demonstrated that impaired formation of ovarian follicles can lead to reduced fertility and earlier reproductive aging.

“Whether the differences observed in our study have implications for fertility and age at menopause in humans remains unknown and will require long-term follow-up of the girls in our cohort.”

She cautioned that women who had used paracetamol during pregnancy “should not be alarmed by our findings”, as the study found associations rather than direct causation and outcomes for individual women and children are unclear.

“Importantly, our study does not evaluate whether [acetaminophen] causes reproductive problems, nor does it provide evidence that prenatal exposure affects future fertility or age at menopause,” she said.

“Although we observed similar associations in an independent cohort, long-term follow-up is needed to determine whether these early-life differences have any clinical significance later in life.”

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