Diagnosis
IVF in transition: 2025 realities and what device manufacturers must do now
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.
Credits
- Original, full report by Circular Communications
- Shared on Linkedin by Georg Griesinger
Article produced in association with Spital Clinic
AMH has become one of the most-requested blood tests in private women’s health. The number it gives back is useful, but only when it is read in context.
AMH testing in the UK has gone mainstream over the past few years. Home-testing kits sell it as a snapshot of “your fertility”.
Private clinics include it in screening packages. On social media, individual AMH results are now routinely treated as a verdict on whether a woman will be able to have children.
That reading isn’t accurate. Anti-Müllerian Hormone (AMH) does carry useful information, but only inside a wider clinical picture.
Looked at on its own, it produces a lot of unnecessary anxiety, and often hides the questions that matter more.
What AMH measures
AMH is a hormone produced by the small follicles in the ovaries, the ones that haven’t yet been recruited for ovulation. Because these follicles are relatively stable across the menstrual cycle, the test can be done on any day, without needing to be timed to a period.
A higher AMH level tends to indicate a larger pool of these follicles. A lower level suggests the pool is smaller. That, broadly, is what the result shows.
The HFEA, the UK’s independent regulator of fertility treatment, describes AMH as an indicator of ovarian reserve, while making clear that fertility test results of this kind “are not guaranteed” as a predictor of fertility outcomes.
Put simply: AMH is a count of what is there. It says nothing about how well the body will use it, and it cannot predict if or when conception will happen.
Where AMH fits in a modern fertility assessment
In current UK private practice, AMH is rarely tested in isolation. A meaningful fertility assessment will pair it with a fuller hormone profile (FSH, LH, oestradiol, prolactin and thyroid function), along with markers such as Day 21 progesterone, vitamin D and rubella immunity where relevant.
This is the structure used in a trying-to-conceive screening, and there is a reason for it: each of these tests answers a different question that AMH on its own cannot.
It is this combination, not the AMH number on its own, that gives a clinician enough information to say anything meaningful about an individual’s reproductive picture.
Misconception 1: “A low AMH means natural pregnancy isn’t possible”
This is the misconception that causes the most distress, and it is consistently wrong.
Several large prospective studies of women in their 30s and 40s trying to conceive naturally have found that women whose biomarkers, including AMH, pointed to a diminished ovarian reserve were no less likely to conceive within twelve cycles than women with reassuring results.
That is why neither UK regulators nor national guidance treat AMH as a test that can predict natural fertility in women who have no known infertility issue.
The reason is simple. Natural conception only requires one good egg, released in a normal cycle, in the right window.
AMH doesn’t measure egg quality, and it doesn’t reveal whether ovulation is happening. A woman with low AMH may still ovulate every month with high-quality eggs.
A woman with high AMH (often the pattern seen in polycystic ovary syndrome) may not be ovulating regularly at all.
The NHS emphasises that age is the strongest single predictor of natural fertility. A 35-year-old with a low AMH and regular cycles is, on average, more likely to conceive naturally than a 40-year-old with a normal AMH and irregular ones.
If AMH comes back low for someone who is trying to conceive, the more useful question isn’t whether pregnancy is still possible (the answer is almost always yes), but whether there is reason to investigate the wider picture now rather than waiting twelve months.
Misconception 2: “A normal AMH means everything is fine”
The opposite assumption is just as risky.
AMH tells you about egg quantity. It does not tell you about:
- Egg quality, which is closely tied to age
- Whether ovulation is happening regularly
- Whether the fallopian tubes are open
- Whether there are structural issues such as fibroids, polyps, ovarian cysts or endometriosis
- Sperm parameters in a male partner
- Whether implantation will succeed
A reassuringly normal AMH at 38 still sits alongside age-related changes in egg quality. A slightly lower-than-average AMH at 28 may carry no real-world implications at all.
That is why no UK clinical body recommends AMH as a routine screening test for healthy women who have no fertility concerns. NICE’s fertility guideline, NG73, treats AMH as one component of a broader investigation, not as a verdict in itself.
Imaging is the natural counterpart to the blood test. A transvaginal pelvic ultrasound directly visualises the small follicles that produce AMH, the antral follicle count. It also picks up structural findings a blood test will never reveal, including ovarian cysts, fibroids, polycystic ovarian morphology, and abnormalities in the uterine cavity. A full ovarian reserve assessment normally includes both.
Where the AMH number actually matters
There are three settings in which AMH carries real, decision-relevant information.
Before IVF or egg freezing. AMH is one of the better predictors of how the ovaries are likely to respond to stimulation medication.
A higher AMH usually predicts more eggs collected per cycle, and a very low AMH may shape decisions about protocol or whether to bank cycles before treatment.
During a fertility investigation. If a couple has been trying for twelve months, or six months if the woman is over 35, AMH becomes part of a wider assessment that should also include ovarian ultrasound, a fuller hormone profile, semen analysis and an assessment of tubal patency.
As context for women planning ahead. Women who want to understand their reproductive options before they are ready to conceive (for example, ahead of a decision about egg freezing) can find AMH informative, provided it is interpreted alongside age, antral follicle count, and other markers, by a clinician who can place the number in context.
Reading the number properly
For anyone who has had an AMH test, three things make the result more useful:
- Pair it with age. A “normal” AMH at 25 means something very different from the same number at 38. Age is doing more work in the equation than the AMH value itself.
- Pair it with imaging. Ultrasound shows what is actually in the ovaries today, rather than relying on a single biochemical marker.
- Read it with a clinician. A number on a screen, with no context, no follow-up and no plan, is the worst way to use a test that, properly interpreted, can be very informative.
AMH is a useful tool. It just isn’t the headline it has often been turned into.
Disclaimer
This article is produced for informational purposes only and does not constitute medical advice, diagnosis or treatment. Clinical guidance referenced reflects published HFEA, NHS and NICE information available as at May 2026. Individual circumstances vary; readers are advised to consult a qualified healthcare professional before acting on any information in this article. This piece was produced in association with Spital Clinic, which provided background clinical information for editorial purposes. Hyperlinks to external sources are included for reference only and do not represent an endorsement of any product, service or organisation.
Female sex may not raise stroke risk across all atrial fibrillation (AF) patients, with higher risk mainly seen in women aged 75 and older, a study suggests.
Researchers said stroke prevention for women with the condition should be more personalised, especially for patients under 75.
Dr Amitabh C Pandey, director of cardiovascular translational research at Tulane University School of Medicine, said: “For years, female sex has been included as a risk factor along with other factors such as high blood pressure and diabetes, meaning women were more likely to be prescribed anticoagulants.
“Our study shows younger women may not have as much added stroke risk as previously thought, while older women, particularly those over 75, appear to have a higher risk that deserves close attention.”
The new Tulane University study challenges a long-standing assumption in heart care that being female automatically increases stroke risk for patients with atrial fibrillation.
Atrial fibrillation, often called AF, is a common heart rhythm disorder that causes the heart to beat irregularly.
It is associated with a higher risk of stroke and is often treated with anticoagulants, also known as blood thinners.
The study found that stroke risk did not increase equally across all female patients with AF.
Instead, researchers said being female may act more as a risk modifier, with increased stroke risk seen primarily among women aged 75 and older or those with a greater burden of other health conditions.
Clinicians often use a scoring system to decide whether people with AF should be prescribed blood thinners.
The system gives points for factors including age, heart failure, diabetes, previous stroke, vascular disease and high blood pressure.
Women also receive one point for sex alone.
Researchers said this can mean women with AF become eligible for blood thinners earlier or more often than men with otherwise similar risk profiles.
While blood thinners can help prevent clot-related strokes, they can also increase the risk of bruising, prolonged bleeding, gastrointestinal bleeding and other serious complications.
The researchers analysed approximately 950,000 patients with AF using TriNetX, a large anonymised electronic health record database.
They compared stroke outcomes between male and female patients across three age groups: younger than 65, 65 to 74, and 75 and older.
Male and female patients were matched based on age, other health problems and whether they had been prescribed anticoagulation medicine.
Among patients younger than 75, the study found no significant difference in one-year stroke risk between men and women.
However, among patients aged 75 and older, women had a modest but statistically significant increase in stroke risk compared with men.
In patients aged 75 and older with no additional risk factors beyond age, women had about one additional stroke per 629 patients compared with their male counterparts.
The findings support growing interest in a newer AF risk score, known as CHA2DS2-VA, which removes sex as a standalone risk factor.
However, researchers said more studies are needed and medical guidance remains inconsistent.
Han Feng, assistant professor at Tulane University School of Medicine, said: “This general approach came from women being underrepresented in AFib trials and studies comprising only about one-third of study populations.
“Our study shows not all women with AFib have the same risk profile, and these decisions should be individualised.
Pandey said: “These findings highlight the need for modern tools and approaches that can personalise risk profiles to individuals.
“The goal is not to undertreat patients who need stroke prevention, but to better identify who is most likely to benefit from anticoagulation and who may be exposed to unnecessary risk.”
AI may help speed breast cancer diagnosis for high-risk women after abnormal mammograms, a study suggests.
Women with abnormal mammograms often wait weeks to learn whether they have breast cancer.
Researchers at UC San Francisco and UC Berkeley said an AI-guided workflow could help reduce that wait by quickly identifying those most likely to have the disease. Some women could move from imaging to evaluation, and sometimes biopsy, in a single day.
Dr Maggie Chung, first author of the study, said: “This is a really an exciting time.
“This moves us closer to personalised care, where we can tailor a plan so that each patient gets the right intervention at the right time.”
The study used an open-source AI model called Mirai.
The model was trained on hundreds of thousands of mammograms linked to patients’ cancer outcomes.
A mammogram is an X-ray scan of the breast used to look for signs of cancer. A biopsy involves taking a small tissue sample to test for disease.
The AI tool is designed to detect subtle patterns in screening mammograms and predict a woman’s cancer risk.
Researchers at UC San Francisco and UC Berkeley applied the model to more than 4,100 screening mammograms at Zuckerberg San Francisco General Hospital and Trauma Center.
Mirai identified 525 women, about 12.7 per cent of screened patients, as high risk.
Those patients could receive an interpretation of their mammograms immediately after the scan and have additional diagnostic imaging for suspicious areas on the same day.
Some women who needed biopsies were also able to have them on the same day.
The researchers said Mirai reduced the wait time for diagnostic evaluation from several weeks to about an hour.
For women who were ultimately diagnosed with breast cancer, it reduced the average wait for biopsy from more than two months to fewer than 10 days.
The researchers stressed that Mirai does not replace radiologists or make diagnoses on its own.
Instead, it acts as a triage tool to help physicians identify the patients who can benefit most from accelerated care.
The team analysed more than 114,000 archival mammograms before launching the programme, to ensure the model would capture enough high-risk patients without overloading the clinic with too many expedited evaluations.
The researchers said they hope AI will support a more personalised approach to breast cancer screening tailored to each patient’s breast cancer risk.
Chung said: “Right now, many women follow the same screening schedule but their individual risk can be very different.
“AI risk assessment gives us the chance to identify the women most likely to benefit from expedited care and get them what they need.”
Adam Yala, senior author of the study and a data scientist at UC Berkeley, said: “This is a powerful example of how AI can be a collaborative partner for physicians.
“It shows how we can improve care when we bring clinicians and data scientists together to design these systems.”
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