An independent inquiry will be launched into Leeds maternity services following a parent-led campaign over care failures stretching back 14 years.

Health secretary Wes Streeting said he was deeply concerned about problems at Leeds Teaching Hospitals NHS Trust, calling it “a real outlier” for perinatal mortality — deaths around the time of birth — compared with other hospitals nationally.

The announcement follows maternity services at the trust being rated “inadequate” after an unannounced Care Quality Commission inspection in December and January.

A subsequent NHS England report raised “significant” concerns about safety and quality of care.

After meeting affected parents in the city, Streeting said the trust — which runs maternity units at Leeds General Infirmary and St James’s Hospital — required scrutiny similar to the ongoing Nottingham maternity inquiry.

“I’ve decided that we need a Nottingham-style independent inquiry into what’s going on with maternity and neonatal services in Leeds,” he said.

“I think we need clear answers, accountability and improvement… I do think we need that independent look, not just for what’s happening now but stretching back to historic cases as well.”

The Nottingham review — the largest maternity inquiry of its kind — has examined hundreds of baby deaths and injuries at Nottingham University Hospitals.

It has led to the NHS paying out tens of millions of pounds for claims dating back to 2006 and prompted a police investigation, with findings expected next year.

Dozens of baby deaths in Leeds in recent years are thought to have been preventable.

Families affected by avoidable deaths of babies or mothers have long campaigned for an independent investigation.

Streeting has already commissioned a national review of NHS maternity services but said Leeds was an “exceptional case” that warranted its own inquiry.

“I don’t want to drown the NHS across the country in a whole series of local reviews into what I think is a national problem,” he said.

“But I have been persuaded, having been to Leeds recently to listen to families and look at the data.

“Given the challenges still evident — not least from the most recent Care Quality Commission inspection — and Leeds’s scale as one of the largest teaching hospitals in Europe, I think all of those things point to Leeds as an exceptional case for this kind of inquiry.”

He said details of the inquiry’s scope would be announced soon.

“I’ll proceed without fear or favour. If there are individuals who need to be held to account, I will ensure accountability.

“Where systemic improvements are needed, I will make sure they happen, and that’s why I believe this specific investigation is necessary.”

Campaigners welcomed the decision, describing the current system as “rotten”.

Fiona Wisner-Ramm and Daniel Ramm, whose daughter Aliona died 27 minutes after birth in 2020 following what an inquest described as “gross failures” in care, have been among those leading the campaign.

“This means that Leeds Teaching Hospitals NHS Trust will now be properly investigated, allowing for meaningful changes to its culture and practices,” they said in a statement.

“We hope that this inquiry will finally break the cycle of repeated errors and inadequate leadership, helping to prevent further deaths and injuries to mothers and babies.”

Scientists have developed a powerful new approach to detecting endometriosis which could transform how the disease is researched, diagnosed and treated.

In a world-first clinical study, scientists tested a pioneering diagnostic process which involves directly isolating menstrual blood-derived stem cells (MenSCs) from menstrual blood samples for analysis, rather than analysing cultured cells.

Scientists believe MenSCs are the cells that drive lesion formation in endometriosis.

Culturing the cells alters their make-up; whereas freshly isolating the cells without culturing preserves their molecular integrity, enabling a deeper and more direct view into how endometriosis behaves than ever before.

Dr Francisco Carmona is former president of the International Society of Endometriosis and Uterine Disorders, head of the Endometriosis and Uterine Transplant Unit at Hospital Clínic Barcelona, and co-author of this study.

The researcher said: “This study marks a significant leap forward in our mission to understand the biology of endometriosis.

“It has far-reaching implications: the methods tested could power the development of non-invasive patient stratification and diagnosis, better treatments and personalised care pathways, transforming the lived experience of patients with endometriosis and how we approach their care.”

In this landmark study, scientists were the first to analyse freshly isolated MenSCs using a process called DNA methylation profiling, which is already widely used to diagnose cancer.

They achieved an accuracy rate of 81 per cent and were clearly able to distinguish participants with endometriosis from those without.

The approach means scientists can use readily available menstrual blood samples to accurately diagnose and categorise endometriosis: a significantly less invasive process for patients than the current diagnostic gold standard, which involves a surgical procedure called a laparoscopy.

It also enables scientists to uncover critical information about the disease that can’t currently be provided by diagnostic imaging or biopsies.

Scientists hope the new technology will enable clinicians to detect endometriosis far earlier and without surgical intervention, reducing endometriosis diagnosis times from an average 7-10 years to just a few weeks.

The team also hopes to lay the foundation for the development of targeted therapies to treat different types of endometriosis.

Their approach could enable clinicians to stratify patients based on how the disease is behaving, and give patients access to targeted treatments before the condition has advanced.

The study was carried out by researchers at Hospital Universitario Insular de Gran Canaria and Hospital Clínic Barcelona – a leading centre in endometriosis care and research.

It was led by endogene.bio: a Paris-based precision medicine organisation on a mission to turn cutting-edge science into clinical tools that can close the female health gap. The endogene.bio team comprises world-leading experts in epigenetics, gynaecology, immunology and computational biology, many of whom also suffer from endometriosis.

Dr María Teresa Pérez Zaballos, co-founder and CEO at endogene.bio, said: “We wanted to design something that we as patients, but also as researchers, wished had existed.

“By accessing the molecular signals in menstrual blood, we’re unlocking information about endometriosis activity that was previously only available through surgery.

“Our approach shows DNA methylation profiling is a reliable, non-invasive way to diagnose endometriosis.

“Our findings also support the use of menstrual blood as a stable diagnostic sample.

“Many members of our team are endometriosis patients themselves, myself included. Our firsthand understanding of the diagnostic delays, clinical blind spots, and emotional toll of endometriosis shapes every decision we make, from sample collection design to clinical priorities.

“This is a company built by scientists who understand the molecular complexity of the disease and by patients who know exactly where medicine has fallen short.”

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