Reimagining Pelvic Health: FemTherapeutics' Personalized Solution to an Overlooked Crisis

In a recent episode of talk is biotech!, a podcast produced by Scispot, host Guru Singh sat down with Negin Ashouri, CEO of FemTherapeutics, to explore a silent crisis in women's health and an innovative solution. Guru Singh, who serves as Founder and CEO of Scispot, brings extensive expertise in biotech innovation to the podcast. Scispot is a leading provider of AI-powered technology stacks designed specifically for life science laboratories, helping researchers streamline their operations and accelerate discoveries.

Through talk is biotech!, Scispot shines a spotlight on cutting-edge biotech innovations that are transforming healthcare.

In Episode 2, the discussion centers on pelvic health, specifically pelvic organ prolapse, the risks associated with current surgical treatments, and FemTherapeutics' groundbreaking journey in developing a personalized medical device solution.

FemTherapeutics, founded by Negin Ashouri and her team, is a medical device company focused on revolutionizing women's pelvic health through innovative, personalized solutions. The company emerged from McGill University's Surgical Innovation Program and is pioneering the development of custom-designed pessary devices using advanced 3D printing technology and AI-driven design platforms.

The Unspoken Epidemic: Understanding Pelvic Organ Prolapse

Pelvic organ prolapse (POP) is a condition where one or more pelvic organs, such as the uterus, bladder, or rectum, descend from their normal positions into the vaginal canal. This medical condition is far more prevalent than most people realize. Current medical research indicates that at least one in three women will experience some form of POP during their lifetime. Some comprehensive studies suggest that approximately half of all women develop some degree of prolapse, yet this significant health issue remains poorly understood and rarely discussed openly.

This stark disconnect between prevalence and awareness has led many healthcare professionals and advocates to characterize POP as a "hidden" or unspoken epidemic in women's health. The silence surrounding this condition has created a cascade of problems that affect millions of women globally.

Widespread Yet Silent Impact

Pelvic organ prolapse significantly impacts quality of life, affecting everything from physical comfort to sexual health and daily activities. However, the condition has historically been underdiagnosed and undertreated within healthcare systems worldwide. The stigma and embarrassment associated with pelvic health issues create substantial barriers to care.

Research indicates that approximately half of women experiencing pelvic floor dysfunction don't report their symptoms to healthcare providers. This reluctance stems from multiple factors, including cultural taboos around discussing intimate health concerns, lack of awareness about available treatments, and fear of judgment. Many women suffer in silence, believing their symptoms are a normal part of aging or childbearing.

Healthcare providers themselves sometimes contribute to this problem by overlooking or downplaying pelvic health issues. The medical community has traditionally given less attention to women's pelvic health compared to other health areas, leading to gaps in both awareness and treatment options.

Neglected Innovation in Treatment

Perhaps most concerning is that treatments for POP have seen minimal evolution over the past six decades. The condition has been chronically underfunded in medical research and overlooked in medical device innovation. This pattern reflects a broader systemic issue where women's reproductive and pelvic health receives disproportionately less attention and investment compared to other medical areas.

As a result, standard devices and surgical procedures have remained largely unchanged, even as millions of women continue to struggle with debilitating symptoms. The lack of innovation has left patients with limited options that often fail to provide adequate relief or come with significant risks.

This combination of social stigma and stagnant medical solutions means that POP is frequently managed inadequately or not addressed at all. Many women resign themselves to "just living with" their symptoms, while healthcare providers often resort to outdated approaches that may not serve patients' best interests. This situation underscores the urgent need for fresh perspectives, innovative technologies, and renewed attention to bring pelvic health treatment into the modern era.

The Problem with Surgery: Risks and Limitations

When prolapse symptoms become severe enough to significantly impact daily life, the conventional medical approach often leads to surgical intervention. The most common procedures include hysterectomy (surgical removal of the uterus) and repair using surgical mesh implants. Unfortunately, these invasive procedures carry substantial risks and demonstrate significant limitations that patients and providers must carefully consider.

Many women find themselves facing surgical options primarily because less invasive alternatives have failed to provide adequate relief. For instance, traditional pessary devices, which are commonly prescribed as first-line treatment, fail to work effectively for up to 50% of patients. These failures often result from poor fit, discomfort, or device displacement, ultimately pushing women toward more invasive surgical interventions.

High Intervention Rates and Surgical Complications

The prevalence of pelvic floor surgery is surprisingly high across North America. Statistics show that approximately one in five women diagnosed with pelvic floor disorders like POP will undergo surgical repair procedures such as hysterectomy or mesh implant surgery. These procedures aim to provide structural support or reposition organs to their proper anatomical positions, but they often come with significant costs to patient health and quality of life.

Surgical interventions for prolapse demonstrate notably high failure rates and risk profiles. Medical literature indicates that roughly 30% of prolapse surgeries fail, meaning nearly one in three women may experience symptom recurrence or require additional operations. These statistics are particularly troubling given the invasive nature of these procedures and their impact on patients' lives.

Complications from prolapse surgery can be severe and long-lasting. Patients may experience chronic pain, infections, organ damage, or mesh-related injuries. The use of synthetic mesh implants has been particularly problematic, with some devices causing tissue erosion, chronic pain, or other serious complications that sometimes prove more debilitating than the original condition.

Patient Dissatisfaction and Public Health Concerns

The human impact of surgical complications has been profound and well-documented. Many women report experiencing new forms of pain, discomfort, or dysfunction following prolapse surgery, often undermining the quality-of-life improvements they initially sought. This troubling reality was brought to widespread public attention through the Netflix documentary "The Bleeding Edge," which examined how surgical mesh devices for prolapse and incontinence caused serious harm to patients.

The documentary highlighted cases where surgical mesh devices led to severe complications, prompting recalls, lawsuits, and regulatory action. Public outcry over these cases emphasized a disturbing pattern: for many patients, the surgical "cure" proved as life-altering as the original disease, but in negative ways that were often irreversible.

These outcomes illustrate a fundamental problem with the current treatment paradigm. While surgical procedures like hysterectomies and mesh repairs remain widely used, they represent a troubling reality where patients often face choosing between inadequate options. The combination of high failure rates, significant complication risks, and widespread patient dissatisfaction clearly demonstrates the need for innovative solutions that don't require women to risk their long-term health and well-being for symptom relief.

FemTherapeutics' Vision: A Personalized, Non-Invasive Alternative

Recognizing the critical gaps in current treatment options, FemTherapeutics has developed a revolutionary approach to pelvic organ prolapse management. The company's innovative solution centers on a personalized, 3D-printed pessary device that offers a genuine non-surgical alternative for women struggling with POP symptoms.

This groundbreaking approach represents a modern evolution of traditional pessary therapy, much like how Invisalign transformed orthodontic treatment by replacing one-size-fits-all braces with custom-designed aligners. FemTherapeutics is fundamentally reimagining the pessary as a patient-specific medical device rather than a generic product that patients must adapt to fit their unique anatomy.

The Genesis of Innovation

Negin Ashouri and her founding team at FemTherapeutics embarked on this innovative journey after witnessing firsthand the significant shortcomings of existing treatment options. Through their involvement with McGill University's prestigious Surgical Innovation Program, the founders spent extensive time in hospital operating rooms, observing numerous prolapse surgeries and their outcomes.

This direct clinical exposure revealed a troubling pattern: many of the surgeries they observed might have been preventable if a superior non-invasive alternative existed. The team recognized that the fundamental problem wasn't just the invasiveness of surgery, but the lack of effective conservative treatment options that could provide meaningful symptom relief.

Their observations led to a clear vision: developing a custom pessary solution tailored to each woman's unique anatomy. This device would provide internal support to relieve prolapse symptoms without requiring surgical intervention, potentially helping thousands of women avoid unnecessary operations and their associated risks.

Customization as the Core Innovation

Traditional pessary devices represent a significant limitation in current care approaches. These devices are typically mass-produced in a limited range of geometric shapes and sizes, with fitting accomplished through a frustrating trial-and-error process that often fails to achieve optimal results.

FemTherapeutics has completely reimagined this approach by placing customization at the center of their solution. Their innovative process utilizes advanced measurement technologies to capture each individual's unique vaginal geometry and pelvic anatomy. This detailed anatomical data is then processed through sophisticated 3D modeling software to design a pessary that precisely matches that patient's specific requirements.

The goal is achieving a comfortable, secure fit that remains effective throughout daily activities while addressing the 50% failure rate and comfort issues that plague traditional pessary devices. By creating devices that conform to the patient rather than forcing patients to accommodate standardized devices, FemTherapeutics aims to dramatically improve both efficacy and patient satisfaction.

Balancing Personalization with Scalability

During the early development phase, the FemTherapeutics team discovered that while fully bespoke 3D printing for each individual patient showed promising clinical results, this approach faced significant scalability challenges due to cost considerations and production time requirements.

Negin Ashouri explained that while personalization clearly improved patient outcomes, the solution needed to balance customization with practical considerations for widespread adoption. The team's innovative response was developing what they term "standardized, adaptive models" - essentially creating an intelligent library of pessary designs that can be efficiently customized to meet each patient's needs without requiring complete redesign for every case.

This approach mirrors successful models in other industries, particularly Invisalign's production of personalized orthodontic aligners using standardized software platforms and manufacturing processes. FemTherapeutics' device designs can be rapidly adjusted using specialized software and produced on-demand through 3D printing, combining precision customization with manufacturing efficiency to maintain affordability and scalability.

Non-Invasive, Patient-Centered Care

The FemTherapeutics pessary is specifically designed for home use by patients, offering effective symptom relief without requiring hospitalization, surgical procedures, or extended recovery periods. The devices are manufactured using biocompatible, medical-grade materials that prioritize both comfort and safety while avoiding the complications associated with rigid plastic pessaries or surgical mesh implants.

The device can be easily inserted and removed as needed by the patient, transforming prolapse management from a life-altering surgical intervention into a manageable daily therapy similar to wearing contact lenses or other medical devices. This approach empowers women to take control of their pelvic health while maintaining their quality of life and avoiding surgical risks.

By combining custom design principles with advanced 3D printing technology, FemTherapeutics' vision represents a fundamental shift toward patient-centric care. This innovative approach exemplifies how emerging technologies including 3D modeling, precision manufacturing, and artificial intelligence can converge to address long-ignored health problems and provide meaningful solutions for women worldwide.

Data, Design, and Dynamic Biology

Creating a personalized medical device for anatomy as variable and complex as the vaginal canal presents unique engineering and medical challenges that FemTherapeutics has had to solve through innovative approaches. One of the most significant insights from their development journey involves understanding that traditional imaging or sizing techniques fail to capture the dynamic nature of vaginal anatomy.

The shape, dimensions, and characteristics of the vaginal cavity undergo constant changes based on factors including body position, muscle tone, hormonal fluctuations, and life stage. This means that static measurements from a single examination or standard imaging techniques like MRI scans may provide only a limited snapshot that doesn't reflect how a device will perform during real-world use.

Rather than relying on traditional one-time measurement approaches, FemTherapeutics developed a sophisticated data-driven modeling system specifically designed to address these biological complexities.

Advanced Modeling for Biological Variability

FemTherapeutics has created an AI-powered design software platform that utilizes parametric simulation models to generate each custom pessary design. Instead of directly translating a single anatomical scan into a 3D-printed device, which might capture only one moment in time, their process begins with comprehensive data collection using multiple measurement approaches.

The system incorporates data from standard pelvic organ prolapse quantification examinations (POP-Q), which provide standardized clinical measurements, combined with FemTherapeutics' proprietary measurement tools that capture additional anatomical details. These multiple data points are then processed through sophisticated software that creates a three-dimensional simulation model of an optimally fitting pessary.

The software's algorithms account for how pelvic tissues move, adapt, and change throughout daily activities, generating device designs that maintain effectiveness even as the patient's body position and muscle tone vary. This approach avoids the significant limitations of static imaging by building in appropriate tolerances for biological dynamics and movement patterns.

Scalable Data-Driven Design Platform

By leveraging cloud computing infrastructure and artificial intelligence, FemTherapeutics has created a comprehensive pelvic health platform that can deliver personalized design solutions without requiring complete customization from scratch for each patient. Healthcare providers can visualize a patient's specific prolapse characteristics within a detailed 3D digital environment, then virtually test and refine pessary designs before physical manufacturing.

Once the optimal design is determined through digital simulation, advanced 3D printing technology fabricates the actual device using medical-grade silicone materials. This streamlined digital pipeline creates opportunities for continuous improvement, as data from each patient interaction can be fed back into the system to further refine design algorithms and improve outcomes for future patients.

This approach maintains the high efficacy of fully customized solutions while achieving the production efficiency necessary for widespread adoption. Even though the manufacturing process utilizes standardized platforms and automated systems, each resulting device remains uniquely tailored to the individual patient's anatomy and needs.

Dynamic Fit for Real-World Performance

Traditional pessary devices frequently fail because they employ rigid design approaches, both in terms of physical material properties and fitting methodologies. FemTherapeutics' data-centric approach produces devices that not only accommodate initial examination measurements but also remain effective and comfortable as patients engage in normal daily activities.

The combination of flexible, biocompatible silicone materials and iterative design optimization helps ensure that each pessary maintains proper positioning and provides consistent support even as the body moves through various positions and activities. By incorporating dynamic biological factors into the initial design process, the company eliminates much of the trial-and-error fitting procedures that currently frustrate both patients and healthcare providers.

This represents a fundamental shift toward applying software-engineering principles to solve complex hardware challenges. By using advanced simulations, comprehensive data analysis, and AI-driven predictions to determine optimal designs rather than relying purely on physical fitting sessions, FemTherapeutics demonstrates how data science can tackle problems once considered too personalized and variable to scale effectively.

Navigating Biotech: Funding, Regulation, and Pilots

Developing and commercializing a medical device involves far more than technical innovation; it requires successfully navigating a complex landscape of regulatory requirements, funding challenges, and market validation. FemTherapeutics, like many biotech startups, must operate within a highly regulated environment where their custom pessary device is classified as an FDA Class II medical device.

This classification requires a comprehensive approval process, typically involving a 510(k) premarket notification that demonstrates the new device is as safe and effective as existing approved devices. Negin Ashouri has detailed how bringing any medical device to market represents a significant undertaking, particularly challenging for startup companies with limited resources compared to established medical device corporations.

Regulatory Compliance and Quality Standards

Compared to established medical technology giants like Medtronic or Johnson & Johnson, startup companies face disproportionate challenges in meeting stringent regulatory requirements. FemTherapeutics must conduct extensive benchtop testing followed by rigorous clinical studies involving human participants to generate the comprehensive evidence required for regulatory clearance.

Every aspect of their device and manufacturing process faces intense scrutiny, from biocompatibility of materials and software reliability to quality control systems and clinical efficacy data. Regulatory bodies including the FDA and Health Canada maintain the same high standards for all companies regardless of size, but for small organizations with limited financial and human resources, this process can be particularly demanding and expensive.

There are no shortcuts or simplified pathways for innovative startups. Early-stage biotech companies often need to invest heavily in bringing on experienced regulatory advisors, developing comprehensive documentation systems, and implementing robust quality control measures that meet or exceed industry standards. Modern biotech companies are increasingly leveraging GXP compliance platforms to streamline their regulatory processes and ensure data integrity throughout development.

The FemTherapeutics team has addressed these challenges by emphasizing meticulous preparation and strategic collaboration with regulatory experts throughout their development process. Their approach of thorough groundwork and careful documentation has enabled steady progress toward FDA approval while maintaining the high standards required for patient safety.

Capital Requirements and Investment Challenges

Biotech innovation operates on extended timelines that require significant patience and risk tolerance from investors. The complete development and approval cycle for a medical device typically spans multiple years, during which companies require substantial capital investment well before generating any revenue or demonstrating market traction.

Ashouri has spoken candidly about the fundraising challenges FemTherapeutics faced, particularly in early stages when many investors considered the company "too early" for investment. This feedback reflects a common challenge in biotech financing, where the combination of high technical risk, lengthy development timelines, and regulatory uncertainty makes it difficult to secure funding during critical early phases.

The biotech investment landscape requires investors who understand both the significant risks and the potential for transformative impact. Success often depends on persistent advocacy and education to help investors understand the vision, market opportunity, and long-term potential of innovations that may not reach commercial sales for 5-10 years.

FemTherapeutics ultimately overcame these initial fundraising challenges by systematically demonstrating strong preliminary results, clearly articulating the significant market need, and showing measurable progress toward regulatory milestones. Their success in securing several million dollars in seed funding demonstrates that with the right combination of innovation, execution, and persistence, biotech startups can attract the patient capital necessary for long-term success.

Strategic Pilot Programs and Market Validation

One particularly effective strategy employed by FemTherapeutics has been the implementation of strategic pilot programs with healthcare providers. These collaborations allow practicing physicians to evaluate the personalized pessary technology with real patients in controlled clinical settings, providing valuable dual benefits for the company.

These pilot programs serve as both validation mechanisms and early revenue generators. From a validation perspective, they provide critical real-world data on device performance, patient satisfaction, and clinical outcomes that strengthen regulatory submissions and investor presentations. Simultaneously, they generate initial revenue streams that help sustain company operations during the lengthy development process.

For any startup, having even modest revenue from pilot sales or strategic partnerships provides tremendous value beyond the financial impact. Early revenue demonstrates market demand and validates that healthcare providers are willing to adopt the innovation, providing crucial credibility with investors and stakeholders.

The early pilot successes achieved by FemTherapeutics have provided essential momentum during critical development phases. By building their own comprehensive case studies and demonstrating that their device works effectively in clinical practice, the company has established a foundation of credibility that supports continued growth and development.

Successfully navigating the intersection of innovation, regulation, and commercialization requires strategic thinking and careful execution. FemTherapeutics illustrates how biotech companies can succeed by combining scientific innovation with rigorous regulatory compliance, strategic pilot partnerships, and persistent fundraising efforts. While biotech development cycles are inherently long and challenging, the potential to improve millions of lives makes these efforts ultimately worthwhile.

Changing the Narrative: Investing in Female-Founded Innovation

The insightful conversation between Guru Singh and Negin Ashouri on talk is biotech! explored important themes about female leadership in the biotech industry and the critical importance of supporting women-led innovation in healthcare. Ashouri's personal and professional journey provides a compelling example of resilience, determination, and barrier-breaking achievement in a traditionally male-dominated field.

Negin Ashouri's path to founding FemTherapeutics began in Iran, where she excelled in robotics and engineering before setting her sights on pursuing advanced studies in the United States. However, the implementation of travel restrictions and visa limitations abruptly derailed those original plans, forcing her to completely reimagine her educational and career trajectory.

Rather than allowing this setback to end her aspirations, Ashouri redirected her path to Canada, where she discovered both a welcoming startup ecosystem and a profound sense of mission in addressing women's healthcare challenges. What initially appeared to be a career-ending obstacle instead became the catalyst that led her to co-found FemTherapeutics and tackle one of the most overlooked areas in women's health.

Immigrant to Innovator

Ashouri's story from Iran to Canada highlights how diverse perspectives can drive innovation in biotechnology. Her background in engineering, combined with lived experience as a woman aware of women's health gaps, positioned her uniquely to tackle a problem like pelvic organ prolapse. What could have been a career-ending obstacle instead became the plot twist that led her to co-found FemTherapeutics.

This underscores the value of inclusive talent in biotech: breakthrough ideas often come from those who have non-traditional backgrounds or global experiences. The biotech industry increasingly recognizes that female entrepreneurs bring unique perspectives to healthcare challenges that have been historically overlooked.

Bias in Biotech Funding

Despite progress, female founders, especially in deep-tech fields like biotech, still face implicit bias and structural hurdles in fundraising. Ashouri experienced this first-hand during her fundraising journey. Investors were skeptical not just of the technical risk, but perhaps of the very profile of the founders. She was often the only woman in the room and heard comments that the company was "too early" - feedback that many women entrepreneurs interpret as a sign their credibility is being underestimated.

Statistically, women-led startups receive a small fraction of venture capital funding in healthcare, and the problem is even more pronounced for women of color or immigrant women. The podcast discussion acknowledged these challenges: being a woman in biotech can add another layer of complexity on top of the usual startup struggles.

Resilience and Validation

Ashouri's response to skepticism was to let results speak louder than biases. By focusing on building a strong product and securing those hospital pilot programs, she proved the naysayers wrong. Her persistence paid off - FemTherapeutics not only raised capital including a seed round of several million dollars but also delivered tangible proof that their solution works and that patients want it.

Each milestone achieved by FemTherapeutics from successful prototypes to regulatory milestones has helped change perceptions. It sends a message that data-driven, women-centered innovation can be both good medicine and good business. Guru Singh and Negin discussed how women founders often have to navigate unique obstacles, but with resilience and a clear vision, they can drive meaningful change in biotech.

Shifting the Narrative

The story of FemTherapeutics is part of a larger shift in healthcare and venture capital: recognizing that problems like pelvic organ prolapse, long ignored, represent massive opportunities for impact. As more female founders address women's health issues, and as they begin to succeed, the narrative is slowly changing.

Investors and industry leaders are taking note that areas such as pelvic health, menstrual health, and maternal health are underserved markets with huge potential. Ashouri's journey from being underestimated to securing validation for her product embodies this turning tide. It's a narrative of optimism: when innovation is inclusive and truly addresses patient needs, it can overcome biases and deliver value.

Supporting female-founded companies isn't just about equity; it's about unlocking solutions to problems that half of the world's population faces. In the end, everyone benefits when we invest in diverse innovators solving real-world health challenges.

The conversation concluded on a hopeful note. With pioneers like Negin Ashouri leading the way, the future of biotech looks more inclusive and attuned to previously neglected issues. Data-driven, AI-enabled platforms like Scispot's Lab Operating System are accelerating these developments by giving small startups the tools to run like much larger organizations. And as FemTherapeutics demonstrates, a combination of technology, tenacity, and a patient-first mindset can yield breakthroughs that improve lives. The pelvic health crisis may have been unspoken for decades, but with innovation and advocacy it is finally getting the attention it deserves.

Key Takeaways

A silent women's health crisis: Pelvic organ prolapse affects a huge number of women (at least 1 in 3 globally) yet remains underdiagnosed and shrouded in stigma. Decades of silence and underinvestment in this area have left patients with limited options.

Legacy treatments fall short: Traditional solutions for POP - namely off-the-shelf pessary devices and invasive surgeries - have high failure and complication rates. Over 50% of women can't tolerate or properly fit existing pessaries, and about 20% end up undergoing surgeries that carry significant risks including ~30% chance of failure or recurrence. Scandal over surgical mesh injuries exemplifies the urgent need for safer, better treatments.

Personalization as a game-changer: FemTherapeutics is pioneering a personalized, non-invasive alternative - a custom 3D-printed pessary tailored to each patient's anatomy. This approach is analogous to Invisalign in orthodontics: using digital models and 3D printing to create patient-specific devices at scale. By fitting the device to the individual rather than forcing the individual to accommodate the device, it vastly improves comfort and efficacy.

Data-driven design and scalability: A key innovation is the use of AI and dynamic modeling to design pessaries. Instead of relying on static imaging, FemTherapeutics' platform uses pelvic measurements and a parametric simulation model to generate the optimal device shape for each woman. This data-driven process allows for mass customization - every device is unique, yet the design cycle is efficient and repeatable. The result is scalable personalization, delivering custom care without prohibitive cost.

The road to market is challenging but navigable: Bringing a medical device from concept to clinic requires navigating strict regulatory pathways (FDA Class II, 510(k) clearance) and securing significant funding. FemTherapeutics illustrates how a startup can succeed by being meticulous in testing and documentation, leveraging pilot programs with hospitals for early validation and revenue, and persistently educating investors about the value of its innovation. Modern biotech companies benefit from understanding that biotech timelines are long, but with strategic planning, even small companies can meet regulatory standards and gain market traction.

Women-led innovation is transforming biotech: Negin Ashouri's journey as an immigrant and female founder highlights both the biases in the industry and the progress being made. Female entrepreneurs often face skepticism in fundraising, yet their insights into women's health needs are driving solutions that have been overlooked by others. Success stories like FemTherapeutics are changing perceptions, proving that investing in women's health and women-led companies yields not only social benefits but also significant business and healthcare returns. Each breakthrough in femtech is helping to rewrite the narrative, fostering a more inclusive and innovative biotech landscape.