On International Women’s Day, it’s crucial to shed light on the ongoing gap in women’s health equity and the pressing need for further support. This year’s theme of ‘Inspire Inclusion’ underscores the transformative power of including women in all facets of life, fostering a sense of belonging, relevance, and empowerment.
Particularly, we turn our attention to the Femtech industry, which has sparked discussions around the potential to enhance and innovate medical devices and software aimed at advancing women’s health. From research to prevention and treatment, Femtech embodies inclusivity and progress in healthcare.
What is Femtech and how does it improve women's lives?
Femtech, short for ‘Female Technology,’ focuses on the unique healthcare needs of women, enhancing their lives through developed technologies such as healthcare products, software, diagnostics, and services tailored to different life stages.
Femtech addresses the underrepresentation of women by promoting inclusivity in healthcare through MedTech, covering categories such as Menstruation & Period Care, Fertility & Birth Control, Menopause, Pregnancy, and much more.
As Femtech continues to evolve, driven by growing awareness and investment in women’s health, it highlights the importance of ethical and equitable development, especially for marginalised communities. This progress has been significant in promoting funding for sex-specific analyses, enhancing inclusivity, accessibility, and affordability of healthcare services for women.
At Rephine, we actively assist progressive Femtech start-ups averting acceptance, usability, and regulatory hurdles, all whilst prioritising patient safety. So, we wanted to spotlight three pioneering companies in Femtech, and highlight their impactful contributions to ‘Inspire Inclusion‘ and bridge the gap of women’s health equity.
EndoGene.Bio spearheads a transformative approach towards endometriosis management. Focused on molecular biomarker discovery in female health, their pioneering work revolves around epigenetic markers found in menstrual blood. Their primary objective lies in developing non-invasive biomarkers to revolutionise endometriosis diagnosis and management, promising a brighter future for those affected by this condition.
Why their innovation matters?
With 10% of women and girls affected worldwide, controversy persists over limited access to care and the absence of a cure for endometriosis. EndoGene.Bio’s dedication to biomarker discovery in female health via their menstrual blood collection device holds promise for more effective early detection.
This Femtech advancement enhances diagnostics and enables more personalised care actions, ultimately empowering women, physicians, and the pharmaceutical industry.
By prioritising accessibility, EndoGene.Bio aims to ensure that their Femtech device facilitates effective treatment, inspiring inclusivity in women’s healthcare and treatment.
How have Rephine helped EndoGene.Bio with their QA journey?
Collaborated since design stages, focusing on establishing the right appropriate structures to meet regulatory requirements from the beginning of product development
Continue conducting technical documentation required for CE marking with ongoing support
Innitius, a Femtech start-up dedicated to advancing women’s health diagnostics, is currently developing FineBirth—an innovative patented intravaginal probe, combined with a web application featuring an integrated predictive algorithm. FineBirth measures the consistency (shear modulus) of cervical tissue, serving as a specific marker correlated with the date of delivery. This portable solution serves as a tool to provide OB/GYN doctors with immediate risk assessments, supporting the decision-making process. By integrating their pioneering Torsional Waves technology and AI algorithm, FineBirth emerges as a groundbreaking diagnostic Femtech device.
Why their innovation matters?
Innitius’s FineBirth medical device technology addresses challenges in False Positive TPL Cases, where current technologies have a low trust level due to a 30% positive predictive value*. FineBirth aims to revolutionise the Femtech landscape by minimising negative clinical impact and the cost of over-treating false Preterm Labor (PTL) threats. It achieves this through safe, real-time Point-Of-Care diagnostics, providing more accurate results and ensuring accessibility without constraints due to its portability.
FineBirth’s innovative technology offers reassurance through appropriate care, marking a significant advancement in Femtech, promoting inclusivity and equity in women’s healthcare.
How have Rephine helped Innitius with their QA journey?
Collaboration with their design and development phases with FineBirth device, to help with maintaining high-quality standards
Help with obtaining authorisation from the health authorities to conduct a clinical study that will allow them to achieve CE marking at a later stage
Frontwave Imaging provides an accessible supercomputing Software as a Medical Device (SaMD) that creates high-resolution 3D ultrasound images, enhancing breast cancer diagnostics. They also provide seamless data transfer to Cloud services, incorporating image reconstruction, and enabling analysis through a user-friendly interface.
Why their innovation matters?
Frontwave Imaging’s technology offers accessible cloud software for early detection and tumour progression monitoring. Amid the high breast cancer statistics. their ultrasound software provides safer, cost-effective, and more accurate diagnostics by eliminating radiation risks in mammography.
Their continuous image reconstruction improvements enhance diagnostic precision, making it sensitive to all breast types and providing high-resolution imaging comparable to MRI. Their innovation inspires inclusivity by prioritising patient safety and enhancing diagnostic accuracy for all women worldwide.
How have Rephine helped Frontwave Imaging with their QA journey?
Focused on establishing the right QA environment, with appropriate structures and processes to maintain high-quality standards in their operations
Continue conducting the functional verification of their software, with ongoing processes for the Technical File required for CE marking
In celebrating the progressive technologies of EndoGene.Bio, Innitius, and Frontwave Imaging, Femtech emerges as a transformative force in women’s healthcare. Their commitment to innovative, safe, and accessible solutions not only propels diagnosis, prevention, and bespoke care forward but also advocates for equity in healthcare.
Femtech demonstrates the power of developing tailored solutions to diverse needs, fostering inclusivity and patient-centred care. By addressing direct health disparities, Femtech will ultimately bridge healthcare access gaps, ensuring better health outcomes and improved quality of life for all women.
Rephine has extensive experience of supporting SMEs breaking into the Femtech markets
From acting as your Person Responsible for Regulatory Compliance (PRRC) to implementing cloud systems, you can find more about our Medical Device services, and contact our experts by visiting our Medical Devices page.
