This October 10^th, on Ada Lovelace Day (ALD) which is an international celebration of the achievements of women in science, technology, engineering and maths (STEM), IMed Consultancy would like to take the opportunity to give a shoutout to all women scientists, medics, entrepreneurs and business people in the medical devices world!

Female leaders for female technology

As a female-founded company we have a natural interest in promoting female leadership roles and in supporting female-led businesses. Given our areas of expertise, we’re also particularly invested in all things FemTech, and all the cutting-edge solutions that are increasingly disrupting the health tech market, improving reproductive, menstrual, sexual, pelvic floor, vaginal, oncological, bone, brain, autoimmune and heart health, and new ways for healthcare providers to reach patients[1].

What is FemTech?

The term FemTech refers to software, diagnostics, products and services, that use technology to support women’s health. The term itself was originally coined by Ida Tin, the founder of Clue, a period tracking app, who introduced it during her discussions with (mostly male) investors and almost unintentionally created a whole new category of products[2].

In recent years women’s health technology has taken the start-up world by storm, with a market value of over $30 billion in 2022 and an expected growth rate of 16% through 2023-2032[3]. While previously overlooked as a taboo subject, women’s reproductive and sexual health is now becoming an important focus area for new investment and start up development.

Areas for FemTech growth

McKinsey[4] lists four main areas where FemTech is making huge inroads in improving patient lives as well as shaking up the industry. These are:

Improving care delivery: Virtual clinics and direct-to-consumer prescription delivery services.

Enabling self-care: Trackers and wearables.

Improving diagnoses: Clinical diagnostics companies that are finally addressing unmet medical needs in areas such as endometriosis.

Addressing stigmatized areas: such as the menopause and menstrual products.

Delivering culturally sensitive and tailored care: Solutions tailored to specific groups of individuals.

Medtech Startups and Regulations: a complicated relationship

Unfortunately, the statistics are dreary with 9 out of 10 start-ups globally reported to fail[5] and as we know all too well, when it comes to MedTech, one of the main reasons start-ups fail to bring their innovation to market is delaying thinking about regulations and how these will affect them. Noncompliance can cost medical device start-ups millions per year and with hundreds of international requirements and regulations being continuously amended, it’s easy to feel overwhelmed or miss something.

How IMed Consultancy is supporting FemTech

In agreement with the rest of the team at IMed Consultancy I have taken on a leading role in nurturing FemTech start-ups and am proud to have become a mentor for femtech labs.

The lab’s mission is to accelerate fair healthcare for all women around the world, and to ultimately help women reach their full potential through better understanding their bodies and cyclic nature. In my role I offer expertise in business growth and guidance on Medical Device and IVD Regulatory and Quality strategies – as part of IMed’s ‘giving back’ to industry – to this amazing community.

Regulatory and compliance support for FemTech founders & leaders

That’s why relying on a team of highly skilled and experienced medical regulatory professionals, with proven sector expertise such as IMed Consultancy’s can really make a difference when it comes to the future of your start-up! We are delighted to be working with some talented women heading innovative early stage women’s health businesses already, like Marissa Fayer, CEO of Deeplook Medical, which is providing consistency and a vivid display of tumour morphology to help ensure the highest standard of care in oncology, or Shannon Beattie, CEO of GenoME Diagnostics, a spin out from Queen’s University Belfast who are developing novel blood tests for earlier detection of diseases in dire need of clinical improvement. Their initial current target is the development of a novel test for earlier and more accurate detection of ovarian cancer, which is already expanding into new disease areas.

Need help keeping up with regulations? Contact us at hello@imedconsultancy.com

[1] HealthTech Magazine, “What is Femtech and How Is It Evolving in Healthcare?”

[2] FemTech Insider, “So What is FemTech, Anyways?”

[3] Global Market Insight, Femtech Market Size & Forecast 2023-2032

[4] McKinsey, The Dawn of the Femtech Revolution, 2022

[5] Failory, Many startups fail and why