An Eclipse, Shocking News About FemTech Funding & PQE Groups’s 25th Anniversary

Ciao peers, colleagues, family, and friends! Welcome to another edition of my monthly roundup of interesting industry trends and insights. If you’re a first-time subscriber, welcome! This month we’ll be exploring interesting new developments in the world of wearables, R&D, and emerging markets, three promising topics poised to elevate care worldwide.

FDA Seeks To Stop The Spread Of Viruses

On the 11th of this month, the FDA announced the formation of a New Advisory Committee on Digital Health Technologies. This committee is purpose-built to, “help the agency explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software.” In addition to helping prevent the spread of foodborne pathogens, the agency has now broadened its purview to encompass computer viruses as well, noting, “Digital health is a rapidly evolving, cross-cutting space that spans a wide range of technologies. In addition to the technologies mentioned above, it also includes issues such as decentralized trials, patient-generated health data and cybersecurity.”

Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health is optimistic about the rapidly growing medical wearables sector, noting how this new technology? is designed to bring “prevention, wellness and healthcare to all people where they live – at home, at work, in big cities and rural communities.” Wearables companies seeking to reach patients whenever they are - be they in underserved rural communities, or receiving care at a research hospital in the beating heart of one of our busiest metropolises - will receive the same cybersecurity and data security guarantees under this new watchdog organization’s guidance.?

I imagine this will lead to interesting developments in the world of healthcare compliance in the months to come, on the heels of a similar update to Medtech software rules earlier this year.

Male-Led FemTechs Secure The Most Funding

When it comes to the world of FemTech, startling new research suggests that male founders of FemTech companies actually raise more money than Women.?

That’s correct: startup companies founded by women offering products and services for women, garner less of financial backing from Venture Capitalists than their male FemTech founder counterparts.?

As a female founder and CEO of a quarter-century-old company that operates in 28 countries, I’m well aware of the challenges women face in the male-dominated business world, and female founders are often overlooked. Even though 70% of FemTech Startups are founded by women, we still have this startling statistic from PitchBook, “Last year, 57 femtech companies with all-male founding teams raised $731m, while 105 FemTechs with all-female founding teams shared a total $408m.” Roughly $13 million per male team vs. $3.8 million per female team.

Graceful, Ageless - FemTech For All

This Irish Times article on FemTech for Menopause spots an interesting trend on the rise as Developed Nations begin facing the reality of an aging population.?

Like all medical devices and tools meant to give us a better understanding of the human body to preserve our good health, it’s exhilarating to see the FemTech sector is broadening its reach to all women in need of care, from girlhood to old age.?

I believe this trend may be the tip of the iceberg when it comes to destigmatizing menopause and allowing women to age gracefully and without the taboos associated with it.?

Trips to Mexico, Boston and PQE Group’s 25th Anniversary

I was lucky to witness a once-in-a-lifetime event while visiting Mexico, a solar eclipse from the beautiful Sian Ka'an lagoon and nature reserve on the Yucatan Peninsula.?

This beautiful wetland is replete with jaguars, dolphins, and other coastal Caribbean wildlife that truly lives up to the translation of its Mayan name: “gate of heaven” or “place where the sky is born.”

In astrological symbolism, an eclipse represents change - not necessarily positive or negative, but merely a reference to the engine that drives life itself.?

It’s been a wonderful month full of memories and life-changing events including the 25th Anniversary of PQE Group. I was happy to share this momentous occasion with my Partners, colleagues, and other leaders who joined in the celebration.?

It's amazing how quickly PQE Group has grown from just a handful of dedicated employees into a diverse international organization spanning 28 countries and counting around the globe. I am grateful to all my colleagues who have helped and supported our mission to improve patient care by overcoming regulatory and compliance hurdles, bringing their ideas to market, and impacting lives.

With November in full swing, I reflect with gratitude on the experiences I've encountered and the joy of reconnecting with both old and new friends.