Transformative Legal Solutions for the Women's Health Revolution
Women are not small men.
Women's health companies are dedicated to introducing innovative solutions that address a wide range of issues faced by this demographic in the healthcare industry.
These issues include (i) a lack of access to health solutions for conditions specific to people with a uterus, and (ii) disregard for the unique ways women might experience conditions that impact all humans.
As a founder or executive in the women’s health space, you're at the forefront of a dynamic sector of the healthcare industry where the potential for growth and positive change is vast.
And while women’s health is often considered a "niche" market, women make up 49.72% of the global population. That’s a pretty big opportunity!
We know that with great opportunity comes even greater complexity, especially when it comes to navigating the legal and regulatory landscape affecting women’s health and FemTech companies.
As a healthcare innovation law firm, Nixon Gwilt Law proactively monitors and responds to the constantly changing regulatory environment and policy landscape so we can help our clients navigate these complexities and enter the women’s health market with a solid revenue model and a firm foundation of compliance.
Clients Say:
It's a good thing [NGL requested a full demo and product walk-through] because it made us review everything before it's too late…we may have been really focused on our business model or our contracts, but then they also brought our attention to the fact that no, you also need to be really careful of how you're laying out your platform, all these different considerations."
Navigating the Intricacies of Women's Health Regulations and Data Privacy
Women’s health companies need to navigate multifaceted legal challenges, including:
Privacy and Security concerns: Many technology companies in the women's health space collect highly sensitive personal data, including information on menstrual cycles, pregnancy status, or fertility. Some states are proposing privacy legislation that is specific to this highly sensitive data. We help women’s health companies protect their users and communicate transparently about how data is being used.
Varying state legal restrictions on reproductive health: The women’s health legal landscape in the U.S. is constantly in flux, especially following the Dobbs v. Jackson decision, and women’s healthcare innovation companies need to ensure they’re compliant with all relevant regulations. For example, we’ve worked with an accredited online pharmacy company to ensure they follow all U.S. state laws around prescriptions specific to women’s health.
Difficulty with device authorization: Getting FDA authorization for innovative women’s health devices—particularly ones that are the first of their kind to go to market—can be challenging. We’ve helped numerous women’s health and Femtech companies navigate the FDA approval process and get medical devices authorized.
Marketing hurdles: Women’s health companies also face marketing challenges due to restrictive social media policies that censor ads mentioning women's body parts or health conditions. We can offer guidance on language you can use in ad campaigns to make it more likely you’ll get advertising approval on major platforms.
Funding problems: While there are many female founders in this industry, there aren’t a lot of female investors. Many women’s health companies still struggle to secure venture capital and historically have lower valuations. We can help you build a comprehensive and organized corporate governance foundation to build trust with investors and demonstrate a successful legal strategy in your pitch deck.
Comprehensive Legal Support for Women's Health Innovation Companies
We help women’s health innovation companies:
Tailor corporate structures to fit the unique needs of women's health business models.
Navigate reimbursement pathways.
Design revenue models that align with the women's health and wellness market dynamics.
Optimize sales strategies to resonate with women's healthcare providers and end-users, so they can expedite deal closures.
Recruit key personnel with expertise in women's health, from clinical insights to FemTech.
Draft investment documents with a keen understanding of the women's health landscape and investor interests.
Navigate FDA processes specific to women's health devices and software, including those related to reproductive health, maternal care, and other specialized areas.
Create a robust IP strategy that ensures proprietary women's health innovations remain safeguarded.
Stay ahead of Privacy and Security mandates crucial for sensitive women's health data and patient confidentiality.
Launch with comprehensive regulatory compliance in place.
Clients Say:
“I love that you can deal in the grey zone, because I’m totally in that space with my own business.”
Why Women’s Health Innovators Choose Nixon Gwilt Law
Nixon Gwilt specializes in working with healthcare innovators who want to protect their interests and maximize opportunities. That’s the work we do, day in and day out.
Every year, we work with numerous healthcare innovators who are revolutionizing the way women care for their bodies. Our expertise in the women's health industry isn't just theoretical; it's practical, tested, and refined through years of hands-on collaboration.
We also take a unique, comprehensive approach to working with our clients. Yes, we analyze regulatory issues, but we’ll also help you figure out how regulations fit into your overall business model and your revenue stream.
NGL also takes an innovative approach to service delivery. With flexible fee structures and a collaborative approach, we can extend expert legal guidance without adding to your in-house team.
We’re pretty unique in the healthcare innovation law firm space as a female-founded, female-led, and majority-female firm, too.
Clients Say:
"NGL provided consistent guidance as we continued to develop our platform and acted as a real ally, ensuring that we continued on the right path."
Frequently Asked Questions
What is the difference between Women's Health and FemTech?
Women's health is a broad field focused on the unique health concerns and needs of women, encompassing everything from reproductive health and maternal care to issues like breast cancer and menopause.
FemTech is a specific sector within women's health that uses technology to create software, solutions, diagnostics, products, and services tailored to women's health issues. While FemTech is an exciting and growing sector, it represents just one facet of the larger women's health landscape. At Nixon Gwilt Law, we're dedicated to serving companies across the entire spectrum of women's health, including (but not limited to) FemTech.
What are the most common legal challenges faced by companies in the women's health sector?
Companies in the women's health sector grapple with multifaceted regulatory requirements, including navigating the requirements for product safety and efficacy, securing FDA approvals for specific devices and treatments, and ensuring compliance with evolving data privacy laws, given the sensitive nature of women's health data.
Intellectual property protection for innovative solutions is another pivotal consideration, as is adapting to the changing landscape of reimbursement. Addressing these challenges effectively requires specialized legal expertise and a deep understanding of the women's health industry.
What makes NGL different from other law firms?
We have a deep bench of experts who have a highly nuanced understanding of the women's health and FemTech industries. Our specialized team has extensive experience working directly with innovators in this sector, which allows us to offer tailored legal strategies that many generalist firms might overlook. We don't just offer legal counsel—we anticipate challenges and leverage our unparalleled industry knowledge to help you move your business forward.
Why is data privacy particularly crucial in the realm of women's health and femtech? How can NGL help my company ensure data privacy compliance?
Data privacy is paramount in women's health and femtech due to the deeply personal and sensitive nature of the data collected, such as reproductive health details, menstrual cycles, and more.
Ensuring the confidentiality of this data is a legal necessity, and it’s also crucial for building trust with users. At NGL, we provide comprehensive guidance on data collection, storage, and sharing, so our clients stay compliant with local and state privacy regulations and establish robust data management practices to safeguard user information.
I'm an international women's healthcare innovator looking to enter the U.S. market. How can NGL help me?
Entering the US market presents a unique set of regulatory and legal challenges. NGL can assist international women's healthcare innovators by providing insights into the U.S. regulatory environment, assisting with FDA approval processes, ensuring compliance with intellectual property laws, and offering guidance on market-specific nuances in women's health.
Our team understands the complexities of transitioning from international markets to the U.S. landscape, and we're here to facilitate a smooth entry.
How does NGL navigate the FDA approval process for women's health devices and treatments?
NGL has a proven track record of guiding clients through the FDA approval maze. We begin by understanding the specific nature of your device or treatment, then chart a comprehensive strategy that aligns with FDA requirements.
Our team continually stays updated on evolving FDA guidelines for women's health so we can streamline the approval process for our clients.
How much do your legal services cost?
We offer flexible fee structures and work with our clients to develop a legal strategy that meets their budget.
Resources for Women’s Health Innovators
Want to know more? Explore these resources for women’s health companies:
Podcast episodes:
Marija Butkovic, Founder and CEO of Women of Wearables, speaks to Carrie Nixon about what the funding landscape looks like for women’s healthcare companies, and gives tips on marketing an early or growth stage business.
Telemedicine is incredibly well-suited for customized menopause care—find out why in this interview with Gennev CEO Jill Angelo.
Trish Costello, CEO of Portfolia, talks to Carrie Nixon about why women’s health is underfunded and how to drive innovation in this niche.
Roundup: Nixon Gwilt Law’s 2023 List Of Venture Funds And Accelerators For Women
You can also get legal and business insights delivered straight to your inbox by subscribing to our monthly email for novel and disruptive healthcare business leaders.
Pioneering in women's health requires top-tier legal counsel, and Nixon Gwilt Law delivers unmatched expertise tailored to your business goals.
Schedule an introductory call with one of our attorneys now to find out how we can help your company navigate the complex legal landscape of the women’s healthcare industry and position you for success.