Wellness by Design
Volume 2, May 2024
Welcome to the latest edition of Wellness by Design, Guidea's quarterly newsletter dedicated to exploring the frontiers of healthcare innovation through the lens of human-centered design.?
This month, we share a curated collection of insights, updates, and success stories showcasing the power of design in driving meaningful change in healthcare. From the remarkable growth of Software as a Medical Device (SaMD) to the groundbreaking achievements of our award-winning partners, we explore the trends and events shaping the future of health and wellness.
So join us as we dive into the latest developments in the world of healthcare design and innovation, and let's design a better future together.
SaMD: Pioneering the Future of Healthcare
The world of SaMD is experiencing unprecedented growth and innovation. In our recent article, "The First 500 FDA-Cleared SaMD," we explore the current state and future potential of this transformative technology and provide a database of FDA-cleared SaMD products..?
As of April 2024, there are ~530 FDA-cleared SaMD products across various categories, with radiology leading the way, followed by cardiology, diabetes management, and neurology. The global SaMD market, valued at $1.2 billion in 2022, is projected to reach $5.4 billion by 2032, fueled by advancements in AI, cloud computing, and personalized medicine. Our analysis of various sources, including the ARPA-H Nationwide Health Innovation Network, USPTO, and ClinicalTrials.gov, reveals a promising future for SaMD innovations.?
We are also excited to share, in a groundbreaking development, the FDA recently approved MamaLift Plus?, the first Digital Therapeutics (DTx) specifically for maternal mental health. Developed by Curio and studied through a randomized control trial, this milestone marks a significant step forward in addressing the unique mental health needs of new mothers.?
As the SaMD landscape continues to evolve, Guidea remains committed to helping pioneers in this space navigate the complexities of designing, developing, and deploying these life-changing solutions.
FDA Clearances: Paving the Way for Innovative Solutions?
Four Femovate sponsored startups have now achieved significant regulatory milestones by obtaining FDA clearance for their groundbreaking products.?
DeepLook Medical has received FDA 510(k) clearance for DL Precise, a software tool that automates the measurement of suspicious objects in medical images. DL Precise's innovative features include one-click activation, streamlining the segmentation process and eliminating the need for complex manual setup. The technology behind DL Precise is patented and forms the foundation for future products that will utilize radiomic data to offer essential metrics and bolster AI/machine learning applications in medical imaging. DeepLook Medical has also achieved UK regulatory clearance for DL Precise, further expanding its reach and impact.
Cosm Medical has achieved FDA clearance for Gynethotics? Pessaries, the first personalized pessary available to patients. With nearly 10 million pessary configurations that clinicians can conveniently order online, Gynethotics? Pessaries offer an unprecedented level of customization and precision in pelvic care, setting a new standard in gynecology.
The PherDal Kit, developed by PherDal, has been cleared by the FDA for over-the-counter home use by individuals who have been unable to conceive through intercourse or have chosen not to conceive through intercourse. This sterile, safe, and science-backed at-home fertility option promises to provide a much-needed solution for those struggling to conceive, single parents by choice, and members of the LGBTQIA+ community.
Nesa Medtech, a company addressing clinical unmet needs for patients with symptomatic uterine fibroids, has received FDA 510(k) clearance for its Fibroid Mapping Reviewer Application (FMRA). This technology enables physicians to generate 3D models of the uterus from ultrasound images, assisting in the accurate diagnosis and planning of interventional procedures for patients with uterine fibroids.
Celebrating Healthtech Pioneers: Award-Winning Innovations?
It is also exciting to see a number of our partners —Amalgam Rx, BrightInsight, WellDoc, and ClosedLoop—are included? on Newsweek's prestigious World's Best Digital Health Companies list for 2024. This inaugural ranking showcases 400 global leaders across seven critical digital health segments. We're honored to have been part of their journey through our collaborative design partnerships.
We also extend our heartfelt congratulations to BBImaging, a member of Guidea's 2023-24 Femovate cohort for winning the FemTech World Maternal Health Innovation Award. BBImaging's groundbreaking remote sonography product, Telescan, promises to revolutionize maternal care access and experiences for women worldwide.
领英推荐
We are also immensely proud of our founder, Theresa Neil, for being named the Female Executive of the Year: Consultation by the 2024 Titan Women in Business Awards, for her tireless efforts in pioneering women's health equity through Guidea’s Femovate program. Theresa's visionary leadership and unwavering dedication to empowering women through innovative design have been instrumental in driving meaningful change in the femtech space. Congratulations, Theresa! ??
Transformative Trends: Shaping the Future of Health and Wellness
The healthcare landscape is undergoing a much needed transformation, driven by visionary innovators and cutting-edge technologies.
Historic Funding for Women’s Health
The Biden Administration's Fund for Women’s Health Research, signed into law in March, marks a historic moment in the fight for women's health equity. This legislation paves the way for the ARPA-H Women's Health Sprint for Innovation, a groundbreaking initiative that seeks to revolutionize women's healthcare through unconventional approaches and innovative research.?
Guidea is actively collaborating with visionary partners to develop and submit grant proposals that leverage the power of human-centered design to address the most pressing challenges in women's health.
The Rise of Conversational AI
As traditional chatbots become increasingly obsolete, the rise of conversational AI represents a paradigm shift in how we approach patient engagement and support. The future lies in AI-powered solutions that deliver personalized, empathetic, and contextually relevant interactions, redefining the way patients interact with healthcare systems and access support.?
Our recently released eBook, "Designing Conversational AI for Patient Health," co-authored by our Director of Product Innovation and Strategy, Jeanine Harriman, and our founder, Theresa Neil, provides a comprehensive guide for product teams looking to create engaging, effective, and empathetic conversational AI experiences in healthcare.
Recognizing that Food is Medicine
The concept of "Food as Medicine" is gaining traction in the healthcare industry, recognizing the crucial role that nutrition plays in preventing and managing chronic diseases. By integrating dietary interventions and personalized nutrition plans into patient care, healthcare providers can empower individuals to take control of their health and well-being. Innovative solutions, such as digital platforms that connect patients with registered dietitians and AI-powered apps that provide personalized meal recommendations based on individual health profiles, are transforming the way we approach nutrition in healthcare. Companies like Life Chef are combining the power of personalized nutrition with the convenience of meal delivery.?
The Evolution of Gyms as Health Centers
The boundaries between fitness and healthcare are blurring, as gyms evolve into comprehensive health and wellness centers. By incorporating preventive care services, such as health screenings, blood tests, and personalized pharmaceutical interventions, alongside traditional fitness programming, gyms are becoming one-stop destinations for holistic health management. This trend is driven by the growing recognition of the importance of preventive care and the role that lifestyle factors play in overall health outcomes. As gyms transform into clinics, they are partnering with healthcare providers to offer integrated care models that address the full spectrum of an individual's health needs.
Designing a Brighter, Healthier Future Together
In this edition of Wellness by Design, we've explored the remarkable advancements and innovations that are transforming the healthcare landscape. At Guidea, we are inspired by the visionary leaders, passionate innovators, and dedicated healthcare professionals who are driving this change. We remain committed to our mission of designing a brighter, healthier world for all by collaborating with our partners to create solutions that empower patients, improve outcomes, and revolutionize the way we approach health and wellness.
Join us on this transformative journey as we work together to design a future where every person has access to the care they need, delivered with compassion, dignity, and respect. Stay connected with us by subscribing to our newsletter, following us on social media, and reaching out to explore how we can collaborate to bring your vision to life.
Thank you for being a part of the Guidea community. We can't wait to see what we'll achieve together!