Passionate advocate for use of artificial intelligence and innovation in medicine to transform global healthcare for both children and adults.
Maurizio Vecchione
From his LinkedIn:
I am focused on driving high impact solution to help improve the health of the planet and of all humans on it. I believe that solving some of the world’s biggest problems unlocks some of the greatest opportunities. I am an advocate for climate and health innovation, health equity, an impact fund leader, and a global transformation architect.
My career spans over 30 years at the forefront of climate tech, global and public health, focusing on innovation to improve the lives of the world’s most vulnerable people. I am the Chief Innovation Officer of the Terasaki Institute for Biomedical Innovation, a non profit where I am helping a strategy for translation of breakthrough technologies in life sciences and bio-medicine, for planetary health and human health. I am also jointly appointed at the non-profit Washington Global Health Alliance, an alliance that federates the leading organizations working to achieve global health equity. I am also the President of Openwater, an early stage company pioneering new modalities for stroke care and prevention as well as neuroscience and neurodegenerative disease.
I am an investor in life sciences and advise multiple venture and private equity funds, especially around impact investing, including as a Partner at Ethos Capital and at Adastral Funds.
Previously I led Global Good Fund, the collaboration between Bill Gates and Intellectual Ventures to invent and deploy technology specifically focused on improving life in developing countries, I have been at the forefront of research & development and commercialization of novel cancer screening digital health technologies, novel in-vitro diagnostics, disruptive biotechnology and medical devices as well as in the use of data science for predictive analytics in disease epidemiology and bioinformatics. I have pioneered new models for reverse innovation and private sector investment in impact innovation which I have executed with companies and governments around the world.
I also serve on the Board of the UCLA Ronald Regan Medical Center, the University of Washington Department of Global Health, the Italian Scientists and Scholars of North America Foundation (ISSNAF) and as the Pacific Leadership Fellow at the University of California, San Diego.
April Zambelli-Weiner
From her LinkedIn:
My #1 priority is to leave the world better than I found it.
Throughout my career as a Hopkins-trained epidemiologist and healthcare business innovator and entrepreneur, I’ve always had my eye and my heart on the world’s most marginalized and underserved populations. My primary motivator has never been the prestige of being a Johns Hopkins scientist. It has always been patient advocacy. Working to influence healthcare policy and navigating companies with promising research and medical technologies through this complex marketplace can transform healthcare from the top down and the bottom up.
In this industry, what I often see is a disconnect between innovation and our highly regulated medical landscape. My team and I work to bridge this gap, to help MedTech companies understand how to navigate the complex healthcare landscape with integrity so they can not only bring true innovation to the market but can also operate across the entire business lifecycle.
I bring a unique combination of expertise and experience as both an executive and a scientist with 20+ years of leading and executing real-world evidence strategy, evidence generation, clinical-economic studies, analytics, post-market study design, and value communication. The breadth and depth of my journey has given me a comprehensive integrated view of the marketplace as I work to bridge the gaps that hinder healthcare innovation from reaching patients.
I believe in maximizing the micro-opportunities of addressing humanity’s rarest diseases – which impact only 1% of the population – with new research and emerging medical technologies. As a family member and caregiver of patients with rare congenital defects, I am personally vested in changing the hierarchical model of healthcare to place the patient and the provider back at the center. My success in designing studies that impact policy change is a value-add to companies pursuing opportunities to enter the market.
Bradley Bostic
Experienced board member and innovative business executive. High achievement as a visionary leader building and operating disruptive companies in competitive industries, achieving consistent double-digit annual growth rates and billions in enterprise value. Skilled in all facets of leading a business including strategic planning, P&L, product development, infrastructure, operational processes, marketing, and scaling to the next level. Known for ability to drive meaningful purpose, attract and inspire A-team players, and establish the resources, focus, and alignment to ignite performance.
Strategic leader and investor who delivers shareholder value through targeted growth investments into multi-billion dollar addressable markets that are ripe for disruption. Expertise in capital aggregation including private equity and publicly traded special purpose acquisition company (SPAC) transactions. Delivered returns in excess of 2.2x invested capital and a top tier IRR over the past 20 years. Excels in harnessing collaboration across a syndicate of investors to optimize business impact and returns. Known for bold ability to pivot and sustain performance through economic cycles. Adept in drawing others into the conversation while providing decisive leadership direction for success.
Renae Franz
Industry leader with 30 years experience developing, leading and commercializing healthcare solutions, which includes efforts nationally & globally advocating for patient welfare & safety. Recently founded a Tech Indie beauty company that focuses on bringing technology together with sustainable, vegan, clean beauty. Whether it’s bringing a new healthcare solution to solve clinical problems, or in this case a cosmetic line that is good for you, the environment and our communities, my commitment is to empower people.
Jose Bohorquez
Jose founded Bold Type to help companies solve hard technical problems. He has more than a decade of experience as a technical contributor and executive in various industries. These include the semiconductor industry, medical devices, consumer electronics, health and fitness, and the Internet of Things. Jose completed his PhD in electrical engineering and computer science at MIT with a minor in business administration from the Sloan School of Management.
Carrie Britton
From his LinkedIn:
Over the past twenty-five years, I have honed my expertise in regulatory and quality affairs, with a specific focus on global regulatory strategies, FDA engagements, and compliance with international standards. My experience includes successful regulatory submissions, product approvals, and the development of Quality Management Systems (QMS) that align with both FDA and EU requirements. I have also led cross-functional teams to ensure product compliance and quality, fostering a culture of regulatory
excellence, and driving continuous improvement initiatives.
With a profound commitment to medical device regulation and quality, I manage complex regulatory landscapes, driving innovation and patient safety. My role involves being a communicative force, adept at negotiating and partnering with C-level executives to identify profit-focused opportunities and uphold the highest standards in the healthcare industry.
I am an accomplished regulatory consultant focusing strongly on FDA and EU compliance and strategic guidance for digital health technologies, medical devices, and combination products. With over twenty years of extensive experience, I have established myself as a vital partner for companies tackling the complexities of regulatory pathways, ensuring their innovative healthcare solutions achieve successful market entry. My expertise encompasses a broad spectrum of FDA premarket submissions, including the 510(k) premarket notification process, De Novo classifications for novel devices, and the demanding Premarket Approval pathway. Furthermore, I provide unwavering support for post-market compliance, ensuring my clients maintain regulatory alignment throughout the entire product lifecycle.
I am a leader in quality system management, empowering organizations to implement and uphold robust quality frameworks in line with FDA regulations, including 21 CFR Part 820. My services also include risk management, regulatory strategy development, and preparation for FDA inspections and audits, equipping my clients with the essential tools and confidence to meet and exceed regulatory expectations. By delivering customized solutions and harnessing my comprehensive regulatory knowledge, I enable companies to navigate challenges effectively and accelerate the commercialization of transformative medical products.
Gunter Wessels
Dr. Wessels founded LiquidSMARTS℠. He leads the global practice and is a member of the leadership team. He is passionate and dedicated to the improvement of human performance and ethical business practices in sales and marketing. His expertise comes from more than 25 years in the healthcare industry, including 14 years as a consultant to global and local marketing and sales teams. His clients gain rapid performance improvement through analysis, design, implementation of market approach, and commercial operations execution. He leads the field in providing micro-learning for business professionals. His micro-learning approach teaches people essential soft-skills and influencing and leadership behaviors in a few minutes per day.
Dr. Wessels is a sought-after speaker on the practical implications of industry change, and accelerating performance during disruption. Dr. Wessels has a Ph.D. in Management with an emphasis in Marketing and Psychology from the University of Arizona, an M.B.A. from the A. Gary Anderson Graduate School of Management, and a B.S. in Biology from the University of California.
Mohamad Foustok
Mohamad has more than 25 years of leadership experience developing secure software for mission-critical applications. His leadership experience ranges from CTO at a medical devices startup to Chief Software Architect at a Fortune 500 company. He has led hundreds of software projects ranging from embedded drivers in tiny microcontrollers to global enterprise and government communication systems with the highest levels of security. Mohamad designed and implemented the first and only in-browser crypto module to receive FIPS 140-2 certification and the only FIPS 140-3 compliant solution for securing commercial devices in classified spaces. He has worked directly with the highest security organizations in the US (NSA, CIA, DISA, DoD) to develop highly secure communication systems, and he designed one of the only software systems in the world that can thwart both Spectre and Meltdown attacks per NSA’s review. As a partner and Chief Software Architect at Bold Type, Mohamad now dedicates his vast software and cybersecurity expertise to helping medical device companies bring secure, FDA-compliant software to market. Mohamad received a Bachelor of Engineering degree from Imperial College, London, and has a Master’s Degree in Computer Science, completing all coursework required for a PhD with a 4.0 GPA.
Angelina Lisandrelli
From her LinkedIn:
Dedicated and passionate individual focused on patient safety and public health by continually educating, assessing, improving, and implementing quality systems according to regulatory standards and guidance in the medical device field. My mission extends beyond professional obligations and is driven by a deep commitment to safeguarding public health and ensuring patient safety and quality excellence in the medical device sector. This commitment includes reinforcing compliance with global regulatory standards and ensuring all products meet the highest safety criteria.
Additionally, I am passionate about mentoring and coaching young regulatory professionals, guiding them as they embark on their careers, and helping to shape the future of healthcare regulation through nurturing the next generation of leaders.
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