The Acceleration of Medical Device Development:
How to Build and Plan for Successful Execution of Early-Stage Product Development
Join BioscienceLA and UCLA Biodesign for a conversation about the acceleration of medical technology development. Hear from two leading medical device product design experts on how to successfully develop early-stage product development timelines and reach key milestones. During the development of a novel medical device, it is essential to think and execute in a phase-specific approach, not working to develop a complete solution at once but rather taking into account multiple considerations throughout the development cycle. Robert Miros, CEO of 3rd Stone Design, and Michael White, CTO of Fusion Biotec, have over 40-years collectively of medical device design and development experience working with innovators to advance their products through successful regulatory clearances in the U.S. and abroad.
Participant Biographies
Robert Miros is the CEO of 3rd Stone Design Inc., a privately held product design and development company engaged in engineering, manufacturing, and product strategy. Products developed run the gamut from medical devices, to alternative energy systems, to consumer products. Business activities include design, distribution and marketing of its own products, joint ventures with research institutions and government entities, and consulting services to multinationals, NGO’s, and inventors. Through the company’s subsidiary, Hadleigh Health Technologies, LLC, a novel global health device, the Pumani bCPAP, is manufactured, sold and distributed in 36 countries. 3rd Stone Design is a founding partner of the NEST360 program, funded by the MacArthur, Gates, and ELMA Foundations to reduce neonatal deaths in Sub-Saharan Africa by 50% over the next 10 years. Mr. Miros is a prolific inventor with over 40 granted patents to his name. He earned degrees in engineering product design and international relations from Stanford University. He has taught design, engineering, and entrepreneurship as a lecturer and guest faculty at Stanford and Brown Universities.
Michael White is CTO of Fusion Biotec – where he brings over twenty-three years of product development and engineering experience, mainly in medical devices. Early in his career, he worked for General Motors designing and developing engines and electric vehicles. In 2000, he received the GM Fellowship to attend MIT Sloan. While studying business at Sloan, he developed a passion for medical technology, and founded Cambridge Medical Devices, LLC, to develop and patent an orthopedic surgical navigation system. More recently, as director of product development at Beckman Coulter, he recruited and led a team of fifty engineers responsible for development of IVD instruments and reagents, life sciences instruments, electronics, and mechanical components and subassemblies. That team’s value engineering effort saved Beckman Coulter over $250 million. More recently, Mr. White has consulted on FDA design control compliance and DHF remediation for 510(k) and PMA instruments. Mr. White takes a hands-on chief engineer approach, with expertise in rapid product development, design controls, and mechatronics in all phases from concept to manufacturing and sustainment. In addition, Mr. White has expertise in Value Engineering and compliance related to DHF, GMP, and design controls on 510(k) and PMA devices. He was featured in the OC Register’s “Spark of Innovation.” BSME and MSME from Stanford.
David J. Whelan serves as Chief Executive Officer of BioscienceLA. Having spent 20 years in Los Angeles, he is passionate about leading the growth of a vibrant ecosystem that will create new opportunities for all stakeholders. Dave is a seasoned strategy, business development, and general management executive, building businesses and inspiring entrepreneurs at the intersection of technology, health, and wellness. His experience spans genomics, wearables, digital health, consumer health services, wellness and nutrition, enterprise health services, and healthcare providers, among other areas. He was an integral part of the creation of New York Genome Center, a unique not-for-profit scientific research institute, where he served as Senior Vice President, Business Development & Chief Strategy Officer. Recent engagements include incubating a digital health and media start-up, steering a multi-year strategic and financial plan for a leading synthetic biology organization, launching a cancer diagnostic spinoff from a leading hospital, and developing a market assessment and strategic plan for an innovative integrative healthcare research institute. Dave has spent many years as a start-up advisor, mentor, and judge with organizations like Larta Institute, Cedars-Sinai Accelerator, and Women Founders Network. His experience also includes product management and channel strategy for a division of 24 Hour Fitness, where he helped to launch one of the first fitness wearables. Earlier in his career, he spent over six years as a retained executive search consultant. Dave began his career with a biotechnology incubator in San Francisco. He holds an MBA with Honors from the UCLA Anderson School and a BS in Symbolic Systems from Stanford University, and he remains very involved in alumni activities with both schools. He also studied at London Business School and Carnegie Mellon University.
Onike William, NP-C, MSN, APRN, PHN., is a Nurse Practitioner currently practicing as a Nurse at UCLA Santa Monica Medical Center in the Cardiac Intermediate Care Unit. Throughout her career, healthcare research and innovation has been at the forefront of her interests, and Onike is an inventor on multiple patents. Her portfolio of work includes projects to combat postpartum depression with alternative therapies, leverage nanotechnology to accelerate wound healing, and augmented reality software to assist surgeons. Onike earned her Masters in Nursing from Charles Drew University where she was a member of the Sigma Theta Tau Honor Society and earned the award of Excellence in Clinical Nursing Practice. Onike completed her BS in Psychology from Boston University and Nurse Practitioner certification at Charles Drew University of Medicine & Science, where she was an Albert Schweitzer Fellow.