We founded Fusion Biotec in 2016 with the vision of creating a unique workspace that would allow us to provide thoughtful and creative design solutions for our clients. We set out from the start to search for a special space and build a place that would inspire us and our clients. Our Orange design studio is such a space. The building itself is classic, located in the Icehouse, in the heart of the orange packing district in the heart of Old Town Orange. We designed and built our workstations. Designed and implemented our interior style. And even designed and built the redwood deck leading to our entrance.
We were able to keep working during the COVID-19 shutdown. Our cloud based systems allow the team to work at effectively from home and now we are testing everyone once a week.
The articles listed below were written by our team and form a great reference for the medical product development process. These articles were drawn from our blog posts and published MPO magazine over the past several years.
Founders and Management Team
Bruce Sargeant, CEO
Mr. Sargeant co-founded Ocean Scientific, Inc. in 1980 and grew it to over 100 employees before selling in 1986. He next started Frontline Technology, Inc. and there created an indoor training ergometer for cyclists (called the Velodyne) and sold the company to Schwinn Bicycle a couple of years later. After spending a few years as a Schwinn VP, he left to build up a small software development company which grew into product development consulting. In 2004 Mr. Sargeant bought back his former company (now called Source Scientific). After rebuilding the company’s sales from $1m to over $14m, completed the sale of the company to BIT Analytical Instruments in 2012. He continued with the company as CTO of the US operations until March of 2016.
Mr. Sargeant has taught medical product development and FDA design control classes part time for the UCI Extension program for the past several years and has worked with the engineering school as a mentor.
Specialties: Analog electronics, physics and optics. Business focus and experience is in the start-up and turn-around arena, with special interest in the medical device space. BSEE from CSULB in 1975.
Steve Maylish, CCO (Chief Commerical Officer)
Steve Maylish has been a part of the medical device community for more than thirty years, serving management roles in business development, marketing and operations.
Early in his career, he held technical and marketing positions at Fortune 100 corporations such as Johnson & Johnson, Shiley, Baxter Healthcare and Edwards Lifesciences. After receiving his MBA from the University of California Irvine in 2002, Mr. Maylish focused his talents on two early-stage, boutique design and manufacturing firms, both of which successfully exited through acquisition.
Currently he provides guidance to lifescience startups through his participation on OCTANe’s LaunchPad committee, SoCalBio’s Selection Committee, UCI’s Applied Innovation Center and Business Plan Competition and Larta Institute’s NIH Commercialization Assistance Program.
Dave Hines, CAO (Chief Artistic Officer)
Dave is a native of Southern California. He is an inventive and experienced top-level industrial designer with exceptional project management and presentation skills. With over 25 years in the industrial design profession he has consistently demonstrated the ability to design and produce useful and highly marketable products that increase his clients market and share revenue. He is a creative problem solver with a reputation for innovative thinking and quick cost effective project execution.
His portfolio of successful designs includes: Meade Instruments, Bausch+Lomb, Fieldpiece Instruments, Bobrick, Ideal Industries, Siemens, Intralase, Staples, Cybex, Cardiomedics and Cosco Industries. He has an expertise in the design of medical devices, sports equipment, consumer electronics and hand held test devices. His designs have been featured in international design yearbooks and design magazines. He is credited with numerous design awards, design patents and was featured on the TV show American Inventor.
Michael White, CTO (Chief Technical Officer)
Michael White is a product development executive with 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.
Ross Dehmoobed , CIO
Ross Dehmoobed has been creating cutting-edge embedded software for safety-critical systems for over 15 years. His special expertise is developing hard real-time control systems. He is versatile enough to move up and down the software stack easily, from bare-metal firmware to iOS, Android Apps, and IoT devices. He has extensive engineering and product development experience in highly regulated industries such as healthcare and automotive.
Ross started his career in automotive, working on electric drives at General Motors where he was credited with multiple design patents. He has since been enjoying years of applying the same rigor to Software Development for medical devices. Some of the medical device companies he has crossed path with are Source Scientific, Sonendo, and Edwards Lifesciences. With years of experience leading software teams, Ross takes pride in quality of the software products delivered to clients, with special focus on state of the art technologies and testability of the applications.
Ross has a keen eye for software architecture, design, and future expandability of software modules. He is a strong believer in Agile software development practices and Continuous Integration (CI). Ross is solution-driven, and his goal is to deliver products that are functional, reliable, sustainable, and beautiful.