Hal is the Founder and CEO of Xinetix, Inc., a business and technology development company assisting start-up to mid-size medical device companies with business development, strategic /operational planning, and product development. He has held positions as Chief Executive Officer, Chief Operating Officer, General Manager, and Vice President of Research and Development; in addition to serving as company Director on the Boards of client companies. Over 40 years experience in business management and technology development has afforded Hal in-depth cross-functional business experience. He has had direct functional responsibility for R&D, Operations, RA/QA, Marketing, and Intellectual Property management.
Hal is a recognized expert in the fields of ophthalmology and electrosurgery assisting over 50 medical device companies with successful product development and process implementation in support of new product introduction. He has been awarded eight medical device patents for his efforts in these areas. Hal has served as an expert witness and technology consultant in 22 medical product liability and patent infringement cases; a recent infringement case resulted in an award of over $240 million for the client.
Hal obtained a Bachelors of Science in Engineering degree with and emphasis in Electrical Engineering from California State University, Fullerton in 1975. His early career as an electrical engineer and project manager was focused in the areas of communications, control systems, and imaging with several aerospace and commercial companies.
Hai Bui Sr. Director Electrical Engineering Program Management
Hai is a seasoned electrical engineer and program manager with over 33 years of experience in managing, designing, sustaining, and manufacturing medical devices following structured PDP and GMP processes in compliance with safety (IEC60601), EMC, and regulatory requirements
Passionate creative problem solver and a dedicated hands-on technical leader and project manager with a proven ability to translate customer requirements to product specifications and develop product from concept to production and support it throughout its life in a cross-functional environment.
Hai is a graduate of California State University, Fullerton with a Bachelor’s of Science, Electrical Engineering, 1991.
Gregg Hughes Director Mechanical Engineering
More than 35 years’ experience in the medical device industry designing complex mechanical, electro-mechanical systems, and disposables / accessory products with a primary focus in ophthalmology. A recognized expert in plastic injection molding and rapid prototyping Gregg has developed an extensive portfolio of patented product designs for Phacoemulsification, Vitrectomy, and LASIK procedures.
As a serial entrepreneur and key contributor to several successful medical device startup companies, Gregg was instrumental in leading agile project teams creating design innovations resulting in issuance of 13 patents in a wide variety of technical disciplines. Gregg earned BS Mechanical Engineering from California State University, Long Beach 1982 and a Master’s in Business from California State University, Fullerton 1987.
Gary Mocnik Director of Quality and Regulatory Affairs
Over thirty years’ experience in diverse product lines and technical disciplines within the medical device industry. A proven record of implementing technically sound and cost-effective quality systems, organizations and managing teams for numerous medical device startup companies. Expert at USFDA QSR, ISO 13485 implementation and CE Marking under the Medical Device Directives.
A proven record of product development, organizational development, and conducting clinical trials resulting in FDA approvals and marketing clearances for a wide range of Class 3, 2 and combination devices. Gary’s efforts have been instrumental in positioning multiple startup companies for successful strategic acquisition. Gary was granted a Bachelors’ of Science Degree in Industrial Engineering from California State University, Long Beach in 1985.
Dr. Joely Gardner Director of Usability / User Experience
Dr. Gardner is a licensed psychologist with more than 20 years of experience in product development, voice of customer research, customer experience research and usability testing. She focuses on developing research findings that management can trust and creating actionable recommendations for change.
Joely is a highly rated part-time professor at California State University at Fullerton in the graduate-level Customer Experience and User-Centered Design Certificate Program* and has taught “Measuring Customer Satisfaction” at UCSD Graduate Business School Extension Program.
She regularly works with companies such as Sony in the development of new and innovative consumer products. She has worked with Quest Diagnostics, Fuel Cell Energy and ITT in international Voice of Customer projects. Other clients include Intuit, CareFusion, and Bespak Injectables in the UK to name a few. She is a highly skilled researcher in product development, voice of customer, concept testing, and usability testing of products, websites, mobile devices, and software.
Joely received her doctoral degree in Cognitive Psychology from Boston University, a master’s degree in Business Education from Boston University, and a B. A. in Business Administration from Simmons College in Boston.
Richard Cook Director Software Development / Program Management
Highly motivated and energetic professional leading both projects and teams to successful completion. Responsible for Team Management, Team Building, Project Planning, Budget Planning, Project Scheduling, Project Life-Cycle, Regulatory Requirements, Customer Interface, and General Department Planning. Complete integrated system Life-Cycle experience from R&D level prototype design to production design and transfer including service/maintenance and finally end of life. Strong understanding of the FDA device submittal process, including the unique requirements for software. Champion of forward design for Mechanical and Electrical systems to cohesively integrate with system Software design. Practitioner of Agile project management Richard invaluable design and management skills to the Xinetix team from prior experience at Cardiac Science, Sonendo, and Source Scientific.
Richard received a Masters of Science, Computer Science from California State University, Fullerton in 2004, and a Bachelor of Science in Animal Science from California State Polytechnic University, Pomonain 2000.
Tim Hays Sr Software Developer / Cognitive Scientist
Developer of advanced Artificial Intelligence algorithms, mobile Apps, Web, and video with over 40 years’ experience as a developer on over 100 products/projects in the areas of basic science, artificial intelligence (AI), entertainment, education, business training, corporate marketing, biotech and defense. Published senior member of the IEEE with design patents awarded relating to artificial intelligence and display of intelligent animated game characters.