At Xinetix, every team member is a discipline specific expert; meaning your project doesn’t get allocated to a preexisting pool of generalized talent. Our model ensures that any person or team designated to your project is at the highest level of proficiency in your product category and is carefully selected to meet your exact requirements. It translates to peace of mind that the project will get done on time, on budget and on goal.
Hal is Founder and CEO of Xinetix, Inc., a business and technology incubator assisting start-up to early-stage medical device companies with product and business development, strategic and operational planning. 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 Chairman and Director on the Board of three client companies. Over 40 years of experience in technology development and business management has afforded Hal in-depth cross-functional business experience. He has had direct functional responsibility for R&D, Operations, RA/QA, and Intellectual Property management.
Hal is a recognized expert in the fields of ophthalmology, electrosurgery, and respiratory care assisting over 80 medical device companies with successful product development and process implementation in support of new product commercialization. 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 over 25 medical product liability and patent infringement cases; a recent infringement case resulted in an award of over $200 million for the client.
Hal obtained a Bachelor’s of Science in Engineering degree with and emphasis in Electrical Engineering from California State University, Fullerton in 1976. His early career as an electrical engineer and project manager was focused in the areas of communications, control systems, and digital imaging with several aerospace and commercial companies.
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.
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 1, 2, 3 and combination devices. Gary’s efforts have been instrumental in positioning five startup companies for successful acquisition by strategic partners and investors. Gary was granted a Bachelors’ of Science Degree in Industrial Engineering from California State University, Long Beach
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 ___ 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
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
Experienced in systems, analog, digital, and power electronics circuit designs including: linear and switching power supplies and power amplifiers, EMC, power distribution, motor control systems, high voltage ultrasonic drivers, embedded microprocessor control systems, audio and video electronics, all types of sensors used in medical devices. Expert in cataract surgical procedures and equipment with patents issued for active ocular infusion pressure control (Patent No. 6986753)
Hai is a graduate of California State University, Fullerton with a Bachelor’s of Science, Electrical Engineering
Larry is a seasoned product development manager with a core expertise in electronics engineering. Key accomplishments include development of 50 different products for 40 different companies. Specialty(s) include embedded systems, wireless products, low power design, communications, video product, instrumentation, among others. Larry also has a vast knowledge of designing for regulatory approvals due to his experience in the medical, aerospace and consumer industries.
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.
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.
Expert in Unity3D Pro Applications development, Self-Adaptive Artificial Intelligence (AI), Evolutionary Computation (EC), Artificial Object Neural Networks (NN), Genetic Algorithms, Intelligent Agents, Networked Distributed Computing, Fuzzy Logic, Adaptive Machine Learning, Pattern Recognition, Predictive Analytics, Signal Processing, Sensor Processing (spectral, imaging, sound), Data Mining.