Helene Chon is a cross-functional medical device and combination product (FDA Class I, II, III) expert. A lifelong learner, she has accumulated 25+ years of diverse experience in development, manufacturing, quality, and leadership roles.

This versatility enables a holistic and strategic approach to product development. By integrating cross-functional and downstream perspectives into her work seamlessly, she proactively mitigates costly redesign, remediation, and manufacturing down time. With fewer distractions, clients can focus on bringing life-saving and therapeutic products to patients in a safe and expedient manner.

Helene has been instrumental in early implementation and expansion of the combination product programs at Genentech and Gilead Sciences. Either as an independent consultant or as a member of reputable medical device design firms, she has also consulted for companies such as Covidien, Ethicon Endosurgery, Lifescan, and Stryker Neurovascular as well as various startups.

Helene holds a BSME from Stanford University and an MBA from SFSU.

– Expertise: design control (including verification and validation), risk management, human factors, statistical techniques, test method validation, equipment qualification, process validation, cGMP, root cause analysis

– Therapeutic Areas: virology, oncology, ophthalmology, endocrinology, cardiology, gastroenterology

– Product Types: implant, pen injector, prefilled syringe, kit, IVD device, catheter, electromechanical device

– Manufacturing Processes: formulation, fill/finish, injection molding, laser welding, ultrasonic welding, adhesive application and curing, assembly, labeling, packaging, serialization

– Regulations/Standards: 21 CFR Parts 3/4, 210/211, 600, 809, 820; EU MDR/IVDR; ISO 13485, 14971

– Tools: Minitab, JMP, Excel, Solidworks, Veeva