Kenneth Wu Email & Phone Number

California, United States

We are a clinical-stage medical device company developing a platform neuromodulation technology to treat diseases of undesired neural activity. Our initial indication is chronic pain.Learn more at: www.presidiomedical.com

• Instructor for medical device innovation courses to promote and develop awareness of medical device and healthcare innovation careers and methods.• 2017 Hong Kong DreamCatchers Medtech Hackathon at Hong Kong University• 2017 Health++ Seminar Instructor

• Mentoring of companies focused on needs with hardware solutions.• Specific focus on medical device / health technology companies.• Provide general product development, regulatory, quality, operations input.

At Siris Medical we are leveraging AI to improve outcomes for radiation oncology patients.• Heading company operations including quality, product development, manufacturing, and product commercialization efforts as well as managing the company IP Portfolio.

• Provided consulting services to provide medical device innovation training by applying design thinking processes to the healthcare environment for a large medical device manufacturer.• Learning modules included clinical observation at El Camino Hospital, needs identification and refinement, and brainstorming and ideation.

• New technology development services• Brainstorming• Prototyping• Testing• Vendor assessment

• President of the Biodesign Fellowship Alumni Association• Organized the SBAA board in its mission to provide professional development, networking, and service for Stanford Biodesign Fellowship program alumni. http://biodesign.stanford.edu/.• Held events with industry leaders to facilitate educational events such as policy related panels.• Maintained compliance with 510(c)(7) non-profit status.

Led development of company’s acute care product line platform including:o Customer (physician/caregiver) needs evaluationo Device component design and prototyping, human factors evaluationo Execution and management of product development under design control for clinical and market release and 510(k) clearance (drawing drafting, part sourcing, vendor management, in house assembly, verification & validation testing, clinical and full market release)Project management and execution experience from concept-to-commercialization.• Led submission efforts with regulatory group for 3 successful 510(k) clearances• Technical file development for product CE marking. • Managed and maintained product design history files (DHFs).• Ensured compliance with quality systems and preparation of risk management documentation (Hazard Analysis, Design / Component FMEA, Use FMEA, Process FMEA).• Represented the company during regulatory audits of projects for Design Control compliance• Provided materials selection assessment, test development across multiple product lines.Managed and developed IP portfolio growth from 1 prov. and 1 filed utility patent to 60 issued or allowed patents (100+ worldwide pending / issued patents). Inventor on 12+ issued patents and 20+ pending patents. Primary point of contact with legal counsel. Interfaced with legal counsel to guide IP-related strategic company issues.Cross-functional management experience (R&D, operations, materials, marketing, sales, upper management) and direct engineering management experience.Specific engineering product development tasks:o CAD (SolidWorks) modeling and drafting of components and assemblieso 3D printing for rapidprototyingo Development of detailed understanding of rotary die conversion processeso Adhesive formulation development for long term wear hydrocolloid adhesiveso Development of test protocols, execution, and documentation of results (technical reports).

Stanford, Ca, Us

-Animal Study device characterization: implemented key animal study for device for post-surgical scar reduction. Chronic study using a porcine model which required near daily evaluation. Fun fact: Included design and fabrication of protective "pig jackets".-Business end experience: negotiated licensing agreement for the company (Neodyne Inc) spun out of Stanford work with the Office of Technology and Licensing; identified key leadership for standalone operations outside of the university setting.

Boston, Ma, Us

-Performed R&D work to evaluate new microneedle platform for transdermal drug delivery including implementation of MATLAB image processing assessment program to determine penetration efficiency of microneedle array systems.

-Fellow in program leading to a number of experiences:--Evaluation of medical needs with a focus on plastics and reconstructive surgery.--Significant hospital and operating room (OR) observational experience--Development of device concepts, IP, and business models--Spin-out of InSite Medical Technologies, a company focused on improved delivery of epidural anesthesia (key prototype development, IP generation, license negotiation, company structure formation experiences)

Phd, Mechanical Engineering, Materials Science

B.S.E., Mechanical Engineering