Chris Folk, Ph.D. Email & Phone Number

San Diego, California, Us

Leading a team of fifty engineers to develop a next generation CGM (continuous glucose monitor) wearable platform / product.

Carlsbad, Ca, Us

Chartered with overhauling culture, engineering team, and products en route to re-commercialization.• In 2020, resolved existential product deficiency, insufficient shelf life• Overhauled product development systems, and resolved FDA Form 483 deficiencies across functions• Spearheaded the engineering team's growth to a complete team of engineers, program managers, and technicians. Established mechanical, electrical, software, and system engineering capacities• In 2021, upgraded laser technology to double the energy per pulse to expand future product portfolio. • Led the upgrade of CPU to modern hardware, software, and operating system.• Obtained first 510k clearance for product with stabilized shelf life.• In 2022, obtained second 510k clearance for new catheter product.• Directed successful lithotripsy research, opening access to an $8B market opportunity. • Grew patent portfolio from 7 to 11 issued U.S. patents.

San Diego, Ca, Us

Expanded management scope to both engineering and device GMP manufacturing. Re-introduced PEC-Encap to the clinic.• Achieved programs within a $2.5M budget by exceeding development timelines critical for venture financing and growing team from six to fourteen employees. • Shortened time to clinic for design iterations by 3 months.

San Diego, Ca, Us

Guided engineering team to design and develop products from conception to successful clinical introduction, including intended launch product, PEC-Direct. Led device development, aseptic processes to combine cellular drug substances with the device, and clinical techniques with physician partners. • Designed new products and surgical tools, co-led collaboration with W.L. Gore, and sponsored successful fundamental research on microscale transport and inhibition of foreign body response. • Authored successful Investigational New Drug (IND) submissions/amendments to FDA and Clinical Trial Applications (CTA) to Canada regulatory authority. • Won CONNECT Most Innovative New Product Award: Life Science Products, Clinical Stage for PEC-Direct.

Thousand Oaks, Ca, Us

• Repatha autoinjector caused drug product glass vials to fail during clinical trials. FDA mandated issue resolved before commercial launch. Worked with tiger team to identify root cause, develop mitigations, and salvage Repatha autoinjector schedule for launch. Repatha generated $300 million worldwide by 2017.• Co-developed device strategy for $11B+ device-dependent revenue. Canvassed needs and identified drug delivery solutions across Amgen’s portfolio, including 20+ candidate drugs spanning Cardiology, Neurology, Inflammation, and Oncology. • Propelled decision to invest $75M in Unilife by orchestrating feasibility studies of autoinjector, wearable patch, and nascent technologies, such as sensors, connectivity, microneedles, and exotic actuation from both established companies and startups.

Minneapolis, Minnesota, Us

Led cross-functional teams through either partial or entire product development process to commercialization for three catheters: HyperForm balloon catheter line extensionNavien guide catheterOrion stent delivery microcatheterThese product launches were conducted in concert with the Solitaire stentriever and the Pipeline flow diverter, which revolutionized the treatment of ischemic and hemorrhagic stroke, respectively.Led early R&D efforts with 7+ direct reports for additional neurovascular access tools, including microcatheters, guide catheters, balloon catheters, pumps, and valves.

Van Nuys, California, Us

• Cardiovascular: Technical manager for NIH-funded minimally invasive heart surgery research to resolve patent foramen ovale. Co-invented device published as first all-MEMS surgical tool.• Endoscopy: Redesigned 1mm-diameter biopsy forceps for major device manufacturer. Leveraged designs to create world’s smallest 0.4mm-diameter biopsy forceps. • Electrophysiology: Designed array of high surface area electrodes, subxiphoid epicardial lead delivery tools, mechanical switches, and lead attachment devices for bi-ventricular implantable cardioverter defibrillator (ICD). • Spine: Co-designed 1mm diameter cutting tool with aspiration for endoscopic spine operation. Designed microfluidic system for removal of macerated tissue. Designed Microfabrica’s first commercial product, a micromachined probe card contact, which maintained company solvency.

Phd, Aerospace, Aeronautical And Astronautical Engineering

Ms, Engineering Mechanics

Bs, Aerospace Engineering