Ling Tong Email and Phone Number

The thought leader that envisioned the CVAC system in the realm of kidney stone care. Led the development of the CVAC system from concept to commercialization. The CVAC system is a paradigm shifting product that enabled physicians to produce superior stone free outcomes that simply were not possible before. This system positioned the company for explosive growth by far exceeding both customer and sales expectations. • Shared the vision and fostered the belief that a paradigm shifting solution exists in a well established market • Inspired the product development team to do the best work of their entire careers• Hired most of the foundational employees that created a bright vibrant high achieving culture that celebrated wins

Project Manager UroLift UL400: P13 Program, the evolution of the UroLift UL400: P12 Device • Led the project team and launched a product that reduced cost of goods by 12% and increased Product Reliability over 99.5%• Redesigned nine distinct mechanical components and developed new production processes.• Managed a total of 11external consultant direct reports, and 1 internal direct report over a total of 7 distinct projectsLed the design and development of UroLift UL400: P12 Program, a novel and game changing device treating Benign Prostatic Hyperplasia. • MDM: 2011 Medical Device Excellence Award – Silver Winner.• More effective than drugs, and none of the side effects from surgery.• Launched the design effort that reduced device part count from over 250 components to 42 components.• Conducted design reviews, optimized parts using Finite Element Analysis and emphasized Design for Manufacturing.Led material testing efforts to gain multiple regulatory approvals: FDA IDE, FDA DeNovo, NSAI• Subject matter expert on potentiodynamic corrosion testing and leachable/extractables testing. • Managed external cadaver labs, analytical test labs, design consultants, toxicologists, and analytical chemists.

Led the development of a unique spinal implant targeting annular repair• Technical design leader on a minimally invasive implant and insertion instrumentation.• Responsible for designing custom test methods simulating a functional spine unit.• Performed failure modes and risk analysis on a viscoelastic implant anchoring system.• Worked with key surgeons in animal and cadaver studies.• Managed outsourced test labs and design consultants.

Project Manager for the inhaled GLP-1 Project• Coordinated efforts of various groups including dosage form, mechanism design, reservoir development, superseal strip, and industrial design.• Managed the GLP-1 master project schedule.• Examined technical risks and developed a logic flow chart of all possible combinations of the device.• Wrote an invention record of “Synchronous dual extrusion” and performed testing to demonstrate improved aerosol generation performance. Led all battery related development efforts on the AERx portable inhaled insulin device• Internal subject matter expert on all battery development activities.• Tested and evaluated various lithium ion and lithium polymer high rate battery chemistries.• Performed cycle life testing, abuse tolerance testing, storage testing and safety testing.• Developed a custom high rate battery, which reduced size by 67%, weight by 79% and produced 450% more power than the first generation battery pack.• Designed and built custom automated battery cycling fixtures.• Visited multiple battery factory manufacturers and performed manufacturing quality evaluations.• Cultivated relationship with numerous battery manufacturers.• Insured integration with electronic hardware and firmware for optimal battery fuel gauging, performance, and safety cutoffs.Led key efforts on inhalation flow management• Worked as the technical lead for the AERx device for a successful Pk/Pd clinical trial.• Evaluated various mechanical and electro mechanical concepts to manage the inhalation flow.• Invented a “burst valve” mechanical device to regulate the inhalation rate of the patient• Developed fixtures and equipment to analyze the inhalation profile of various users.

Led the device development of the Macroflux combination drug delivery project• Developed the mechanical components for an injection molded, spring actuated handheld micro-needle drug delivery system.• Optimized the parameters of the application device for superior drug delivery.• Designed and manufactured the next generation disposable drug delivery mechanism that used 55% less material and had a 43% lower profile than the previous version while meeting or exceeding all system requirements.• Received leadership training, breakthrough achievements, enrollment, and intensive alignment.

Responsible for leading development teams in a small and aggressive company dedicated to resorbable implants and biosurgery.• Led cross-functional teams on successful launch of craniomaxillofacial and neurosurgical products. Delivered the LP (low profile) cranio-facial system in less than one year. Designed a battery powered driver, a sternum closure device, and evaluated new polymer formulations.• Project management experience includes bioabsorable implant and instrumentation design, single use disposable products, custom implants, and reusable capital equipment.• Wrote protocols for design validations and conducted design reviews.• Cultivated relationships with surgeons and business development managers in order to refine development strategies.• Established groundwork for the research and development test lab.

Responsible for managing the biomedical mechanical test lab for an established orthopaedic medical company.• Designed tests and procedures for diverse biomechanical testing focusing on clinically valid situations and ASTM protocols.• Communicated test results through written reports and oral presentations.• Performed stress analysis on test specimens.

Responsible for assisting the engineering group of a high end loudspeaker manufacturing company. Built prototypes that were integral to the launch of the Boston Acoustics Rally component and subwoofer series as well as the RM coaxial series.• Assisted in the design, development and manufacturing of home and car audio loudspeakers. Supported new system development by building prototypes and by testing numerous configurations.