Mark DeStefano

Develop and manage the drug delivery device strategy and device technology assessments for Teva including for current pipeline assets and for developing forward looking solutions for future applications and formulation technologies.

Lead Teva's device strategy and early device development and feasibility efforts for needed drug deliver technologies. SME in injectable drug delivery technologies. Developed and established the device feasibility and early device development Advanced Technology function at Teva for innovative products. Responsible for device strategy against pipeline, landscaping, selection, new technology development and feasibility functions. Initiated device platforming efforts for Teva global. Lead Drug Delivery Device Technology and Combination Product Development for injectable drug delivery.

Design and Development of novel disposable drug delivery systems and wearable injector devices for large and small molecule biologics with the goal of providing simple, end user centered, self administration devices. Responsible for the Design, Development and Testing of small and large volume, high reliability disposable wearable injector systems and sub systems including high speed automatic needle insertion mechanisms. Mentor and lead design team on key product design elements. Participate in all aspects of design conceptualization, physical design, design analysis, tolerance analysis, FMEA and Risk Assessment activities. perform rapid prototyping for proof of concept activities. Manage external suppliers for low and high volume molded parts fabrication and custom mechanical parts production. Assemble, test and perform design and functional assessments of first generation rapid prototypes and initial high volume first generation design components and systems. Inventor/co-inventor on several patents and patents pending for novel drug delivery systems and subsystems.

Custom medical product design and development in the Neonatal and Respiratory therapy space. Developed Neonatal resuscitation device and associated disposable tubing set currently in use. Developed a custom infant surgical bed system currently in use as multiple facilities. Developed an Adult resuscitation device to replace the aged and error prone BVM used for emergency resuscitation. This device provides pressure controlled resuscitation and has an Auto-breath feature that allows the user to easily provide rescue breath to a human in distress. responsibilities included design, development, prototyping, detail drawing creation, vendor selection, assembly instructions, verification testing, risk analysis, and 510K submission support.

Consultant for medical device design, development, prototype fabrication, system engineering, and Legal product liability consulting. Developed respiratory therapy devices and cosmetic surgery devices. Also designed a specialized medicated horse food pressing and cutting device and a designed and installed a portable horse ring irrigation systems to reduce dust.

Portable Insulin Pump system engineering, design and development. Program manager for the technical development of the Ping remote controlled Insulin Pump and BG meter system. Responsible for all development activities, Design History File creation, Risks Assessment activities, Patent activities and supprot for 510K submissions. Disposable Infusion set design and development. Program lead for the development of a novel nitinol based infusion set for insulin delivery. Responsible for the product design and development, using external development consultants for performing development activities, and testing of initial designs including Animal testing. Subject Matter expert for Animas products related to Product Liability litigation and Patent Infringement litigation.

Implantable Optical Biosensor R&D, Design and Development. Development and testing of an implantable active optical glucose sensor. Responsible for grant management, mechanical and optical designs, prototype fabrication and lab and animal testing. Portable Insulin Pump design and development, Assisted with the mechanical design, development and manufacturing scale up of the first Animas pump systems including key product enhancements that reduced manufacturing time. Solely responsible for ETO sterilization validations of the disposable pump cartridge systems. Provided risk assessment, DHF and regulatory submission support for this device.

Development of Hi power Surgical laser systems, disposable fiber optic delivery systems and surgical instrumentation for tissue ablation and coagulation for various surgical specialties. Responsible for the mechanical redesign of the Surgical Laser systems CLMD laser. Developed a variety of fiber optical laser delivery systems and contact tips for laser surgery. Directed the delivery systems development team and was responsible for the manufacturing groups producing the disposable delivery systems. Helped establish the quality system and obtain CE approval. participated in CE an FDA audits. Performed risk assessments and provided documentation for FDA submissions and controlled product manufacturing. Designed, built, and was responsible for a class 10,000 level clean room for device manufacture and packaging.

Manufacturing Development Center, Automation Systems Design Bell Labs, Murray Hill, Morristown, Breinigsville. Design and development of custom automation system including vision guided precision laser die bonders and active optical fiber aligners.