Benjamin Rush

R&D Engineering Leader with over 24 years of experience in product development and innovation. Results- oriented with proven success in developing and commercializing medical devices and combination product systems with robust quality and design control integrity. Experienced in building and leading high throughput, high performance technical teams and collaborating with internal and external business partners to achieve business objectives.

Pfizer Inc. Lake Forest, IL 2015 - present

Sr. Dir., Head of Device and Combination Product Innovation and Development

▪  Directed product development and LCM for combination products that support global small molecule and biosimilar portfolio. Related internal and external technologies include: nested glass pre-filled syringe (PFS), plastic PFS, cartridge based PFS, auto-injectors, multi-dose pen injectors, on-body injectors, CSTD, dual chamber and pre-mix bag systems.

▪  Using a Customer Centric Innovation model, partnered with Commercial and Medical to identify unmet customer and patient needs and unite these with emerging technologies for safer, easier to use, and cost-effective new products.

▪  Partnered with manufacturing stakeholders for instrialization, scale-up, and Design Transfer. Recent launches include NexJectTM PFS, Nivestim® PFS, and NyvepriaTM PFS.

▪  Led Due Diligence for evaluation of external technologies and product deals for inorganic growth. Provided contracting terms and development plans that optimize the partnership and manage business and technical risk.

▪  Partnered with Legal to manage device Intellectual Property (IP): catalog key competitor patents, capture internal IP, and perform FTO assessment for external deals.

▪  Managed a team of 35 engineers: Design, Development, Systems and Risk, Human Factors, and Material Science in the development of combination products in accordance with relevant regulatory and corporate QMS requirements.

▪  Experience directly interfacing with Health Authorities in regulatory submissions and inspections. Partnered with quality, regulatory, and manufacturing leadership to define Design Control procedures and policies for combination products to address development and post -market quality and regulatory requirements.

Hospira Inc. Lake Forest, IL 2010-2015

Manager, Consumables R&D

▪  Led Innovation and pipeline development activities for medical devices and combination products. Closely partnered with Commercial to identify unmet user needs; coordinated internal and outside development resources to derive low-cost and manufacture-able designs; evangelized projects across business solos and with executive leadership.

▪  Managed engineering staff and associated R&D budget in the development of medical devices and combination products. Providing leadership for project definition and scoping, resource planning, technical capability development, and strategic outsourcing.

▪  Oversaw design development and LCM for various technologies: reconstitution systems, PFS, vial access systems, IV bulk fluid containers, lure activated IV access sites, and pain medication injector systems. Launched ADD-Vantage ADDaptorTM.

▪  Design owner for Device Change Review Board and for post-market consumables device DHF remediation.

Radius Product Development Chicago, IL 2008-2010

Director of Engineering

▪  Managed an engineering team developing a wide range of medical device and packaging related new products. Responsibilities included resource planning, staff development, quality management, and engineering services sales and business development.

▪  Program managed the development of the Roche MyDose electromechanical on-body injector. Provided system integration for an international team of three design firms to develop the mechanical architecture, motor drive, and needle insertion technologies.

▪  Program managed the turn-key product development of the 3M Taper Dry Powder Inhaler (later licensed to Adamis Pharma) based on a novel micro-embossed substrate technology. Oversaw the development of mechanical solutions and IP for dose counting, moisture control, and substrate advancement and tension control.

Nanosphere Inc. Northbrook, IL 2005-2008

Engineering Lead

▪  Designed and developed a reagent storage and micro-fluidic cartridge for Nanosphere’s VERIGENE® molecular diagnostic gold nanoparticle chemistry. Conceptualized and commercialized core technology from initial sketches to cGMP manufactured and FDA approved application. This became Nanosphere’s first shipping product and basis for ongoing revenue generation.

▪  Developed requirements and specifications for micro-fluidic cartridge and electro-mechanical pump and oversaw software algorithm development through Design Verification.

▪  Developed key patented technology: indirect ultrasonic energy fragmentation and denaturing of DNA to consistent base pair lengths; valve control and precise metering of micro-fluidic volumes for molecular biology assay.

▪  Designed, built, and validated automated assembly and testing stations for laser welding, heat staking, part washing, and automated in-line flow and pressure decay testing.

IDEO Evanston, IL 1999-2005

Project Manager and Engineer

▪  Led the mechanical design for 3Com AudreyTM internet appliance and managed design transfer at Flextronic Guadalajara. Received IDSA Bronze award 2001.

▪  Project manager and lead designer for Eli Lilly Humatrope® reconstitution kit. Led project from concept to mfg production of 1.4M units/year. Received MDEA Silver award 2005.

▪  Led mechanical engineering team in the turnkey development of the Gyrus Diego powered dissector for rhino logical and otolaryngological procedures. The resulting product had high impact on marketplace, creating a 200% increase in disposable revenue and increased surgical efficiency to allow an additional procedure per day. Received MDEA Silver award 2004, IDSA Gold award 2004, and Business Week Gold design award 2003.

▪  Project managed the concept generation of a physical therapy product for ChicagoPT, a local robotics startup. Received IDSA Silver award 2005.

BSME, Northwestern University Evanston, IL 1992-1997