Ogden, Utah, United States
I have 35-year experience in the innovation and delivery of medical devices and combination products across start-ups and multi-national organizations in areas of manufacturing engineering, design, design controls and FDA market approvals, project management, and business strategy. I take pride in the diversity of technologies I have immersed myself in and the key leadership roles I have had in their development and success. My diverse experience has offered me opportunities to mentor others in realization of novel technology and new product delivery. I apply an agile mindset in my practice influenced by Deming, Schonberger, and other ‘Lean” pioneers whose teachings fit so well today for risk reduction and maturation of technology, assuring the right technology is developed for the right solutions. I am driven to deliver value to the business, the patient, the customer and user with success measured by speed to market, market acceptance and impact. I am driven to support others in their technical and business development, end to end, and assist in creating the operational environment to do so. Your success is the measure of my success.
Coach, mentor and builder of innovation culture and practice from Start-ups through large Global organizations with experience primariliy in value generation for Medical Devices.
Pioneered and mobilized agile innovation processes realizing several technology advances in alignment with corporate strategy and the needs of patients, users and customers. Recruited a community of passionate collaborators including R&D, Manufacturing, Medical Affairs, Regulatory, Legal/IP, Portfolio Management, UX, patients and more across North America, EMEA and Asia Pacific. Subject matter expert for the design, Regulatory approval, manufacturing and use of medical device disposables used in blood purification systems, including hemodialyzers, bloodlines and dialysis fluids. Corporate representative and national expert serving AAMI, ISO and IEC Standards Committees addressing medical systems for treatment of renal disease and detoxification including filtration products, fluids, bloodlines and machines used in treatment.
Managed the product development group responsible for design and development, FDA market approval, manufacturing transfer and market release of blood filtration dialyzers used for acute and chronic kidney failure and hemoconcentration. Served as project manager and group leader. Technologies included polymers and injection molding, adhesives, hollow fiber membrane spinning, assembly processes, packaging, sterilization and the related design verification and validation to assure engineering and user requirements are satisfied.....Promoted from Group Manager in this time period.
Consultant serving pharmaceutics, biologics and medical device industries. • Assessment of equipment capabilities and process flow for pharmaceutics manufacturer. • Expansion planning for injectables and solid dose. • Out-license planning for client IP and proprietary know-how.
Executive responsible for research and development operations of this medical device start-up focused on diabetic wound healing and regeneration of mesenchymal derived tissue. Technology involved aseptic manufacturing of an injectable FDA designated combination product and in-house management of a successful IDE Clinical trial demonstrating both safety and efficacy. This technology was sold in 2001. The technology was born from the company’s initial focus on Xenotransplantation of porcine pancreatic cells as a cure for diabetes. Negotiated and managed 10,000 sq-ft build-out for Clinical Trial product manufacture. Led development planning, capital & expense budgeting, and financial forecasting for this 26-employee operation.
Responsible for establishing infrastructure for development of the Encelle's initial development of a bio-artifical pancreas. Hired and contracted resources for R&D, RA/QA, Analytics and Engineering. Prepared pre-IND submissions to CBER and served as FDA liaison/contact. Managed organ fabrication and pre-Clinical studies, securing IACUC approvals. Supported design of physical Xenotransplant device and method of assembly.
Recruited to develop a polymer vapor deposition (PVD) process for non-immunologic encapsulation of a porcine based bio-artificial organ. This coating served as a membrane allowing transport of insulin, glucose and moieties required to sustain organ health. As a xenotransplant, the device was intended to resolve diabetes in the human population. Served as key GMP mentor for this early-stage company.
Managed 15-member cross-functional team in a $4mm+ project to re-engineer the DTXTM line of disposable blood pressure transducers. Responsible for design for manufacturability and reliability, development and qualification of assembly/test automation, and overseas transfer. Outsourced key subassemblies, reducing incoming part count 50%. Maintained close quality partnerships. Elliminated rework. Met cost, quality and customer service goals. Steered project through relocation to Singapore and plant closure in US.
Recruited to implement continuous improvement program into operations including elements of Lean Manufacturing and Six Sigma. Managed 16 engineers and technicians in technical manufacturing and packaging support of sensor based medical devices and accessories.