Category Archives: Project Management And Leadership

MANUFACTURING SITE TRANSFER

Leveraging of a large, focused, manufacturing plant was desired by a major medical device manufacturer.  Dellshire leadership and several industry experts led the project and completed many tasks required to close a small satellite manufacturing facility and transfer all equipment and documentation to the focus site.  Organizing documentation and preparing for ERP integration was the initial focus of the team. Concurrently,

Dellshire drafted the manufacturing strategy, and once approved, limited equipment purchases were made and legacy equipment was moved. QS procedures were updated to accommodate the new products and processes and upgrades to manufacturing work instructions insured the transfer of knowledge and preserved focus plant compliance. Once all processes were validated at the focus plant, products were released to market, enabling the company to reduce their manufacturing site base and achieve their goals.

NEW COMPANY STARTUPS

Dellshire leadership and several industry experts recently helped two different, unrelated startup companies in need of various elements of strategic guidance and hands-on, early-stage product development. Both companies were similar in size, each with 1-3 full time employees and their objective was to develop and implement a new technology or product into the medical device space. With fairly minimal experience in developing medical devices,

Dellshire was able to step in as an interim head of R&D and small engineering team on a short/medium-term project. A comprehensive plan was created intended to define and enable a core set of competencies required to continue feasibility and development risk reduction. Additionally, a ‘right-sized’ documentation system was provided to insure regulations were met at the right time in their business/product evolution. Completion of this work provided the companies what they needed to continue and complete product development with a structured approach complaint with regulatory requirements.

TECHNOLOGY TRANSFER

Led project to transfer an acquired medical device business, including manufacturing process and engineering design knowledge and specifications. Dellshire project management and engineering services were leveraged to insure performance to schedule and overall timeline.  Pilot build start up was completed on-time five months from start and subsequently released to the field.  Portfolio included 2 instruments and 30 disposable and electronic kits. Impact areas: Design History File (DHF), Operations, ERP, V&V, Quality Systems (QS), Regulatory Affairs/Quality Assurance (RA/QA), Supplier Management, embedded software remediation, complaint handling.

DUE DILIGENCE

Provided technical support to corporate business development acquisition team.  Area of focus included R&D portfolio review and assessment, quality operations and management processes and staffing, manufacturing operations. Assessed selected elements of compliance to FDA and global regulations.