Author Archives: Dellshire

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.

CAPA/ PROBLEM SOLVING

Focused multi-team effort was oriented around several CAPA projects.  Effectively completed root cause analyses, validation, design transfer and implementation. Structured problem solving approach was customized for medical device client and deployed to resolve open CAPAs; implementation process architected for rapid deployment and risk management of product design and manufacturing process changes.  Training program created and deployed throughout operations, quality and engineering organizations.

DESIGN CONTROL/DESIGN VERIFICATION

A major medical device manufacturer requested a recommendation for improving its ability to select statistically valid sampling plans for Design Verification activity supporting its new product in development.  An assessment determined several opportunities for improvement including clearly delineated design verification requirements; identification of risk classification; leverage of legacy acceptance criteria; new acceptance criteria with statistical rationale.  The output of this database was valuable in planning and writing the appropriate design verification protocols.

PRODUCT QUALITY IMPROVEMENT

Issues associated with medical device product quality, design and manufacturing were resolved on a recent new product introduction; improved supplier quality management practices; organized strategic approach to resourcing, team structure, task management, communication and reporting. Communication operating mechanisms were established to effectively report to corporate executives and local management team and leaders.  Sustaining engineering approach and tools were deployed to maintain improved levels of product quality upon reducing customer returns by 35%.

DISPOSABLE DESIGN AND DEVELOPMENT

Disposable component and thermoplastic films were designed for medical device product and drug containers.  Materials Science and Chemistry expertise was leveraged to provide functional material selection and configuration; provided material properties testing, (density, DMA, abrasion and DART impact resistance, coefficient of friction, layer thickness measurement using stereomicroscopy) using partner laboratories and plastics processing suppliers; completed manufacturing development of multilayer films using prototype and pilot film co-extrusion supplier partners.

INSTRUMENT DESIGN AND DEVELOPMENT

Medical device instrument software and electronics design and analysis. Failure investigations and root cause analysis of failed printed circuit boards were completed following critical failure observation in R&D laboratories and the field; objective technical review of in-house designs and redesigned PCBA were completed; component stress and derating analyses were completed.

QUALITY SYSTEM DESIGN AND IMPLEMENTATION

An industrial supplier of metal components was entertaining a pharmaceutical client in need of components for a drug delivery device and was in need of a quality management system to meet the requirements of this customer.  Dellshire consultants authored and deployed a complete quality management system, customized and “right-sized” for their business scale and processes.  The supplier then was able to secure this new business and develop a new business segment for medical products.

FASTENERS EVALUATION

Fasteners used for assembly and manufacture were assessed for their design appropriateness, including head design, driver design, fastener material, interfacing materials, insert design and torque specifications and limits. Theoretical finite element modeling of fasteners and empirical data generation were used to successfully complete project concerning a medical device electromechanical instrument.  This project eliminated issues associated with missing and loose instrument fasteners following distribution and field use.