Category Archives: Product And Manufacturing Development

DESIGN REVIEW: INSTRUMENT BOARD DESIGN

An R&D Project Leader at a major medical device manufacturer required a review of the electrical design of a new product.  This product was in development, and the primary focus of the Design Review was to be a derating analysis of the components and a thorough inspection of each printed circuit board layout. This review would support the design release for engineering builds and the subsequent release of design verification units. Dellshire SMEs completed an independent technical review utilizing proven techniques for board designs which includes providing a list of issues/findings; discussion of any identified or potential issues discovered; recommendations for resolving identified issues; recommendations for improvement of the design to prevent potential issues or in support of good design and manufacturing procedures. The review met the clients schedule needs and provided several key areas for improvement or risk reduction. In addition, new design approaches were identified which would improve the robustness of the design.

TRANSLATION SERVICES: SOFTWARE AND MANUALS IMPLEMENTATION

During the integration of an acquired product line, it was desired by a mid-size medical devices company to update the product manual and provide the manual in additional languages.  It was also desired that several languages be added to the capability of the software and the graphical user interface (GUI) of the instrument. Dellshire resources completed the required translations from English to five foreign languages for the instrument operator’s manual as well as the software GUI.  Prior to start, a Translation Verification project was completed on the software including 210 (42 x 5 languages) screenshots used in the Operator’s Manual and 155 screenshots (31 x 5 languages) generated from 7 common error messages; 90+ legacy issues were identified with the translations that were completed and implemented by the founder company. Operator’s Manual branding updates and translation display edits were completed on 14 foreign language manuals; Service Manuals were updated similarly.  These changes allowed the company to increase sales in foreign markets they currently enjoyed with other products.

SOFTWARE ISSUE RESOLUTION/IMPROVEMENT

A medical device manufacturer requested that Dellshire investigate an unexpected operational error in a fluid processing system; solutions were being routed to incorrect containers resulting in unacceptable mixing and waste levels. It was desired by the company to understand further if a software bug is present or if conditions were met for this to occur.

Dellshire software and mechanical experts reviewed run logs and error reports as well as conducted internal testing on a hardware simulator. A code review was also completed and subsequently a code change was proposed to resolve the logic error. Dellshire installed the code fix for this bug and re-ran all protocols that the company had identified with solution handling errors.  After analyzing the test results, the results show that the system operation is now consistent with the instrument logic and that the system is operating as intended and designed.

SOLUTIONS STABILITY STUDY DESIGN – SME DATA REVIEW

A major provider of solutions based medical devices and drug products sought consulting advice to analyze their existing stability database and prepare stability summary reports in support of several pre-sub 510k submissions. This activity was required to fulfill a commitment made to the FDA. Dellshire expertise ensured the timely preparation of the required stability summary reports in support of several key products. Dellshire consultants provided timely and skillful technical advice, data analysis expertise and technical writing skills in order to ensure the client satisfied their internal and external regulatory commitments within the required schedule.

BIOCOMPATIBILITY AND EXTRACTABLES TESTING

A major medical device manufacturer needed to implement material changes to their product line with outdated regulatory files. Dellshire experts designed and provided biocompatibility (ISO 10993 Part 6) and extractables testing protocols written for the family of products. Procedures and processes were reviewed; studies were designed and monitored at contract laboratories that conducted the biocompatibility testing. A laboratory was contracted to complete extractables testing and materials evaluations. Dellshire reviewed and provided guidance on completion of the extractables protocols and draft reports from the analytical laboratory. This project provided the data and information needed to update the regulatory files for material change control and keep the products on the market.

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.

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.

COMBINATION PRODUCT DEVELOPMENT

A comprehensive Product Development Process was created and customized for a pharmaceutical company engaged in new product development of combination products (drug/device) considering new rule released by FDA for combination products (21CFR Part 3); Completed audit of new, draft, Design Control procedures and completed authoring of updates. Multiple client engagements were completed in this area.