Author Archives: Dellshire

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.

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.

SOLUTION YIELD ACCOUNTABILITY IMPROVEMENTS

A pharmaceutical manufacturer contacted Dellshire to improve their raw material yield and accountability practices. The company reported an unacceptable variation in yield calculation which had resulted in CAPA’s and nonconformances which were open for an unacceptably long period of time.

The Dellshire business process improvement SMEs leveraged LEAN/Six Sigma methodologies and multiple tools throughout the project execution. Work sessions with a cross functional team were conducted to methodically investigate the contributing factors which resulting in significant learning related to causes for the current performance.

Issues relating to process equipment variation, data entry documentation and calculation errors, and inadequate specifications were identified and characterized at a detailed level. An action plan was created and implemented which included the development of a new yield worksheet with improved, simplified, calculations. Process capability studies provided additional control and benefits and also were used to establish the acceptance limits for yield calculations and reestablished process limits.

The company piloted the changes and later reported greater yield of raw material; reducing costs significantly and also superior compliance as accountability methods and accuracy were improved.

DESIGN HISTORY FILE REMEDIATION

Completion of a program to implement product design improvements prompted a major medical device manufacturer to update their DHF which did not keep pace with regulation or previous product changes. Dellshire SMEs worked with the management and technical teams to devise a product portfolio plan that would leverage required remediation work pertaining to Design Inputs. Products were then prioritized based on schedule and business impact, and work was initiated. On occasion, it was found that some requirements were needed that were not defined or understood. Dellshire led the effort to produce test samples, define and qualify inspection methods, and generate the data necessary to understand legacy product performance and define the Design Inputs.  This template was applied to all products in the product family, and once complete, the company was able to move forward and complete design verification on the improved product designs.

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.

FDA 483 REMEDIATION: VERIFICATION AND VALIDATION

A medical device manufacturer received a FDA 483 concerning their procedures and practices regarding design verification and validation. Dellshire experts completed a deep dive to fully understand the breadth and scope of the issues and provided a comprehensive plan to address the company’s needs. Procedures for Design Controls were remediated as well as procedures for other key aspects of their business including Risk Management, CAPA, Complaint Management, and Document Control. Once all procedures were approved and implemented, training was conducted and a retrospective review and qualification of design changes was completed in accordance with these procedures. Completion of these tasks and providing this service allowed the company to address the concerns of FDA, improve the integrity of their quality system and reinforce the quality of their products in the market.

ROOT CAUSE ANALYSIS AND IMPLEMENTATION

Product complaints were being received by a medical device manufacturer and resolution of a design issue was needed to address product quality and safety issues. Dellshire engineers recommended that a root cause analysis be completed using a structured problem solving approach. After a clear and accurate problem statement was created and agreed upon, root cause analysis tools were deployed including Is-Is Not, Fault Tree Analysis, Fishbone Diagram and Contradiction Matrix to quickly identify probable root cause. A test machine was designed and built and was used to evaluate design options. The business was able to evaluate the implementation plans for the viable options and determine the appropriate course of action based on the work that Dellshire completed.