Regulations, Documentation, and the Digital Thread

Regulations, Documentation, and the Digital Thread

Architects and engineers develop architectural drawings with the intent to develop design ideas into a coherent proposal, to communicate the design to clients, builders, tradesmen, and specifically for approvals from governing agencies. In the case of governing agencies, they communicate the designer’s understanding and execution against local, regional, and national design standards and regulations. The completed set of documents are submitted for review and approval. A basic set of plans contains the following components:

  • Title and Legend Sheet
  • Plot Plan (site plan)
  • Foundation/Floor Plans
  • Elevations
  • Framing Plans
  • Window and Door Schedules
  • Details and Section Views
  • Mechanical/Electrical/Plumbing Plans
  • Specifications

Engineers and designers of Medical Devices produce similar sets of documents for the same reasons; develop design ideas into a coherent proposal, to communicate the design to clients, builders, tradesmen, and specifically for approvals from governing agencies. Specifically, compliance with quality regulations as outlined in Title 21 Code of Federal Regulations Part 820 govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. Two sets of documentation are submitted for review, the Design History File (DHF), and the Device Master Record (DMR).

The DHF contains all the information gathered along the development journey of the device. It contains the following:

  • Design and Development Planning
  • Design Input
  • Design Output
  • Design Review/Verification/Validation
  • Design Changes

The DMR details the specific materials, equipment, and environmental requirements for production. It contains the following:

  • Device Specifications
  • Production Process Specifications
  • Quality Assurance Procedures and Specifications
  • Packaging and Labeling Specifications
  • Installation, Maintenance, and Servicing Procedures and Methods

Traditionally, these are captured in documents and hundreds of rows and columns of spreadsheets and finally collated at the end of design development then presented to the governing authority in a large binder. A process that is time consuming, prone to errors and endless revisions—adequate in an earlier era where time to market and disruptive competitors were not major issues. And, useful for obtaining approvals, but time consuming and resource intensivegathering and collecting from disparate sources and processes, but not connected to any reality to derive useful information or analytics going forward.

Fortunately, many organizations are actively investing in projects related to Digital Transformation. While many miss the mark, the promise is still there to transform technology and processes to take full advantage of product data across the enterprise and across the product lifecycle to operate more efficiently and to avoid disruption. Innovation, growth, and compliance are the foundational goals of creating a Digital Thread. A Digital Thread enables full product lifecycle traceability, allowing previously siloed teams across the enterprise to work concurrently with the latest product information. It facilitates the generation of the DHF and DMR by creating connections to critical information, allowing you to track a product and its digital assets, from concept, through design, manufacturing, quality, and field maintenance. The generation of compliant document sets is largely automated, once the Digital Thread is in place, resulting in dramatic drops in data entry, eliminating spreadsheets and siloed data.

A Digital Thread is best developed within a product innovation platform, such as Aras Innovator, where all items are connected across the platform and across the lifecycle. A platform approach connects all users and critical information, cultivating continuous creativity and collaboration in a single environment. This helps you generate process improvements and develop innovative next-generation, higher-quality products, while transforming compliancy requirements, avoiding risk, and approaching any audit exercise with confidence. In addition, organizations that can connect siloed data, processes, and disciplines within a Digital Thread are better able to deliver on-time product launches, improve product quality and support, support new markets, new service business models, create new product offerings, and share backwards configuration and operating information to enable improved product designs and manufacturing quality.

This is the second in a three part series that explores the premise that the only efficient way to document a medical device product’s lifecycle and “Own its Lifecycle” is within a modern, resilient Product Lifecycle Management (PLM) platform where all requirements and design decisions are captured, and a traceability matrix or digital thread is automatically created as design work proceeds; not as an afterthought or manual effort. You can read the first in the series here: “Regulations, Documentation, and the Product Lifecycle”. The third in the series will be published next week. Also, learn more at our web site:

Sean Coleman