You’re a budding medical device startup with a crazy awesome concept for a device that your proof of concept research reveals would fill a niche need for consumers that currently has no competitors. How do you increase the odds that your concept successfully navigates the design process without unnecessary hitches and setbacks?
You could start by formulating an ironclad bill of materials (BOM) strategy that covers all the regulatory bases of the U.S. Food and Drug Administration’s (FDA) 21 CFR 820.30 that sets out the requirements for device design and development.
Tamara Burch-Williams, a services implementation manager with MasterControl working with product management and systems development, said the most important stage in a device’s product development is the engineering segment.
“The design is the key to mitigate defects, ineffectiveness and unsafe products,” she said. “This can be achieved by incorporating a design control process as part of the quality system requirement” of 21 CFR 820.30.
For many device makers, design control documentation during this phase of a product’s life cycle can be the most painful. Matt Lowe, the executive vice president of product for MasterControl and a device SME who holds five patents, said the process’ propensity for being problematic can be eased by preparation on the startup’s part.
“This requirement indicates that document control is intended to be a prospective activity in the development process. You must incorporate a planning period into your development process upfront to ensure timely product launch and minimize the risk of product failure,” he said.
A BOM helps a device maker secure and analyze the utilization of resources through the product life cycle by forming an all-inclusive view of product specifications, which include parallel financial data. In essence, the role of the BOM is to provide design control throughout the product design approval process. It accomplishes this by capturing the device manufacturer’s interrelated practices and procedures, which results in greater consistency in the design process. More specifically, the BOM is a multi-level document that maintains an account of design and development activities, such as design change/revision, history, product use, cost, review and approvals.
“The BOM, as it applies to the quality management system (QMS), serves as a blueprint of a product and must be developed and managed in detail,” Burch-Williams said.
But as you can well imagine, there are a host of variables, such as changes in design, communication, complexities, timing and process workflow, that make creating and maintaining an accurate and consistent BOM a challenge.
As previously mentioned, a BOM covers a series of functions of design and development that include design, engineering, quality and purchasing groups. The multiplicity of these various processes presents a logistical and management challenge during the design approval process to an organization’s quality team and its QMS, particularly if the organization is relying on a paper-based or hybrid data system. Some of these speed bumps include:
However, introducing and implementing a controlled BOM management procedure can allow BOM activities to increase the turnaround time of deliverables and improve design control during the product design approval process.
Breaking down the components of design control — from design and development planning all the way through design history file compilation — the key to successful management is, not surprisingly, document management. Implementing an integrated, digital document management system will allow you to take command of all your documents as they pertain to product design and development precisely because its puts controls in place for you to drive and make sense of your metadata.
A dynamic, automated QMS will allow your organization to keep BOM data and updates organized, efficient and readably accessible in real time by your organization’s engineering team, the quality team and the C-level to help ensure that your device product design approval process undergoes as few hiccups as possible. That way, you’ll be able to see the original vision of your device concept carried through from design and production phases all the way to market and into the hands of health care professionals and patients.
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