For all their innovation in science, technology, and engineering, aerospace and medical device engineers often rely on some of the same outdated tools and cumbersome workflows. Printed circuit board (PCB) design engineers, for example, track system requirements in spreadsheets and share files by email.
This, in high-risk, highly regulated industries with complex supply chains. Is it time to put a stop to spreadsheets?
In aerospace, they have. Here’s why.
While asynchronous communication tools are familiar and get the job done, they increase risk of design errors caused by lost communication and information. An engineer may inadvertently design on out-of-date specifications, leading to time-consuming revisions. Or, an engineer may overlook an email, a file, or a comment, leading to a design flaw or another costly revision.
In aerospace, if these issues cause an undetected design error, it could result in system malfunctions or catastrophic failures. At best, cumbersome workflows may make it more difficult to document design revisions, which regulators want to see before certifying a product.
Medical device companies experience similar challenges. A minor oversight could lead to an expensive problem if not identified and rectified early. At worst, a product recall. At best, a longer timeline that delays a 510(k) or PMA submission.
In an industry that demands quality, that requires rigorous documentation, and that prioritizes speed to market, it’s time for PCB engineers and other engineering teams to embrace a cloud-based platform tailored to electronics design collaboration.
The Altium 365 Requirements & System Portal makes system requirements readily accessible to electronics design teams. As requirements change, the system automatically tracks and records those changes, allowing users to compare requirements across versions, while also ensuring teams have and maintain compliant documentation. If requirements change later in the design process, engineers will receive an alert if some of their work has fallen out of spec.
The tool’s continuous verifications process resolves compliance issues faster by identifying them immediately. Engineers can resolve issues in the moment, helping expedite design and development.
Real-time collaboration generates real ROI
Engineers may believe they work faster in spreadsheets because they know the software. However, the data show a cloud-based alternative leads to significant time and cost savings.
Forrester Research interviewed five companies in early 2023 to assess the economic impact of Altium 365. They found a PCB design engineer could save an average of 159 hours per year. Per design, a company saves an average of 15 hours per year from a more effective production cycle.
More effective design cycles lead to an average of $142,000 in savings annually as well as $398,000 on average in technology cost savings.
“Now, we meet the documentation and process standards to qualify us to support new field requirements from a compliance standpoint,” said one PCB engineer for the study. “Our design process used to be piecemeal. Now, we have a more cohesive process and revision controls to allow more transparency into our design process to meet compliance standards to expand into medical or aerospace.”
Quality in the cloud
Most PCB designers follow IPC standards for design and ISO 9001 for quality. However, ISO 13485 is the international standard for medical device quality management systems (QMS).
Organizations involved in medical device product design, development, manufacturing and/or servicing typically use quality systems certified to ISO 13485 standards. In the United States, they will likely also comply with CFR 21 Part 820, the Quality System Requirements specified by the FDA.
To comply with ISO 13485 and CFR 21 Part 820, medical device companies must keep detailed, complete, and auditable records of design defects and solutions, as well as component documentation. That includes PCBs—whether designed in house or outsourced.
Medical device companies that outsource PCB design must expect similar compliance from their vendors. In addition to ISO standards and CFR 21 Part 820, medical device PCB manufacturers must adhere to installation qualification, operation qualification and process qualification standards. A cloud-based solution for electronics design must have the capabilities to implement QMS features in line with applicable standards. A few of those capabilities include control over user access, sharing, and recordkeeping.
In Altium 365, PCB design data is shared and tracked; however, data access can be restricted to certain individuals, and each user can be granted a certain level of permission. This control protects sensitive intellectual property (IP) from those who don’t need to see it. It’s hard to maintain this level of control in spreadsheets.
It’s rocket science
Both the aerospace and medical device industries excel in innovation. Aerospace companies are exploring additive manufacturing/3D printing for low-volume component production, AI for route optimization, and hypersonic and supersonic flight technologies. Medical device companies are leveraging advanced technology to streamline processes and develop sophisticated medical device software.
Even as medical devices are becoming more software driven, PCBs remain a core component of many products. For PCB engineers to design these components efficiently, they must work within a system that helps them minimize risk, enhance compliance, and collaborate in a secure environment.
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