Oct 21 2019
It’s no secret that medical device regulations are complex and confusing to understand. Each year, EMERGO’s Global Medical Device Industry Outlook report consistently finds that the changing regulatory environment is the biggest challenge facing the medical device industry, with 72% of organizations ranking it No. 1 in 2019. This is why it’s very common for medical device companies to send their employees to compliance training to learn how to navigate the complex regulatory environment.
However, in recent years, new product development has grown to become the second biggest challenge for the medical device industry. Nearly half of EMERGO’s survey respondents ranked it as a significant challenge — the only standout in the list besides regulations.
So if it’s best practice to complete compliance training to learn about regulations, it makes sense that medical device design teams should also be investing in training to tackle new product development challenges. But while medical device regulations are an issue in and of themselves, they also create unique challenges for medical device design teams.
Understanding medical device regulations is difficult due to their complexity and continuous changes. While keeping up with regulations is a concern for everyone from quality assurance employees to medical device salespeople, regulations can be particularly tricky for engineering design teams.
In the medical device industry, design teams must follow FDA Design Controls. These controls are set to help medical product developers with quality control, meeting all product requirements, and preventing future issues or recalls. There are FDA Design Controls for every stage of the design and development process:
The product design cycle becomes much more convoluted for medical devices because of the controls at each stage. This is best illustrated by the FDA’s widely-used waterfall diagram:
Many medical device companies send their employees to compliance training (including training specific to FDA Design Controls) to learn how to work with regulation requirements. Engineering design training is the next natural step. Honing your team’s design skills can improve performance at each stage of product development, making it easier for engineers to create and change designs so they comply with regulations. Understanding how to manipulate designs earlier in the process saves significant time and money later on by avoiding rework after review. Not to mention, the cost and time requirements of online engineering training are insignificant compared to those of many compliance training sessions.
In addition to making the design cycle more complicated, FDA Design Controls also require organizations to maintain a complete record of design changes and design history files. Improving documentation skills such as Geometric Dimensioning and Tolerancing (GD&T) and learning how to use advanced file management tools (e.g., SOLIDWORKS Enterprise PDM) can make these stages much easier to handle.
It doesn’t stop there. Engineering design training can also help mitigate other new product development challenges such as higher design risk, keeping up with Industry 4.0, and more. Check out our free e-guide to find out how.
Find out which skills design teams need to efficiently work with FDA medical device regulations in the product development process.
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SolidProfessor commercial content marketer and unironic classic rock record collector