The medical industry faces strict regulatory requirements. Meeting these standards requires close attention and thorough planning as early as the pharmaceutical equipment design phase. That can be difficult with conventional approaches, but new manufacturing technology can optimize the process.

Designing equipment around pharmaceutical standards before production ensures compliance with minimal disruption. Consequently, while most people may not think of manufacturing workflows when they picture medical regulations, production technology plays a critical role in compliance and quality. Here’s a closer look at how this tech shapes these factors.

Identifying needs

Manufacturing technology starts affecting equipment quality and compliance before companies even build anything. Designing an effective piece of equipment means understanding the current market’s needs, and new tech can provide that insight.

Artificial intelligence (AI) can review data from lab results, purchasing habits and other market indicators to identify any unmet or underserved demands. Pharma equipment manufacturers can use these gaps as a starting point for their designs. By targeting an unmet need from the beginning, they can ensure a new device offers tangible value before bringing it to market.

Similarly, AI analysis tools can find, compare, and compile any regulatory standards a new device must meet. Humans can easily miss or confuse these requirements, especially considering different medical device rules apply in Great Britain, Northern Ireland, and the EU. AI can verify which standards apply without room for human error.

Highlighting early design concerns

Similar technologies can help refine pharmaceutical equipment designs. AI-assisted computer design tools can analyze 3D models as engineers create them, highlighting potential issues as they arise.

Some design flaws may be difficult for humans to spot before manufacturing and testing because they’re small or look fine until trying to use the device. However, even seemingly minor problems can have serious consequences in this industry. A 25-gauge butterfly needle can impact blood test results when one just two sizes smaller doesn’t. AI can catch these issues before testing.

Machine learning tools are better at spotting minor details and trends in data than humans. They can also simulate real-world tests to verify a design works before sending it to prototyping. Catching these concerns earlier ensures quality and compliance before remediating them would cost too much.

Ensuring equipment accuracy

Once a design is ready for prototyping or production, manufacturing technology can ensure it meets applicable standards. Even a device with a compliant, high-quality design can feature significant flaws if there’s an error in manufacturing. New technologies prevent and catch these issues before companies send equipment to downstream suppliers or labs.

Manufacturing typically involves many repetitive motions. When humans perform this work, they’ll eventually get tired or distracted, leading to inefficiencies and errors. Consequently, automating repetitive production tasks with robotics boosts assurance that all parts meet quality and efficiency standards.

New manufacturing tech can also automate the quality control process. Machine vision systems can scan equipment for defects faster and more accurately than humans. That’s advantageous in any manufacturing process but crucial for an industry with standards as high as pharmaceuticals.

Streamlining regulatory steps

Manufacturing technology also plays a crucial role in testing. The Medical Devices and Healthcare Regulatory Authority (MHRA) doesn’t outline a specific timeline for clinical investigations—only saying they should be sufficient to represent a realistic test. However, meeting all three investigation phases can take years, but new technologies can streamline the process.

Using computer-aided design (CAD) tools with AI functionality to design medical devices offers more quality and regulatory assurance from the beginning. Similarly, using more reliable production and quality control techniques through automation minimizes the chances of something going wrong during trials.

Rapid prototyping technologies like 3D printing can also produce initial designs in minimal time, letting manufacturers begin testing sooner. With all of these factors working together, they can complete sufficient investigations in a shorter timeline, enabling a faster time-to-market and less disruptive regulatory compliance.

Managing costs

By optimizing pharmaceutical equipment design with automated tools and streamlining the compliance process, companies can minimize costs. Lower room for error means fewer chances of issues requiring re-design and re-testing, preventing production losses. Faster times-to-market yield more significant returns on investment.

Since advanced manufacturing technology offers more assurance for regulatory compliance, it also minimizes the chances of noncompliance penalties. The MHRA can impose unlimited fines for medical device noncompliance, so ensuring products meet these standards from the beginning can prevent severe financial blows.

These cost-savings translate into direct benefits for labs using this equipment. When tools cost less to produce, manufacturers can sell them for a lower premium, minimizing equipment expenses for end users.

Manufacturing technology is critical to lab equipment design

Pharmaceutical equipment design is a crucial part of ensuring both performance quality and regulatory compliance. To make the most of these considerations, businesses must consider how manufacturing technology helps them meet those goals.

New production tech offers advantages from pre-design research all the way through final manufacturing. Capitalizing on these benefits will result in savings that echo throughout the pharmaceutical sector.

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Emily Newton is the Editor-in-Chief of Revolutionized. She’s always excited to learn how the latest industry trends will improve the world. She has over five years of experience covering stories in the science and tech sectors.