Creating a medical device is an exciting endeavor, as the result of the project can improve the quality of life for many individuals. After completing the design, you will move it through the medical device manufacturing process. Following the guidelines will position you well for the production stage. 

Do:

Consider what the end-user needs.

When initiating the design process, focus on what problems users face and how the device can help overcome them. To meet your customers' needs, think about the product's ease of use to ensure they don't face difficulties when utilizing it. You should also consider potential risks and safety issues so you can address them during the design stage and avoid creating a defective device.

Comply with regulations.

State, federal, and international regulations protect you and your customers from the hazards that materials used for medical device manufacturing can pose. Keeping these rules in mind throughout the design process will help achieve the goal of successful production. 

Work that fails to meet applicable requirements wastes time and resources and delays the process. Therefore, ensure your team is familiar with the applicable rules, including those addressing safety and accessibility, while developing the device.

Don't: 

Neglect continual testing. 

The concept of "kaizen," which refers to continual improvement to eliminate waste and improve efficiency and productivity, helps guide the work of business owners and scientists. Put this idea into practice during medical device manufacturing by not skipping testing at every stage, as this process ensures you can continually improve the design. 

Identifying issues early in the development process allows you to modify the product. This essential practice also ensures you can avoid potential technical problems and consumer claims of faulty design.

Ignore documentation.

Keeping track of every step taken in the design process will help you find flaws and validate successes. By recording detailed notes, diagrams, videos, photos, and prototypes, you make it easier to apply for patents and protect your intellectual property interests. Your documentation also provides primary sources and historical data for future researchers.

If you are ready to turn a design into a piece of equipment, seek help from Pacific Integrated Manufacturing in Bonita, CA. This company offers more than 20 years of experience in medical device manufacturing. Their team of experts produces top-quality products for various industries and is ready to guide you through every stage of the process. Visit their website for more information on their medical device manufacturing services, and call (619) 921-3464 to discuss your project goals.