Michael Siemer, Director of Engineering, Noble04.01.16
The process of 3D printing has impacted many industries by making the development and prototyping stages quicker, more cost-effective, and efficient. One industry that has seen the largest impact is the health and medical sector, specifically the pharmaceutical device space. Rapid prototyping and 3D printing techniques offer the ability to get these complex devices to market quickly. A prototyping process that previously took several months or even years can now be completed in just days.
Thanks to 3D printing, developers no longer have to wait months for a sample of a device they’ve designed on the computer. Instead, it’s possible to have a tangible prototype within hours, ready to test. The benefits of this include quicker improvements, faster approval, and more time to dedicate to other tasks.
Trial and Error
The primary reason 3D printing has made the prototyping process more productive is due to a considerably shorter trial and error process. Previously, design teams had to send prototype sketches to the manufacturer who would then send back the physical device. This process could go back and forth several times before the design of a device was approved. Utilizing 3D printers, a design sketch can become a physical device within several hours, saving valuable time and resources.
The 3D printing and rapid prototyping processes also challenge designers to create the best product possible. By designing and printing a variety of prototypes at once, they can test each one simultaneously to see which design works best. Through trial and error, designers discover which device features and functions are most effective, making for more user-friendly designs. This process not only allows for devices to come to market quickly, it makes it easier to design patient-centric devices that give brands a competitive advantage.
Quality Control Standards
With any innovation, it’s important to have a quality control process in place to ensure the caliber of medical devices isn’t compromised. While 3D printing has made inarguable advancements in the efficiency of the development process, new standards for quality control will need to be implemented in order to deliver high-quality products to market. One example of quality control working in the space can be seen in designing training devices for the pharmaceutical industry.
For training devices, there is a stage-gate product development process in place to guarantee quality assurance from design and development through production. Quality control begins with client meetings to determine objectives and design requirements, including device characteristics, functionality, performance, legal and regulatory requirements, end-user goals, and other attributes. By having a firm understanding of client needs, bringing a product to realization is more cost and time efficient.
Once the scope of work has been determined, industrial designers and engineers work side-by-side in designing concepts of the device’s form and function. Throughout the process, project managers continually communicate with the client to gather feedback and other pertinent information to ensure the product expectations are met. After conceptual sketches and renderings are approved, prototype development begins.
As mentioned previously, 3D printing creates a more efficient design and development process, enabling extensive engineering and benchmark testing to be performed. A major benefit of 3D printing and part of the quality control process is the ability to perfect a design—with multiple iterations—ensuring client expectations are met and design requirements and specifications are efficiently transferred to optimize high-volume manufacturing.
Through these rigorous quality controls, brands are assured devices meet form and functionality standards, thus protecting brand reputation.
Increased Revenues
Companies that utilize 3D printing to achieve an expedited prototyping process and employ a strict quality control model are better positioned for faster approval timelines. Not only does this keep shareholders happy, it also helps get the necessary medication into the hands of patients who need it. Additionally, the quality control process reduces the risk of product recalls or issues during manufacturing. Due to the speedy approval process and resulting revenue flow, developers free up their time and resources for new projects and a higher volume of clients, thus improving revenue and growth.
Additional benefits of 3D printing include lower overhead costs and environmental advantages. Companies that use 3D printing during the prototyping phase invest less in product inventory, which means less storage space is utilized. Further, since the process is optimized for time, employees can be more efficient. The 3D printing process is also helping businesses become more sustainable as less product is wasted and fuel is saved since prototypes don’t need to be shipped back and forth throughout the trial and error stage.
Conclusion
Although 3D printing has been around for several years, the pharmaceutical device industry is just beginning to tap into its value. It is now regarded within the industry as a valuable technology that produces high-quality prototypes. As more companies tap into this potential and quality control processes are implemented, the industry will begin utilizing 3D printing for mass production.
Michael Siemer is the director of engineering at Noble—a global, advanced rapid product development and manufacturing company focused on next generation pharmaceutical training products, combination injection and respiratory devices, and other home healthcare products. He offers more than 20 years of product development, 3D printing (additive manufacturing), and production experience. Siemer started his professional career at the University of Central Florida where he earned his BS in aerospace engineering and MS in mechanical engineering.
Thanks to 3D printing, developers no longer have to wait months for a sample of a device they’ve designed on the computer. Instead, it’s possible to have a tangible prototype within hours, ready to test. The benefits of this include quicker improvements, faster approval, and more time to dedicate to other tasks.
Trial and Error
The primary reason 3D printing has made the prototyping process more productive is due to a considerably shorter trial and error process. Previously, design teams had to send prototype sketches to the manufacturer who would then send back the physical device. This process could go back and forth several times before the design of a device was approved. Utilizing 3D printers, a design sketch can become a physical device within several hours, saving valuable time and resources.
The 3D printing and rapid prototyping processes also challenge designers to create the best product possible. By designing and printing a variety of prototypes at once, they can test each one simultaneously to see which design works best. Through trial and error, designers discover which device features and functions are most effective, making for more user-friendly designs. This process not only allows for devices to come to market quickly, it makes it easier to design patient-centric devices that give brands a competitive advantage.
Quality Control Standards
With any innovation, it’s important to have a quality control process in place to ensure the caliber of medical devices isn’t compromised. While 3D printing has made inarguable advancements in the efficiency of the development process, new standards for quality control will need to be implemented in order to deliver high-quality products to market. One example of quality control working in the space can be seen in designing training devices for the pharmaceutical industry.
For training devices, there is a stage-gate product development process in place to guarantee quality assurance from design and development through production. Quality control begins with client meetings to determine objectives and design requirements, including device characteristics, functionality, performance, legal and regulatory requirements, end-user goals, and other attributes. By having a firm understanding of client needs, bringing a product to realization is more cost and time efficient.
Once the scope of work has been determined, industrial designers and engineers work side-by-side in designing concepts of the device’s form and function. Throughout the process, project managers continually communicate with the client to gather feedback and other pertinent information to ensure the product expectations are met. After conceptual sketches and renderings are approved, prototype development begins.
As mentioned previously, 3D printing creates a more efficient design and development process, enabling extensive engineering and benchmark testing to be performed. A major benefit of 3D printing and part of the quality control process is the ability to perfect a design—with multiple iterations—ensuring client expectations are met and design requirements and specifications are efficiently transferred to optimize high-volume manufacturing.
Through these rigorous quality controls, brands are assured devices meet form and functionality standards, thus protecting brand reputation.
Increased Revenues
Companies that utilize 3D printing to achieve an expedited prototyping process and employ a strict quality control model are better positioned for faster approval timelines. Not only does this keep shareholders happy, it also helps get the necessary medication into the hands of patients who need it. Additionally, the quality control process reduces the risk of product recalls or issues during manufacturing. Due to the speedy approval process and resulting revenue flow, developers free up their time and resources for new projects and a higher volume of clients, thus improving revenue and growth.
Additional benefits of 3D printing include lower overhead costs and environmental advantages. Companies that use 3D printing during the prototyping phase invest less in product inventory, which means less storage space is utilized. Further, since the process is optimized for time, employees can be more efficient. The 3D printing process is also helping businesses become more sustainable as less product is wasted and fuel is saved since prototypes don’t need to be shipped back and forth throughout the trial and error stage.
Conclusion
Although 3D printing has been around for several years, the pharmaceutical device industry is just beginning to tap into its value. It is now regarded within the industry as a valuable technology that produces high-quality prototypes. As more companies tap into this potential and quality control processes are implemented, the industry will begin utilizing 3D printing for mass production.
Michael Siemer is the director of engineering at Noble—a global, advanced rapid product development and manufacturing company focused on next generation pharmaceutical training products, combination injection and respiratory devices, and other home healthcare products. He offers more than 20 years of product development, 3D printing (additive manufacturing), and production experience. Siemer started his professional career at the University of Central Florida where he earned his BS in aerospace engineering and MS in mechanical engineering.