The capabilities of manufacturers are growing to enable the fabrication of components that are extremely tiny, very complex, and incredibly intricate. These advances are leading to medical devices that could not have been developed just a few years ago. With this in mind, this months Perspectives asked about how these capabilities would impact future devices.
How will new(er) manufacturing technologies impact the design and/or capabilities of upcoming medical devices?
Engineering Manager, EPIC Technologies
Wearable patient monitoring devices with wireless communications technology are growing in popularity. Patients have greater mobility and hospitals improve staff utilization.
Much of the technology supporting these devices is coming from technology developed for small form factor consumer electronics, such as cell phones. At the board level, one technology contributing to greater functionality in a smaller form factor is three dimensional stacking of ICs. Known as package-on-package, the technique may increase board height by 1-2 mm, yet reduce the overall board area by up to one square inch per IC, as ICs originally laid out across the board are stacked in a single location.
The placement requirements and process technology are not significantly different from individual BGAs. Following screen printing, the first component is placed. Then, the second component is flux dipped and placed. In some cases, up to two or more BGAs may be stacked. In EPIC's process the only significant modification was purchasing a flux dip module for its placement machines. Thermal profiling during reflow was the same as boards of similar thermal mass. Process quality needs to be carefully monitored. Any distortion in the bottom component will be reflected in the components above it.
CEO, Numerical Algorithms Group
From the point of view of one of the world's only technology organizations that goes back four decades, two trend lines that can be expected to have high impact on upcoming medical device design are:
1. Optimization Algorithms Are Improved
Quality local optimization code typically needed for medical device prototype development is dauntingly long and tricky to write, especially when there are many constraints inherent in design requirements. Global optimization code presents its own challenges to ensure that the true "global" minimum or maximum is found. Now, there are rigorously tested and robust algorithms that overcome these historic difficulties. Device manufacturers may consider themselves far afield from those designing the next generation of hybrid vehicles, financial derivative products, or spacecraft, but at the level of core algorithmic development, the medical device industry is the beneficiary of cutting edge technical computing advances for a wide array of industries.
2. Parallel Software Engineering
The new Moore's Law is that there will be roughly twice as much parallelism every 18 months. Medical device development teams that take the time and resources to reengineer their applications with the assistance of computational scientists who are experts in scalable parallel computing (and how to revamp applications to keep pace with the increasing parallelism and manycore architectures [including GPU's]) will become dominant market players as they consistently speed time-to-market.
Solutions Manager, Sparta Systems
The medical device industry is under constant pressure to introduce new and innovative products at ever-decreasing prices in order to maintain a competitive edge while providing improved health benefits. But as with all new technologies, this innovation increases the risks to device quality and consistency. It is therefore imperative that medical device manufacturers invest resources in maintaining a quality management initiative as part of their product manufacturing plans. Doing so will avoid slowing down or hindering adoption of new products due to long compliance cycles, and prevent quality-driven problems, such as negative public opinion or costly recalls.
A holistic and well-integrated quality management initiative will enable companies to continuously invest in and implement new manufacturing technologies while maintaining the high quality standards demanded by government agencies, the medical community, and the public. An integrated quality system will also allow for rapid manufacturing adjustments and will streamline compliance reporting to drive rapid release of products into the market. Quality assurance will play an increasingly important role as new manufacturing technologies with new risks and quality needs are incorporated into device production, but an investment in a strong quality management plan will mitigate those risks while driving rapid market release, ensuring regulatory compliance, and maintaining healthy customer satisfaction.
Director of Product Marketing, 3DVIA, Dassault Systèmes
Most manufacturers are already relying on CAD systems to design and deliver better products more quickly than ever. Medical device manufacturers, like Beckman Coulter, are beginning to embrace technology that enables non-technical users to access this valuable 3D design data and manipulate it into interactive information that everyone can understand. With the right technology, they can leverage their CAD data to create interactive 3D documentation that becomes invaluable throughout the product lifecycle–from assembly to service to regulatory approval to end-user and consumer documentation. Companies are now able to easily create interactive 3D work instructions from the latest iterations of the engineering designs, and deliver them–paperlessly–to the shop floor workers. They are eliminating the need to photograph individual prototype parts to create instruction manuals, while shattering language barriers and reducing training time for new employees from weeks to hours.
In the end, the emergence of interactive 3D documentation frees the engineer's time to focus on design and innovation, while other departments leverage that information to create robust and comprehensive content that is used to produce high-quality products, in much less time, and with fewer resources than ever before. Soon you may even see interactive 3D instructions right on the devices themselves, helping operators to setup, run, and maintain the equipment. Imagine the device showing the operator–in fully interactive 3D–not only where the problem is located, but how to repair it? This is the power of the universal and interactive language of 3D, and it is available today.
Key Account Manager, Medical, EOS
Laser-sintering technology is already allowing product developers to create medical devices that disregard the "manufacturability rules" imposed by traditional processes. Without those rules and related costs, it is simply easier to imagine, and then accomplish, innovation based on freeform geometry.
Designers will now be able to reach for lofty functional goals first. For example, concerns about mold draft angles, metal draw depth, and machining toolpaths will vanish. A proposed medical solution that depends on maximum fluid or gas flow can be pursued to the limits of the material and other physical laws, instead of being driven by shop guidelines.
What's more, engineers will be able to integrate many individual components of laboratory and monitoring equipment into single complex parts, dramatically cutting assembly and other costs. One centrifuge manufacturer has already done so, reducing part count on a washing rotor from 32 to three with plastics laser-sintering.
Best of all, because the technology permits mass customization of parts, doctors will be able to order individualized orthopedic surgical tools and implants, as well as "perfect-fit" prostheses tailored to the patients' bodies and needs.