One of the most used phrases to describe the evolution of thought and events over time is: the more things change, the more they remain the same (or some variation of this idea). This idea, first penned by French novelist Jean-Baptiste Alphonse Karr as “plus ça change, plus c'est la même chose,” remains valid because everything indeed undergoes change but some part of the original entity always remains. Usually, the remaining part has a great deal of significance. This is certainly true of the physicians in the medical profession, who have always been rooted in following the ethical discharge of service without harmful intent, according to the Hippocratic oath.
The motive of medical service has not changed nor has the commitment to utilize treatment with judgment and ability. Yet, the mechanisms or medical devices used to administer treatment have changed dramatically and continue to do so at a breakneck pace. Although medical devices must meet rigorous standards before they can be used, especially for patient contact, changes due to client demands, technology advancement and regulatory requirements necessitate a quick response from developers. Meeting these demands can best be achieved if your development process incorporates agile manufacturing for the medical devices industry.
Prior to discussing how to achieve agile manufacturing for your medical devices, however, let’s first define what agile manufacturing for the medical devices industry entails.
Agile Manufacturing For The Medical Devices Industry
The rapidly expanding and changing landscape of application for PCBs and electronics means that your development of these systems should exhibit a degree of fluidity; otherwise, you risk failing to be competitive. Changes in customer demands, advances in the state of the art of applicable technology and new standards and regulations can all require modifications to your design and manufacturing that must be instituted quickly. Agile manufacturing can be thought of as a measure of how well your contract manufacturer (CM) is able to respond to these types of changes with the lowest costs in terms of additional time and equipment expense.
The ability to modify a well-defined PCB manufacturing process in the midst of product development is not a quality that all CMs possess. And when the product is a medical device, the challenge is even greater. Medical devices, in contrast to most consumer electronics, are predominantly intended for use by skilled professionals like physicians, technicians, nurses, researchers or other trained users. Moreover, products for the medical devices industry must meet strict standards in the following areas:
- Safety: The most important attribute for medical devices is that they are safe to use. For products that may come into contact with patients, such as biomedical devices, this is critical.
- Quality: Next to causing no harm to patients, device quality is the greatest concern. Suppliers of medical devices must institute and document a verifiable quality management system in order to furnish devices to the medical devices industry.
- Reliability: Hand in hand with quality is reliability. Medical devices must be counted on to produce accurate results as they directly influence diagnoses, prognoses and regimens for cure, such as medications and surgery. To assure reliable performance, medical devices must go through strict testing regimens.
- Security: In order for medical devices to be accepted for use by the medical industry, efforts must be taken to manage the risks associated with their development. This emphasis on security extends to design data transfers.
Agile manufacturing for the medical industry of your design is not the sole responsibility of your CM. Effective utilization of this capability for product development depends upon actions taken by the developer.
Incorporating Agility into Your Medical Devices Manufacturing
The development of medical devices, as is true for other critical systems, requires that the development process follow regulatory procedures and institute specific management oversight. However, instituting these rules and guidelines for design and manufacturing are difficult, if not impossible, to achieve when the design and manufacturing are done as separate isolated processes. Furthermore, the added adaptability capability demanded for agile manufacturing for the medical devices industry places even greater emphasis on the developer-CM relationship. The best chance for success in meeting these challenges at an acceptable level for the medical industry is with a white box approach to PCB manufacturing, which is characterized by the following:
- Open communication
The first key to incorporating agile manufacturing into your development is to establish open bilateral communication with your CM. Doing so enables you to transfer design changes quickly and your CM to provide manufacturing modifications in a timely manner.
- Design and manufacturing process transparency
Your familiarity with the challenges of the manufacturing process and your CM’s understanding of your design criteria enables both of you to make the best decisions when changes are required.
- Designer-Factory integration through the institution of CM-specific DFM
Making design decisions tailored to your CM’s capabilities ensures that your design is buildable without any significant capability or equipment changes.
|Tempo's Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development
A white box approach to the development of your boards essentially brings the factory to the designer and can lead to the optimization of the entire process if instituted throughout all stages from planning through manufacturing.
At Tempo Automation, the industry leader in the fast manufacture of PCBs that meet the high-quality standards of the medical devices industry, we advocate a white box approach to PCB development. And to help you get started on the best path, we furnish information for your DFM checks and enable you to easily view and download DRC files. If you’re an Altium user, you can simply add these files to your PCB design software.
If you are ready to have your design manufactured, try our quote tool to upload your CAD and BOM files. If you want more information on agile manufacturing for the medical devices industry, contact us.