It is undeniable that the quality of life for most people has improved over the past few decades as we have eradicated some once dreaded diseases, like polio. We have also beat back the ominous predictions that maladies such as autoimmune deficiency syndrome spawned when first discovered in the early 1980s. Add to these successes our ability to treat virtually all forms of cancer, and we do have reason to be optimistic that in the future, we will see even longer and healthier lives. No one could argue that technological advances and more capable medical devices are not responsible for much of these results.
Centrifuge for testing blood in a laboratory
Often overlooked is the tremendous amount of research, typically years, that goes into developing medical devices. Most of this time is spent in the laboratory going through testing regimens. Laboratories may be public or private dedicated research sites, located at OEM facilities or on college campuses. In either case, high-quality medical laboratory testing is required in order for research and innovation to occur. Meeting this mandate poses challenges to medical device manufacturing. Let’s explore these and see how these manufacturing challenges can be met.
Challenges of Medical Device Manufacturing
Testing equipment that can be found in medical research laboratories encompasses a wide range of devices. These devices include equipment used to analyze and evaluate the performance of devices and systems under development, as well as the developed devices and systems themselves.
Electronic circuits in ECG
For example, as shown above, an electrocardiogram (ECG) machine under development would most likely utilize an oscilloscope or similar device to analyze its performance. Testing equipment, such as multimeters, spectrum analyzers, power meters, and other devices are typically used to analyze the electrical performance of medical devices that incorporate electronics and circuit boards.
The manufacture of all medical devices is subject to a great deal of regulatory control. This oversight is intended to protect patients from harm, which may be direct or indirect. Direct harm refers to systems that come in direct contact with patients, such as through invasive surgery. For laboratory testing equipment, which would fall direct harm is not a concern. However, patients can be adversely affected by incorrect measurements leading to misdiagnosis and improper and potentially harmful prescriptions or other treatments. Therefore, the building of electronics and PCBs that comprise laboratory testing equipment must meet high standards, such as IEC 61010 for safety, ISO 13485 for quality management and ISO 14971 for risk management.
In addition to the regulatory challenges for medical device manufacturing, laboratory testing equipment boards must meet precise or high-performance metrics that design objectives mandate. These may include high-speed signal processing and internal power supply design. Overcoming these regulatory and design challenges depend upon your choice of contract manufacturer (CM) to build your boards.
Overcoming Medical Device Manufacturing Challenges
As stated previously, the principal challenges to medical device manufacturing of the PCBs and electronics of laboratory testing equipment can be broadly classified as meeting the regulatory requirements and design objectives. As your boards are built by your CM, overcoming these challenges rests with your CM’s ability to incorporate the specifications of required standards and satisfy your design objectives. However, ensuring that your CM’s capabilities and equipment tolerances, as well as manufacturing process, meet the high standards that medical device manufacturing merits. This can best be accomplished by doing the following:
- Selecting a CM certified in medical device manufacturing
- Ensuring your CM’s capabilities and expertise meet your design requirements
- Make sure your CM shares your commitment to quality control
- Verify that your CM has a risk analysis plan that will enable your development to adhere to regulatory standards
|Tempo's Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development|
In addition to choosing the best CM for your medical device manufacturing, you should also maximize the benefits of their DFM by following rules and guidelines to optimize your medical device board development. The PCB industry’s leading prototype and low-volume manufacturer, Tempo Automation, is experienced in building boards that meet or exceed medical industry regulatory standards. Our agile manufacturing process, built upon software-driven automated facilities, coupled with our open, transparent white-box approach is geared to optimize your medical device 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 Designer or Cadence Allegro user, you can simply add these files to your PCB design software. For Mentor Pads or other design packages, we furnish DRC information in other CAD formats and Excel.