Optimal Medical Device Contract Manufacturing

November 13, 2019 , in Blog, Medical

The war to end all wars, as it was called by some contemporaries of the time, ranks high on the list of devastations that have occurred during human history. That phrase embodied the hope that what has come to be referred to as World War I would be the last conflict that would rob humanity of its youth on such a grand scale. Instead of relying on hope, President Woodrow Wilson attempted to get many of the earth’s governments to commit to a framework that could possibly achieve a just peace that could last indefinitely. His idea was the League of Nations that would be comprised of all nations working together to prevent the escalation of war between its members. He realized what almost no one else at the time did, which is the benefit of a strategic partnership to achieve great ends. A brief couple of decades later, many others finally caught on and the United Nations was formed.

Partnerships are also critical in the rigorous endeavor of developing electronics and PCBs for the medical devices industry. For example, the underlying mandate for work done by governmental organizations, such as the Centers for Disease Control and Federal Drug Administration (FDA), is to save lives. The former relies on laboratory testing equipment to ensure the safety of vaccines that control the effect of viruses and other diseases and the latter ensures that all medical devices are safe to use. In order to support the missions of these agencies, as well as research organizations, hospitals and other medical practitioners required that you are able to not only build high-quality boards and electronics but manage them throughout their operational lifecycle. Additionally, competition among medical device suppliers and OEMs is high and the traditional developer-manufacturer relationship has to evolve to keep pace. Let’s take a look at that relationship and then define a means to optimize your medical device contract manufacturing.

The Evolving Developer-Manufacturer Relationship

For a long time, PCB manufacturing was viewed by designers as a completely separate post-design activity. During this period, virtually all board design packages were Gerber files and all fabrication houses accepted them. Once the printed circuit board (PCB) was created, another manufacturer would typically do the PCB assembly or PCBA, unless the design was in full or high-volume production. This paradigm did produce quality boards; however, it was woefully inefficient. A major problem with this black box approach to PCBA development was the isolation of the designer from the manufacturing process.

Isolation versus Integration

The isolation of board design from the manufacturing process also meant that designers were largely unaware of the significance of their design decisions on PCB manufacturing. As a result, a myriad of problems plagued the PCB development process, including:

  • Excessive time to receive an accurate quote
  • Manufacturer required changes
  • Avoidable redesigns
  • Exceedingly long turnaround times
  • Extra design-build-test (DBT) cycles during prototyping or development
  • Unnecessary costs
  • Unreliable delivery scheduling

With this many problems, it would seem that many solutions would be necessary. It is true, that these issues and others can be addressed individually; however, a comprehensive solution is to attack the central issue of isolation between the designer and the contract manufacturer (CM).

That solution is a white box approach built on transparency, collaboration, and integration. By opening up the manufacturing process to developers, designers and engineers would appreciate the need for design for manufacturing (DFM) and embrace it as an essential part of their DRC review process. Equally important is that the CM knows the design intent, which can only be gained through open communication. This enables the CM to assist you with choosing the best materials, stackup and via type that achieve your design objectives and is manufacturable. Effectively utilizing these actions results in an integration of board design and PCBA that minimizes the many problems that plague the traditional, isolated approach to PCBA development.

Currently, the PCB industry is evolving away from the traditional and towards a more efficient and effective white box approach. However, for industries like medical devices, evolving is not enough. To be competitive and meet the quality, reliability and safety challenges demanded of suppliers you must optimize your medical device contract manufacturing process.

How to Optimize Medical Device Contract Manufacturing

When developing PCBAs for critical industries, including aerospace, automotive, and of course, medical devices, quality, reliability, and speed are at a premium. For medical devices, safety can be added as the ultimate consideration. The bar for attaining these mandates is high and you must ensure that your CM is capable of meeting the essential requirements for medical device manufacturing, which are:

  • Transparency
  • Commitment to quality
  • Supply chain security support
  • Documentation control
  • Agile manufacturing process

The level of success that you and your CM have in forming a symbiotic relationship will determine how optimal your medical device contract manufacturing will be and how well you can compete in the medical devices industry.

Tempo's Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development
  • Works with 4 of the top 10 medical devices manufacturing companies.
  • ISO-9001, IPC-600 and IPC-610 commitment to quality certifications.
  • Accurate quote in less than a day.
  • DFM support from Day 1 of design.
  • Fastest turnkey PCB manufacturing in the industry.
  • Rigid, rigid-flex and flex board capabilities for wearables and embedded biosystems.
  • Custom automated BOM verification tool.
  • Sources components from the most reputable suppliers in the industry.
  • Software-driven robotics assembly.
  • Standard quality testing, including X-ray and inline AOI.
  • Superior open, transparent PCB manufacturing experience.

Tempo Automation is a certified and experienced contract manufacturing partner that has helped medical industry suppliers successfully improve their product development schedule. In fact, Tempo leads the industry in fast high-quality prototyping and low-volume PCBA manufacturing. We are ready to form a strategic partnership with you for your medical device.

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.

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 how to optimize your medical device contract manufacturing, contact us.

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