Whenever I hear the word “revolution,” my first response is typically a cringing autonomic reflex. Yet, history teaches us that some revolutions are not only necessary for human advancement but are, in fact, inevitable. If you’ve been around for a few decades or so, it’s impossible to have missed the revolutionary advancements in medical technology that have improved the quality and length of life for many people around the world. The driving force behind this humanitarian leap is the evolving methods, equipment and capabilities of medical device development.
Improvements in medical device development can be attributed to advancements in PCB design, manufacturing and testing, which have produced more precise measurement devices, introduced enhanced flexibility into treatment regimens and enabled better and faster collaboration and information exchange between medical professionals. Another crucial factor is the stringent rules and guidelines for medical devices, some of which we discussed in Part 1: Regulations and Standards of this series. Now, let’s take a look at the medical device development process with particular emphasis on the best ways to make your medical device development plan a success.
Medical Device Development Process
Medical devices are classified as critical systems where failure may have catastrophic results, including loss of life. For this reason, medical devices and their development processes are subject to much higher scrutiny than other electronics and PCBs, such as consumer devices and communications systems. Nevertheless, the medical device development process can be divided into the same three stages as other electronics and PCB development: design, manufacturing and testing.
Medical Device Design
Any electronics or PCB design should be tailored to your contract manufacturer’s (CM’s) capabilities and equipment, and medical devices are no different. However, due to the quality management system (QMS) requirements and other regulations for medical device development, it is advisable to partner with your CM early in the design stage to support your compliance. Besides regulatory compliance, safety, predictability, reliability and usability must be the major concerns that guide your design.
Medical Device Manufacturing
The manufacturing stage of medical device development is a crucial function that significantly impacts the quality of your device and your timeline. Device quality depends on board materials, your CM’s methods, facilities and expertise and your employment of steps to optimize your PCB manufacture.
Medical Device Testing
Medical devices, more so than other types of PCBs, are subject to a great deal of testing. This is primarily due to extensive regulatory testing requirements; however, functional and manufacturing testing are also typically required. Regulatory tests for medical equipment fall into one of two general categories:
- IEC 60601-1: Electrical equipment transferring energy to or from a patient or detecting energy transferred to or from a patient.
- IEC 61010-1: Laboratory test equipment or electrical equipment that does not connect directly to the patient.
As shown above, the three stages of medical device development have additional considerations and requirements beyond those typically needed for non-critical PCB development. Now, let’s take a look at what is necessary to ensure that your development plan will be successful.
Essential Keys to Successful Medical Device Development
The advancements in medical treatment that have impacted so many of us have been made possible by revolutions in electronics and PCB development. However, the critical nature of systems and equipment utilized in the medical industry has necessitated restrictions on medical device development. All of this translates into special considerations that should be incorporated into your development plan.
🔑 Safety - First and foremost, user safety must be your primary concern during design, manufacture and testing.
🔑 Predictability - An essential characteristic of your medical device is that its operation and outcomes can be predicted to a very high degree. This preciseness is imperative for accurate diagnoses and analyses and is the motivation for the extensive testing required for medical devices.
🔑 Reliability - Equally important as predictability is the reliability of your product. This means that its functions will not only repetitively occur for the same situations, conditions or stimuli but do so over the lifetime of the device. To accomplish this, not only must your design be sound, but your CM must also use high-quality components and materials.
🔑 Regulatory Compliance - For your medical device to be put into service, it must meet various regulatory requirements for its specific usage and environment. These standards cover everything from components, materials, and manufacturing processes to quality and risk management.
🔑 Minimum Timeline - The medical industry is a very competitive market and your product’s success may well depend on yours ability to develop it quickly. To a great extent, your development timeline will depend on the efficiency of your CM’s PCB manufacturing.
🔑 Usability - Another factor that can affect the acceptance of your device by medical practitioners and other users is its ease of use. To maximize your chances of successful medical device development, you must maintain the delicate balance between capability and usability.
|Tempo‘s Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development
● 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.
Obviously, your choice of CM is one of the most important considerations for your medical device development. Tempo Automation, an experienced medical device PCB manufacturer, is equipped to meet your needs for high quality and fast-turnaround board fabrication and PCB assembly. We employ advanced technology and software-driven equipment and are committed to providing you with a superb manufacturing experience.
And to help you get started on the best path, we furnish information for your DFM 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 about medical device development or the essentials for your development plan’s success, contact us.
In Part 3: Testing of this series, we will explore testing procedures for your medical devices.