Special considerations must be made when designing electronics to be used in the medical and healthcare industry. Due to the fact that we are talking about human life, the quality and sustainability of these pieces of equipment is important.
Medical electronics manufacturing has become a popular term used to highlight the processes that go into the making of these devices. In this article, we will help you understand what the manufacturing process looks like. You will also find out some of the devices that can be made with these processes.
What are Medical Electronics?
An apt description is that these are the devices or pieces of equipment exclusively used in the medical sector. From the implantable medical devices to the monitoring systems; there are lots of medical electronic devices you can find out there.
These are also the devices used for facilitating different medical treatment options. Hence, producing them the right way is a must. Most times, the medical electronics companies are hired for the job and allowed to control most parts of the process – including component sourcing.
Factors Fueling the Demand for Medical Devices Electronics
Several factors are responsible for the massive demands for medical electronics manufacturing services, whether as a one-off project or an ongoing working relationship.
Improved Life Quality
These devices are used for one major goal – to improve the quality of life (of the patients). Thus, it is expected that the medical electronics will meet the requirements of excellent diagnose and bolstering of the treatment options.
High-Quality PCB Selection
A bulk of the medical equipment’s functionality lies with the quality of the circuit board used therein. Hence, the priority is on choosing an OEM medical electronics manufacturing company that uses high-quality and high-performance Printed Circuit Boards (PCBs).
An Emphasis on Quality Standards
There is an emphasis on the medical electronic devices that meet the desired standards. It is expedient to mention that these standards are in line with the laid-down guidelines by the Food and Drug Administration (FDA), as well as other concerned health-related agencies.
These emphases help the manufacturer to design and manufacture the pieces of medical equipment to meet the strict regulations and standards.
Medical Electronics Design and Manufacturing Processes
If there is one major concern as to how medical devices are to be manufactured, it is usually based on the processes. There are two major processes, which are the traditional method and the additive manufacturing process.
It is noteworthy that both of these processes are unique and offer some considerable advantages over the other.
With that being said, let us quickly look at some of the differences between the traditional and additive medical electronics manufacturing processes.
Traditional vs. Additive Medical Electronics Manufacturing Processes
Traditional manufacturing processes refer to the common methods or pathways used to manufacture medical electronic devices. The popular ones are Injection Molding and CNC Machining. The traditional process is also ideal if you are working on higher volumes of these devices, as it helps to scale the process, cut down on lead time for tooling and saves costs.
On the other hand, you can use the additive medical electronics manufacturing process to make medical devices that are limited. In this instance, you are working on a low volume. You will also find the additive manufacturing process suitable if you are making either the proof-of-concept designs or prototypes of those devices.
1. Types of Traditional Medical Electronics Manufacturing Processes
Let us look at some of the processes or methods that can be used to manufacture medical devices – the traditional way.
This type of traditional medical electronics production process is ideally used for the higher-volume medical devices. We are looking at the likes of:
- Laboratory equipment housings/casings
- Plastic surgical components
- Test tubes and;
For the best results, a wide range of materials are required to attain the reliability of these devices. Examples of the features of the materials required for the process include but are not limited to:
- Flexibility: these materials are required to be highly-flexible. An example of such is silicon plastic.
- Medical-Grade: this is required mostly for making the biomedical implants.
- The materials are required to have a combination of higher durability and strength, especially for the plastics.
- Sterilizable: this property or feature is required when manufacturing specific medical devices, such as dental and surgical tools.
The advantages of the Injection Molding medical electronics manufacturing process include:
- It supports a wider range of thermoplastic polymer colors and materials.
- It is not only suitable for complex geometries. It also offers higher dimensional accuracies.
- Shorter Lead Time: it has a shorter production time, which takes anywhere between 15 and 60 seconds per component, after the initial start-up.
- There is a higher level of consistency and repeatability of the component’s finishing process and the geometry.
Some of the reasons why you may not want to use the Injection Molding process include the limitation of the component materials to the thermoplastic polymers. You will also spend a lot of money to make custom medical pieces of equipment, as well as paying more to manufacture the mold.
This traditional medical electronics manufacturing process is best if you are working with the higher-volume products, which also double as the final designs of the devices.
The best parts or attributes of the CNC Machining process are:
- The CNC machines have applications that are suitable for most part materials and geometries.
- The machines also cover a wide range of machining processes and cutting tools.
For the best results, be picky about the component’s material and geometry, as those two factors potentially influence how the devices’ performance will be like.
The benefits of the CNC Machining process for electronic devices include:
- It offers a combination of automated process, which, in turn, encourages continuous operations.
- Higher dimensional accuracy is attained in the process.
- The CNC Machining process also supports a wide range of materials, as well as complex part geometries.
On the flip side, the process takes longer to complete and this is due to the individualized CNC programming of the parts. You will also spend a lot of money to make a CNC programming of each part and initial training.
Additive Manufacturing Process for Medical Electronic Devices
The additive manufacturing process is your go-to when making prototypes of the electronic devices, as well as producing a limited number of these devices.
The following are some of the processes that can be used:
This additive manufacturing process has an extensive application or use case than some of the others we will discuss in this article. The extensive usage is mainly because of the printing capability for the complex geometrical shapes.
Other factors that bolster the extensive applications are:
- The compatibility of the materials with biomedical implants.
- Higher material properties
- The sterilizability for the surgical tools.
Generally, the Metal Printing additive manufacturing process is ideal for complex medical electronic designs that require improved material strength.
Here are some of the best attributes:
- It supports a wide range of materials, including the superalloys and metals.
- It supports the production of complex and bespoke components with the geometries that the traditional manufacturing processes don’t support.
- Metal Printing enables the miniaturization of components’ weight, as well as the topological optimization of the same.
On the downside, you wouldn’t be able to make something out of the existing designs, especially if you are looking at making 3D prints. Also, the associated costs of making 3D metal prints are higher.
Fused Deposition Modeling
Abbreviated to FDM, this is an additive medical electronics manufacturing process that is ideal for the simple geometries. You also want to use it if you are working within a constrained budget.
For the best results, consider using the Fused Deposition Modeling (FDM) process when making medical devices that don’t require much medical strength.
Here are some of its benefits:
- The availability of several plastic materials, especially those that are sterilizable for surgical devices and compatible with biomedical implants.
- The varieties of available materials are usable for different purposes, such as non-commercial function applications and making prototypes of specific medical electronic devices.
- The affordability makes it easier to produce custom thermoplastic parts and making prototypes of the same.
Selective Laser Sintering
Also called the SLS process, Selective Laser Sintering refers to the production pathway for specific medical electronic tools, such as dental and surgical tools.
You want to also consider using it for the following reasons:
- It makes the small and medium batch productions of medical electronics easier.
- The SLS parts have distinct attributes, such as excellent strength and a higher level of accuracy. The isotropic mechanical properties also make them ideal for the prototypes and the functional parts.
- The streamlined design process is not complicated, hence, bolstering the speed at which the complex geometries can be produced.
Despite these upsides, there are a couple of negativities about the Selective Laser Sintering (SLS) process for additive manufacturing. These disadvantages include:
- It is almost impossible to make the prints on the small holes and large, flat surfaces. This is because of the fact that such could expose the holes and surfaces to over-sintering and warping.
- Owing to the popularity and availability, it takes a long (lead) time to have the 3D prints of the medical devices readied.
With the short form as SLA, Stereolithography refers to the 3D printing technology used for attaining higher levels of aesthetics and details for medical devices.
The attributes include but are not limited to:
- Specialized materials, such as flexible and castable resins are used for the design.
- You can count on the Stereolithography process to support the production of medical electronics with intricate details and higher dimensional accuracies.
- It is the ideal medical electronics manufacturing process for devices that don’t require higher material strength and which lower-cost prototypes.
- The Stereolithography (SLA) process is to be used for making visual prototypes of medical devices and this id due to the very smooth surface finish.
On the flip side, you need to have second thoughts about the process due to the following reasons:
- Visual marks are usually left behind. This often requires post-processing to get rid of the visual marks left behind on the SLA component.
- It is not always possible to use the SLS parts for the functional prototypes of medical devices and this is because these parts are brittle.
Categorization of the Medical Electronics Manufacturing Devices
There are three (3) major categories or classifications of the devices manufactured for the medical industry. These categories are based on the regulations set aside by the Food and Drug Administration (FDA) based on the risks of these medical devices.
Before we delve deeper, note that these categories are based on “Classes” and start from Class I to Class III. The next important point to note is that the medical devices that fall under Class I are considered low-risk, while those between Class II and Class III are considered medium-risk and high-risk, respectively.
1. Class I Medical Devices
Generally, these are the devices or pieces of equipment that don’t find their ways into the theatres or surgical rooms. They are more of randomized devices used for other medical purposes, other than saving or sustaining lives.
Despite the limited usage for supporting life, the Class I medical devices are subjected to some checks to be sure of the accurate performance. They are evaluated along the lines of device registration, branding and possible exposure to adulteration.
2. Class II
These are the medium-risk medical devices. In addition to implementing general controls, the FDA also recommends a couple of other measures to standardize the use of the Class II medical devices. Some of these measures include:
- Evaluating the device’s performance.
- Post-market surveillance and;
- Special labeling requirements
3. Class II Medical Devices
These are the riskiest of the electronics for the medical industry – and should be well-regulated. They are primarily used for different life-saving medical procedures, including surgical operations.
Understanding the FDA’s Regulations for the Medical Electronics Market
The Food and Drug Administration (FDA), has made a list of different regulatory policies in place to facilitate the regulation and confirmation of the performance of medical devices.
The following are some of the regulations in this regard:
This regulation requires any or all of the medical electronic companies, manufacturers and the initial distributors of the medical pieces of equipment and devices to get registered with the Food and Drug Administration (FDA).
This is mostly for the companies looking to offer these services in the United States.
2. Medical Device Listing
After the registration is completed and the manufacturers, and distributors have been registered, they now move to stage 2. Here, the manufacturers are required to list or register the medical electronics and devices they produce with the FDA.
3. Premarket Notification
The fact that a medical electronics manufacturer is registered with the FDA doesn’t mean an expression permission to distribute the devices.
Depending on the risk level (Class/category) of the devices, these manufacturers might be required to hold-off the distribution until they send a premarket notification or approval from the FDA.
It is up to the FDA to determine if your medical devices are ideal for the market or not. If they are, you will get an acceptance letter, giving you the go-ahead to start the commercial distribution of the devices.
4. Premarket Approval
This has to do with the receipt of the acceptance letter by the FDA, permitting you to start commercial distribution of the medical devices. However, you must note that the clinical trial data and any other required documentations would be asked to help determine if the devices are fit for the market.
Besides the distribution of the devices, seeking premarket approval is also important before engaging in an active promotion and or marketing of these medical pieces of equipment.
5. Investigational Device Exemption
Based on the risk exposure (Class) of the medical devices, the FDA might want to subject these medical devices to clinical studies. This is done to gather relevant data that supports whether the devices are ideal for the market, which, in turn, facilitates the issuance of the letter of acceptance.
6. Quality System Regulation
This is the FDA’s way of checking, confirming and overlooking the quality of the medical device contract manufacturer’s internal processes for making those devices.
Some of the processes checked with the quality system include:
- Manufacturing process
- Installation and;
- Servicing of the medical devices
For the best quality assessments, the FDA uses a framework, which aids in the evaluation of the different requirements and specifications that make the medical devices reliable.
The labeling requirements specify the type of information to add in the labels of medical devices. It also has to do with the following:
- The position for applying the labels, including a direct application on the device.
- It specifies whether the information is to be added to the packaging.
- Label requirements also specify the type of options, such as manuals or any other supported form of literature.
8. Medical Device Reporting
With the medical electronic devices readied, approved and pushed into the market, there is another task for the manufacturers. As per the 21 CFR Part 803 of the Title 1 US Code of Federal Regulations (CFR) Code 800, there is a provision for medical device reporting.
It specifies that the medical device manufacturers must report incidences arising from the use of those devices. These reports cut across malfunctioning devices and exposure to incidents that led to death or bodily injury to the users.
How to Get the Best Electronic Manufacturing Services for Medical Devices
Several factors are worth considering to help you make an informed decision on the best ways to get started with medical electronics manufacturing.
The following tips should point you in the right direction:
1. Choose the Best Medical Device Contract Manufacturer
With several medical device contract manufacturing companies, you can be sure to have a lot of options to choose from.
However, you should prioritize the most important factors, such as:
- Make sure that the Contract Manufacturer (CM) is registered with the Food and Drug Administration (FDA). Also, find out whether the CM is permitted to manufacture the type of medical device you want.
- What is the manufacturer’s throughput? This is directly proportional to the types of equipment it uses, the manufacturing process and the number of employees on ground to facilitate the project.
2. Tailored Medical Device Manufacturing Solutions
Your medical device contract manufacturer should incorporate design considerations to bolster the production process. This also includes having an eye for details towards the implementation of the Design for Manufacturing (DFM) guidelines.
3. Risk Management
How effective is the CM in managing the risks arising from manufacturing medical devices? In addition to having the ISO 14971, the manufacturer should also exert the capabilities to trace and fix design errors as soon as possible.
4. Supply Chain Integrity
The reliability of the medical devices is further improved with the traceability of the supply chain. The supply chain includes where the components/parts are sourced. It is important to purchase medical device components from the FDA-registered suppliers.
5. Agile Manufacturing Process
Having an agile manufacturing process for medical devices aids the Contract Manufacturer (CM)’s capability of identify potential risks and have them fixed in real-time. The responsiveness of the manufacturer in this regard is a boost to the production process, as it helps to minimize the prevalence of gaps in the production process.
6. Circuit Board Design Transfer
As the Printed Circuit Board (PCB) forms a baseline for most medical devices, it is expedient to ensure the smooth transfer. Irrespective of the design process/schematic to the board for onward production, it must be smooth and done in accordance to the prevailing documentary controls/procedures.
Final Words: The Medical Device Market at a Glance
Medical devices and pieces of related equipment will continue to be in high demand, as we need to have the right facilities in place to cater to the ailing population. RAYPCB Technology, in a 2022 report, projected a $13.4 billion market valuation for the global medical electronics manufacturing market.
In the coming years, we will see fundamentals and trends like medical 3D printing, the high demand for ventilators, sensors and wireless technologies, as well as an increased adoption of telemedicine influencing the growth of the market.
As these changes are bound to come, you want to secure your spot and manufacture the best medical devices that align with the new trends. Reach to a reliable Contract Manufacturer (CM) today for a quotation!