What are the key challenges of medical equipment manufacturing? How do the standards and regulations apply to medical device PCB assemblies?

By | Date posted: | Last updated: June 7, 2024
Medical device PCB assemblies

Medical PCBs are the heart of diagnostics and healthcare equipment that undergo rigorous testing to meet industry standards. The growing complexity of modern medicine requires high-quality PCBs that can offer precise, repeatable, and safe operations with a long shelf-life. There are several challenges for medical devices during the PCB design and manufacturing phases. You need to consider factors like consistency, accessibility, and durability while designing medical PCBs. They are expected to be small in size and lightweight as implantable devices. Picking a suitable contract manufacturer who has domain expertise and technical ability is the key to building high-performance medical device PCB assemblies and prototypes.

The healthcare sector needs medical PCBs in applications like monitoring devices, diagnostic equipment, and implantable gadgets. Digitization of health records using computer networks has improved the efficiency and speed of patient care facilities. The software tools assist in patient data consolidation which can be of great value to innovating treatment plans. The tiny implantable sensors and wireless handheld monitors have boosted mobile health support. Miniature medical PCBs are used in devices like BP monitors, pulse oximeters, cochlear implants, etc. Imaging devices like MRIs and CT scans rely on high-quality medical PCBs for diagnosing patient health conditions. Energy-efficient and less invasive medical devices use flexible PCBs to support advanced functionalities.

The PCB manufacturing industry is evolving to accommodate increased signal density and high-speed connectivity of modern medical devices. Recently, IoT technology has been adopted in medical PCBs to facilitate reliable communication in healthcare systems. The challenges for medical PCB development have multiplied with the demand for sophisticated features in the healthcare sector.

Key challenges in building medical PCB devices:

Medical PCB devices are categorized under IPC 610 class 3/3A as they are expected to operate in extreme conditions with consistent performance. Patient safety is the highest concern in this application. So, PCB design and manufacturing have several challenges and as a medical device producer, you have to identify and evaluate the capabilities of contract manufacturers before signing the contract.

Medical PCB assembly challenges:

  • The accuracy of signal communication is crucial in medical devices. This depends on many parameters like PCB material, stack up, layout strategy, component selection, etc.
  • Medical PCBs have a high mix of analog and digital circuits and hence the design should strictly follow signal integrity guidelines.
  • Electro-magnetic interference is a common concern for medical devices. Providing shielding circuits for critical signals is mandatory in medical PCBs.
  • Healthcare devices are expected to consume minimal power to run for a longer duration. An optimized power management circuit design is an obvious challenge for PCB assemblers.

Medical PCB manufacturing challenges:

  • Validating the production process for the safety and precision of medical devices is a top priority. The process verification ensures adherence to temperature, pressure, and other environmental requirements while manufacturing medical PCBs.
  • Maintaining the production cost is difficult as medical PCBs require high-grade substrates and superior components to achieve the expected performance and reliability. Also, additional inspection and testing requirements to meet quality measures increase the overall production cost of medical PCBs.
  • Traceability of every part is important in medical PCB manufacturing. Identifying potential manufacturing defects and the ability to backtrack components is essential but difficult.

Standards and regulations for medical PCB devices:

To build quality healthcare devices, the medical industry has outlined some specific standards and regulations. Pick a CM who demonstrates these process compliance and certifications.

The US Food and Drug Administration (FDA) validates the manufacturing and quality control processes of medical device manufacturers. A certified CM assures a quality process that improves product performance and launch timelines.

International Organization for Standardization, commonly known as ISO 9000 outlines the quality and reliability requirements for product design, manufacturing, and testing in all industries. A competent CM essentially obtains and maintains the ISO certification, mostly ISO 9001. Further is an exclusive medical technology standard that defines the documentation process criteria for CMs. This is necessary to track all materials and components used in medical PCB manufacturing. If there are any product recalls, this certification helps your CM to trace back the faulty component source.

IPC-A-600 and IPC-6012 class 3 certified CM can meet the quality and reliability standards for manufacturing medical PCBs. Also, IPC-A-610 describes the acceptability of electronic assemblies.

Medical PCB manufacturing process requirements:

The medical PCB production capabilities and process requirements are quite stringent. The materials used are carefully selected to meet the unique requirements of medical devices. The PCB fabrication and assembly processes need advanced machines to build durable and reliable medical PCBs. Surface mount technology, automated inspection/testing, and trackable documentation are all important requirements for medical PCB manufacturing.

Based on applications like implants, monitors, and diagnostic equipment, the thickness of medical PCB varies. The assembly line should support these varying parameters. Most medical PCBs require RoHS manufacturing setups. A thorough post-assembly cleaning process is compulsory to get rid of any impurities or harmful particles in medical devices.

Medical PCBs are used in critical applications like pacemakers and surgery equipment where data transfer should be highly accurate. Any error in the circuit can have improper consequences on the device operator or user. Thus, medical-grade PCBs should endure rigorous testing before deployment.

Find a certified CM for your medical PCB assembly:

Choose a PCB manufacturer who ensures quality throughout the production process. Testing circuit boards at each step is tedious but crucial for medical PCBs. Though this may increase the cost and delivery timelines, inadequate testing can compromise product safety and usability. To avoid product recalls, your CM should incorporate a robust inspection and test procedure for medical PCB devices.

An expert CM provides supplementary services like design validation, BoM evaluation, and medical industry certifications. They have a well-established sourcing network and can quickly identify component shortages or counterfeit parts in assembly bins. Their domain expertise can assist you in cost-reduction techniques and maximizing production yield. So, work with a CM who is certified in medical technology standards.

Conclusion:

Medical PCB manufacturing involves several challenges as discussed in this article. The importance of precision is paramount in medical PCBs. A tightly regulated process adhering to the medical industry standards can support you in building a successful medical PCB device.

What are the top advantages of ordering bulk PCB assemblies?

By | Date posted: | Last updated: June 7, 2024
Bulk PCB Assemblies

PCB design and manufacturing is a complex and exhaustive process. With the introduction of new types of materials and technologies, the cost of PCB fabrication and assembly is shooting up. Engaging with a contract manufacturer for a small build volume turns out to be an expensive deal. To keep up with the growing costs of PCB development, ordering PCB assemblies in bulk can be a huge advantage. The count here we imply is in thousands and above. Automation of the PCB assembly process is profitable when there is such mass production. Also, the assembly and testing time will reduce significantly.

As the PCB development proceeds from prototype to production, the build volume also increases. A prototype is assembled in counts of tens or hundreds only. The production volume picks up once the design is approved for final production with the necessary certifications. You have to evaluate the market requirements and plan for manufacturing in one go. This will help in increasing the PCB assembly line efficiency. Bulk component procurement can fetch good discounts from vendors and also helps in rapport building.

Several industries like communication, automobiles, and aviation are in continuous need of new products. Assembly and testing PCBs in big volumes can help OEMs maintain their ‘time-to-market’ plans efficiently. This boosts the brand image and customer loyalty. The merits associated with the bulk ordering of PCB assemblies are many. Read further to know them in detail.

Advantages of Ordering Bulk PCB Assemblies

1. Cost-effective solution

The primary benefit of bulk ordering is the reduced PCB assembly cost. The per-unit cost comes down drastically as the components are purchased at wholesale prices. The non-recurring engineering charges become cheaper as the assembly line setup is established only one time for the complete big volume. The inspection and test apparatus run simultaneously with the PCB assembly, hence improving the line efficiency. The cost difference gained as compared to small-volume builds can be effectively used for competitive product pricing in the market.

2. Rapid turnaround time

In the PCB assembly process, some components may get damaged during manual handling. But if components are bulk ordered, there will be enough parts to assemble the first batch without losing time on repurchasing. At wholesale rates for bulk orders, you can buy surplus parts to cover such shortages. Also, the service provider can adopt an automated assembly process if there is enough build volume. This assures faster turnaround time and quick project delivery.

3. Reliable product quality

All the PCB assemblies must have consistent performance. Process automation can fine-tune the assembly line settings for optimum output and is economical for mass production. Each PCB assembly goes through the same quality and testing procedures, resulting in uniform production. Automation reduces the chances of defects and failures in the final product. PCBs built in large volumes undergo X-ray inspection, on-board tests, etc offering steady product quality.

4. Design Customization

One of the significant advantages of bulk ordering is to get customized services from the assembly provider. You can add specific components, modify board size, or choose unconventional box-building, suitable for your customer usage. With larger quantities, your contract manufacturer can easily accommodate any product changes or iterations based on the market requirements and customer feedback. This is possible mainly due to the high build volume. In small-quantity PCB assembly, such flexibility will not be feasible for your vendor.

5. Better Supply chain management

Procuring parts in bulk establishes a good bonding with the component vendors. They may prioritize your order and offer a stable supply of components for your product assembly. Even they may fabricate a batch of specialized parts for you when it is a bulk order. Inventory management is streamlined and administrative overload will reduce when all the materials are purchased in one batch than in small quantities. It allows good control over the available stock and supports prompt order processing. Thus, the supply chain management becomes more robust and reliable.

6. Scalable to meet customer demands

Product scalability is crucial to meet the increasing market demands. Once your contract manufacturer completes a bulk order successfully, you can be well assured of upscaling the PCB production. High-volume PCB assembly saves both time and effort of bulk build orders. You can achieve maximum profit with ready-to-ship PCB assemblies in stock. Electronic appliances and gadgets are consumed in large volumes today. You can grab the market and meet deadlines by choosing bulk-volume PCB productions.

7. Minimizes risks of component obsolescence

In the electronics industry, often new components are introduced and old parts are made obsolete. This fluctuation in the market can affect the pricing and availability of electrical components. If you have procured surplus parts in your bulk order, you can mitigate risks and fulfil your PCB assembly orders without delays. Through wholesale procurement, you are shielded from unexpected price hikes. This offers long-term cost stability for your budget planning.

8. On-demand product delivery

Bulk ordering supports faster time to delivery of the PCB assembly. With enough material stock in storage, you can assemble the product and deliver it on demand. It enables efficient production planning, minimizes build costs, and ensures timely delivery of products to the customer. This is beneficial for OEMs to stay ahead of the competition.

Ordering bulk PCB assemblies can be valuable in reducing the environmental impact also. By ordering large quantities, you can save on packaging material and shipping costs. This will reduce waste generation and improves resource optimization. So bulk PCB assembly promotes sustainability in the electronics manufacturing industry.

Conclusion

If your PCB product is completely evaluated for functionality and ready to go for mass production, then ordering for bulk PCB assembly can be highly beneficial. The top merits of bulk PCB assembly are cost savings, quick turnaround time, consistent product quality, and customization. With large-quantity components procurement, you can streamline your supply chain effectively. Bulk PCB assembly assures scalability with growing product demand in the market. Extra components procured can be helpful if sudden cost changes occur in the market. Further, you can build PCB assemblies on demand if the necessary inventory is in place. Thus, bulk ordering of PCB assembly is a strategic method to stay competitive in electronics manufacturing.

Technotronix is a professional PCB manufacturer with 4 decades of experience and ISO 9001:2015 certified who is equipped with the necessary industry best practices. Feel free to contact us via email at [email protected] or call at 714/630-9200, If you have any questions or any requirements related to PCB assembly service.

How to identify the top PCB assembly company in Southern California?

By | Date posted: | Last updated: June 7, 2024
PCB Assembly Companies

The PCB manufacturing industry is agile and requires proactive assembly service providers. Technical expertise and high-quality manufacturing processes are essential for building successful PCB assemblies. Not all contract manufacturers can offer cost-effective and reliable PCB assembly services. Issues like mismatched CAD tools, inconsistent manufacturing methods, and poor testing support are common in many assembly companies. But Southern California is known for advanced technology and proficiency in PCB assembly services. Identifying the best contract manufacturer needs a comprehensive assessment of all the existing service providers on several parameters.

The PCB assembly involves the mounting of electrical components on a bare board to make it a working circuit. There are two common assembly methods used by contract manufacturers. They are the Surface Mount Technique (SMT) and the Through Hole Technique (THT). Surface mount parts are assembled using SMT and through-hole parts are soldered using THT techniques. The contract manufacturers have to follow the industry standards during these assembly processes to assure quality output. Also, having more than one sourcing channel is mandatory to mitigate any shortage or unavailability of components before starting PCB assembly.

It is recommended to check if the contract manufacturer has experience in the domain of your end product. PCB assemblies used in the medical, aerospace, and automotive sectors have to be compliant with their corresponding industry standards. Most assembly companies display their certification details on their websites. You can verify the same and ask for their previous customer reviews for added assurance. Read further to know the important checkpoints while choosing the best service provider for PCB assembly service in Southern California.

Guidelines to identify the best PCB assembly company for your product:

1. List your service requirements

Based on the design features and complexity of your product, list down the services you require from the PCB contract manufacturer. Consider the lead time, quantity, and cost budget. It is recommended to plan for both assembly and testing of PCBs from a single vendor. Turnkey service providers offer a bunch of services like design review, component procurement, assembly, testing, debug support, storage, shipment, and after-sales services. You can spend enough time understanding your requirements and then proceed with choosing the best PCB assembly services.

2. Verify the company’s domain experience

The PCB assembly company must have prior knowledge of your target domain. Handling IPC class 2 and class 3 PCB assemblies demand technical proficiency and substantial experience. Find vendors who have demonstrated quality output in the same sector. You can ask for references or previous client reviews to learn about their capabilities. The material choice, soldering techniques, and test setups differ as per requirement of printed circuit board assemblies.

3. Check for the quality standards and certifications

There are industry standards established to regulate the quality of electronics manufacturing services. Choose PCB assembly company that is certified as follows:

  • ISO 9001 for general quality assurance
  • IPC-A-610 for acceptability of electronics assemblies in different sectors like medical, aerospace, and defense.
  • AS9100 for aerospace PCBs

These certifications should be timely audited by third-party companies as they are not just a one-time process. The assembly companies have to adhere to the standards and train their staff to follow the set procedures. For RoHS PCBs, the service provider should avoid restricted materials in every stage of PCB assembly.

4. Evaluate the Supply chain management

Top PCB assembly companies will have robust supply chain management in place. The ability to source authentic parts and materials for PCB assembly involves strong communication and networking. Experienced PCB assembly providers will review the final Bill of Materials (BoM) and plan procurement strategically. They will have multiple sources to tackle any component shortages and obsolete parts issues. Also, they source from the approved vendor list to avoid counterfeit parts in their inventory. An updated inventory management system is a must to identify and track materials on the shop floor.

5. Understand the process agility and technological competence

Today’s PCBs are designed for advanced technologies like high-density interconnect (HDI), high-speed, and high-power applications. Flex and Rigid-flex PCB assemblies have special requirements to add auxiliary fixtures and stiffeners. Assembling such complex PCBs is feasible only with modern equipment and trained staff. Your assembly provider has to support product customization and should accommodate changes if required. Evaluate their assembly line for flexibility along with technical capabilities.

6. Look for a transparent customer suppor

Before placing an PCB assembly order, do check if they offer dedicated support for your project. They have to be open to discussions and clear in their communication. If there are delays or ambiguities in their reply to your queries, then it is a warning to reconsider.

7. Acceptable cost and timelines

Contract manufacturers will charge you more to assemble PCBs in a shorter timeline. Go through the quotation and understand the pricing offered. It should match the required services and quality standards. If correctly planned, you can save a good amount on the assembly services without compromising on the quality.

The top PCB assembly companies can easily check if your design is feasible for fabrication and assembly. They can identify ways to improve manufacturability in the design stage itself. Best contract manufacturers track market trends and ensure component availability for your PCB assembly. Their excellent documentation process captures the required data to assist you in future revisions. Top assembly companies integrate advanced test processes to detect errors at the first instance. This reduces the turnaround time significantly.

Conclusion

An accurate evaluation method will guide you in identifying the top PCB assembly companies in southern California. As discussed in this article, factors like industry reputation, design support, technological abilities, supply chain management, industry certifications, and customer support are the key points to consider. Investing time and effort can help you to find the best assembly company aligning with your product specifications.

TechnoTronix – Top PCB assembly company in South California

At Technotronix, we have over 40 years of experience in fabricating and assembling high quality PCBs. We use advanced technology circuits to take control of the plenary process of PCB assembly services. We are working successfully for our customers in varied industries like aerospace, telecommunication, defense, medical, automobile and robotics. You can count on us for high quality PCBs, no matter what the level of complexity.

Get a quick PCB assembly quote or email us on [email protected] or call us on 714/630-9200 to ask your queries related to our custom PCB manufacturing services.

Top common mistakes to avoid while placing PCB assembly order!

By | Date posted: | Last updated: May 23, 2023
PCB Assembly Order

In the fast-paced electronics industry, new products and features are added to the market every day. To stay ahead of the competition, you have to launch your PCB products on time. Avoiding common mistakes while placing the PCB assembly order is crucial in maintaining the delivery schedules. Several checkpoints in the PCB design process can ensure a high production yield. You have to follow design specifications, place components strategically, implement Design for Manufacturability (DFM) guidelines, and share the latest Bill of Materials (BoM) with your Contract Manufacturer (CM). Building trust with your CM is a key aspect during the PCB fabrication and assembly process.

You can generate quotes from different vendors and compare the pricing before finalizing the right CM for your product manufacturing. The PCB fabrication cost depends on details like board dimension, the number of layers, surface finish, and design complexity. Do you need PCB fabrication along with assembly? Will you procure the components or the CM has to source from your BoM list? What is your lead time for getting assembled PCBs? All these questions have to be answered before going ahead with the order placement and collaboration with a contract manufacturer.

Small mistakes in PCB assembly, especially during bulk orders can cause significant time delays and budget overflows. The degraded performance of the product will also affect the brand’s reputation. Hence, it is important to avoid these common mistakes while placing PCB assembly orders.

Common mistakes to avoid while placing a PCB assembly order:

1. Do not choose a CM without evaluating their competence

There are many contract manufacturers available in the PCB industry today. Without rushing to place an order, you have to explore the services and pricing offered by multiple CMs (Contract Manufacturer). You can visit the assembly house to understand their process quality and technical capabilities. Based on your product market, choose a contract manufacturer with relevant industry certifications. An experienced CM can effectively perform component analysis, review designs, and check for product integration. Take time to compare and then decide the best service provider for your PCB assembly.

2. Do not share partial or inaccurate BoM

If you are asking your contract manufacturer to source the components for PCB assembly, then double-check the BoM before sharing. It has to be complete and up-to-date. If you have missed any component details in the BoM then the CM may procure a wrong part, affecting the board performance. The longer lead-time components used in the design should be highlighted for early ordering. Check for obsolete or ‘End of Life’ components in the BoM and replace them with ‘in-production’ parts. Do not forget to share your approved vendor list with the CM. This will avoid sourcing counterfeit parts.

Also checkout: Why Bill of Materials (BOM) is important in PCB manufacturing process?

3. Do not skip PCB design reviews which are essential for high-yield optimization

Along with the functionality review of the circuit design, check if the Design for Testing (DFT) and Design for Assembly (DFA) guidelines are implemented. Missing these recommendations during PCB design will reduce the assembly output. Silkscreen should be readable on both sides of the PCB. Include fiducial markers on the board to assist the pick and place machine during component assembly. Provide edge clearance on the PCB for mounting equipment to get enough grip. This is mandatory for a successful PCB assembly.

4. Do not provide incompatible design output files

Communicating clearly with your CM is highly essential to avoid confusion or delay in the PCB manufacturing services. There are different design output files like Gerber files, IPC 2581, and ODB++ used for PCB fabrication. For Assembly, BoM and X-Y placement files are required. BoMs (Bill of Materials) should be reviewed and shared in standard templates. Schematics and assembly drawings are also part of the design output bundle. It is necessary to provide these files in the formats accepted by your CM.

5. Do not handover ambiguous assembly instructions and testing documents

Provide clear PCB assembly instructions for component mounting sequence, orientation, and soldering techniques. If special components are used in the design, then add associated handling procedures to the document. For example, including the details of EMI-sensitive components and their shielding circuits can save component failures post-assembly.

The PCB assembly document package consists of test specifications and regulatory requirements. Test procedures and expected results must be clearly explained in the test documents. All the assembly documents should be revision controlled for traceability.

6. Do not miss to verify the PCB assembly quality before reordering

Do not opt for low-cost services. It is a common mistake to overlook quality over cost. But this will backfire in the long run. Assess the PCB assembly quality after the first batch output. The PCB assembly should pass the required tests and conform to industry standards. PCB assemblies of inferior quality will result in performance failure. This will add to the debug and rework costs, along with a delay in the delivery.

There are ways to reduce the PCB assembly cost through prior planning. If you are looking for a shorter lead time, then the price will shoot up. Also, the quantity of PCB ordered will impact the assembly cost. CMs will charge for creating soldering stencils, programming devices, preparing test setups, and board inspection. Choosing standard PCB sizes and common materials can help to reduce fabrication and assembly costs. While generating a PCB assembly quote, you must consider all the above aspects. Once you decide on the contract manufacturer, go through the quote in detail and understand the pricing and services offered.

Conclusion

To achieve maximum assembly output, you have to plan and then place the PCB assembly order. Avoiding the common mistakes listed in this article guarantees a smooth and efficient run of the PCB assembly process. The key factor is to evaluate and choose the right service provider. Keep in mind to share the complete and updated BoM. Review your circuit design thoroughly and implement DFM guidelines. As you focus on cost-reduction methods, do not forget to verify the assembly quality before placing your next PCB order.

We have 40 years of expertise in providing PCB assembly services. We use surface mount (SMT), through hole and mixed technology to manufacture consigned printed circuit board assembly, turnkeys, board types with metal cores, etc. as per your requirements. Get a quick PCB assembly quote or email us on [email protected] or call us on 714/630-9200 to ask your queries related to our custom PCB services.