Custom Wiring harness manufacturers are generally involved in the processes of the manufacturing custom wire harness that is intended for an application.
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Finding perfect custom wiring harness manufacturers/ companies can be a hurdle when you want to achieve success for your medical device. Do you want to outsource the wiring/cable harness assembly requirements that can be of value to your medical equipment?
Put in your extra time and effort in researching the best companies for your medical devices. Settling with a firm without proper research can greatly impact your business, time and money.
It is certainly crucial to get associated with experienced companies to get professional work done on your devices. It might be tempting to believe the experience profile claimed by them. Don’t fall for their bait. Although they deem themselves as experienced wiring/cable harness manufacturing partners, it is extremely important to research them on their online ratings, reviews, and customer testimonials and even, maybe check on their client references before we jump in.
Checking on their past client's portfolio could help you to decide if they would be the right fit. Determining the product class category dealt in the wiring harness companies is of para importance. Similarly, determining whether the manufacturer has been positioned in manufacturing full-fledged wiring/ cable harness medical equipment or semi-developed products is ascertained to know.
The firms that have proven longevity down the years will provide an extra sense of assurance in the following aspects such as best manufacturing practices and processes to attain quality medical equipment.
Although It may appear enticing to work with a less experienced wiring/cable harness manufacturer for a lower cost, however, operating with an exceptional company can make a difference for your medical equipment.
Researching the types of wiring/ cable harnesses that the firm uses and the skill set levels in the medical device industry is of paramount importance. Besides that, based on the experience in the industry, it is necessary to find out the level of IPC certification held by the manufacturer and its employees. For instance, IPC offers 3 levels of certifications as Certified Standards Expert (CSE), Certified IPC Trainer (CIT) and Certified IPC Specialist (CIS).
Some of the wire harness pre and post-production processes might either be automated or semi-automated. For better clarity, You will also need to know from them whether the manufacturing processes would be automated or semi-automated or manually assembled. Keen attention should be paid to the proven track record of the manufacturer when it comes to the manual hand-wire harness assembly job.
It is necessary to evaluate their expertise level on various dimensions, likely wire harness design and engineering as it does have a huge effect on the functionality and quality of your medical equipment. Based upon the Mckinsey report, due to the low quality of medical devices, there have been various patient disability, death and hospitalization cases being reported that are likely to double quickly as the rising growth of the medical device industry.
The proficiency of the personnel staff, employees and inspection personnel should be checked in the objective evidence records which provide information on the respective job function training, work experi
Determine the custom wiring harness manufacturing partners who comply with the standards and regulatory requirements of the medical device industry. These manufacturing companies should be able to furnish the required certifications in alignment with harness manufacture. Moreover, select the firms which possess additional certifications that affirm their capabilities in achieving quality medical equipment based upon the customer requirements as per the international standards. A few such certifications to be sought out in the medical device industry are
ISO Standard: International Standard for Quality Management Systems in Businesses or Organizations
IEC standards: International Electrotechnical Commission for all electrical, electronic and associated technologies
IPC J-STD-001: Industry specification for electrical and electronic assemblies issued by IPC
IPC WHMA-A-620D: Standard that proposes Wiring / Cable harness manufacturing requirements and acceptance
It is essential to consider a manufacturing company that has the capabilities of running a dedicated expert team for wiring harness design, engineering and production, and assembly according to the required specifications. Alternatively, the size and capacity of the manufacturing plant and workforce matter too.
Companies with large-sized plants tend to have larger, more experienced workforces compared to smaller companies. However, For smaller batches of medical wiring/cable harnesses, smaller to medium companies can be approached. Generally, larger companies do not accept smaller order requirements as they don’t focus on manufacturing small, limited batches.
On the contrary, selecting a company that specializes in both manufacturing small and large volumes of batches can be of value when you tend to face both requirement scenarios.
Ensure that the team of professional engineers do exist in the firms can guide you on how the harness is utilized in your medical application.
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Check on the following :
1. Time duration involved in the wire harness design, the prototype and the final medical application.
3. Have they manufactured any similar types of harnesses for the same type of applications in the previous projects?
4. Do they implement processes that exhibit repeatability and volume which directly indicates the reliability of the wiring harness?
5. Quality management processes involved during the design, and manufacturing
Choose the custom wiring harness companies which strictly implement various medical quality assurance techniques such as ROHS, Statistical Process Control, PFMEA (Process Failure Mode and Effects Analysis ), Control Measures and Acceptance Criteria, Kaizen, 5S, Total Productive Maintenance, and Measurement System Analysis.
Needless to mention, opt for firms who not only perform extensive testing on the final medical device product but also at every wire harness stage like wire cutting, layout, stripping, crimping, soldering, welding processes etc. Some of the commonly used testing methods are Pull Testers for Crimping, pull testers for Soldering, Magnifiers for assembly inspection, hv testers, and Preprogrammed testers.
Ensure that they have the essential testing equipment such as pre-programmed tester/boards. The test boards are programmed according to the electrical specifications of the intended medical application.
Associating with wire harness businesses who conduct extra, detailed and rigorous quality checks contributes to further advantages to your medical device. Choose the ones that can exceed the quality requirements.
According to the report, A rise in medical device recall events was found to be at 8.8% in when compared to the year . Similarly, based on the report, in Q2 , the medical device recalls soar by a rate of 11% in Europe compared to the previous quarter Q1.
Before collaborating with any company, be sure that apart from meeting the industry standards and requirements, they should also exceed the quality requirements by aiming to continuously enhance the harness processes, services and products. For instance, implementation of the six sigma strategies such as DFMEA ( Design Failure Mode and Effective Analysis ), PFMEA ( Process Failure Mode and Effects Analysis), and maintenance of risk assessment file aids in the identification of risks involved in the wiring/ cable harnesses.
According to the Mckinsey report, few medical device manufacturing companies have utilized Quality Function Deployment (QFD) for accurately capturing their crucial requirements and needs. The report also cites that lack of risk assessment tools and negligence of non-updating the feedback frequently are some of the issues encountered in many manufacturing firms.
A wiring harness testing has various options with respect to test items, specifications, and methods, depending on the product to be tested. The performance and specifications of the cable connecting the tester and the product to be tested must also be appropriate for the job. Indoor conditions and the quality of the power supply, which might be thought to be unrelated to testing, can in fact greatly affect test results. Our experienced professionals, who all have comprehensive expertise in onsite testing, are able to make accurate judgments and provide appropriate advice even if they cannot see your situation on the spot.
An inspection device is like a business partner for people who work onsite every day. That is why we believe the device should not only be easy to view and use, but also have a design that is user-friendly and suitable for long-term use. considering the limited space on worksites, smaller devices are preferable, provided that their functions and performance are equivalent to those of larger devices. Our inspection devices are not just boxes. We would like to be of benefit to our customers and continue to be held in high esteem by them.
With the continuing increase in the production of electronics, the use of wire and cable harnesses is ever changing, and inspection needs are also becoming more and more diverse. We provide models that always accommodate the latest needs by maintaining direct communication with our customers. By responding to inquiries about our inspection expertise, we are engaged in research and development activities every day.
You can see and appreciate the true value of our cable harness testers by actually using it onsite. But it is not easy to rent the testers to customers around the world. We recommend that customers watch the videos at first. You can ascertain whether the cable harness testers fit your needs in terms of performance, features, and specifications, and you can also find out how its design. You can check the specifications on the product page. If you tell us what kind of test you need, we will suggest the best cable harness tester and realize your request.
At a wire harness production site, various types of harnesses are manufactured in small lots. In a short period of time, thousands and thousands of lot numbers and a massive amount of testing data will have been accumulated. There are more than 10,000 pieces of data for some devices. We have a system that can capture the data from a customer’s or third-party equipment, meaning your valuable data will be carried over to the future.
When we customize just one standard product, we produce nearly 100 types of derivative products in average. This shows that the wire harness testing process and operation method are different for each company. Our cable harness testers have the hardware capability potential to accommodate a number of customizations. In addition, our software has many library resources.
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