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Manufacturers’ Contract to Evaluate the Importance of Electronics in Medical Device Applications


An idea manufacturer who has a contract in providing medical devices is important more than a typical transactional contractor which means he is such a significant partner with abilities to improve both the process and launching the product in the market.  In medical ground, PCB manufacturing and electronic toolbox play a significant role. Nowadays, majority of the medical device applications are being employed in hospitals and healthcare settings for diagnosis, tests, patients’ treatment and critical laboratory research which rely on PCB in one or another way.

Some of the EMS’s abilities include high-speed surface mounting and through-hole circuit assemblies which are being used in the major focuses in constructing a specific medical device based on the PCB manufacturing process. For example, such devices for which electronics is the main component for their proper function are pacemakers, defibrillating devices, monitors for heart activity, imaging frameworks, MRIs, X-rays, CT scans, analyzing gases, measuring sugar in the blood and monitoring blood pressure, etc.

Consequently, it is comparatively a standard across the medical device industry that OEMs should shift towards the electronic contract manufacturers (OEMs) that have the ability to deliver the desired high-quality PCBs in the specific desired time of improvement.

PCBA assembly

ECMs are actually those types of companies which work in the designing, manufacturing, testing, and providing post-maintenance services for electronic assemblies and components and allow the medical device OEM for concentrating on the basic capabilities deprived if investing in the classes, persons, and required instruments for electronic manufacturing. Additionally, ECMs provide surety of required components for their reliability and endurance. In the field of medical sciences and practice, if a device or a machine is not properly working due to some fault in the electronic circuit or an improper treatment or diagnosis of the patient or the machine is works as an implantable device for life saving, the failure of PCB could result into significant health related risks.


In case of outsourcing a specific PCB or electronic toolbox by the medical OEMS, the basic criteria of a contract manufacturer selection boils down to pricing, service of quality and product delivery.  Nevertheless, many companies are claiming to provide these three basic elements, therefore, it is problematic to examine whether a present or upcoming contractor is professional and truly reaching up to the desired mark.

Eventually, making a comparison between the options available in the market needs some anticipating questions based on two viewpoints i.e. engineering and supply chain management. Even ifa community exists among the two having some distinctive perspectives in what they need, from an ECM. The function of a specific ECM is to work in more than one partnership instead of being a transactional supplier. This ultimately assists in getting benefits from OEM from more design and manufacturing specialty for serving in the improvement of product and logistics and even decrease the cost of manufacturing. In the United States, with having so many ECMs, lots of them simply operate in the mentality of the customer-supplier communication that makes the job problematic and create several noticed issues.

The Issue of Supply Chain Management

The major focus of professionals working in the supply chain management is on three major elements such as cost, quality and delivery that make their business triangle. The basic idea of the supply management systems is to develop such ERPs which require more work and efforts and maintaining that quality is very rigorous. Whereas a simple consumer-supplier relation or interaction is not enough for achieving the desired goal. As the conditions in business environments are significantly varying and evolving on daily basis, working together with a partner with a focus on improving production methods and logistics can give an edge of competition. It is important for a partner that he should deliver high-speed surface mounted or through-hole prototype PCB assembly and able to do MEMS based boxes, designing engineered board, performing functional tests and manage repairs for customers after installing a particular medical device.

An ECM must have the objective to enhance the competitiveness of the medical OEM through smart and fast work in an effective manner. The contractor should have consistency in calling and visiting even auditing his manufacturing processing for assuring additional value to the OEM. Both the companies can conduct weekly meetings for production yield reviews, any test data in the field, requiring consumer authorization, and many other related issues. Similarly, contractors having potential in the medical field should Potential contract manufacturers should own equipment for production and testing, able to give the desired throughput for the product which is contracted by the consumer.

One of the examples can be taken as Aesynt which is medicine manufacturer and handle equipment supply for healthcare sectors and pharmacies, James Norwood, was looking for more in ECM than three qualities such as cost, quality and delivery.  Being a director of the company, he got extra ordinary technical and managerial skills along with flexibility.  However, the company worked in designing the PCBs along with their specs, the contractor bought all the parts and the combines them to test and ship the completed products.

In the view of Norwood, the company sought a contractor whose workers had great technical history. Also, the most significant thing was that company had certification from ISO 13485 in medical devices which is an international standard for setting out the quality management systems specifically in the field of medical devices.

Furthermore, Norwood said that the ECM had assisted them for improving the quality along with manufacturing design ability and they had completed a Kanban system with the contract manufacturer to ensure the delivery. They kept the PCBs for them and shipped it to them in time after the release of virtual JIT process.


Engineering Design Optimization

EDO is another important outlook that a company sees while collaborating with a contract manufacturer and it is completely based on engineering. Quality is frequently focused in this matter along with other concerns such as cost and delivery. This can be achieved when the contract manufacturer is able to work effectively in engineering and requires several testing procedures for ensuring the quality of product. Additionally, to achieve the best results, the contractor should be able to collaborate in improving the manufacturing process and overall design of the product.

Similarly, selection of a contract manufacturer in the process plays a significant role in the evaluation of the product at initial stage and follows the ongoing evaluation and collaboration in the turnaround time. The contractor must have ISO 9001 certification and production for testing the equipment to get the desired throughput for the contracted product. Additionally, the expertise of a contract manufacturer should be a mixture of manual and automated testing with all operating abilities. The operational testing must have evaluation of voltage, calibration of temperature and other measures of the completed product.

Through proper engineering evaluation in hand with the contract manufacturer, medical device OEMs can significantly decrease both time and cost of the product. As companies have their own evaluation criteria to make decisions which contract manufacture is suitable for their application, selecting one who is ready and show willingness for collaboration for improving both the manufacturing process and product.