Your Guide to Quality Assurance in Medical Device Manufacturing

Avoiding problems and preventing mistakes, defects, and flaws in PCB manufacturing for medical devices is imperative. Quality assurance and quality control impact your end product. Undetected flaws during PCB manufacturing not only directly impact your boards, but could cause a dangerous malfunction for a device designed to save lives. You need to know your medical devices are reliable. This is where quality assurance comes into play. Finding an ECM that goes the extra mile will help ensure consistency and safety during the medical device manufacturing process.

Taking Hold of the Rising Demand for Quality Medical Device Manufacturing

The demand for quality medical device manufacturing is rising steadily and this trend is expected to continue. With the increasing demand for devices, developers are looking for electronic medical device manufacturers to partner with for production. A manufacturing partner will need experience and certain capabilities to meet this demand at the level of quality and regulation these products demand.

Avoid Counterfeit Electronic Components in Medical Device Manufacturing

Avoiding counterfeit electronic components is always important, but when these components are being used for medical device manufacturing, the need becomes even more crucial. If fake medical devices are on the market, it poses a danger to public health and patient safety.

Features of Experienced Electronic Medical Device Manufacturers

The medical device industry evolves at a rapid-fire pace. It must quickly adapt to new clinical needs, and, as part of that process, respond to fluctuating manufacturing demands. It is not an easy balance and as a result, more original equipment manufacturers are relying on partnerships with electronic medical device manufacturers. Med-Tech companies need their electronic medical device manufacturers to solve manufacturing problems they cannot solve on their own. This means manufacturing partners need to offer advanced medical manufacturing capabilities that only experienced ECM's can fulfill.

Turnkey ECM for Successful Medical Device Development

Whether you are just breaking into medical device development or you are a long-standing company with an impeccable track record, sometimes you just need some extra hands to get a project off the ground. In these instances, working with a turnkey ECM could be the perfect solution. Turnkey electronic contract manufacturers can handle not only the manufacturing but also the design, engineering, and manufacturing for your cutting-edge medical device. A turnkey ECM can step in from initial concept or anywhere in the medical device development process and get it market-ready. Better yet, it is all done under one roof. Most electronic medical device companies that turn to turnkey solutions enjoy many advantages of the service, including saving valuable time and money.

Parts Obsolescence in Medical Device Manufacturing - Why?

It is no secret that parts obsolescence is a major concern in the electronic industry. But the problem of obsolete and hard to find components seems to be compounded when it comes to medical device manufacturing. Medical device manufacturing comes with its own unique set of qualifications. The concern with parts obsolescence for electronic medical devices is equally as unique. But in order to begin to combat the problem, you must first fully understand it.

Mitigate Parts Obsolescence in Medical Device Manufacturing with a DFM

Patients often rely on electronics to increase their longevity. Their lives depend on medical devices that have long lives of their own. However, parts obsolescence in medical device manufacturing can complicate this. Many electronic components have life cycles which are shorter than that of the medical device in which they are used. Obsolescence of electronic components is a common problem. Sometimes parts become obsolete before a product is even through production. Often the only chance manufacturers have to battle this is with forecasting and being proactive.

How to Manage Parts Obsolescence in Medical Device Manufacturing

Medical devices are much more complex than even just five years ago. Simply replacing just a part or two is not an option. That being said, reacting to parts obsolescence instead of planning for it is an inadequate process. Planning ahead is a must when it comes to managing parts obsolescence in medical device contract manufacturing. No matter how good your product is, there will come a point when a key component will become unavailable. However, a proactive approach will keep it rolling off the assembly line and into the hands of your customers. Here’s how.

ECMs are Redesigning Medical Devices to Mitigate Parts Obsolescence

Medical devices diagnose diseases and prolong life. They have come a long way since they were first introduced more than a century ago. And while technology allows for a continuous push for smaller and more powerful medical electronics, the real issue for aging medical devices is component obsolescence. The current medical device regulatory landscape is extremely sensitive to this risk.

The Importance of PFMEA in Electronic Contract Manufacturing

In any manufacturing process, there are bound to be issues. From design to prototype to manufacturing, problems can arise, and the failure to address them early can cost you in both time and money. To best mitigate issues like this, implement the Process Failure Mode Effects Analysis (PFMEA) to help streamline your approach.

Management of Parts Obsolescence in the Medical Device Industry

Parts obsolescence is already a big problem in the electronic industry. The fast pace of medical device development only compounds the trouble of hard to source components. Technology--especially medical technology--moves forward rapidly. And, in some cases, parts become obsolete before the final product is even finished. Essential parts become impossible to source. However, this does not mean your cutting-edge medical device has reached a dead end. Finding the right medical device contract manufacturing partner can do a lot to mitigate the issue of parts obsolescence.

Outsource Your Medical Device Manufacturing with Confidence

Over the last decade, the medical device industry has experienced exponential growth. However, as the market has grown, there have been a number of factors driving costs and expenses up as well. Staying on the cutting edge of the industry also means maintaining profitability. Increasingly, more and more companies are turning to outsourcing to stay flexible in an exploding field.

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