Our experience developing tooling has shown one of the fastest return on investments (ROI) for overcoming high manufacturing costs is to improve medical device quality with robotics. The main reason for repeat quality problems is a design that was rushed into production. By skipping over the design for manufacturability process it increases the difficulty and cost to create a properly validated process. Once a medical device is in production most companies are hesitant to change the process due to regulatory issues. The time, cost, and risk associated with re-validating the process are perceived to be too high. As a result, many companies slowly limp along with nagging problems believing “the next lot will be better.”
Quality issues sometimes present themselves as continuous lingering problems. Other times, a quality issue can also result in the sudden loss of an entire lot of product. Hopefully, a quality issue is found at the process step responsible for causing the problem. It is less desirable is when the problem is found at final assembly or lot release. The worst case scenario is when a problem is found in the field and leads to a recall.
It is often hard to take a step back from a lingering quality problem. A series of small fixes may have been put in place to help solve the problem but until the root cause is flushed out it will continue to absorb time, money, and morale. Making an effort to invest the time to evaluate automation options to perform these difficult operations will have large payoffs later. There are several reasons to utilize automated tooling to perform difficult operations in a precise and repeatable manner. Some of the issues surrounding quality are easy to quantify and calculate, but many are a bit more subjective but no less important.
Improve medical device quality with robotics by focusing on the highest costs first. Calculating your current yield loss and evaluating the cost of the lost units will probably be shocking the first time it is calculated. Putting money toward a repeatable process that can be validated and have a high first pass yield will have a rapid ROI and immediate savings. Reduced yield loss is an easy way to justify the upfront capital costs of automated tooling with a simple calculation.
At one company we kept track of hours that went into Non-Conformance Reports (NCR’s) for failed components and assembly processes. After a few
months, we were surprised to find that our average NCR cost $5,000 of engineering and operator time with meetings, paper work, and material disposition. In addition to draining the energy from your operations, a quality problem can also:
Knowing the cost of continuous paperwork churn related to poorly performing processes will also provide for additional justification of automated tooling. Raising the first pass yield with automated tooling will reduce your recurring quality engineering costs. You’ll likely make the engineers assigned to sort out non-conformances much happier.
McKinsey Report: Capturing the value of good quality in medical devices
Your sales reps in the field are the face of your company. They want to be able to stand in front of the customer with confidence. Knowing they have a high quality device will provide them the best opportunities possible to sell the devices you manufacture. Constant, perpetual quality problems or multiple single quality events can cause your reps to rationalize the company’s manufacturing choices with the customer.
They can’t sell well if they can’t trust the product. Developing reliable automated processes that can be validated can build the trust they need to increase sales and brand awareness through a dedication to the highest level of quality.
The complaints process for medical device manufacturers can be a tedious and costly exercise. Developing the proper validated processes can help reduce complaints in the field and reduce the overhead required to manage the complaints processes. In addition, fewer complaints mean fewer returned devices to be processed, which also reduces overhead and minimizes employee contact with contaminated, used devices.
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