Date: Jun 03, 2013 Author: Chris Wiltz Source: MDDI (
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In January 1990 FDA published the results of a report titled "Device Recalls: A Study of Quality Problems," which evaluated devices recalled between October 1983 and September 1989. The study found that approximately 44% of the quality problems that led to voluntary recalls during this period were attributed to poor design drivers that could have been prevented by adequate design controls for critical and noncritical devices. During an earlier time, Munro & Associates identified that, in fact, closer to 70% of quality and cost issues arise, or could be solved, during the design phase for other industries. Whichever is the closer number, the fact is that most quality issues and cost drivers can be solved in the design phase and not the manufacturing phase.
Up to 70% of quality and cost issues arise, or could be solved, during the design phase.
Unfortunately, manufacturers from different industries rarely talk with each other or share technologies and techniques. But savvy medical device companies could borrow from dissimilar industries to create new practices that meet quality, manufacturing efficiency, and innovation goals effortlessly, while also addressing existing unanswered industry needs.
So often when a new design challenge arises in a company with a scope fixed on new industry standards and technology, we lose sight of the fact that the best design is the simplest. Specifically, when dealing with new technology, an overenthusiastic engineer may focus more on the unique material or process, blinding the design team from taking a holistic view of the product and therefore overengineering it.
The engineering team may try to explain this away as a necessary part of the R&D process; however, even with a unique or new technology, a lot of "knowns" still exist, although perhaps in another manufacturing sector. By using this collection of data (whether it is quality-related manufacturability data, material data, or cost data) a superior design team can proactively eliminate poor design choices and cost drivers in the concept phase, while refining and simplifying its design.
So what is new here? Certain tools exist to streamline this process, bringing together these data and helping to eliminate common issues that so often plague manufacturing. In fact, the early implementation of these tools can quite literally mean the difference between a technology that never hits the market and a game-changing technology that meets the highest quality standards, is easily producible and manufacturable, achieves quick time to market, and meets cost requirements.
Why isn't everyone using these tools? So often there is such an emphasis on keeping the new design process internal that outside tools that cut across industries are ignored. This approach kills innovation and keeps very insular medical device processes away from the scrutiny of existing good design principals in other sectors.
It is vitally important to get design right the first time, especially when it comes to implantable devices. Not only does a medical device have to meet high durability and quality standards, it also has to meet a high level of industry compliance and be unobtrusive for patients. If left alone, a general engineer will design a functional design—meeting the needs of the main points of function—but it will most likely not be the simplest design, nor will it have the best pedigree of reliability. By definition, the simplest design with the least number of moving parts (or indeed the least number of parts period) is, by far, the highest functioning and the least problematic design from a quality perspective. When a device needs to perform 24 hours a day, 7 days a week for most of the patient's life, poor quality and mechanical faults are not an option.
A company that manufactures respironic devices found a fault in one of its products. A piece of flashing from a cast part had found its way into the device's breath chamber. While this problem was only discovered once the device was in testing, the product was voluntarily recalled and a new design was engineered with a new casting technology that made such a flaw impossible. Would this scenario have ever been possible had the design scrutiny and process been such that this problem would go unnoticed? The answer is, quite frankly, no. If the company had applied lean design principals and predictive quality control methods, this would never have been the case. Fortunately, the company did proceed with a voluntary recall. But this issue could have been caught and solved early on through the use of predictive tools such as the Quality Report Card.
The case for using predictive tools can even be made when it comes to 510(k) exempt devices. Just because a device is substantially equivalent to another approved technology does not mean that by default the new design will be as safe and have the same level of quality, especially in its first generation. This fact is compounded dramatically when dealing with the more arduous task of getting a wholly new technology approved.
There are tools that can be used to design a device right the first time, and they go beyond the current good manufacturing practices (cGMP) that are employed in the medical industry. These tools can help to identify and eliminate quality and possible failure issues that current standards may miss.
General predictive cost tools are one tool that many companies overlook when considering new product design. The medical industry often does not consider detailed preliminary costing tools in the design phase because there is a belief that factors such as labor are not an important contributor to cost. However, if a new design uses fewer parts or better designed parts, then both labor and assembly time can be minimized. Specifically in the medical device field, we have seen part reductions by more than 50%. If this is a product of higher complexity or one that requires higher-skilled labor to manufacture, then this cost savings is increased many fold.
It's also possible that by creating a better functioning and higher quality design that requires fewer parts or less labor than the existing functional or first design, manufacturing could be kept onshore. Volume quality control issues experienced by offshore manufacturing in low-cost countries could also be eliminated. Both of these could be achieved while remaining competitive on price.
There is also the issue of weight. A better design almost always has a lower weight than a poorer one. This is an important metric from a piece cost and logistical cost-driving perspective. The weight of a device can also impact a patient's quality of life or comfort, or inhibit ease-of-use by a practitioner.
All these factors contribute to a higher metric: risk management. If you have control over the previously mentioned metrics in the design phase, then you can more properly and proactively control your risks once the product reaches the market. Having a process that thoroughly maps and tracks all parts, assemblies and subassemblies, tracking cost, weight, quality, and labor—from the supply chain to the end user—allows a manufacturer to see a complete picture of the new or redesigned product. This allows the manufacturer to evaluate the future issues that could arise from ergonomic, complexity, and manufacturing perspectives—ultimately allowing the team to make good business decisions and avoid many of the pitfalls normally encountered in manufacturing.
