Release date: 2014-07-14
Using advanced design techniques and predictive tools during the design development phase can bypass problems encountered in the middle.
In January 1990, the FDA issued a report entitled "Device Recall: A Study of Quality Issues," which evaluated equipment recalls between October 1983 and September 1989. The study found that about 44% of the quality problems caused by spontaneous recalls during this period were attributed to flawed design drivers, which could be avoided by robust and reliable design control of critical and non-critical equipment.
In fact, at an earlier stage, Munro & Associates realized that in the design phase of other industries, about 70% of the quality and cost issues could be solved. Regardless of the specific number, in fact most quality issues and cost drivers can be solved at the design stage, not at the manufacturing stage.
At the design stage, about 70% of quality and cost issues can be solved
Unfortunately, manufacturers in different industries rarely discuss or share technology and skills with each other. But savvy medical device companies can draw on different industries to create new practices effortlessly to meet quality, productivity and innovation goals while addressing existing industry needs.
New design challenges often arise in companies that focus on new industry standards and technologies, and we ignore the fact that the best design is the most succinct. Specifically, in dealing with new technologies, an overly enthusiastic engineer may pay more attention to novel materials, processes, or dazzling design teams in the overall view of the product, thus over-engineering the product.
The engineering team may try to interpret this as an essential part of the R&D process, however, even with unique technologies or new technologies, a large number of “known technologies†still exist, albeit possibly in another manufacturing industry. By using these collected data (whether quality-related process data, material data, or cost data), a good design team can proactively eliminate flawed design and cost drivers during the concept phase while refining and simplifying its design. .
So what is new here? That is, there are tools to simplify the process and bring these data together to help eliminate common problems that are common to manufacturing. In fact, the early use of these tools can gradually reflect the difference between technologies that have never entered the market and those that meet the highest quality standards and change the rules of the game. The latter is easy to manufacture, to reach the market in a short time and meet the cost requirements. .
Why aren't everyone using these tools? Often emphasis is placed on adhering to internal new design processes, and cross-domain external tools are ignored. This approach stifles innovation and frees medical device processes from the well-established design principles already in place.
Getting the right design the first time is critical, especially when it comes to implants. A medical device must not only meet high durability and quality standards, it must also meet high levels of industry standards and is acceptable to patients.
If you don't, the chief engineer will design a product that meets the main functional points required, but it is probably not the simplest design and will not have the best reliability. By far the definition, the simplest design has the fewest moving parts (or, to be precise, the fewest parts), which has the highest performance and the fewest design flaws in terms of quality. Poor quality and mechanical failure are unacceptable when a device needs to run 7x24 hours in most of the patient's life.
A company that manufactures respironic equipment has found a flaw in one of their products. A piece of waterproof sheet in one casting will enter the breathing chamber of the device. Although this problem was only discovered once in the test equipment, the product was actively recalled, and a new design was carried out with new casting technology, making such a flaw impossible.
Is it possible that this situation has been overlooked during design review and process? Frankly speaking, the answer is no. If the company applies lean design principles and predictive quality control methods, this will never happen. Fortunately, the company made a voluntary recall. However, by using predictive tools such as quality report cards, this problem could have been discovered and resolved early.
There are also use cases for predictive tools even when it comes to 510(k) duty-free equipment. Just because one device is essentially equivalent to another approved technology does not mean that by default, this new design is safe and has the same level of quality, especially in the first generation of such devices. in. The complexity is greatly exacerbated when dealing with such a daunting task of obtaining a completely new technology approval.
There are tools that can be used to make the original equipment design right, and they go beyond the good manufacturing practices currently used in the medical industry. These tools can help identify and eliminate quality issues and possible failures that may be missed by current standards.
When considering the design of new products, conventional cost forecasting tools are a tool that many companies ignore. In the design phase, the medical industry usually does not consider detailed preliminary costing tools because they believe that factors such as labor costs are not a significant impact on costs. However, if a new design uses fewer parts or better design parts, labor and assembly time are reduced. Especially in the field of medical equipment, we have seen a partial reduction of more than 50%. If this product has higher complexity or if the product requires more skilled labor to produce, then reducing costs adds many obstacles.
By creating more functional and higher quality designs, products that require less parts or labor than the initial design of existing functions, manufacturing, may be carried out locally. A large number of quality control issues experienced by offshore manufacturing in low-cost countries can also be eliminated. Both of the above can be achieved while maintaining price competitiveness.
There is also the problem of weight. A better design is almost always lighter than a slightly inferior design. This is an important indicator from the perspective of cost and logistics cost drivers. The weight of the device can also affect the patient's quality of life and comfort, or the ease of use is inhibited by the practitioner.
All of these factors lead to higher metrics: risk management. In the design phase, if you control the aforementioned indicators, once the product enters the market, you can control the risk more appropriately and proactively. Through a process of thoroughly locating and tracking all components, components, and modules, the process tracks cost, weight, quality, and labor from the supply chain to the end user, allowing manufacturers to see the full picture of a new or redesigned product. This allows manufacturers to assess future ergonomics, complexity and manufacturing issues, fundamentally enabling teams to make the right business decisions and avoid common pitfalls in manufacturing.
Source: Design Services
Metamizole Sodium Tablets,Metamizole Sodium,Antipyretic Analgesics Drug,Antipyretic And Analgesics Drug
SHANDONG XINHUA PHARMACEUTICAL Co., Ltd. , https://www.sdxinhuapharm.com