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Workflow Analysis and Medical Device Development

Tue, 01/28/2014 - 11:27am
Michelle Jones, Technical Writer

Workflow analysis has been a central part of business improvement for several years now; however, it is still a relatively new concept in medical device engineering. Medical device development is a rapidly growing industry and globalization is increasing competition for smaller manufacturers. Improvements to the product development workflows may be able provide the competitive edge needed to speed up development and be the first to reach the market with new devices.

The development and manufacturing of new medical devices starts with the physicians and medical professionals. A new device must provide improvements beyond cost savings in the manufacturing process, so a workflow analysis must be integrated into the decision making process and early development stages, as well as in the manufacturing.

The key to a smooth development process is for the physicians involved to have the opportunity to create a very clear and objective set of requirements. A successful piece of medical equipment depends largely on how much value it adds to a medical professional’s work, how affordable it is and how easy it is to operate. Ease of operation and usefulness should be at the heart of all medical devices.

Therefore the first step in implementing a workflow analysis is to ensure that there is a common language between the physicians involved and the developing engineers. A robust, methodological approach that is managed by a well-designed workflow can reduce the development time and the development cycles substantially. This first step should include developing a list of specifications for the new device, which is then categorized and described in detail. At this point simplified solutions for document management are very useful for all involved.

Because medical devices are precision instruments that are guided by the skilled hand of a physician or medical profession, it is very difficult for an engineer to develop a feeling for the tool they are designing. A skilled physician finds this very difficult to explain and the result is that newly developed medical devices often do not fully meet the initial expected design. This results in numerous development cycles until the physician is happy with the new prototype.

The next stage of the process is manufacturing. During manufacturing automation flexibility can also help to improve the process.

Automation Flexibility
An efficient and modern workflow requires automation; however, traditional workflow automation tends to be a simple linear path with fixed points where there is a pass or fail. This model works well in business and manufacturing but it lacks the dynamic flexibility that is required in development and testing. The solution is workflow software, which provides automation but allows an element of flexibility in the process. Automation has been used in automotive, pharmaceuticals, consumer and electronics industries for years, but the use of robotics in medical device manufacturing has been slower on the uptake.

Traditional automation has been too expensive for niche medical device manufacturers to implement. Flexible automation is providing a new opportunity for manufacturers to meet commercial pressures to automate production. Automation flexibility allows different products to be produced on the same system, and allows changes to a product specification to be implemented without the need to rebuild the production line.

Medical device manufacturers often focus on the research and design of a new product and overlook the requirements of the actual manufacturing process. A device needs not only to be perfect for the physician, but it needs to be designed in such a way that it can be manufactured in a cost efficient way.

Automated manufacturing provides benefits to medical device production beyond the initial construction. The nature of medical devices means that they need to be constructed in an extremely clean environment. There can be no risk of cross contamination of devices from humans during production. Using robots in the construction and packaging of devices eliminates almost all risk of contamination.

Other benefits to automating medical manufacturing include improved product quality by eliminating human error; improving worker safety; increased speed of production; reduction in training and staff cover, and faster time to market.

While one of the biggest advantages of flexible systems is the increase in profitability once installed and to reduction in risk, they also allow for the continuous improvement of product development. With flexible automation mature products can be quickly optimized if it is realized that the product does not perfectly suit a physician’s needs. Likewise, the production of the device can also be optimized.

Automation also provides huge cost savings in testing. One example is that of testing balloon catheters. An automated test can be completed in 30 seconds while a human tester will take around two minutes. This represents a cost reduction of around $43,000 a year in the final stages of manufacturing.

As research, development, manufacturing and testing all become more competitive, automation is starting to play a vital role in allowing companies to compete in a global market.

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