In March of this year, the FDA put out a shocking statistic: from 2003 to 2012 medical device recalls almost doubled from 604 to 1,190. More disturbing, there was a decided rise in incidents where the defective device carried a reasonable probability of death and couldn’t be recalled due to the fact that thousands of devices had already been implanted, ranging from defibrillators to replacement joints. A recall for a medical device in the Western world will also carry the added liability of not just being recalled in the country of origin but create a worldwide reporting obligation.
Whether the recalls were as severe as defective implantables or minor quality issues on diagnostic devices, the message is the same: impeccable design, due diligence, and manufacturing quality should be the primary focuses of medical device manufacturers.
Coupling this, the demand for innovation is high in a global economy where keeping ahead of your competition is essential and preventing market-share loss is a constant struggle.
So how can medical device manufacturers ensure that their products exceed industry standards and prevent recall disasters while still being profitable?
The answer lies in advanced design and manufacturing software that combats these issues at the front end of the design process by highlighting potential quality issues in the concept phase – challenging the product design team to find simplified design solutions that incorporate new technologies and materials.
Product lifecycle management (PLM) technologies have taken great leaps in the last decade, but not enough to identify and circumvent many quality and production issues later on the manufacturing floor. You need to have a concise methodology that forces the design team to break traditional design paradigms and objectively analyze a design from a risk-mitigation standpoint. Few software systems encapsulate this sort of rigorous methodology into their code.
When searching for suitable software, there is a list of must-have elements. The first element is that the software should incorporate lean design methodology. With all of the time and money spent on good manufacturing practices, many companies don’t realize that you cannot truly achieve lean manufacturing without employing lean design. Another FDA study found that 44% of voluntary quality recalls during the period of the study were directly attributable to poor design. Previous to that study, Munro & Associates identified that 70% of cost and quality issues take shape in the design phase. However, this is a solvable issue that can be eliminated in this phase if the right design practices are followed.
Manufacturers need to take a holistic approach to product development. They need to attack inefficiencies and bottlenecks on many levels simultaneously, while identifying and eliminating future potential manufacturing, quality, and supply chain issues early in the concept design phase. A combination of vetted market knowledge, design, manufacturing, and cost expertise is needed to bring this goal to fruition.
In order to achieve a lean design no matter what software you use, a cross-functional team needs to be assembled. Teamwork is essential in the product development cycle, and the cornerstone of innovation is a diverse team. To produce a successful and streamlined product launch, the team should be formed from product design engineers, quality, finance, supply chain, and manufacturing experts.
Customer value insights should come from market research, while the executive stakeholder – the champion of this particular project or department – should provide oversight.
The next element is the ability to thoroughly and accurately map the design in a visual step-by-step process that captures all of the proposed parts and all of the required manufacturing and assembly steps. The process should include a concise set of coded symbols that contain a range of data sets the team chooses.
All new product developments contain a series of knowns and unknowns. The baseline mapping process begins with inputting the known data from past product launches. Next, it moves forward into comparing and analyzing proposed new or redesigned parts that are continuously challenged using the lean-design methodology.
Each symbol on the map should capture every detail of the part, including weight, a should-cost piece cost, tooling costs, known quality and warranty data related to existing or similar parts, labor costs, machine cost centers, and time values provided from the team. The rollup of this data should not only give the team a more accurate sense of total accounted costs, weights, and timing, but also highlight areas of concern and places for improvement. This is an ongoing process that works in tandem with and throughout CAD modeling.
The design map is a living document, a guide to be used on the way to completing the final product. Key performance indicators (KPIs) should also be continually referenced and included in this process.
Once all data is entered, a scoring system needs to be implemented in order to address problem parts or assemblies. The team will now have a better visual sense of areas for improvements and potential failures. It is only after this point that the team can honestly asses the manufacturability of design concepts.
All parts should then be challenged to either combine them with other parts or to altogether eliminate them, reducing unnecessary complexity, cost, and quality issues. Added complexity brings added chances for errors and failures. This is especially true in product design. All efforts must be exerted to simplify the design to create more reliable products while reducing labor time, piece costs, and potential liabilities for the manufacturing floor. You don’t have to apply lean manufacturing methods to a cell that never existed if that assembly was eliminated in the design phase.
Another key element is comparing materials and selecting new technology and manufacturing processes. You should do this while considering how the form and function of each piece plays into the whole system as dictated by the customer’s objectives. To provide better quality and reduced costs, several software programs exist that can make material selection easier and quicker. Some of these can now be accessed completely from the cloud or on a smart phone.
Proactive quality predictor tools – such as the cost of quality or the quality report card – are a much needed element in product design software. These tools can calculate sigma and alert the engineer to quality issues and costs in the design phase – before they are experienced in manufacturing and endured for the lifecycle of the design. Using historical data from similar parts or platforms, the engineer can quickly track sigma and mitigate quality risks early, preventing costly recalls and warranty risk exposure.
The next step is to address potential ergonomic issues and dangers. Very often product design engineers are unaware of ergonomic consequences that can be experienced on the manufacturing floor due to the architecture of their designs. So, it is critical to include the manufacturing team early on to illuminate such issues. Using the design map, parts and processes that fall into the ergo category should be marked and highlighted in order to remove them before they are discovered downstream.
At this juncture, poka-yoke issues should also be addressed. Poka-yoke is a Japanese phrase that means to “error-proof” or “fail-safe.” From a design perspective you want to design parts so that they cannot be assembled wrong (backwards, upside down, etc.) Including potential Poka Yokes in the design stage is less costly and more effective than trying to eliminate errors with manufacturing techniques. This is an often overlooked pitfall that is truly low hanging fruit. Having manufacturing involved at the concept stage helps prevent these lurking future quality costs.
Energy consumption and carbon footprint should also be tracked, quantified, and reduced by applying these methods within the software. As carbon taxes become more topical, and energy consumption and reduction is becoming a focus in the global manufacturing arena, all efforts should be employed to address these issues early on.
An added benefit of using software that addresses all of these factors is that you will speed your product’s time to market. A consistent focus on reducing product development times ensures that vital intellectual property leaps are not impeded and potential market advantage is not lost to your competitors.
Investing in cutting-edge product design software tools ensures a faster product design cycle with reduced risk and increased profit while improving a company’s design culture. That can take your company from good to great.
Munro & Associates
About the author: Alistair Munro is director of business development at Munro & Associates/Lean Design Canada and can be reached at Alistair@leandesign.com.