Medical device organizations throughout the world are facing increasing competitive pressures, and developing products quicker and more cost-effectively is becoming a much higher priority. Organizations that follow a more traditional sequential engineering approach are typically at a high risk of very costly product development. Likewise, organizations that fall into the “we’ll fix it later” trap also face very high product development costs.
 
To solve this, medical device organizations need to rethink their approach to design by incorporating more effective collaboration, communication, and decision-making. Design for X (DfX) is a methodology that systematically and proactively designs products to optimize key business goals such as quality, cost, performance, and time-to-market. It approaches the problem across four major steps:
 
1. Diagnose the needs. It is important to ask several questions.

• Which segments of the design process have several reworks?
• How often are designs re-designed?
• What factors should product development teams consider more proactively in design?
• How collaborative and proactive is the current design process?

 
2. Develop tools and processes to embed DfX within the product development procedures and culture.

• Create a set of design checklists and other supportive design tools.
• Establish a process for DfX tool usage within the context of the product development process.
• Develop management, communication, and sustainability routines to support change management within the organization.

 
3. Implement the DfX tools and process by providing training and support for new project teams and a selected group of DfX Champions that supports teams through implementation.
 
4. Sustain and continuously improve the design process through routine auditing and measurement of the business results; make adjustments and improvements as market conditions change.
 
The following case study provides a deep dive into the experience of a major medical device manufacturer who maximized the effectiveness and efficiency of their design process through DfX.
 
A Snapshot of the Problem
In today’s globalized economy, companies are facing pressure from many directions to deliver products and services that are better, faster, and cheaper than their competition’s offerings. To gain a competitive advantage, these business pressures are passed on to product development teams to improve speed and reduce costs, while still preserving creativity and innovation.
 
The major drivers of cost in product development in medical device organizations are materials and production processes. Material costs are typically 70 percent or more of the total product cost. The most significant issues with materials are sole-sourced components, over-specified components, and lack of component commonality. More importantly, 60 to 80 percent of product lifecycle costs are typically established by decisions made within the early design phases.
 
Most medical device companies adhere to a traditional, sequential approach to product development. In this model, each department engages in the product development process only after the product is designed. The reality is that design teams do not always have the tools and capability to design a product that is of high quality and manufacturability. Therefore, if the product is poorly designed, the work of the other departments will be much more difficult. For example, a manufacturing department may have to spend additional time and cost to change the design, update a part, or change tolerances to make the product manufacturable and testable. In addition, many medical device companies fall into the pit of believing that the product can just be redesigned later. In both cases, such changes are typically extremely costly and time consuming within the manufacturing stage of the product. development process.
 
With this traditional approach, design teams are missing out on the ability to leverage the expertise and knowledge from other departments, such as manufacturing, quality, sourcing, etc., that will allow them to proactively design to prevent potential issues that may surface downstream. DfX requires a team to put aside more rigid notions of the design process and consider how all parties involved with product development can contribute to a better alternative.
 
Ideal Solution
The ideal solution implements DfX in the aforementioned four-step approach.
 
1. Diagnose the Needs
The goal is to understand the factors design teams should consider in product development and identify parts of the process that are prone to re-work. In order to answer these questions, the following activities are recommended.

• Process mapping
• Interviews
• Critical-to-quality trees
• DfX readiness assessment

 
2. Develop DfX Tools and Processes
The goal is to leverage learnings from the diagnostics phase to build DfX tools and supporting processes that will enable product development teams to collaboratively design new products.

• Define purpose, goal, and objective of each tool.
• Leverage the knowledge of each department to define the checklist of design considerations.
• Incorporate other functional departments earlier into the design phase.
• Identify and assemble a DfX team to champion and promote the initiative throughout the implementation.
• Introduce metrics that measure design and business performance.
• Develop high-impact management and communication routines to promote DfX and its importance to the corporate culture.
• Establish sustainability routines such as audits and frequent program reviews to assess improvements and implement changes as necessary.

 
3. Implement the DfX Tools and Process
The goal is to use the developed DfX tool and processes within the context of product development projects. The ideal approach gradually brings teams into DfX as they begin new projects over the course of a year. Best practice is to conduct a pilot phase with a selected project to gain insights about tool usage and make any refinements as needed. Activities include:

• Conducting kickoff meetings with executive sponsorship
• Training all departments involved with product development in the purpose and use of the DfX tools and processes
• Initiating management and communication routines to enable change management and raise awareness

 
4. Sustain and Continuously Improve the Design Process
While implementation is underway, it is critical to maintain a constant state of evaluation and improvement. Auditing results and holding DfX team meetings to align areas of opportunity and needed changes are recommended. Continuous improvement is critical to ensure that the tools being used are evolving and remaining relevant as business and design needs change.
 
Conclusion
As competition grows stronger, issues involving speed, cost, and quality will continue to rise to the forefront of executives’ minds. Medical device organizations need a holistic approach that incorporates inputs from subject-matter experts early in the design phases to proactively prevent product design issues. While a set of tools and process are critical to enable DfX, it is even more important that executives promote DfX and take a role in managing the change. Consider this methodology and the significant advantage it will bring to the facilities during these increasingly competitive times.
 

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Adrienne Trangle-Pelleg is a director with Tefen USA. She brings with her over 20 years of experience in operations management with direct P&L responsibilities at a major Fortune 500 company, and many years of Six Sigma and Lean implementations. Additional strong competencies include strategy, finance, organizational effectiveness and change management, and operational excellence in both manufacturing and transactional environments. Trangle-Pelleg holds an MBA with a finance and management focus.