In this episode, Etienne Nichols interviews Perry Parendo, an expert in Design of Experiments (DOE), about the practical application of DOE in medical device development.

They discuss how DOE can be used to better understand systems, reduce risk, and solve complex problems, especially in R&D and manufacturing processes.

Perry shares insights from his extensive career, offering actionable strategies to simplify complex variables, avoid common pitfalls, and ensure a more effective and efficient development process.

Key Timestamps:

• [00:02 ] – Introduction to Perry Parendo and his background in DOE
• [05:50 ] – What is DOE? Perry’s simple, non-technical definition
• [12:00 ] – Common problems DOE solves and its application in R&D
• [22:30 ] – Risk management and DOE’s role in reducing uncertainty
• [35:20 ] – Using DOE in manufacturing processes and real-world examples
• [48:10 ] – Common pitfalls and best practices when using DOE

Key Quotes:

• Perry Parendo: “Design of Experiments is a tool to assist in understanding a system. It’s not just a test plan; it’s a way to create structure and strategy in how you approach testing.”
• Etienne Nichols: “The life of an engineer really happens in that space between input and output—there’s so much to dial in, and that’s where tools like DOE really help.”

Takeaways:

Key Insights on MedTech Trends:

1. DOE reduces risk: It plays a crucial role in risk management, especially in R&D, where understanding system behaviors early is key to mitigating issues down the line.
2. Structured problem-solving: DOE provides a data-driven, structured way to isolate variables and pinpoint causes, streamlining troubleshooting and optimization in product development.
3. Adaptability of DOE: It can be applied to both small and large-scale problems, from manufacturing issues to high-stakes R&D, making it essential for MedTech innovation.

Practical Tips for MedTech Professionals:

1. Start small with DOE: Focus on fewer variables when beginning to ensure you don’t get overwhelmed. Three to seven variables are typically manageable for early experiments.
2. Understand the limits of your tests: Avoid putting all variables into one test; break them down to ensure results are meaningful and actionable.
3. Validate your DOE: Don’t rely solely on DOE results—validate with real-world testing to confirm your findings.

References:

• Perry Parendo: Founder of Perry Solutions, specializing in product development and process optimization through DOE. LinkedIn
• Connect with Etienne Nichols on LinkedIn.

MedTech 101: Explainer on DOE:

Design of Experiments (DOE) is a statistical method used to determine how different variables (inputs) affect a process or product outcome (output). It’s widely used in MedTech for optimizing processes and solving manufacturing or product development issues by systematically testing different variables to identify the most influential factors.

Questions for the Audience:

1. Poll: How often do you use DOE in your medical device development process?

• Frequently
• Occasionally
• Rarely
• Never
• Send your responses to podcast@greenlight.guru.

Feedback & Sponsors:

• Feedback: Loved this episode? Leave a review on iTunes! Your feedback helps us improve and reach more MedTech professionals.
• Contact us at: podcast@greenlight.guru

Sponsor: This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Learn how Greenlight Guru can help streamline your product development process at greenlight.guru.

Sponsor: Today's episode is sponsored by Rook Quality Systems. Rook offers Quality as a Service solutions to help medical device companies navigate the complexities of regulatory compliance. Their team of experts ensures your quality processes meet the highest industry standards, giving you peace of mind while you focus on innovation. Whether you're preparing for an audit or need ongoing quality support, trust Rook to keep your compliance on track. Learn more at RookQS.com.