Whitepapers

Could Lean Product Development Get You to Market Faster?
Every manufacturing engineer is familiar with The Machine That Changed the World: The Story of Lean Production. First published in 1990, this classic book was the first to detail the Toyota Production System from which the principles of Lean Production were derived. The authors predicted that Lean Production would become the gold standard not only in the auto industry, but in every industry worldwide, including healthcare. However, the medical device industry has been slow to adopt Lean systems and techniques. While some contract manufacturers currently apply Lean tools to specific processes or areas, Viant stands out for its systematic use of Lean principles throughout the product lifecycle, from Lean Product Development to Lean Product Launch. For more than a decade, our teams have been applying these techniques to improve product quality, lower cost, and speed time to market. Is Lean Product Development (LPD) for you? When I talk with OEM customers, I ask them 3 key questions to help them assess whether LPD could benefit their organization. This white paper will reveal those key questions, explain how LPD can mitigate risk in each phase of the product development process, and share examples of how Lean Product Development has transformed the way Viant brings products to market.

Case Study - Lean Product Development Dramatically Accelerates Time to Market for Laparoscopic Device
Viant formed a dedicated project team of experienced engineers to assess the design of the customer’s nonoperational prototype. Team members identified 4 priorities: optimizing cutting, adding power, adding a rotating coupler, and reducing cost. The team then used Lean Product Development, a systematic process of leveraging design knowledge and discovering unknowns to reduce time to market, improve product efficacy, and reduce costs.

Case Study - Lean Product Launch with 3P Event Reduces Risk & Compresses Timeline for Energy-Based Device
3P team members included Viant manufacturing, quality, and packaging engineers, as well as senior equipment operators; 4 representatives from the customer company; and representatives from Viant’s automation partners, which would be designing and performing the full integration of the assembly equipment.

Case Study - Advanced Energy Device Engineered with Ultra-Precise Tubing Tolerances for Superior Performance
Viant facilitated the design and managed the production of the inner and outer tube. Viant’s deep engineering and process expertise drove development to optimize critical areas of the tube to reach the extreme tolerances needed to achieve the desired performance.

Case Study - Reverse Engineering & Manufacturing Transfer Result in Cost Savings, Reduced Risk, and Increased Security
The Viant team leveraged its product design experience to reverse engineer 35 components, using in-house inspection as well as laser and CT scanning to get accurate 3D geometry.

4 Best Practices to Mitigate Risk in Manufacturing Transfers
Medical device companies can mitigate the inherent risks associated with manufacturing transfers by choosing a contract manufacturing organization that understands how critical it is to execute programs on time and on budget. The people you partner with can make or break your manufacturing transfer. Choosing an experienced partner with skilled teams and robust processes and procedures in place to manage risk can ensure a smooth transfer and give you peace of mind. For medical device companies wondering what to look for in a manufacturing partner, this white paper will share 4 best practices to mitigate risk for a successful manufacturing transfer.

Case Study - Collaborative Transfer of Surgical Device Meets Aggressive Time Frame
A leading, multinational medical technology company needed to transfer manufacturing of a medical device to free up cleanroom manufacturing space for a new product. The customer was facing an aggressive 12-month time frame for the transfer to avoid interrupting product supply. The technology transfer involved a complex, single-use, molded electromechanical hand piece used in a urology procedure. The programmable device comprised more than 40 components, including temperature sensors, nitinol needles, and an irrigation port.

Case Study - Quick Transfer of Tools for Complex Molded Components Increases Customer Satisfaction
A midsize, market-leading blood management company was having major quality issues with the molding supplier for critical components of its flagship product, resulting in supply chain interruptions and a high rate of customer complaints. The customer needed to transfer tooling for 3 acrylic, single-use components of a blood transfusion device—a total of 8 multicavity hot runner tools—with an aggressive deadline of 4 months. These were complex components with tight tolerances and more than 20 critical-to-quality (CTQ) requirements. The customer had worked with Viant before and felt confident that Viant had the technical expertise and resources to meet its needs.