Industry Perspectives

  1. How To Utilize Extrusion To Optimize Processing And Supply Of High-Quality Tubes For Use With Stents, Scaffolds, And Other Medical Devices 10/16/2020

    This interview with Dr. Thiago Borges covers how to utilize extrusion to optimize the processing and supply of high-quality tubes for use in stents, scaffolds, and other medical devices.

  2. A Methodology For Developing Injection-Molded Plastic Parts For Your Medical Device 9/21/2020

    This article describes a methodology that addresses the questions that have a reputation for being “troublemakers” in the process of injected plastic product development, without compromising innovation and creativity.

  3. "Quality Culture" And CGMP Compliance: The Perception-Vs-Reality Gap 9/16/2020

    This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.

  4. What 3D Printing Technology And Material Is Right For Your Medical Device Application? 9/9/2020

    In this interview with Balaji Prabhu, from Evonik’s Medical Device Competence Center in the U.S., we review how medical device companies can best evaluate current biomaterial options for the four leading 3D printing technologies.

  5. How To Design Medical Device Test Fixtures For Maximum Repeatability 9/9/2020

    Test fixtures and inspection equipment are only useful to the extent that they produce accurate, repeatable data. In fact, flawed test fixtures that don’t produce such data can be more harmful to the program than if the test hadn’t been performed at all.

  6. UDI At The Point Of Use: Should You Implement Direct Marking Now? 9/7/2020

    Looking at the FDA and MDR compliance deadlines for UDI marking can be deceiving. The intense knowledge buildup, planning, and supply chain preparation efforts necessary, along with internal procedure readiness and process changes, require a long lead time.

  7. Environmental Monitoring And Sterility Assurance Control For Medical Devices And Combination Products 8/11/2020

    The establishment of an environmental monitoring and microbiological control program for sterile medicinal devices is necessary to ensure microbiological safety and finished product quality. The level of environmental control is primarily dependent on the method of product sterilization.

  8. Trends In Medical Device Contract Manufacturing — What Medtech OEMs Need To Know 8/6/2020

    The global medical device outsourcing market, worth an estimated $52B in 2019, is projected to grow at an 11.4 percent CAGR through 2025, outperforming overall medical device industry growth. Consequently, the organizational, business, and competency models of outsourcing organizations, as well as the types of client-vendor engagement, are evolving to define novel paradigms.

  9. Incorporating Injection Molded Plastics In Medical Device Design — Initial Considerations 7/29/2020

    Even a great component idea can be undermined by gaps in knowledge surrounding plastic materials, from engineering and design considerations to optimal procedures for turning that idea into a reliable plastic part that can be consistently produced, affordably and with high quality.

  10. How To Drive Powerful CAPAs With Lean Six Sigma 7/10/2020

    Corrective and preventive actions (CAPAs) are an important and integral part of any quality system for a life sciences company. And yet, strangely, CAPAs rank among the top reasons why companies get 483s and warning letters from the FDA. This article explains how Lean Six Sigma tools and techniques can be applied to improve the CAPA process.