By Matthew Jorgensen, PhD, DABT- Senior E&L Expert; Audrey Turley- Senior Biocompatibility Expert; Thor Rollins- Director Toxicology and E&L Consulting The 566-page Medical Device Regulation (MDR), which replaces the EU’s Medical Device Directive (93/42/EEC) and the Directive on Active Implantable Medical Devices (90/385/EEC), has caused much discussion, training, debate, and stress in the medical device […]
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New Project Based Rapid Precision Prototyping Program
Your First Step Is the Most Important Designing for tomorrow’s precision instruments calls for a different set of rules. Leading OEMs in the medical device sector have redefined what they need to maintain a successful new product development and new product introduction pipeline. These elements include: Precision tolerance prototyping Access to a solid manufacturing support […]
10 Medical Product Development Gotchas and How to Avoid Them
Sunrise Labs delivers ‘best in class” medical device design and engineering expertise for all stages of product development. By Adam Jacobs, CTO, Sunrise Labs One of the benefits of working at a medical product development company is seeing many products developed with a wide range of organizations. Supporting over 30 client projects a year gives […]
Modernizing Clinical Research: Keeping Pace with Medical Device & Diagnostics Innovation
By: Kevin Liang, Senior Director Strategy, Veeva Medical Device & Diagnostics Clinical studies are the foundation of successful development of device and diagnostic products. Studies are also complex, from site selection and subject enrollment, to study monitoring, and data management. This year, on top of the usual challenges, COVID-19 brought many clinical studies to a […]
MDR Might Be Delayed but That Doesn’t Mean Your Plans to Implement Should Be
Alwin van den Broek, Project Manager and Data Protection Officer Anne Leijsen, Director, Medical Writing Long before the pandemic, medical device companies were scrambling to meet the European Union’s new Medical Device Regulations (MDR), slated for adoption on May 26, 2020. As COVID-19 began to take hold of the world in March 2020, the Trade […]
Human-centered design drives meaningful product development
Delve helps pharmaceutical and medical device companies develop human-centered design cultures. By Ami Verhalen, Vice President of Design, Delve When your innovation and new product design (NPD) inputs are focused on the customer, it’s likely your data set may be well informed, but not well inspired. It’s the kind of mindset that focuses on narrow […]
Want DFM that delivers value?
Your First Step Is the Most Important Design for Manufacturability (DFM) involves designing parts or products so that they meet the critical needs of an application while simultaneously being designed for optimal, efficient, and cost-effective manufacturing. It is the Holy Grail of design in the world of high-precision metal parts and components for any industry […]
Human Factors Engineering: 3 Practical Tips for User-Centered Design
by Orlando Soto (Engineering Manager), Omar Bermudez (Senior Industrial Designer), and Sarah Faulkner (Director of Marketing) Human factors engineering is a critical – and in some industries, mandated – part of the product development process. The data generated from human factors activities can help you to create products that are useful and can stand up […]
Let BD Peripheral Vascular OEM’s Experts Share Their Knowledge and Experience to Help You Develop or Expand Your Device Product Portfolio
For over a century, C. R. Bard, Inc. – now part of BD – has been a leader in the medical device industry. BD Peripheral Intervention OEM products combine BD’s technologies with a proven commitment to quality and recognized regulatory heritage to meet the needs of some of the world’s leading OEMs and innovative, emerging […]
Reshoring Checklist for Manufacturers
It’s Not Only Timely, It’s Costly if You Don’t By Anthony Bracale, Strategic Market Development Manager, (860) 349-1756, ext. 170 It’s topical to write about reshoring in the middle of a global pandemic, but there’s been a deeper discussion underway that pre-dates our current situation. There are many variables that influence reshoring, but the first […]
The Next Decade of Medical Device Trends
In medical device manufacturing, data technologies are forever changing the way the industry does business. In this EBook, we discuss the current landscape of the industry and the forces taking shape today that will drive growth into 2030 and beyond. From new technology to shifting patients’ experiences, we’ll explore how a wide range of issues […]
