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 […]
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Rethink Post-market Surveillance (PMS) for Medical Devices
How Smart, Connected Medical Devices Can Deliver Critical Insights Six years after receiving FDA clearance, a medical device company’s investment in a new therapeutic area is finally paying dividends. But a new patient injury report could send the company reeling if it can’t identify the root cause of the device failure quickly. The financial impact […]
Cloud Gaming Technology Raises the Bar for Remote Sales Rep Interactions
Groundbreaking Technology Allows Surgeons and Sales Reps to Perform Ultra-realistic Virtual Procedures Remotely By Tom Donnelly, Chief Revenue Officer, Level Ex When Netflix launched its streaming services in 2007, few people foresaw what that would mean for brick and mortar video rental stores. I’m reminded of the complete transformation of that industry as I stand […]
Component Testing & Analysis: How to Gain Deeper Insights with a Universal Testing System
By Landon Goldfarb, Senior Applications Engineer, Instron Component Testing & Analysis: How to Gain Deeper Insights with a Universal Testing System Universal testing systems are most commonly known for performing tensile or compressive tests on raw materials, often with specimens in simple geometries. These tests are usually driven by testing standards, and insights are typically […]
Your MDR Strategy – Start with a Gap Analysis
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 […]
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 […]
