By Jesse Darley, Director of Mechanical Engineering & Principal, Delve No doubt, you are passionate about the impact medical devices have on the lives of the patients that need them. In many cases, devices save lives. In more cases, they extend or improve lives. At the core of most devices is a technology that solves […]
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3 Clinical Trends Shaping the Medical Device Space in 2019
By Mike Rigert, Staff Writer, MasterControl Perhaps no other sector of the life sciences is experiencing as much growth, transformation and opportunity as the medical device industry. Globally, the medtech arena is expected to grow every year by more than 5 percent, with annual sales worldwide reaching $800 billion by 2030, according to KPMG.(1) In […]
Understanding the MDR & IVDR: What Medical Device Companies Need to Know
By Brandy Chittester, MS, CCRA, President These regulations are intended to place a greater emphasis on safety, with greater requirements for clinical evidence and increased oversight by regulatory agencies. The regulations will not allow grandfathering of previously approved products, so device manufacturers will need to re-evaluate their entire product portfolio to identify the steps needed […]
From 8 Weeks to a Few Days: How Vaupell helped K2M increase speed to market on their life-saving medical prototypes
The Company K2M, now a part of Stryker, is a medical device innovator and manufacturer that works closely with surgeons to design spinal implants and surgical instrumentation. Industry: Spinal medical devices Location: Headquartered in Virginia, with offices in the UK and Germany Company Size: 500 Employees The Project Critical Business Issues: K2M’s prototyping process was […]
The Future of Laser Micro Manufacturing in Medical Device Markets
Introduction Laser Micro Manufacturing Technologies and its Impact on Medical Device Manufacturing Laser micro manufacturing is a compilation of technologies developed to address an ever increasing demand for micro-scale manufacturing in the Medical Device and Advanced Diagnostics Markets. These technologies include laser ablation, laser cutting, laser drilling, and laser welding. Each technology addresses a common […]
The Critical Importance of an Effective Data Strategy for EU MDR
The deadline for the new European Medical Device Regulation (EU MDR) is just around the corner. Are you ready? By now, your organization has probably conducted a portfolio review and assessment. You might have even progressed to your Clinical Evaluation Report. But during the assessment process, you may have discovered significant data gaps. You might […]
Next Generation LSR Technology for Medical Injection Molding
Manufacturers across industries from automotive, consumer goods, and healthcare, use a liquid injection molding (LIM) process to create silicone rubber parts that are durable and easy-to-mold. The current LIM process utilizes a two-part liquid silicone rubber system. Typically, the Part A base polymer contains a catalyst to begin the crosslinking process. The Part B polymer […]
Quick Launch Program for Micro Medical Production
By Lindsay Mann, Director of Sales & Marketing For OEMs who need a rapid prototype of their new medical device design, there are plenty of vendors to choose from. But for OEMs who are ready to move into production or need to miniaturize a next-generation product already on the market, it can be much more […]
Connecting the Next Generation of Medical Data and Devices to Improve Patient Outcomes
Every day, hospitals and doctors collect infinite amounts of data on individual patients, diseases and medical procedures. The rise of a new generation of robotic, precision, and surgical devices has created vast stores of video, imaging, and other electronic surgical notes, while the proliferation of digital patient technologies, such as electronic medical records, wearable sensors […]
Outcome-based Pricing Initiatives in the Healthcare Industry
By Joe Miles – Global Vice President, Life Sciences (SAP Industries) and Bob Steller – Industry Principle, Life Sciences (Vistex) A distorted reimbursement model has driven healthcare costs ever higher, and elevated healthcare spend to the top budget item for many governments across the globe. But several major industry players have begun to experiment with […]
Clinical Study Cleanup: How to Get Your Study Back on Track
By Kelly Jasko, Lead Clinical Research Associate Every year, the U.S. Food and Drug Administration (FDA) releases metrics detailing the outcomes of the Bioresearch Monitoring (BIMO) inspections done at facilities conducting clinical research within the previous year. Of the 104 Sponsor/Monitor/Contract Research Organization (CRO) inspections done in fiscal year 2017, 36 percent were found to […]
