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 […]
Silicone Materials for Long-term Medical Implants: Innovate for the Future
By Feifei Lin, Ph.D., Business Development Manager, Healthcare, Elkem Silicones USA Corp. With the growth of the aging population, the number of age-related diseases has increased. Every year millions of patients sustained or improved their lives through surgical procedures involving implanted devices. Medical implants such as orthopedics, pacemakers, cardiovascular stents, defibrillators, neural prosthetics or combinational […]
Delivering Quality – The ISO 13485 Certification
By Charlie Sears, Quality Manager, Goddard Inc. The medical device industry is one of the most highly regulated verticals worldwide. Devices and quality systems must satisfy stringent requirements before they can be marketed and sold in the U.S. and worldwide. The ISO 13485 standard specifies requirements for a quality management system (QMS) for an organization […]
Devices Roar Into The Next Decade
Medical device investments skyrocketed in 2018, and these trends are continuing into 2019. The activity now will influence healthcare for the next decade. This year, the medical device and diagnostic industry saw record-breaking increases in the investment scene. As noted by Silicon Valley Bank’s (SVB) analysis, Trends in Healthcare Investments and Exits 2019, investing in […]
Life in the Fast Lane: 3 Lean Tools to Speed Products to Market
By Don Welling, Sr. Director of Technical Solutions, Viant The average driver can change a tire in about 20 minutes. A NASCAR pit crew can change all four tires in less than 20 seconds, thanks to the right tools and processes. Of all the tools used in NASCAR racing, the air wrench has saved the […]
The need for new business models under MDR/IVDR
In less than 12 months, the world’s second largest market for medical technologies is going to be turned upside down. The new medical devices regulation (MDR) and in vitro diagnostic device regulation (IVDR) — which set forth more stringent safety and data requirements for devices distributed in the EU — will go into effect in […]
