By Nemanja Spasojevic – Senior Polymer Development Engineer Ridgeback Technologies not only provide normal catheter balloons, we also provide Perfusion Balloons, Cutting Balloons and Sensor Balloons with highly competitive lead times due to our in-house resources covering all aspects of Balloon Design and Manufacture. For many years it has been a desire of medical device […]
Overlooked details and unexpected surprises can derail your next product launch
Your company may have done a decent job of making sure your products are compliant with the new European MDR (Medical Device Regulation). But have you addressed all the potential pitfalls: unanticipated reclassification of existing products; surprise audits, sample requests and product testing; and updated labeling requirements, etc.? And are you absolutely certain that all […]
Saving time with solvent compatibility testing
By Thaddeus Williams, D.V.M., Study Director of In-Vivo Biocompatibility, Toxikon Corporation Introduction When developing a preclinical testing plan for medical devices, selecting the correct extraction solvents can be confusing. Incompatibility between solvent and device may result in an extract that is unusable or harmful to the test system. A Solvent Compatibility Test can make the […]
The top three reasons manufacturers choose medical-grade silicone for medical devices
Silicone is a highly versatile material widely used across many industries. Over the past 60 years, medical-grade silicone has been a material of choice for medical device OEMs, and the number of complex and safety-critical applications in this field continues to grow – from surgical devices and implants to orthotics, prosthetics, and more. Silicone’s unique properties are […]
Australia Medical Device Reimbursement: Incentives From the Land Down Under
By Deborah Bell, executive director of business development in Australia, Avania Whether to control costs or to recruit a larger population, medical device manufacturers are looking beyond the U.S., the EU, and Asia to conduct clinical trials. When planning global studies and early commercialization, Australia is a strongly considered market. The access to innovative medical […]
Critical components, technologies, and designs to consider for catheter delivery systems
By Mike Schultz, Spectrum Plastics Group, Vice President of Innovation and Development Minimally invasive surgeries (MIS) that utilize steerable catheter systems represent an expanding market in the healthcare space. As the variety of catheter-based procedures continues to grow, with physicians and therapies demanding tools and technologies that increase access and performance, the steerable catheter market […]
NetSuite quality management solution for medical manufacturers
An Overview of NetSuite ERP and Quality Management By Ben Katerberg, Luxent, NetSuite Solution Architect For many medical manufacturing companies ensuring quality standards are being met by vendors and/or by internal manufacturing operations is critical towards external compliance standards and the lifeblood for long-term profitability and customer satisfaction. Many medical manufacturing companies have historically maintained […]
Dealing with disruptive events
Don’t let a crisis become a disaster The term “crisis” has become much too familiar in medical device companies. Whether it’s an FDA 483 or warning letter, plant audit, product recall, or other unplanned event, a crisis disrupts your operation and can pose a significant risk to your business. And the challenge doesn’t have to […]
How Elkem Silicones helps customers achieve compliance to healthcare regulations
Regulatory requirements in the medical technology industry are complex and getting tighter almost every year. Continuous changes and amendments to the rules mean there’s a lot to keep up with, and medtech manufacturers are required to prove compliance to the regional regulation if they wish to market their products in the area. The process behind […]
Testing and certification of refurbished medical equipment
By L. Matthew Snyder, Sr. Director of Certification at Intertek Medical electrical equipment such as MRIs, anesthesia machines, surgical equipment, scanning systems, patient monitors and other types of products are a significant investment for any healthcare organization. Refurbished medical equipment, devices that are reconditioned and made comparable to new products, are becoming a realistic option […]
Advancing next generation medical products
An aging population and the growing threat of emerging infectious viral diseases, such as COVID-19, mean that healthcare around the world is an extremely important issue, and is changing in dramatic and dynamic ways. To meet these changes, a new generation of specialized and sustainable medical material solutions is being born. Read on to learn […]