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 […]
5 Considerations for Designing Battery Operated Products
By Bill Scheremeta, Principal Electrical Engineer at Sunrise Labs Extending battery life is one of the most important considerations for portable product design. For example, extending the battery life of implantable medical devices lengthens the time between surgical procedures. For consumer and industrial products, having the best battery life is a crucial competitive advantage. Customers […]
Collaborative innovation for silicones: A win-win scenario
Bringing together the expertise of a material manufacturer with that of its medical devices customers is a powerful way to develop more effective, innovative solutions. Sean McPherson, senior business development manager for silicone manufacturer Elkem, discusses the importance of collaboration and how it leads to better results for Elkem’s customers. Elkem’s approach Elkem takes on […]
Laser processing and its role in medical device manufacturing
By Matthew Nipper, Director of Engineering – Laser Processing Technologies, Spectrum Plastics Group Laser micromachining is one of the highest-precision processes utilized in medical device manufacturing. In fact, lasers may be the only option to produce delicate features, especially in thin or sensitive materials. Lasers can cut micron-sized features quickly with sub-micron tolerances, without defects—thereby […]
Innovative silicone adhesives for biomedical and medtech assembly
By Michael Goglia, Americas Healthcare Market Manager, Elkem Silicones Silicone based adhesives continue to play a major role in the advancement of medical devices. Silicones have long been a material of choice for MedTech OEM’s and fabricators due to their inherent properties of biocompatibility, chemical inertness, environmental stability, and high performing physical properties. Elkem Silicones […]
Precision metal stamping metamorphosis: Meeting challenges, setting new standards
Hobson & Motzer began in 1912 as a tool and die shop aiming to fill a gap in the market for complex, high-precision tool work for local manufacturing companies. People who are familiar with us today are often surprised to learn that for our first 50 years or so, Hobson & Motzer did not offer […]
Medical device startup Fisher Wallace has raised nearly $3 million on StartEngine
Medical device startup Fisher Wallace Laboratories has been named one of “5 Health-Tech Startups to Watch in 2021” by Entrepreneur magazine and has raised nearly $3 million on StartEngine, a leading equity crowdfunding platform. The majority of the company’s investors are its own customers – people who have used Fisher Wallace’s prescription wearable to treat […]
