FDA Registration: MedTech Edition
The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety and efficacy of medical devices. Medtech manufacturers must comply with FDA regulations. In this article, we will discuss the registration process for medtech manufacturing, its importance, and how to verify a company’s registration status. Understanding the Registration Process The registration […]
MedTech Legend J. Mark King on Trust, Mentorship and Results
Mark King is no stranger to the medical device space. He’s been a fixture in the industry for more than 30 years with leadership roles at many leading medtech organizations, including Tegra Medical, Clinical Innovations, AccuCirc/SafeCirc, Avalign Technologies, Argon Medical, Angiotech/AMI Holdings, Johnson & Johnson and Cardinal Health. We’re thrilled to welcome Mark to the […]
How We Successfully Produced Life-Saving Bend-Free Vascular Guidewires When Others Failed
When a Salt Lake City-based biotechnology firm approached us in 2019, they were working with our competitor to help them manufacture specialty neurovascular guidewires, a critical device component designed for two stroke intervention procedures: thrombectomy and endovascular coiling. Upon reconnecting with them a year later, the firm revealed that their current vendor was struggling to […]
3 Supply Chain Bottlenecks in Medtech Manufacturing – and How to Avoid Them
Manufacturing medtech components for medical components is a highly precise skill that leaves no margin for error. After all, lives are often on the line, and devices must work reliably and accurately if they’re to execute their missions effectively. But what happens when manufactured components fail to meet the exacting standards they’re designed to achieve? […]
Revolutionary Innovation In Centerless Grinding Is The Future Of MedTech Devices
The medtech industry continually develops cutting-edge solutions to save lives and improve health. The minimally invasive surgical device market is a growing medtech sector projected to reach $28.9 billion globally by 2026, thanks to the rising demand for innovative therapies to address healthcare needs safely and effectively. This demand has spurred increasing investments in the […]
How It’s Made: Medical Guidewires
Medical guidewires are often the most critical component within an ever-growing portfolio of interventional devices used for neurovascular, cardiovascular, and peripheral vascular procedures. These wires lead, or ‘guide’, life-saving devices to address critical patient issues such as aneurysm coiling, clot extraction, interventional cardiology, angioplasty, neuromodulation, and thrombus busting and extraction. These high-precision components are commonly […]
Interview with John Shegda at MPO Summit 2021
Focusing on the world of outsourcing for medical component manufacturing coupled with a keen awareness of innovation in the space, Medical Product Outsourcing’s conference series—the MPO Summit—has provided the medtech industry with the most comprehensive programs for more than 15 years. At this year’s event in Salt Lake City this past September, KMM Group CEO […]
Introducing Our New ISO 14644 Cleanroom
When we said we were committed to continually fulfilling customer requirements and improving our quality management system, we took this promise to heart. To us, continuous improvement isn’t merely an industry buzz phrase – it’s our reality, as evidenced by the latest advancement in our production process: a new ISO 14644 cleanroom. Our new cleanroom […]
Leading the Way With EDM
Have you ever worked with biomedical materials, in particular Trabecular Metal? Do you know what Trabecular Metal (TM) is? In the picture above, the TM is on the right, and a picture of the structure of bone is on the left. The, obviously, similar structures of the two, fosters the ability of the bone to […]
