In this authors first article, he examined the first five of nine traits to BE as you move your medtech innovation further along the path to commercialization, growth, and profitability.This article focuses on the other four traits.

Read about most commonly cited conditions that led to the issuance of Form 483s to drug companies last year (as summarized by the FDA in the most recent 12-month inspection period on record) and practical tips for avoiding them.

Standards are a form of technical infrastructure, and their influence is felt throughout the electronics industry. For example, formed in 1924, theElectronic Industries Alliance (EIA)was an American standards organization that established an alliance of trade associations in the United States electronics manufacturing industry.

The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond. As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive.

Medical device companies of all sizes are often concerned about speed-to-market, new device clearance overhead costs to maintain compliance, and lack of certainty about what is needed to maintain compliance, and fear of non-compliance consequences. We explain how to meet these compliance standards by following these best practices to bring new medical devices to market with success.

Security now needs a seat at the medical device design table, accompanied by its own list of requirements. Here are resources to identify specific areas to focus cybersecurity efforts throughout the products life cycle.

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMCs demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

The margin for error when it comes to critical components for medical device manufacturing is zero. Thats why Accumold ensures robust production processes, extremely tight requirements, and part-to-part consistency.

Cardinal Healths OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.

PTIs expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

MasterControls supplier management solution automates supplier management processes and ensures supplier quality and compliance.

DSM Biomedical delivers a versatile and tunable hydrophilic polymer technology designed for adhesive applications. This technology mimics the proteins of marine mussels when they bond to underwater surfaces.

The Lee Company is a leading supplier of miniature, precision fluid control products to a wide range of industries including medical devices and scientific equipment.

Carclo Technical Plastics is an international engineering based company led by engineers coupling industry standards with a Six Sigma culture. We specialize in injection molding and contract manufacturing services for medical devices, medical equipment, optics, and electronics applications.

The EUs Medical Device Regulation (MDR, effective May 26, 2021) and the In Vitro Diagnostics Regulation (IVDR, effective in May 2022) are certainly hurdles for medical device manufacturers to tackle. However, those arent the only new regulations in Europe to prepare for.