Embolization coiling is a minimally invasive catheter-based procedure that employs a coil that can cause an occlusion. What’s important is that the design is made easy to handle and produces the desired effect at the intended location.
The new MAH or Marketing Authorization Holder Policy has opened up a whole new level of opportunities for medical device companies. OEMs must capitalize on the major changes taking place in the Chinese market in allowing high-quality medical devices to be manufactured and marketed without as many restrictions as they experienced prior to the MAH Policy.
If these core elements are not carefully assessed, planned and tested through prototyping, the problems arising at the FDA approval stage, production stage and usage with the end-users will negate profitability
The biocompatibility of materials used in Structural Heart Devices is of the utmost importance. We explore the challenges presented by each material’s specific functional profile and how it will react when used in a Structural Heart (SH) Device
As rumors of Covid-19 spread in January 2020, and fear gripped most of China, the management had to face facts and realize that a serious crisis was in the offing. Instead of being paralyzed by fear and uncertainty, Quasar’s leadership headed by Ayal Amitai, CEO, began looking ahead, considering courses of action to get the plant working again.
Many supply-chain vulnerabilities stem from long lead times and high levels of cyclicity that prevent the maintenance of the right inventory balance. OEM companies must identify and solve supply-chain vulnerabilities and risk exposures by creating effective mitigation and business-continuity plans.
It takes veteran manufacturers who are specialized in the field of interventional cardiology equipment, to be able to smoothly navigate through this ever-evolving market.
From one-off and per-item costs to quality, repeatability, and customer satisfaction. Strategically automating a process provides the best way to ensure the medical device’s manufacturing success.
“Expanding our global footprint to North America strengthens our commitment to support our current USA customers with direct staff, while positioning Quasar to service new customers with our unique capabilities and technologies.” – Ayal Amitai, CEO
Finding the right low-cost country for medical device manufacturing can play a key role in gaining a competitive advantage for your product. The leading regions are South America, Mexico, and Asia. As per our analysis, Asia is where you will find the most advantages when considering the supply chain as the key success factor.
Outsourcing the production of your medical device manufacturing can be a big step for your organization. As an Original Equipment Manufacturer (OEM), putting your product in the hands of a Contract Manufacturer (CM) will free up significant time for your design and production teams, streamline the manufacturing process and even give you access to new world markets.
For an OEM, the prospect of outsourcing manufacturing should be an attractive way to cut costs and simplify a new product workflow. The purpose of this article is to take a closer look at how a Contract Manufacturer (CM) can help an OEM save money and work more efficiently.