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
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.
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.
ISO 13485 manufacturing is an established quality standard, pertaining to medical device manufacturers. However, as with any quality standard, it is more a set of general guidelines which every manufacturer applies to their own situation according to their status, infrastructure, and working conditions, rather than a recipe for success. There are multiple ways in which it can be applied to each manufacturer’s case, therefore making each medical device manufacturer responsible for guaranteeing their operational effectiveness and success, independent of their ISO 13485 manufacturing certification. An Overview Of ISO 13485 Manufacturing Quality Standard First published in 1996, ISO 13485 in manufacturing is [...]
Often, when working on developing a medical device and its design control, designers and engineers find themselves stuck or having to repeat the same processes, again and again, to fix and perfect their design. Considering these seven common steps for design and control of medical devices can help a team avoid some of the most common pitfalls. Since 1990 and 1993, the US (21 CFR 820.30) and EU (MDD 93/42/EEC) respectively included Medical Devices in their GMP (Good Manufacturing Practices) set of rules and regulations, with the International Standards Organization (ISO) following suit in 1996 by publishing their voluntary ISO [...]
The Four Phases of Medical Device Product Development Lifecycle 1. Conception This phase contains several steps from idea conception, the use context of the medical device, initial concept development, up to proof of concept. These ideation processes generate abstract concepts in need of further development, refinement, and adaptation, to result in a workable base for developing a medical device that is effective to use, feasible to produce, and can achieve regulatory compliance. 2. Design & Development New Process Development (NPD) Medical device product design should be carried out with manufacturing in mind. From the early stages of device components design, factors such as practical [...]