There is a problem in the medical device industry and as a start-up company, it will be a problem that you may already be familiar with. You need support for your project, whether you are at the concept and prototyping stage or are further along on the research and development journey. However, all too often, … Tailored Support for Your Medical Device Start-Up Company
Neuro stimulating needles are used to treat a wide and ever-increasing range of conditions. In this blog, we will give an overview of the main design and manufacturing considerations of neuro stimulating needles. Neuro stimulating needles are a type of neurostimulation medical device. While neurostimulation has been used as a treatment for many decades, recent … An Introduction to Neuro Stimulating Needle Design and Manufacturing
Balloon catheters are used for a range of medical procedures and applications, from delivering stents to opening blockages to dilating vessels to delivering therapeutics directly to a target location in the body. As a result, balloon catheters have transformed patient outcomes, particularly in complex procedures. Balloon catheters have been used in healthcare for many years … Balloon Catheter Design – Process Overview and Key Considerations
Neurovascular microcatheters have transformed the treatment of patients around the world. They enable minimally invasive treatments in a challenging part of the body, so have significantly advanced health-care in this field. The range of neurovascular conditions that microcatheters are used to treat includes cerebral aneurysms, ischemic stroke, and other conditions that affect the vessels that … Neurovascular Microcatheter Design Overview
Occlusion balloon catheters are widely used for a range of medical procedures and treatments, from emergency hemorrhage control or the treatment of neurovascular aneurysms, to temporarily stopping the flow of blood during heart surgery. Despite the varied applications that currently exist, there continues to be new innovations in occlusion balloon catheter design. Those innovations are … Occlusion Balloon Catheter Design and Development Overview
This whitepaper outlines in detail the design process required to successfully design a new medical device product, developing it to a point where it can obtain regulatory approval and move into the manufacturing and commercialization phases. Download the whitepaper The whitepaper is based on Arrotek’s well-established Six-Step Design Process. This process has a proven track … Six-Step Medical Device Design Process Whitepaper
Multi-lumen catheters are used for several different applications, including highly complicated procedures. They can also be designed with a wide range of performance characteristics. Furthermore, advances in the design of catheter devices are opening up new opportunities and making it possible to create new multi-lumen catheter products that will improve the treatment and diagnosis of … An Overview of Multi-Lumen Catheter Design
Effective catheter design and development are essential to successfully bring your idea for a new device to market. From the earliest stages of concept development through to scaled-up manufacturing, it is a complex process with a range of considerations and potential challenges that can impact success. However, with the right approach and expertise, there are … Catheter Design and Development – Key Considerations to Get Your Product to Market
If you have an idea for a new medical device and want to sell that product in the US, you will need approval from the Food and Drug Administration (FDA). Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. What is a 510(k) submission? What types of devices … What is an FDA 510(k) Submission
Not all medical devices are the same. Some are non-sterile and pose minimal risk to patients, while others are implanted in the body and carry a high risk. Therefore, regulations for medical devices must distinguish between the different types, setting appropriate requirements for regulatory approval depending on risk. Regulators do this with a classification system. … EU Medical Device Classifications Explained
