Getting a new medical device product approved by regulators is complex and often challenging. What do the statistics tell us about the approval process for a new medical device? What can we learn, and how can you ensure your path to regulatory approval is as smooth as possible? The following five statistics about the medical device regulatory approval process are not only informative, but also highlight the importance of getting expert support as early as possible. 1. The Average Time it Takes to Get an FDA 510(k) Decision is 5 Months The most common regulatory pathway in the US is...
With the development of new products, innovations, and technologies, analysts are predicting healthy growth in the medical device industry over the coming years. What are the main trends in MedTech as we go into 2023? More specifically, what are the trends in minimally invasive medical device design? Prioritising Ease of Use, Clinical Outcomes, and Patient Satisfaction We all live in a world of rapid innovation, where technology influences multiple aspects of our lives. It isn't just any technology, either, as we are all now very accustomed to technologies that are easy to use, highly functional, and that deliver beyond expectations....
Medical device regulations are complex. They are also regularly updated and refined. So, rather than being a fixed set of rules, they constantly evolve. Therefore, it’s essential to have access to medical device regulatory experience and expertise during the application process. Third-party regulatory support can be beneficial for companies of any size, but it is particularly helpful in organisations that have a limited level of in-house regulatory expertise. What Support Can a Medical Device Regulatory Consultant Provide? An experienced regulatory consultant can support all aspects of bringing a new medical device product to market. This includes regulatory compliance consultancy as...
Medical device company SmartWise Sweden AB selected Arrotek as its design partner for the development of a novel endovascular injection catheter. It is an ongoing project, but this case study outlines the work we have done with the SmartWise team to date, developing the product, optimising the design, and providing support as it achieved FDA regulatory approval. You can download and read the SmartWise case study here. Arrotek specialises in the development of catheters and other minimally invasive medical devices. We work with start-up companies, medical professionals, SMEs, and international corporations, providing medical device design, regulatory, and manufacturing support. If...
Running a start-up medical device company is an exciting but often very busy time with so many things to do and decisions to make. It’s not surprising that much of your focus is on the here and now, i.e., what you need to do to move your company, project, and product to the next stage. Despite this, it remains important to also have a long-term view to ensure you maximise the future value of your company. For example, you might have a particular exit strategy in mind for your company. The decisions you make today and the actions you take...
Design transfer is a phrase that describes the activities and processes that introduce a medical device design to production. Effective design transfer is required by regulators but it also keeps manufacturing costs under control and ensures production milestones and deadlines are met. Furthermore, effective design transfer can reduce time to market and improve product quality. What is involved in the design transfer process and what are the requirements? At Arrotek, we have a Three-Phase Design Transfer process to prepare a design for commercial manufacturing. The final phase involves a comprehensive checklist that is important for the process itself as well as...
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, the support that is available comes with a big price tag. You also have to make big commitments while putting up with the fact the support you get is not tailored to your specific needs. There must be a better way. There is a better...
Our modular approach to the delivery of medical device design and development services means we can help with whatever level of support you need, whatever expertise you need, and wherever you are in the development process. While there are similarities across all medical device design and development projects, our experience at Arrotek is that every project is different. As a result, we have experience in everything from providing consultancy services to handling a single element of a larger project to providing full end-to-end services from ideation to commercialisation. With our modular approach, we can slot in wherever you need us,...
It is now over a year since the new EU Medical Device Regulation (MDR) came into effect. Whether you are an early-stage start-up, a company further advanced in your start-up journey, or an established medical device company, what are the current realities of EU MDR compliance? The fact is, there are challenges that will impact just about every medical device company operating or planning to operate in the EU. Before we get into those challenges, though, a quick recap of where we are. Fast-Approaching Deadlines All new medical devices seeking approval for the European market must now go through the...
Without interventional guidewires, many minimally invasive medical procedures that are common today simply wouldn’t be possible. They are an essential component of many interventional, therapeutic, and diagnostic devices, including catheters, and they have become increasingly sophisticated and innovative. Excitingly, however, we haven’t yet reached the innovation peak of interventional guidewires. Cutting-edge technologies, new ways of using materials, and intelligent design concepts are continually being developed, pushing the boundaries of what is possible. If you have an idea for a new medical device, what are the design considerations that you need to be aware of for the interventional guidewire component? Here’s...
