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...
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...
Since their introduction in the early 1980s, interventional guidewires have transformed medical procedures beyond recognition. This, in turn, has transformed patient outcomes, highlighting the importance of innovative interventional guidewire design. Those first devices were basic compared to today's sophisticated interventional guidewires, but they were pioneering. That said, technologies and innovations in the field of interventional guidewires continue to advance at an exciting and rapid pace. As a result, outcomes for patients continue to improve, more advanced procedures are becoming possible, procedure times are being reduced, and the risks associated with complex medical interventions are continually being mitigated. The Importance of...
Usability engineering is a common concept in many areas of product design, but its importance is elevated in medical device product design because of issues of safety and effectiveness. In fact, the importance of usability engineering is increasing as medical devices become more complex and smarter. Medical devices are also being used in a growing number of situations and to treat an ever-widening range of conditions. Microcatheter technologies are a good example, given the advances that are being made in neurovascular microcatheters. What is usability engineering in medical device design, and what does it mean for your design project or...
Design for assembly, or DFA, means designing a new medical device product so it can be assembled as easily as possible. It is a crucial part of the design process, particularly as the product moves to the pilot manufacturing, full manufacturing, and commercialisation stages. DFA is a process that applies to medical device products with multiple components and is particularly important for complex devices. With the right DFA approach, assembly costs and timescales can be reduced to a minimum. Essential DFA Considerations Minimise the Components One of the main objectives of DFA is to design the device with as few...
The process for bringing your idea for a new medical device from the concept stage through to commercialisation is known as a New Product Introduction, or NPI. The exact steps required will depend on the device you plan to develop. As each marketplace has varying regulatory requirements, where you plan to launch will also influence the NPI process. That said, a good place to start to get an overview of a typical NPI process is guidance provided by the Food and Drug Administration (FDA) in the US on how to bring a novel medical device to market. This guidance describes...
You will probably work with a design partner to develop your idea for a new medical device. They will handle the design process, bringing the concept through to the initial prototype and then final prototype stage, ready for you to move to the next stage of your business plan. There are things that you can do to facilitate the design process as well as to ensure the developed product meets your goals and objectives. The following tips are a good place to start. Focus on Designing a Product One of the mistakes that is sometimes made when designing new medical...
A product requirement specification outlines what needs to be achieved during the medical device design process. It is an important step in the process as it ensures design engineers fully understand what is required so they can deliver the best possible product. A good product requirement specification also makes the design process more efficient, and it ensures the development of a better-quality product. Furthermore, your product requirement specification will make it easier to ensure compliance, and it helps with progressing your product through the regulatory approval process. Your medical device design and development partner will guide the process of creating...
A crucial part of the medical device design and development process is to create a product requirement specification. The creation of this document takes place in the very earliest stages of the process. In fact, in our Six-Step Medical Device Design Process at Arrotek, creating the product requirement specification is one of the primary objectives of Step 1. A product requirement specification clearly defines the purpose, functionality, features, and behaviour of your new medical device idea. Importantly, it focuses on what you want to achieve with the new product, but it doesn't look at how. Looking at how you deliver...
Medical device design projects require a broad range of expertise as well as established processes and procedures. The project management function and the project manager are central to ensuring medical device design projects run smoothly. Of course, effective project management plays a crucial role in the product design process in other industries too. However, because of regulatory considerations, safety issues, and the complexity of many modern medical device products, project management is even more important in the medical device industry. The Path to Successful Medical Device Product Launches The overall objective of a medical device design project is to bring...
