Knowledge Hub

An Overview of Risk Management in Medical Device Product Design

by Ger O'Carroll
Risk management is an essential part of the medical device product design process. It ensures the safety of patients, users, and operators so it’s no surprise that risk management is a regulatory requirement. Risk management is also essential to the medical and commercial success of the new product you plan to develop. In terms of the processes and steps required to ensure the proper management of risk, this is part of the Quality System that you need to have in place when designing a medical device product. In addition to risk management, a Quality System includes management controls, document control,...

Medical Device Design Verification and Design Validation – What They Are and Why They Are Important

by Ger O'Carroll
Design verification and design validation are essential parts of the medical device product development process. Sometimes referred to as V&V, it’s important to understand what both terms mean and how they differ if you are about to embark on a medical device product development project. This is because V&V can take more time than necessary if proper design controls are not put in place in the early stages of the design process. In other words, both design verification and design validation are made easier if you have well-documented user needs, design inputs, design outputs, and outcomes from design reviews. What...

Documenting User Needs – Key Questions You Need to Answer

by Ger O'Carroll
In a previous article, we outlined the importance of identifying and documenting user needs when designing a new medical device product. In that article, we looked at the two objectives you must achieve when documenting user needs: Defining the intended use of your new medical device product Defining the indication for use of your medical device product This sounds straightforward enough but when you go through it in practice, the process can be quite tricky, not least because documenting it is a regulatory requirement. So, how do you create the above definitions to complete the process of documenting user needs?...

How Design Changes Impact Medical Device Product Development Costs and Time to Market

by Ger O'Carroll
You have an idea for a new medical device – this is the starting point for all new product development projects. Where the project goes from there, however, the costs involved, and the timeline depends on a range of factors. Examples include the complexity of the product, availability of funding, regulatory issues, medical trials, and more. Unfortunately, you have limited control over many of these factors. That said, there is another factor that can have a substantial impact on the cost of product design as well as the time it takes to bring your new medical device to market. As...

What You Need to Know About User Needs When Designing a New Medical Device

by Ger O'Carroll
When you first came up with your idea for a new medical device, you probably had a fairly clear picture of how it could help improve health outcomes. In the medical device product design process, this is known as User Needs. What often happens next, however, is new ideas start to come to mind. For example, you might think of other clinical areas or conditions that your new medical device product could help with. Or you might come up with ideas for alterations you could potentially make to the product further down the road that would make it even more...

Understanding Process Validation in Medical Device Product Design

by Ger O'Carroll
If you have looked into the steps involved to design and develop a new medical device product, you are likely to have come across the term process validation. It’s an essential term and concept to understand as it helps ensure your design, develop, and then manufacture a product that meets the needs of end-users – usually patients or customers. Process validation is also crucial to getting regulatory approval for your product. What Is Process Validation? Process validation takes place throughout the product’s entire lifecycle, starting during the design stage. It involves collecting and then evaluating data to prove the product...

How Long Does It Take to Design a New Medical Device Product?

by Ger O'Carroll
A question we are often asked at Arrotek is how long it takes to design a new medical device product. Knowing this helps entrepreneurs and businesses plan future steps, including those that come after the product is designed, including putting the product through clinical trials. The problem with answering the question of how long medical device design takes is that it is variable. The simple answer is three to six months. To understand further, it helps to explain our process, the things that can cause delays, and how we mitigate those delays. How We Work At Arrotek, we put a...

Benefits of an Iterative Design Process

by Ger O'Carroll
The best approach to developing a new medical device product is to use an iterative design process. Iterative design is a methodology used to create products in all industries, from physical products to software. What is iterative design, however, and what are the benefits? What is Iterative Design? Iterative design involves the development of a new medical device product using a cyclical process. This involves bringing the design to a certain point and then analysing, evaluating, testing, and getting feedback on that design. This is all fed back to the design team to inform and shape the next stages of...

FDA Medical Device Classifications Explained

by Ger O'Carroll
To sell a medical device product in the US, you need approval from the FDA (the Food and Drug Administration). A key part of getting FDA approval is the classification of your medical device. Not only will the classification determine much of the design and development process, it will also determine what is required to get approval. This is because the process for getting FDA approval differs depending on the classification of your medical device. This is very similar to the system in the EU. We covered the EU medical device classification system in a previous blog. In this one,...

EU Medical Device Classifications Explained

by Ger O'Carroll
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. In other words, understanding the classification that your new medical device falls under is a crucial step in the design and development process. The classification will inform how the development progresses as well as the steps required to obtain regulatory approval. EU vs US Regulations...