Ger O'Carroll

Using Coil Reinforced Polymer Tubes with Ultra-Thin Walls to Develop Advanced Catheter Technologies

by Ger O'Carroll
Coil reinforced polymer tubes have enabled the development of a wide range of minimally invasive medical devices, including catheter solutions. The coil reinforcement increases the flexibility of the device inside the body, preventing the tube from kinking or collapsing. These kink-resistant capabilities make it possible for catheters to access difficult to reach parts of the body. As a result, many coil reinforced catheter solutions have been developed and are currently being used for both diagnostic and therapeutic purposes. Just because there are effective coil reinforced catheter solutions in use doesn't mean the medical device industry can declare mission accomplished, with...

Estimating the Probability of Occurrence and Severity of Harm When Assessing Medical Device Risks

by Ger O'Carroll
There are a number of steps that need to be taken in relation to risk management when designing a new medical device. This includes identifying hazards and hazardous situations. You then need to evaluate the hazards and hazardous situations you identify before, potentially, putting control/mitigation measures in place and then monitoring those controls. The second stage of the above process, evaluating hazards and hazardous situations, involves estimating two essential factors: The probability of occurrence The severity of harm By combining these two estimations together you will be able to define the risk as being either acceptable or unacceptable. This definition...

Medical Device Risk Management Plan – What You Need to Know

by Ger O'Carroll
As we have covered in a previous blog, risk management is essential when designing and developing a new medical device product. An important part of this process involves creating and maintaining a risk management plan. Before going any further, it’s helpful to define risk management. What is risk management? Risk management is not the act of carrying out a risk analysis at various points during the design of your medical device. This is an action that is part of risk management. Instead, risk management is a process and, for that process to be effective, documented, and transparent, you need a...

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...