Arrotek

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

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

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 – … Understanding Process Validation in Medical Device Product Design

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

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 … Benefits of an Iterative Design Process

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 … FDA Medical Device Classifications Explained

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

Design controls are essential to ensuring your medical device idea achieves regulatory approval. Without design controls, you won’t be able to launch your product, while the poor implementation of design controls, particularly in the early stages of a project, will delay the launch of your product. What are design controls? Design controls are part of … Quality Systems and Design Controls in the New Medical Device Development Process