When it comes to designing and building novel medical devices to meet the needs of patients and healthcare systems, developers should rely on the core skills of engineering and design to inform their process. But there are “lessons learned” that are unique to the medical device development process.
- Human Factors Engineering as a Means to Mitigate Potential Harm for the Patients
Human factors engineering is a critical part of the product development process. And for medical device development, this work is mandated thanks to the medical device regulations put forth by the FDA.
Human factors engineering is defined as the interaction between humans and systems. It can apply to everything from a button’s size to the room that the product will be in.
Human factors engineering activities, such as user-testing, provide product development teams with vital data that should be used to help inform and evolve a product’s design. In the medical device development process, this data can be used to identify misuse of a product, helping to root out potential harm to the end-user.
Medical device developers need to integrate human factors engineering into their development process, not only because it’s mandated by the FDA, but as good design practice for thorough user research and testing.
- Designing for the User and the Use Environment
When developing any product, it’s crucial to consider the product’s user and use environment. For the medical device development process, this means defining who in the healthcare system will be using the product (doctors, patients, technicians, etc.) – is there just one user or multiple users? What skills do these users need in order to effectively use the product?
As product developers, there is a lot to consider when it comes to designing and implementing a product in a hospital or healthcare setting. For example, if we are creating a product to be used in an operating room, it is imperative that we understand the sights and sounds of the surrounding environment.
If we are making a product that alerts users using an audible cue, we need to know what other sounds are present in the same environment – are there sounds that will be similar in pitch and length compared to our product?
Knowing our user’s needs and the use environment are critical components of the medical device development process – and it’s not something to save until the end of your product design efforts. Gather this data early and use it to help inform the design process.
- Meeting the Aesthetics of Modern Healthcare
Here’s another important consideration for the medical device development process: product creation is not just about function. Your product’s form needs to stand up to the sleek, modern aesthetic of today’s healthcare facilities.
A well-designed product will enable proper use, but it should also help you stand out on the market. As you move through the medical device development process, be sure to thoroughly research and evaluate the aesthetics of the market in which you intend to sell your product. Then, design with those category-leading features in mind.
- Navigating FDA regulations
Medical device regulations put forth by the FDA for the medical device industry are not boxes to tick off at the end of a development cycle. Practical application of medical device regulations early on in the product development process will ensure a safe and effective product that will also meet the user’s needs.
It’s one thing to read and understand the requirements put forth by the FDA for medical technologies. It’s another thing altogether to know when and how to apply those rules to the medical device development process.
At the start of a new product creation effort, it’s important to map out the design and development work needed to meet scheduled business milestones and regulatory requirements.
This is where experience really pays dividends. Teaming up with a product development company that knows the regulatory landscape will help you understand exactly how much work you’ll need to do along the way – no more, no less – to satisfy regulators and develop a highly effective product.
- Systems Engineering and Interoperability
Very few devices operate in a silo in medtech. You need to know where your device fits into the larger picture of the technology with which your end-user interacts.
For example, let’s consider that we are building a medical device intended to be used within a patient’s room at a hospital. From the outset of our product development efforts, we need to know if this product needs to be equipped to share data with other products in the patient’s room, like a monitor or an electronic health record system.
These kinds of questions should be asked and answered in Phase Zero of the medical device development process. This often undervalued phase is critical in setting your team up for success.
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