In the first installment of our series on developing NICU medical equipment, we explored the first three stages involved in bringing new advanced medical equipment to market. During ideation, you think about what type of medical device you’re creating and determine what need that product will fill. Then, you take your time moving through the regulation stage so you can make sure your device will meet all compliance requirements before it goes to market. From there, you start designing your product to demonstrate that it’s safe, effective, and well-suited to the market’s needs.
These initial stages are essential to getting your idea off the ground and ensuring the success of your new product, but they’re only half the story. In this second installment of our series, we’re covering the final three stages of the medical equipment development process: testing, risk management, and product launch.
Also known as design verification and validation, the testing stage of the medical equipment development process can be confusing for new developers. At its core, this stage is a continuation of the work done during the design control stage. Once you have your design inputs — the basis of the device design as a whole — it’s time to test them using these two separate (but closely linked) processes.
Design verification double-checks that you have designed your device according to the specifications detailed in your original design. During design verification, ask yourself, “Have I designed the device correctly?”
Design validation ensures that you have designed the device you set out to create in line with users’ needs. Development teams often have to go back to the drawing board multiple times while creating advanced medical equipment, and it’s always a good idea to make sure the current iteration of the device hasn’t strayed too far from the original design. During design validation, ask yourself, “Have I designed the right device?”
After design validation and verification, teams can start testing for biocompatibility, usability, wearability, and a variety of other criteria.
The risk management stage is designed to help ensure the safety, usability, and regulatory compliance of new medical equipment. As outlined in ISO 14971, the basic steps of risk management are as follows:
1. Identify hazards.
Start by defining potential sources of harm and working through the foreseeable sequences of events that could follow each hazardous situation. Also, be sure to check your design for potential hazards related to raw materials and waste, environmental factors, and human factors like ineffective delivery or incorrect information. Use these findings to estimate the probability of each of these potential hazardous events occurring.
2. Estimate and evaluate risks.
Medical equipment developers calculate risk by considering the severity of potential harm and the probability of that harm occurring. After you’ve estimated the risk, you need to evaluate it. Are these risk levels acceptable? If they aren’t, revisit earlier stages of the development process and make changes that will lower risk levels.
3. Develop, implement, and monitor the effectiveness of risk control measures.
If you’ve determined that risk levels are too high, create risk controls to bring them down to an acceptable level. The most common risk control measure is editing product labeling, but that’s not always the most effective approach. Ideally, you should try to implement risk controls through the design process and/or include protective measures in the device.
The final stage of the NICU medical equipment development process is the most exciting: launching your product! Before getting your product to market, you have to complete the design transfer process so that your manufacturing team can build your product and triple-check that it matches the product used during testing. You should also take the time to set up a solid distribution network to ensure your product reaches a wide audience.
From there, develop and curate marketing materials that address all stakeholders who might be interested in purchasing your product. Marketing materials include everything from technical documentation to white papers to posts on social media.
Finally, the FDA requires all medical device developers who market Class II and Class III NICU medical equipment to engage in post-market surveillance (PMS). PMS helps you fulfill your responsibility to monitor product performance once your product has launched.
Launching Your New NICU Medical Equipment with Kentec
If you’re an aspiring developer looking to launch your new NICU medical device, you’ll need a manufacturing partner like Kentec Medical. Our commitment to customer service means you’ll have support every step of the way, from ideation to testing to launch. Kentec’s streamlined business model sets us apart from other medical device development companies and helps you get your product to market faster than you ever thought possible.
Contact us today to learn more about how Kentec Medical can help you get your advanced medical device to market!