The medical device industry is one of the most heavily regulated industries in the world. Strict regulations are in place to protect patients, and while this is undoubtedly for the best, it creates a range of challenges to bringing new medical equipment to market — especially medical equipment that’s intended for NICU use. Aspiring developers must take a slow and systematic approach if they want to succeed, but it can be hard to get a firm grasp on everything that must be accomplished to get a product to market.
To help developers navigate this complex but exciting landscape, we’ve crafted a two-part overview of the most important steps in the medical equipment development process. In this installment, we’ll explore the first three stages of the process: ideation, regulation and compliance, and design control.
In the ideation stage, you determine what exactly you’re creating, whether it’s new advanced medical equipment or a variation of an existing device. The first step is identifying a need within a target market that your device will fill. You then need to create a product definition for your new medical device.
Broadly speaking, your device will either be a “vitamin” or a “painkiller.” Vitamins are devices that don’t offer a solution to a specific problem, but do provide a better way of doing something. Conversely, painkillers are devices that address a specific problem. It’s helpful to look at market analyses to ensure you’re meeting the target market’s perception of their need as closely as possible.
Once you have your product description, you can start attending to considerations like FDA-defined classification and intellectual property rights. These factors will help you determine whether there are risks or pre-existing intellectual property that could interfere with the production of your medical equipment. You’ll need a strong development team at this stage, including experts in engineering and design, usability engineering, the medical industry, regulatory affairs and quality assurance, and intellectual property law.
From there, you can move into the discovery phase of ideation, where you complete product conceptualization through initial design, prototyping, proofs-of-concept, and iteration-driven redesign.
Regulation and Compliance
To ensure its usability and quality, your new medical equipment has to meet a number of compliance standards before you can bring it to market. While some of these standards are regional, you’ll likely encounter a few international standards, as well, including International Standard for Organization (ISO) 13485, ISO 14971, and International Electrotechnical Commission (IEC) standard 60601-1, which covers general health and safety guidelines for medical electrical equipment.
Though complying with these regulations is crucial to the viability of your medical equipment, compliance does not guarantee that the FDA will clear your device for market use. The FDA will also evaluate your device based on its own risk management procedures as part of the design control phase. Regulation and compliance is often the most time-consuming stage of the NICU medical equipment development process, and a little help from a medical device manufacturing partner goes a long way.
Design controls are how a medical equipment developer proves that their device is effective, safe, and suited to the market’s needs. They also prove that the device’s production process meets regulatory requirements. Design controls are defined in FDA 21 CFR 820.30 and are meant to help regulatory bodies ensure that new medical equipment is safe for users before manufacturers can begin marketing it.
Categories of design controls include design and development planning, design input, design output, design review, design verifications, design validation, design changes, design transfer, and more. Given the many components of design control for advanced medical equipment, successful implementation requires working with professionals with both technical and non-technical backgrounds.
Getting Medical Equipment to Market with Kentec
Aspiring developers hoping to get their NICU medical equipment to market need a manufacturing partner like Kentec Medical. Our proven business model focuses on speed to market and capital efficiency. We’re more streamlined than most medical equipment development companies, allowing us to implement our speed-focused model and surpass standard industry benchmarks. More importantly, Kentec’s commitment to customer service means you will have support every step of the way as you develop your advanced medical equipment.
To learn more about the rest of the process for developing NICU medical equipment, stay tuned for the second part of this series! In the meantime, please feel free to contact us to find out how Kentec Medical can help you get your devices to market.