Although this report focuses on the development of a Nipple Shield, the insights and methodology are broadly relevant to a wide range of similar medical devices providing general principles and realistic planning assumptions to guide innovators through the development landscape, especially for devices that might appear simple but involve hidden complexities.
The assessment is based on our understanding of typical product development pathways and the points at which clients usually engage with us. In cases where specific project details were unavailable, we have provided informed projections to aid strategic planning.
A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.
The nipple shield is a handheld, reusable medical accessory designed to cover and protect the nipple of a nursing woman. Typically made from soft, skin-safe plastic, it serves a therapeutic role, helping address challenges such as nipple pain, irritation, or latch-on difficulties during breastfeeding. While it allows for continued nursing, its primary function is to act as a barrier, reducing direct friction or trauma to the nipple while still enabling milk transfer.
Unlike breast pads, which protect clothing from milk leakage, nipple shields are intended for direct skin contact and play an active role in the breastfeeding process. Because it touches the skin but does not enter the body, it falls under the category of non-invasive, external-use devices. The shield does not contain any electronics, mechanical parts, or power components, simplifying its use and reducing associated safety concerns.
The FDA identifies the nipple shield under a Class I classification, meaning it’s recognized as low risk and exempt from design control requirements. This makes it an approachable device for first-time medical product developers, provided its design and manufacturing processes ensure safety, hygiene, and efficacy.
The nipple shield is a low-complexity, low-risk device with a clearly defined therapeutic purpose and user base. Its simple form factor and lack of power or electronics make it an excellent starting point for early-stage development, particularly for inventors entering the medical device field for the first time. While it bypasses many of the complex regulatory hurdles faced by more sophisticated devices, success still depends on careful design, user safety, and clear demonstration of benefit.
At this stage, the nipple shield project is in its earliest phase of development, with a concept or proof-of-concept in mind but no formal design documentation or prototype iterations yet completed. This means the foundational thinking is in place, but most structured development activities, like CAD modeling, materials testing, or feedback from multiple users, are still ahead.
That’s not a bad thing. In fact, this is often the most exciting point in the journey: when an idea becomes real, and decisions made now will shape the entire product’s path forward. The project is supported by a clinical champion, which is a strong asset at this stage. Clinical voices can validate real-world needs, guide feature prioritization, and help establish a credible user-centered design approach.
You’ve already cleared one big hurdle: patent protection. With one granted patent in a single country, you’ve carved out a defined space for your product. While broader international protection can come later, this initial IP signals a serious commitment to innovation and helps reduce risk when approaching partners or investors.
Unlike many early-stage devices that rely heavily on software, electronics, or novel materials, this product is purely mechanical and low-tech, which brings both advantages and limitations. On one hand, development can be faster, cheaper, and more streamlined. On the other, differentiation must come from form, comfort, clinical benefit, and user experience, not from digital functionality.
The fact that no customization is required simplifies production and inventory management. A universal or semi-flexible size range may be sufficient. And since the product is intended to be reusable with minimal cleaning, that adds value for users and avoids regulatory challenges related to disposability or sterilization.
Additionally, the supply chain looks favorable. With a need for mostly off-the-shelf materials, sourcing components should not require long lead times or specialty vendors. That gives the project agility, something that can be lost quickly in later stages of development.
Next steps should focus on moving from idea to tangible form. This includes:
One risk to watch is overconfidence in simplicity. Even “easy” devices like this one require deliberate planning around biocompatibility, reusability, and clinical benefit. And while Class I exemption means fewer formal regulatory burdens, poor design or unclear labeling can still lead to delays or rejections.
This project is in a strong position: early, but with clinical support and IP already in place. By focusing on user-centered design, comfort, and manufacturability, and advancing methodically through early-stage milestones, the development can stay cost-effective while maximizing impact. You’re not just building a device; you’re shaping a solution trusted by mothers and clinicians alike.