Although this report focuses on the development of an incentive spirometer, 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.
All prebuilt Zewski Reports are developed with two core assumptions:
The product exists only as an idea.
Each report assumes the device is in its earliest conceptual stage and requires full development—covering human factor engineering, industrial design, mechanical and electrical engineering, prototyping, proto-production tooling, testing, regulatory clearance, and manufacturing planning.
The device does not currently exist.
Even if the device appears simple or is already on the market in some form, our reports consider the effort required to create it as if it were a brand-new invention. They ask: What if this concept were being introduced for the first time? What technical, regulatory, and market challenges would need to be overcome? What resources would it take to bring a novel, ground-breaking version of this idea to life?
Zewski Reports do not account for "Me Too" products.
Our reports are not designed for estimating cost and time to duplicate existing solutions, which may require considerably less time and financial resources. Instead, they focus on the process and challenges of original innovation in today's market. We believe this give innovator the best glimpse of challenges in creating something groundbreaking.
An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.
The incentive spirometer is a small, handheld respiratory therapy device designed to encourage deep breathing in patients recovering from surgery, illness, or extended periods of immobility. It operates through simple mechanical means, typically including a plastic chamber, a piston or ball to visually indicate airflow, and a flexible tube through which the patient inhales.
Unlike diagnostic spirometers, which measure lung function quantitatively, incentive spirometers provide visual feedback to motivate patients to achieve therapeutic breathing goals. The device does not contain any electronics or software components and requires no external power. Its simplicity and reusability make it an effective, low-cost solution in both hospital and home care settings.
This specific device concept remains in the early stages of development, with a focus on basic functionality rather than digital integration or customization. Materials are standard medical-grade plastics, and the design is reusable with minimal cleaning — a consideration that impacts both usability and regulatory pathways.
Note: This report incorporates certain assumptions based on our understanding of typical product development pathways and the stages at which our clients commonly engage with us. Where specific project details were unavailable, we’ve provided informed projections to support strategic planning.
This project centers on the development of a simple, mechanical incentive spirometer intended for therapeutic use. While the concept builds on a long-established product category, the project is still in its conceptual phase, without prior iterations, formal documentation, or institutional support. This early stage presents both challenges and opportunities — particularly in defining the product’s niche and planning a cost-effective development path.
The project is at the very beginning of the development journey — currently an idea or proof-of-concept with no formal prototyping or engineering work completed. The lack of design for manufacturing (DFM) considerations or testing history underscores that this is a pre-development initiative, and significant groundwork is needed before engaging with regulatory, production, or clinical stakeholders.
The absence of a clinical champion or institutional support means the project will need to generate credibility through strong prototyping, validation testing, and potential pilot trials. Strategic networking with clinicians, respiratory therapists, and procurement decision-makers will be critical as the concept advances.
Although the device itself is not functionally unique, this doesn't eliminate its potential. Instead, the lack of uniqueness shifts the focus to incremental innovation — such as improving ergonomics, simplifying the user experience, reducing manufacturing cost, or addressing sustainability in reuse and materials. Differentiation may also come from aligning with institutional purchasing trends (e.g., single-patient reusable devices, infection control priorities, or remote monitoring integration down the line).
The next key steps involve defining clear product requirements, exploring cost-effective manufacturing methods, and confirming clinical usability. These tasks will be critical to refining the idea into a viable prototype that addresses real-world needs. Given the moderate supply chain complexity and some custom components, early supplier identification and design-for-assembly considerations will help reduce delays later in the process.
Though still conceptual and not yet unique in function, this incentive spirometer project has a clear therapeutic purpose and a manageable development scope. Future success will depend less on innovation in core technology and more on clever execution, thoughtful design refinement, and early alignment with user needs and supply chain realities.