Accelerating Device Development Through Prototyping

Insight by Nemera is committed to helping customers develop groundbreaking drug delivery devices for self-administration while navigating a complex journey. With our extensive expertise in the combination product landscape, we drive successful development and ensure that patient needs are met with innovative devices and user experiences. Our integrated CDMO offering allows us to manage risks and accelerate time to market for our customers.

Prototyping plays a crucial role in this process. It allows us to turn ideas into tangible concepts, assess feasibility, and conduct thorough testing before moving on to industrialization and commercial manufacturing. Each prototype helps us evaluate different aspects of the device function and user experience, reducing risks and increasing efficiency.

What is a prototype? While traditionally thought of as physical embodiment of complex mechanical and electrical systems, they are employed much earlier in the development process and in various forms by all our disciplines to accelerate successful outcomes.

Take, for example, our Design Research group, which utilizes storyboards as prototypes to envision future states of chronic disease management. These visual narratives provide valuable insights into how potential users would adapt to new scenarios, helping us define our approach for the program. Similarly, our User Experience Design team uses physical form models and soft prototypes of digital user interfaces to establish a deep understanding of how an envisioned user experience will impact users; for example, success at driving engagement and compliance.?

The choice of prototype type depends on project goals, design complexity, development stage, and associated risks. At Insight by Nemera, we employ a variety of physical and theoretical prototyping (in-silico modeling, etc.) methods for our engineering driven technical development programs, each serving a unique purpose and offering distinct value.

For physical prototypes, we follow a defined cadence with increasing fidelity:

• Proof of principle prototypes: These prototypes assess the functionality of high-risk components in the early stages, assessing the viability of early-stage concepts against functional requirements. They are done quickly, often with multiple iterations, using rapid fabrication methods such as 3D printing.
• Proof of concept prototypes: These prototypes prove the functional viability of integrated subsystems to identify any functional changes when assembled as a complete system. Testing focuses on high-risk design inputs, providing crucial data for addressing any changes before the detailed design phase. They are fabricated using 3D printing, machining, or low-cost prototype injection molding.
• Proof of design prototypes: These prototypes demonstrate functional performance at the system level using production-intent processes and materials. Testing focuses on high-risk design inputs, enabling informed decisions about further changes before moving to the industrialization stage and setting the foundation for future verification testing. They are fabricated from sourced components and injection molded components from high-quality tooling using production intent processes.

Throughout the process we integrate the appropriate level of design for manufacturing and assembly input into the process at each stage to reduce the risk of transfer to manufacturing by leveraging our global expertise and track record of successfully industrializing devices.

Prototypes play a key role in evaluation for all aspects of technical and user experience elements. By breaking down complex systems into smaller, more manageable sub-systems and components, we can quickly identify areas that need improvement. Our risk-based approach focuses on testing high-risk items without wasting time on already proven functionalities.

Understanding the operational characteristics of device concept subsystems and their interrelationships early on is essential. As complexity grows, troubleshooting takes more time. That is why we invest in a thorough understanding early in development, speeding up delivering robust devices to the market.

In conclusion, our strategy for physical prototype development and evaluation significantly accelerates product development. When combined with our commercial manufacturing and combination product consulting services, we become a single integrated partner for our customers, ensuring innovative and reliable devices reach the market in an accelerated timeframe.

To know more and to get in touch with us: Insight by Nemera - Nemera