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Proof of Concept and Prototype Creation
At this stage, we evaluate whether your product will perform as intended. We design fully functional prototypes with critical features in place. Our advanced CAD tools use computer-based modeling to help you visualize your end product. With the FMEA (Failure Mode Effects Analysis) process, we identify possible failures in the medical device design and manufacturing processes, and we use that information to design an effective risk management plan for you.
Our clients rely on us to achieve competitive differentiation early in the design phase. As leaders in our field, we believe in iterative design, the kind that takes into consideration evolving consumer needs. Our prototyping phase promotes product viability and ultimately, business agility.
Medical Device Proof of Concept and Prototyping
At CUBE Medical Innovations, we begin with medical device ideation. In this exciting phase, we identify the need for your idea/product and research its potential market size . We then gauge your product's commercial viability and its adaptability to demand fluctuations. Data analytics spotlights how your product will perform against similar offerings in the market.
In short, we guide you from concept definition to proof of concept.
You get a clear picture of size and cost constraints at the beginning of the medical device development cycle that impacts the prototyping process which follows.
It is our privilege to help you turn pioneering ideas into functional, clinically-viable prototypes. Our medical device prototyping process includes robust testing procedures prior to entering preclinical and clinical trials to ensure quality assurance and regulatory affairs compliance. We test for manufacturing constraints, technical performance, and market viability.
With our experts at your side, you gain valuable insight into Class I, II, and III FDA quality assurance and regulatory requirements. With our medical device prototyping stage, we enable you to confidently navigate a confusing world of general controls, special controls, Premarket Notifications 510(k), and Premarket Approvals (PMAs).
With our fully-functional prototypes, you will know which Class I and Class II devices are exempt from Premarket Notification 510(k) requirements. We ensure that Class I devices meet CFR Title 21 (Parts 862-892) definitions before we certify that they merit exemption status. We are also familiar with which Class II devices are exempt from Premarket Notification requirements under the 21st Century Cures Act (signed into law in 2016).
Additionally, we help you comply with labeling (21 CFR Part 801), quality system (21 CFR Part 820), and medical device reporting (21 CFR Part 803) regulations.
If you're developing a Class III device, our partners at Eminence Clinical Research (ECR) can help you navigate the Investigational Device Exemption (IDE) process per 21 CFR Part 812. An IDE is a crucial piece of the PMA or Premarket Notification 510(k) FDA submission process.
Throughout the medical device prototyping process, we ensure quality assurance and regulatory affairs compliance with all pertinent FDA regulations.
This vastly increases the likelihood of your project clearing all regulatory hurdles during the FDA approval process.
Having confidence that your medical device will fill an industry void and support a patient need is not enough to overcome the fluctuating medical market sectors, hesitant medical administrators, and aggressive competitors. Challenges will arise at every step seeking to prevent or minimize your success. Our job is to get your staff and your business processes up and running - ready for success and avoiding costly failures.
Our proprietary process is built on solid business practices that strategize a custom path for your medical device prototyping. We address any obstacles to medical device product viability through risk management and quality assurance, ultimately, concluding with regulatory affairs compliance. At CUBE Medical Innovations, we bring your invention to life using years of business expertise and our own medical industry contacts and resources to position your new medical device for high volume sales.