Services Quick Links
CUBE Medical Innovations: The Smart Choice for Product Realization
We live in the era of industry. Our need for innovation is insatiable, and we relish creative capital. At CUBE Medical Innovations, we specialize in medical device development from prototype to regulatory approval. Our prototype systems infrastructure is focused on adaptive, secure technologies that deliver innovative, value-based care to patients.
Our approach is patient-centered, and our focus on design efficiency is paramount. Leverage our medical device product development ecosystem to enjoy shorter time-to-market and cost savings.
Idea Generation or Concept Creation
In this preliminary stage, we begin the implementation of design controls while focusing on understanding your goals. Based on early ideas, we identify possible design risks and sourcing considerations for your medical device product. We explore innovative technologies and discuss intellectual property issues.
Most importantly, we analyze specific KPIs (key performance indicators) to determine the costs of accommodating critical product requirements. Together, we analyze product performance, safety/regulatory performance, environmental durability, packaging specifications, volume estimates, , and optimum weight levels.
Essentially, we evaluate the full cycle of your medical device development from prototype to regulatory approval in order to design a plan to help you transform your vision into a viable commercial investment.
Cybersecurity Within the Development Life Cycle
In the era of ransomware and business compromise scams, we take the security of your intellectual property seriously. At CUBE Medical Innovations, we maintain periodic functionality updates during the development life cycle of your medical device requiring electronics. Our goal? To address every possible threat vector hackers may exploit. We also verify that important encryption and authentication controls don't interfere with product functionality.
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 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.
Product and Manufacturing Process Validation
At this stage, we ensure that all beta prototypes meet or surpass your expectations. We leverage advanced engineering processes to validate your manufacturing claims. We also assure that your manufacturing facilities can support a quality finished product. Solid manufacturing production controls ensure efficiency and consistency in product quality.
At CUBE Medical Innovations, we utilize ISO 9001, ISO 13485 suppliers. This ensures that medical device development and quality system compliant manufacturing processes consistently produce products that meet customer requirements.
Manufacturing Scale-Up and Advanced Medical Engineering Processes
Whether your medical product has just started selling or you are in the stage of development where you want to go from the device prototype with regulatory approval to production manufacturing, we have you covered.
Scale up while meeting cost, quality, and delivery targets. With CUBE Medical Innovations, we create the kind of supply chain transparency that facilitates efficient and sustainable volume manufacturing. With our scalable manufacturing infrastructure, we stay in control of negotiations with contractors and suppliers.
Our teams are experts in leveraging design innovation trends, automation, and advanced robotics to revolutionize the patient experience.
We incorporate important checkpoints along the medical device development life-cycle: it's exactly what the doctor ordered. This continual process of refinement, testing, and analysis results in compact, more discrete, and smarter devices.
Medical Device Product Launch
Now that your product has completed the medical device development journey from prototype to final regulatory approval, our clinical liaisons at Eminence Clinical Research (ECR) will assist your customers in the acquisition and adoption of your product. Our experts train hospital and critical care staff in device set-up and use at their facilities. At CUBE Medical Innovations / ECR, we're with you every step of the way.