New Product Development
At Moellers Operational Excellence we are specialized in managing innovative healthcare technology and medical device development projects.
We can support you from the idea and concept to the launch of the product and beyond. Our technical New Product Development expertise covers a wide range of device categories, types and classifications including Clinical Chemistry instrumentation, CLIA analysers, pre- and post-analytical automation systems, software solutions, general chemistry and immunochemistry reagents, to name a few. Here our services provided include, but are not limited to:
· Proper product development specification setting involves defining detailed requirements and criteria for a new product. This process includes outlining functional, technical, and design specifications to ensure the product meets market needs, quality standards, and regulatory requirements. By establishing clear specifications, your teams can align on goals, streamline development, and minimize risks, ultimately leading to a successful and market-ready product.
· In technical problem solving we support your teams identifying, analyzing, and addressing engineering or design challenges that arise during the creation of a new product. This process includes troubleshooting issues, developing solutions, and iterating designs to resolve technical obstacles. Effective problem solving ensures that the product meets performance, quality, and safety standards while staying on schedule and within budget.
· Reliability testing in life science product development focuses on assessing the durability and consistent performance of medical devices, diagnostic tools, or other life science products under rigorous conditions. This involves conducting extensive tests to simulate real-world usage, environmental stressors, and potential failure modes to ensure the product meets stringent regulatory and safety standards. The goal is to verify that the product performs reliably over its intended lifespan, minimizing risks to users and ensuring accurate, dependable results in critical applications.
· Setting up and maintaining a robust risk management in technical development involves evaluating potential risks and assessing the practicality of new technologies or systems. We help your team to identify and mitigate potential issues that could impact project success, such as technical failures, regulatory challenges, or cost overruns. Feasibility testing examines whether a concept or design can be effectively developed and implemented within the given constraints. Together, these processes ensure that technical developments are viable, safe, and capable of meeting performance expectations while addressing and minimizing potential risks.
