Occam is a full-service medical device design and contract manufacturing company. We provide a comprehensive range of engineering and manufacturing services, with the ability to take your project through all stages of development: ideation, design, engineering, manufacturing, regulatory, go-to-market strategy.
Ideation
We help innovators brainstorm, transforming their identified problems into market-desirable solutions. Our team refines ideas, ensuring that every potential solution is explored thoroughly. Once a solution is established, we can swiftly turn concepts into functional prototypes, allowing you to visualize and test your ideas in real-world scenarios.
Design
Our industrial designers can draft an initial sketch, develop a prototype, create a market-ready product, and much more in between. We work closely with you at every stage, ensuring that each aspect of your idea is refined and tailored to meet your exact specifications. Whether you’re starting from scratch or looking to enhance an existing concept, we are committed to delivering a solution that exceeds your expectations.
Engineering
With over 30 years of experience engineering medical devices, we offer a comprehensive suite of capabilities that streamline the development process. Our dedicated project managers oversee every aspect of your project from start to finish, ensuring fluid, consistent, and transparent communication throughout. They tailor their approach to identify the best possible solutions for each project’s specific requirements.
Manufacturing
We provide comprehensive services including contract manufacturing, short-run production, component procurement, and assembly. Our state-of-the-art five Class VI clean rooms enable us to manufacture custom catheter systems and components with precision and quality. As an ISO 13485 certified, 60601 compliant, and FDA registered facility, we are committed to delivering products that meet the highest industry standards.
Regulatory
Our team delivers a complete range of services, including regulatory consulting, testing and validation support, and a Quality Management System (QMS) compliant with ISO 13485 and other relevant standards. With expertise in document preparation and clinical trials management, we ensure that your product meets all regulatory requirements efficiently. With our support, you can confidently navigate the regulatory landscape, keeping your project on schedule and within budget.
Go-to-market Strategy
Occam Design offers comprehensive support for both front-end and back-end sales strategies. On the front end, we assist with Voice of Customer (VOC) insights, value analysis, and market validation to refine your product’s positioning. On the back end, we connect you with key players, including Group Purchasing Organizations (GPOs), Independent Delivery Networks (IDNs), and Regional Purchasing Coalitions (RPCs). Our integrated approach ensures a swift and efficient journey to market, maximizing your path to profitability while keeping everything managed under one umbrella.