Strategy & Planning
HSD is committed to uncovering opportunities for businesses seeking to innovate or revise their technology. Our team includes leaders with the expertise to guide our clients from the white board to the manufacturing floor. HSD’s collaborative team is not limited to creative and technical expertise; project managers, regulatory, strategists, and specific technology experts are all involved in development. Our dedicated project managers have both the development knowledge and the extensive capabilities to meet your project needs, regardless of the stage or phase of your product’s development. HSD specializes in solving complex problems in order to reveal the best path to innovation. Our process puts defining customer’s goals and opportunities early in the project, reducing risks down the road.
Specialized Technology. We leverage technology to bring your medical or life science device to market quickly and meet the latest standards to ensure that your device is both safe and successful. HSD experience covers over 40 years of working with medical device manufacturers, healthcare startups, and early stage medical device companies. This comprehensive experience enables us to easily move our clients through the technology commercialization process, helping to move a venture from concept to the market.
Guidance to Market Realization. Taking a product from a prototype to a production part can be a daunting task, which is why we offer general tooling and manufacturing reviews all the way to full production support. Our effort starts with early involvement with manufacturers to guarantee quick time to market, high quality and rapid implementation. We work with our manufacturing partners to design tools and modify component features to reduce cost and complexity without compromising the aesthetics, so that our clients have the best chance of having a successful product.
For integrated “one stop” concept through production programs, we offer proven long-term partnerships with select contract manufactures. Together we combine a full range of contract services from design to manufacturing including expertise in precision fluidics, internal automation mechanisms, lasers, chemistry system integration, thermally controlled systems, embedded systems, user interface development, sensor design and systems integration. All designed to meet the FDA’s stringent requirements.
Complete Start-to-Finish Support. Additionally, we have developed exclusive partnerships with world class molders for designing low to high volume parts and assemblies. HSD has capabilities in delivering fully-integrated design, prototyping, engineering, assembly, tool-making and production of components manufactured through multiple molding technologies. Whether you are producing medical devices, drug delivery devices, disposable healthcare products, hospital and surgical components/products, or diagnostic components/equipment, we can help you design, develop and commercialize your products.
Our capabilities in Strategy & Planning include:
- Business / Product Strategy
- Agile Processes
- FDA and CE regulations
- Project Management
- Risk Assessment and Management
- Regulatory Pathway
- Manufacturing Liaison