Medical Device Development Process

Lubrizol Life Science Health provides support and quality assurance throughout the design and manufacturing of your medical device. Working as an extension of your team, we follow your approved standard operating procedure while adding value at every stage of medical device product development. Our process expertise, project management approach and transparency in production help ensure the quality and success of every medical molding, medical extrusion and medical device assembly.

1. Design and Engineering

With extensive experience, LLS Health’s medical device engineering team works with you to make preproduction design adjustments that can save thousands of dollars in the long run. We refine your medical device design for manufacturability, design the optimal tooling and fixturing, and help you select the best medical grade silicone or thermoplastics for your application. We work with top suppliers and tooling manufacturers to expedite this first stage of the medical device development process.

2. Quick Response Prototyping

Our long-standing relationships with tooling manufacturers enable us to provide quick-turn medical device prototyping without sacrificing quality. We keep a stock of top and base plates readily available for liquid injection molds. We also build our own pin-and-die sets in-house to reduce time-to-market on many extruded prototypes.

3. Validation

LLS Health validates every process, every tool and every fixture to ensure it will yield the desired results during full production. We optimize our master process for your unique part and run samples for inspection and statistical analysis — making improvements as needed to achieve reliability and repeatability.

4. Manufacturing and Assembly

Product Development Process

Once you approve the product design, tooling and process, our project engineers oversee a smooth transition to the production line. Semi- and fully automated processes ensure precision during medical device manufacturing. Our skilled team is able to produce moldings, precision extrusions, and assembled, finished devices in our facilities, saving you time and money.

5. Product Inspection

We continually verify the quality of our work throughout the process and complete thorough inspections of finished product.

6. Packaging

At LLS Health, we provide packaging that reflects the quality of your brand. Quality control ensures accurate labeling, and automation speeds the process.

7. Distribution

With a comprehensive understanding of international shipping standards, LLS Health’s global distribution network ensures prompt, accurate delivery to any location.

We are ready and equipped to repeat the process for every production run.