MANUFACTURING THAT CHANGES LIVES

During more than 40 years serving the medical device industry, Donatelle has established a strong record of success helping companies develop medical devices and bring them to market. Companies like yours make Donatelle their partner of choice for many reasons:

First-in-Class Engineering Resources

From design through sterilization, your unique needs will be managed by a Project Team Lead, supported by staff hand-picked for your project from our technical team of more than 50 people.

We Take On The Tough Stuff

Donatelle has long been recognized as the “go-to” company for challenging projects, from parts with wall thicknesses smaller than a human hair to exotic materials that defy the conventional laws of molding. If you have a technical challenge, big or small, Donatelle is the partner you’re looking for.

Lowest Total Program Cost

Experienced sourcing specialists know that the cost of a program goes beyond the quote. When it comes to total program cost, medical device companies rank Donatelle among the very best. Beginning with early program involvement, we are often able to realize significant savings through our design for manufacturing (DFM) efforts. Other significant program savings result from our efficient program management, consolidated resources, lean initiatives and tool management.

Complete Vertical Integration Under One Roof

From design to prototyping to molding to precision machining to assembly and packaging to process validation, we offer all the capabilities that you need at one location. The results are optimal efficiencies in terms of project communication, lead time and supply chain cost.

Superior Quality

As an FDA registered and ISO- 13485:2003 and ISO-9001:2000 certified facility, Donatelle boasts a stellar quality record. With approximately half of our business involving implantable devices, patients’ lives depend on us. Every Donatelle employee has a vested interest in meeting your quality standards.

Delivery You Can Count On

Whether it relates to adherence to product development schedules or delivery of finished goods, you can count on Donatelle. We lead the industry in delivering on time and on budget. Using real-time planning and management tools, we proactively capture and report performance metrics so you know where your device stands at any given time. We are proud to share that our on-time production delivery record has averaged over 99% for each of the past five years.

Medical Focus

Donatelle has served the medical device industry for more than 40 years. In fact, it is our exclusive focus. Regardless of your device or the medical indication that you are treating, we understand the environment in which you are operating, your risks and your concerns. We speak your language.

Rock-Solid Financial Position

During these uncertain times, customers have expressed concerns about supply chain stability. Since our founding, we have managed the financial side of our business conservatively. We have the financial security to assure you that we will be here well into the future.

Services Provided

Whatever your specific requirements dictate, you can count on Donatelle as a full-service resource with manufacturing capabilities that currently include:

• Product Development
• Tool Design & Fabrication
• Prototyping
• Injection Molding
• Micro Molding
• Liquid Silicone Injection Molding
• Machined Metal Component Fabrication
• Device Assembly
• Packaging
• Process Validation
• Sterilization Management