Donatelle.... A Vital Partner of Medical Device OEMs
For more than 45 years, many of the world’s leading medical device companies have partnered with Donatelle to develop and manufacture products that sustain, save and transform lives.
Founded as a tool design and fabrication business in 1967, Donatelle today is an FDA-registered, ISO-9001:2008 and 13485:2003 certified medical device manufacturer whose products are making a difference for people across the globe.
With medical device engineering expertise ranging from cardiac rhythm management and cardiovascular surgery to diabetes, spine and neuromodulation, we excel in helping our partners achieve their goals.
Our services span the medical device development and manufacturing process, from concept through commercialization, in volumes ranging from a few hundred to millions of parts. We help develop products that perform better, get them to market faster and launch them more successfully.
Above all, we’re here to make sure you can have absolute confidence in the products you bring to market, from adherence to specifications to regulatory compliance.
Our contract medical device manufacturing capabilities include:
- Product Design
- Product Development
- Rapid Prototyping
- Thermoplastic and Elastomeric Injection Molding
- Liquid Silicone Injection Molding
- Precision Machining
- White Room, Class 10,000 and Class 100,000 Cleanrooms
- Welding (plastic and metal)
- Sterilization Management
- Bar Coding
Lowest Total Program Cost
Medical device companies rank Donatelle among the very best for total program cost. Not surprising since, as experienced sourcing specialists will tell you, the cost of a program goes far beyond the quote. We’re often able to identify significant savings opportunities right from the start, through our Design For Manufacturability (DFM) process. We also achieve savings through efficient program management, consolidated resources, lean initiatives and tool management.
Delivery Like Clockwork
Donatelle leads the industry in delivering on time and on budget. That goes for everything from product development schedules to delivery of finished goods. The numbers say it all, with an on-time production delivery record for each of the past five years averaging over 99%.
Everything Under One Roof
From design to molding (injection, liquid silicone rubber, micro, insert, over) to Swiss machining to assembly to sterilization management, we offer all the capabilities that you need at one location. That optimizes project communication, lead times and supply chain efficiencies.