Case studies

Every day, Donatelle helps medical device companies develop and manufacture products that save and enhance lives – and build businesses. These stories showcase a few of the projects we’ve worked on, helping companies succeed with complex devices, demanding parameters and tight deadlines.

Getting fast-tracked complex Class III orthopedic device to market on time – and in spec

After working for 10 years on prototypes for a novel orthopedic device, a globally leading biotechnology company earned Breakthrough ... read more

Transforming device for single-use improves safety and saves costs for global OEM

A large medical device OEM planned to convert a reusable orthopedic instrument kit to single-use disposable. At the time, the product, ... read more

DFM with dual prototyping paths delivers repeatable micro-features for innovative cardiovascular device

A global cardiovascular market leader needed help producing a game-changing medical device for the treatment of atrial fibrillation. read more

Struggling to find a solution for cardiac device component, global OEM entrusts Donatelle’s innovative engineers

To replace a tedious and expensive legacy process, a globally recognized leader in cardiac pacing solutions developed a unique solution read more

In a race against time, startup takes advantage of Donatelle’s pure medical expertise and vertical integration for novel Class III device

To gain U.S. Food and Drug Administration (FDA) approval and be first to market in the United States, a startup with a novel Class III ... read more

Leading cardiovascular company leverages vertically integrated capabilities for intricate implantable component

A world-leading cardiovascular and endovascular medical technology company needed a specially designed micro seal for an implantable ... read more

Pushing the limits of micro manufacturing, Donatelle helps OEM create implantable grade component to improve cardiovascular device

A global OEM came to Donatelle with a concept to replace an existing component used in the tip of a catheter, designed for ablation of ... read more

Vertical integration adds value – and viability

A medical device OEM came to Donatelle with a problem. One of their products, a device used for rapid sternal access in the ... read more

Tall order, high stakes

A fast-growing medical device company aiming to be a global leader in minimally invasive spinal therapies asked Donatelle for design ... read more

Accelerated time-to-market keeps critical launch on track

The market need was strong, the timing tight and the challenge steep: A large OEM set out to address the demand for real-time glucose ... read more

Our suite of integrated contract manufacturing services, enhanced by our SmartStack® and NeuroStack® technologies, provides a competitive advantage with customizable linear contact systems. Plus, our facility features controlled environments, ISO 7 (class 10,000) cleanrooms and cleanroom production cells with integrated vision systems capable of operating at ISO 5 (class 100) level. *Moldflow® is a registered trademark of Autodesk® Inc.

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