RNDR Medical

Capabilities

From concept to launch, RNDR is there through every phase of making your medical device a reality.

Catheter Development

RNDR Medical catheter development and rapid prototyping capabilities include 16 and 32 carrier braiders, catheter lamination (reflow), laser welding, heat bonding and tipping, as well as the technical knowledge to quickly develop complex catheter designs. Our processes enable designs for optimal mechanical shaft performance, single and multi-plane deflection, complex steering modalities and compound deflection curves. These technologies are critical to electrophysiology, structural heart, endoscopy, drug delivery, custom balloon catheters, delivery systems, steerable guide sheaths and introducer products.

Anatomical Model Development

RNDR Medical has years of experience developing anatomical models and methods for device testing and evaluation in multiple markets.  These include cardiovascular/heart models, upper GI models, urology models, stent deployment, balloon occlusion, and drug delivery models. RNDR Medical also has a collection of various 3D anatomical models that can be fabricated into benchtop models.

 

Concept Development to Manufacturing

RNDR Engineering is capable of supporting your project team at any point in the development process, or developing your product from conception to launch. All RNDR employees have years of product development experience, from beginning stages, to product launch. Every RNDR engineer has overseen numerous successful product lines. We excel in early concept development and IP generation, but are equally experienced in post DF, DV&V, process development, and design for scalable manufacturing. 

 

Design for Manufacture and Moldability

DFM starts with the first concept sketch. RNDR Medical prides itself in providing solutions that are manufacturable, scalable, cost efficient, and innovative.

Our Industrial Design process specializes in DMF, particularly design for moldability. We are experts at applying good ergonomics and mechanical functionality to design practical parts from the first CAD model – no redesigning an aesthetic form late in the project for manufacturability.

It is not uncommon while performing DFM reviews of existing products to identify design efficiencies that result in 1:1 performance with fewer total parts, less expensive components and capital savings, and improved manufacturing yields through ease -of -assembly features and poka -yoke design.

Through our partnership with AuST Medical Manufacturing, RNDR Medical provides a full complement of engineering services to best -in -class FDA registered clean room manufacturing, providing the “gold standard” to get your product to market.

Industrial Design & Human Factors

RNDR Medical Industrial Design is distinguished for its creativity in regard to producing myriad patentable IP for its customers. We feature over 20 years of direct industry experience designing for ISO 62366, HE 75:2009, including focus on anthropometrics and ergonomics. Our design process includes the activities specific to your product development needs, such as KOL/VOC interviews and focus groups, simulated use testing, user interface analysis, SOU and work flow analysis to provide the right documented Human Factors evidence for your product submission.

 

Laser Welding

RNDR Medical’s prototype and fabrication capabilities include metal laser welding to enable rapid development and iteration of component subassemblies for device integration.

 

Local Animal Lab Access

Working with RNDR Medical includes access to local physician KOLs as well as university research animals and fresh tissue labs.

 

Rapid Prototyping including 3D Printing & Casting

In addition to a collection of various 3D anatomical models that can be fabricated into benchtop models, RNDR Medical features a number of rapid prototyping technologies and methods that allow us to quickly iterate, test, and develop a concept.  These include 3D printing in various engineering resins, urethane casting, metal component fabrication, silicone casting for hemostasis valve design, and foam modeling among others.