RNDR Medical

What RNDR Medical does

RNDR Medical is a privately held medical device design and development services firm headquartered in Jeffersonville, Indiana (Louisville metro area), founded in 2018. The company provides full-service engineering from early research and ideation through manufacturing transfer, with a specialization in catheter-based technologies and minimally invasive surgical devices. Its capability stack spans catheter development (16 and 32 carrier braiding, reflow lamination, laser welding, heat bonding, tipping), industrial design and human factors engineering, rapid prototyping (3D printing in engineering resins, urethane and silicone casting, metal fabrication), anatomical model development, design for manufacture, and access to local animal and fresh tissue labs. The firm also sells proprietary component products: braided catheter tubing in multiple sizes and configurations, stainless steel torque wire with best-in-class rotational response for devices up to 260cm, and production-ready control handle design platforms.

RNDR serves medical device companies ranging from well-funded startups to multinational strategics, with documented engagements across cardiology, structural heart, electrophysiology, endoscopy, urology, vascular surgery, peripheral and endovascular, pulmonology, ophthalmic drug delivery, and general surgery. Named enterprise clients include Ajax Health, Acutus Medical, and Bolt Medical, with evidence of multi-program repeat engagements. The team is described as carrying over 100 years of combined medical device experience and over 100 patents, with prior devices developed by team members generating over $1 billion in cumulative global sales. Two FDA 510K approvals are documented: a Single Use Ureteroscope System and the first fully rotatable single-use Pancreaticobiliary Scope System (concept to approval in 19 months).

The business operates on a sales-led, direct B2B engagement model with project-based custom pricing disclosed via website inquiry, phone, and email. Revenue is generated through professional services (concept-to-manufacturing engineering), hardware/component sales (braided tubing, torque wire, control handle platforms), and managed services via a partnership with AuST Medical Manufacturing for FDA-registered clean room production. Pricing is quote-based with multi-year contracts noted, and there is no public pricing tier or disclosed revenue figure. The go-to-market relies on website content marketing, case study publication, and direct enterprise outreach rather than mass-market channels.

Name

RNDR Medical

Legal name

RNDR Medical

Website

https://rndrmedical.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

RNDR Medical is a privately held medical device design and development services firm specializing in catheter-based and minimally invasive surgical devices, providing full-service engineering from concept through manufacturing transfer to startups and multinational medical device companies.

Ownership category

akta.pro rank

Headquarters

HQ city

Louisville

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales

Revenue model

1. Medical Device Design & Development Services: Full-service engineering and design services from concept to manufacturing transfer. Services include catheter development, industrial design, human factors, rapid prototyping, and design for manufacture.
2. Product Sales: Sale of proprietary products including braided tubing, torque wire, design platforms, and R&D solutions designed to reduce cost and lead times for customers.
3. Manufacturing Partnership Services: Through partnership with AuST Medical Manufacturing, provides FDA registered clean room manufacturing services. Gold standard for getting products to market.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels3 records

Core offering

RNDR Medical provides full-service medical device design and development services from concept through manufacturing transfer, specializing in catheter-based and minimally invasive surgical devices. The company sells a portfolio of ready-made components and design platforms—including production-ready control handles with actuation and rotation, braided catheter tubing, and torque wire solutions—alongside engineering services spanning catheter development, industrial design, human factors, rapid prototyping, and anatomical model development. Through a partnership with AuST Medical Manufacturing, RNDR also offers FDA-registered clean room manufacturing.

Product overview

RNDR Medical offers a portfolio of medical device components and design platforms designed to cut down cost and lead times. The portfolio consists of four main products: R&D services (providing comprehensive research and development support from early concept through commercialization with expertise in multiple clinical domains), Design platforms (production-ready control handles for delivery systems and deflectable catheters), Braided tubing (specialized catheter tubing with deflectable shafts and multi-planar capabilities), and Torque wire (stainless steel wire solutions providing best-in-class torque response for rotational control). Together these products enable rapid medical device development and manufacturing.

Differentiator

Problem solved

Functional benefit

Products and services

• R&D Research and development services for medical devices, covering early research, ideation, bench models, and pre-clinical animal studies. Supports multiple clinical domains including cardiology, electrophysiology, endoscopy, urology, and structural heart, with expertise in machining, rapid injection molding, and sustaining manufacturing injection molding.
• Design Platforms Production-ready control handles with actuation and rotation of distal elements for endoscopy, urology, and pulmonary applications. Includes control handles for delivery systems and deflectable catheters with simple modifications for client-specific needs.
• Braided Tubing Manufactured braided catheter tubing in various sizes and configurations, available with or without lubricious liners and in single or multi-durometer formats. Features deflectable shafts with single or multi-direction and multi-planar deflection capabilities.
• Torque Wire Stainless steel wire providing best-in-class torque response through tortuous anatomy for precise rotational control of distal elements within catheters or sheaths. Common sizes range from 0.012 to 0.025 inch diameter, with demonstrated rotational control on devices up to 260cm in length.

Quantifiable outcome

• Over $1 billion in global sales generated from devices developed by the team
• +3 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• AuST Medical ManufacturingcoreStrategic or Co-development PartnerRNDR Medical is partnered with AuST Medical Manufacturing, described as 'the industry recognized expertise of AuST Medical Manufacturing.' This partnership provides a full suite of engineering services to best-in-class FDA registered clean room manufacturing, described as the 'gold standard' for getting products to market.

Scale indicators5 records

Expansion highlights4 records

Direct peers

• Ximedica: US-based medical device design, development, and manufacturing services firm serving startups through large strategics. Comparable in offering integrated product development, human factors, and manufacturing transfer services to medical device clients.
• StarFish Medical: Canadian medical device design, development, and contract manufacturing firm with a similar boutique profile serving catheter, diagnostic, and therapeutic device OEMs. Directly comparable as a full-service development partner from concept through low-volume manufacturing.
• Donatelle: Medical device contract manufacturer and design services firm with strong catheter and minimally invasive device capabilities. Comparable for catheter-based development, design for manufacturability, and clinical-stage production services.
• Tegra Medical: Medical device contract manufacturer specializing in metal and plastic components, complex assemblies, and catheter-based devices. Comparable for catheter component manufacturing and integrated design-to-production services.
• Cambridge Consultants: Product development and engineering consultancy with a major medical device division serving startups and strategics. Comparable for high-complexity catheter and minimally invasive device design engagements and IP-rich innovation work.
• Gilero: Medical device design, development, and contract manufacturing firm specializing in single-use devices, combination products, and catheter-based systems. Comparable as a similarly sized full-service partner covering concept, design, and manufacturing.

Broad incumbents

• Integer Holdings: One of the largest medical device outsource manufacturers, offering design, components, and finished device manufacturing across multiple therapy areas including cardiovascular and endoscopy. Comparable as a scaled catheter and minimally invasive device partner, though much broader in portfolio.
• Jabil Healthcare: Global manufacturing services platform with a dedicated healthcare and medical device division offering design, prototyping, and high-volume manufacturing. Comparable for end-to-end medical device development services though at much larger scale and broader geographic reach.
• Nolato: Polymer-based medical solutions provider with catheter and minimally invasive device manufacturing capabilities, including design and development services. Comparable for catheter components and integrated device manufacturing at significantly greater scale.
• Nordson Medical: Medical device division of Nordson Corporation providing catheter component manufacturing, design services, and finished device solutions. Directly comparable in braided tubing, catheter shafts, and minimally invasive device capabilities, with much greater scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about RNDR Medical