Product design, development and strategy of the Neochord medical device. Product design, development and strategy of the Neochord medical device
Mayo clinic

A partnership in minimally invasive heart surgery

Skills Used
Engineering, Industrial Design, Prototyping, Research & Strategy, Human Factors & Technical Writing

One in five people over the age of 55 has some degree of mitral valve regurgitation. Left untreated, blood flows backwards into the heart, resulting in cardiac failure. Many who suffer from this condition opt out of treatment, as they are often too ill to survive an invasive open-heart surgery.

Giovanni Speziali, MD, a cardiac surgeon at the Mayo Clinic, proposed a solution that would enable surgeons to access the heart through the ribs and repair the damaged valve, leaving the ribcage intact. NeoChord, Inc., a Minneapolis-based medical technology start-up, obtained an exclusive license for Dr. Speziali’s technology and partnered with Worrell to develop the device.

Industrial design of Neochord honored with a Medical Design Excellent Award
Industrial design of Neochord honored with a Medical Design Excellent Award
Engineering of Neochord medical device
Industrial design of Neochord honored with a Medical Design Excellent Award
Original concept presented to Worrell

Our Approach

Worrell’s researchers began by conducting an operative immersion, documenting preliminary feedback from surgeons performing similar procedures on animal specimens. Back at the studio, Worrell designers created a test fixture to simulate the procedure and experimented with various physical design concepts. The leading concepts were reintroduced into the field as behavioral prototypes and evaluated by renowned Mayo surgeons. The refined design concepts included a tip, ideally shaped for easy insertion through the chest plate and into the beating heart, allowing surgeons to locate the mitral leaflet, place a suture with accuracy and repair the damaged valve.

Neochord: Research
NeoChord: Engineering
NeoChord: Prototyping

Key Activities

Clinical Observation

Task Flow Analysis

Use Case Scenarios

Behavior Prototypes

Proportion Studies

3D Modeling

Medical Packaging Design

Instructions for Use

Usability Testing

Design for Manufacturability

Performance Testing

Pilot Build Management

Functional Prototype Development

Results

Worrell’s engineers prepared the leading design concept for full-scale manufacturing. Our team introduced NeoChord to key manufacturing and supply chain vendors and their collaborative efforts resulted in a product that was cost effective and easy to manufacture.

Worrell also supported NeoChord’s graphics design assets, which included branding, logos and package design. Worrell’s efforts in navigating the complexity of the regulatory pathway turned a novel idea into an established medical brand, positioned for long-term success.

NeoChord: Clinical Observation
NeoChord: Clinical Observation
NeoChord: Engineering
NeoChord: Engineering

Update

Due to its vastly less invasive procedure, the Neochord surgical method is predicted to reduce mitral valve surgery hospital stays from eight days to two. This surgical method already shows an acute procedure success rate, which is >96% in patients with favorable anatomy. Neochord’s surgical method received regulatory approval in the European Union in December 2012, and on April 4, 2014 announced the treatment of their 100th patient.

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