Titan Medical – the young, upstart Canadian robotic surgery company – is making a comeback this year.

Just today, the company announced the completion of initial formative human factors studies for its Sport single port robotic surgical system. The Sport system boasts the ability for a variety of surgical instruments on snake-like arms to be deployed through a single 25 mm incision for a minimally invasive surgery. Surgeons get to work at a mobile, ergonomically designed workstation with a 3D high-definition endoscopic view inside the patient.

Completing the human factors study was an important milestone under the leadership of Titan’s new CEO David McNally, who took over in January. McNally previously led Domain Surgical to a successful merger with OmniGuide Surgical. He succeeded interim chief John Barker, who had replaced John Hargrove in October 2016 after the company had to put the development of the Sport platform on hold amid a lackluster funding round. (Providence, R.I.–based Ximedica and Titan revived Sport development after Titan closed on a $7 million round later in October.)

Since McNally took over, there have been a number of other important developments at Toronto-based Titan:

• In February, the company brought in senior biomedical engineering executive Perry Genova, PhD, to be its VP of research and development;
• Titan in March closed on a $5 million funding round;
• In April, the company brought in senior executive Curtis Jensen to be its VP of quality and regulatory affairs;
• Titan in April ended talks with Chinese distributor Longtai Medical so that it could better focus on winning regulatory approval in the U.S. and Europe for the Sport system.

MDO recently caught up with McNally to ask him about Titan’s goals, including the company’s need to raise $70 million for commercialization, and how McNally sees the company standing out in a surgical robotics market still dominated by Intuitive Surgical:

MDO: What are your major goals for the company?

McNally: At a high level, we’re focused on completing product development, which is well under way. Our plan is for the company to manage the product development process more closely than it has in the past. That began with the successful recruitment of a new vice president of research and development to head up our product development process … a measured move by the company to own the product development process more closely than it has in the past. We still rely on our contract development and manufacturing partners. But it’s very important for us to own the user requirements of the translation of those into our design requirements.

From a product development perspective, I want to see us with fully functional advanced prototypes operating in live animal models this year – and with clarity on the regulatory pathway, preparing for FDA clearance and CE Mark, in order for us to be applying for both by the end of 2018, in anticipation of commercialization at selected sites in the U.S. and Europe in 2019.  That’s also why we added an experienced regulatory executive to our staff early this year.

The good news is that the feedback from surgeons that we have shown the system to, at trade shows last year in 2016, was very encouraging. We continue to engage our surgeon advisors for input on the design of the product … as we iteratively continue to improve the product, focusing on ergonomics, not just for the surgeon but for the entire hospital staff.

Get the full story on our sister site, Medical Design & Outsourcing.