INTRODUCING THE NOBOT

user interface of the robotic system and must be considered and often included in the validation test.

Impact Of User Interface Design

User research insights that can inform the use-related risk assessment and regulatory strategy apply to the design and development of the robotic system’s user interface.

Consider the example of the lead surgeon’s user interface. There is a need to understand the negative and positive transfer bias in the physical user interface.

Robot Assisted Surgical Devices (RASD) are not really robots. To be a bonafide medical robot, the system would have to duplicate human activity, and today none of these RASDs are autonomous, or even semi-autonomous with that ability. They are bionic systems created specifically to enhance the healthcare provider’s performance with electronic or electromechanical devices.

This distinction is critical to the design and development of the robotic system.

Looking At The Regulatory Impact

Many current robotic systems are based on technology that could execute a procedure autonomously but the complexity of validating safety and efficacy for regulatory approval would be cost-prohibitive. Regulations require a demonstration that proves the RASD could safely manage contingencies that are often unpredictable during a procedure. A machine programmed by humans can only do what it’s been trained to do and thus lacks the creativity and quick thinking that a human brings to reacting and managing a contingency.

Sophisticated capital equipment such as a RASD does not have the same ROI that could justify such a massive validation investment. However, as the clinicians are in control and the system is recognized as an extension of their abilities, the human is still responsible for the outcome. This means that the validation process must be viewed as a function of the clinician’s interaction with the robotic system’s user interface.

Case In Point

A surgical robotic system impacts the surgical workflow meaning all the staff involved in the surgical procedure. A conventional surgery is typically a symphony of interactions between a team of clinicians.

The identification of all the people involved is crucial to ensuring a favorable outcome for the patient because there is a new factor in the operating room – the robot. A new physical layout may also be required to accommodate the robotic system in an already congested environment. This can impact how the team members interact with each other. The intention of the robot is to introduce an optimized instrument for the surgeon, but in application, it can affect the responsibilities of the extended surgical team.

These team dynamics are important when it comes time to validate the

The way the surgeon executes a manual procedure can result in either a positive or negative transfer bias depending on how the new control interface is designed. Negative transfer bias can introduce a potentially hazardous condition and use error that could lead to harm. Conversely, the user interface design can afford positive transfer bias by emulating or carefully transitioning from a norm behavior and interface to the new user interface and workflow experience. A proactive approach to understanding the user’s expectations and aspirations with an in-depth understanding of perceived attributes that determine the intended behavior is a robust approach.

Medical Robots With A Human Touch

Introducing medical robotics into a clinical environment offer advantages to clinicians and patients but must always be considered enhancements to the processes and procedures, not replacements. The human touch will always be important in certifying risk mitigation, patient and environmental safety, and regulatory requirements. Design and development of these devices include a myriad of steps that should be deployed early on to make sure that not only the device itself, but its complex interfaces mirror the users’ behaviors to assure the optimum outcomes for all.

After The First Stop Of

Greenlight

True

How

DID

THE ROAD SHOW PARTNERSHIP WITH GREENLIGHT GURU BEGIN?

As a company that designs develops and manufactures medical devices, we are deeply interested in the industry. We’re also interested in connecting with the people in the industry.

Our business is to take people’s ideas and turn them into reality. The Greenlight platform is pretty solid as a cloud-based platform for quality management and as a result it tends to attract younger companies because it is an outof-the-box quality management system.

And so, at a roadshow with Greenlight Guru, those younger companies sometimes need engineering discipline from companies like ours and so it’s been a really magnifi cent partnership with them for several years now where our goal is to work with the people that Greenlight already knows and help them be successful and turn their device ideas into commercial reality.

WHAT MAKES YOUR PARTNERSHIP WORK?

I’m huge fans of them as a company. I just really like the people there, they have a lot of the same cultural attitude that we have, which is this cando attitude. I sat with a client yesterday in Minneapolis and I said, “look, we’re not going to get it right the fi rst time every time, but here’s what I can promise you, we will continue to work stubbornly until we do get it,” and I see that same thing at Greenlight. They are just can-do problem-solving people, which I really like.

YOUR FIRST STOP WAS HOUSTON IN MARCH, HOW DID THAT GO?

At the Houston stop, I was a featured speaker. I like to interact with people. I’m an electrical engineer by training, but people are my passion and helping entrepreneurs understand how to navigate culture, attract staff, attract funding, navigate problems - that’s really where I’m strong and so to interact with the audience around that idea is fantastic.

One of the questions that I got from the audience and I’ve talked about several times since the roadshow is - is there a point in time as an entrepreneur that you feel like you have made it? It was fun because I could look that guy in the eye and I could say absolutely.

For me, that time was that exact moment. I started Velentium 10 years ago from nothing. I was the fi rst employee. Now there’s 130 of us and it continues to grow, but there’s that point in time where you go “you know what I think a year from now, this company will still be here whether or not I am”. Not only will Velentium be around, but it’s not so founderdependent and is legitimately established as its own thing, and not just an extension of me.

WHAT WAS THE THOUGHT PROCESS BEHIND THE CITIES CHOSEN?

For us, most of our clients are either in Minneapolis or one of the coasts and you’ve got Boston and California as the areas where all this medtech is happening.

Houston is really trying to become the third coast to create medtech. So, I was glad that the Roadshow came here, just because there is a lot of innovation happening here.