Capping off a medtech career spanning more than three decades, John Mazzola had only been retired from Becton Dickinson for about a week when Vicarious Surgical co-founder and CEO Adam Sachs hired him to lead strategic manufacturing planning.
One year later, the surgical robotics developer has promoted Mazzola to the newly created position of chief operating officer, covering product development, manufacturing, supply chain, quality, clinical, regulatory, IT, people and culture.
Mazzola spoke with Medical Design & Outsourcing about the latest from Waltham, Massachusetts-based Vicarous Surgical (NYSE: RBOT), its plans for manufacturing and outsourcing, the company’s recent layoffs and lessons learned about developing and launching products.
Where is Vicarious Surgical on development and what milestones are next?
Mazzola: “We’re going through sort of the final stages, if you will, of our development process and preparing for the next phase, which is V&V (verification and validation). And our plan is to be exiting Phase II, entering Phase III V&V toward the end of this year, first quarter of next year. Then we’ll proceed through V&V and then through a human clinical trial for de novo authorization that we’ll be seeking through the FDA. … There are different elements of the system that are a different maturity through their development stage, but we’re probably at 80% of the design complete.”
How much of the manufacturing is Vicarious Surgical doing in-house, how much is off-the-shelf, and what’s your philosophy on that?
Mazzola: “One of the things that I did when I first came in is I said, ‘What do we want to do for manufacturing strategy both to get us through V&V, as well as our initial scale, our initial launch?’ And I think what we’re going to do is take an approach where we do more of the pilot manufacturing and more of the assembly here initially, and then eventually transfer and partner with one of the three big CMs (contract manufacturers) to move more of it as we scale to them. We have a clean room that we’ve set up where we can do human clinical builds, and we plan to use that for both our V&V builds as well as our clinical builds. But then as we submit for approval, and as we prepare for scale, we’ll probably start shifting some of that to contract manufacturers that are better positioned and have better infrastructure to meet the requirements and the scale that we’re going to need.”
Who are those big three contract manufacturers?
Mazzola: “Jabil, Celestica and Sanmina are three that I’m familiar with just based on my work at BD that we used quite a bit in the diagnostic area. But there are other mid-size contract manufacturers that do both disposable as well as capital-type builds. … Working with contract manufacturers that have huge buying power and great leverage, we’re able to secure better responsiveness and better supply [than dealing with suppliers directly] as a small company on our own.”
What are some of the other outsourcing partners that you’ll use?
Mazzola: “Our system has a disposable drape that will be used to drape our patient cart. There are companies where that’s all they do, development and manufacturing of custom drapes. We partner with them not only for the manufacturing, but also the development work. … Same with things like the trocar, where we partnered with an outside design firm that will also do our initial manufacturing for our trocar. We’re going to focus on the things that we do best: some of the capital, the surgeon console and the patient cart, as well as the instrument arms and cameras. The instrument arms and cameras — which are the two other disposable elements to our system — are probably at the center of what we’re doing. It truly differentiates our technology from what’s out there right now.”
Those arms and the camera — they’re entirely disposable?
Mazzola: “Yes, that is our goal. That’s one of the differences that we have versus some of the competitors out there. The four elements of our disposable model will be the arm, the camera, the trocar, and the drape. And the only thing that will be multi-use Is the hardware, the capital, the patient cart and the surgeon console. One of the other benefits is because we’ve simplified the hardware, the capital up-front expense to a hospital is significantly less than that of our competitors right now. They built a lot of the complexity into their capital equipment.”
Is there any potential for those disposables to be able to be reprocessed, recycled or scrapped in any way?
Mazzola: “We’re probably going to go out at a cost that is higher than what we want to get them to. But with the work that we have going on to drive cost out of those — looking at more economic material selection, as well as looking at where we manufacture these and the scale at which we manufacture — I think that will drive the cost out. We’re designing it as single-use disposable, and I’ve worked on a lot of single-use disposables that were attempted to be reprocessed and reused. We will control what we can control.”
Vicarious Surgical had layoffs earlier this year like a lot of other medtech companies. Are we getting to the point where you think there will be rebuilding this year or next?
Mazzola: “We’re constantly being opportunistic in our hiring. And we currently have probably close to about 20 positions that we’re looking to fill, some just based on progress that we’re making and now the time has come to start filling some of those positions, and others for replacement of folks that have left for one reason or another. But we’re constantly looking at that and we’re being a little bit selective and making sure that we don’t get ahead of ourselves. I think that was part of the challenge we had with the last RIF (reduction in force) is that maybe we got a little bit too ahead of ourselves and were hiring for positions that were a little bit in advance of where we were as a company.”
What have you learned in your career about developing and launching products that you could share with MDO readers?
Mazzola: “What we need to do more of rather than wait until an issue occurs and then react to it, is to be a little bit more proactive with our thinking. Understand where some risks could occur and put in plans now before they occur. That helps with driving a timeline. Throughout my whole career in medical devices, the most important thing that any product manager or project manager is faced with is time to market, a schedule. Everything has a window of opportunity, and you want to seize on that window of opportunity. Timeline management, managing to milestone is critical. And you don’t want to have surprises. So as much as you can, be proactive and contemplative in terms of what could go wrong and putting in plans now will help you manage a more aggressive timeline.”
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