Taking Novel Technologies to Market and Beyond

Miach Orthopaedics has gained traction in the sports medicine space in recent years with its BEAR Implant, a bio-engineered implant that restores ACL quality and size similar to the non-injured ACL without the need for a graft.

The resorbable implant is secured via suture to bridge the gap between the torn ends of a patient’s ACL. The patient’s blood is then injected into the implant to form a device-protected clot that enables the body’s healing process. Within about eight weeks, the implant is absorbed and replaced by the body’s tissue. BEAR received FDA De Novo approval in 2020, and Miach began commercial release in late 2021.

While the technology is a novel approach to ACL repair, the company is following the playbook of a previously successful startup. Martha Shadan, President and CEO, joined Miach after successfully selling Rotation Medical to Smith+Nephew and helping integrate the acquisition into Smith+Nephew’s portfolio. Rotation Medical developed a bioinductive implant to support the body’s healing of rotator cuff tears, and it quickly eyed a purchase after reaching the market.

We sat down with Shadan after she presented at the Canaccord Genuity Musculoskeletal Conference and talked about various topics, including Miach’s technology, building a successful orthopedic startup and developing a more inclusive orthopedic industry.

Why do you think we’re seeing more ACL companies enter the market today?

Shadan: I think this sector of the space is ripe for innovation. It’s been over 30 years since the basic approach to ACL rupture was developed, and there have been some innovations, but nothing that has disrupted reconstruction. We all know that surgeons are looking for an opportunity to heal the native tissue. So, I think that’s what companies are trying to do.

There are some companies that are augmenting the tissue, the reconstruction. I don’t consider that to be in the same category, right? If you’re augmenting a reconstruction where you take a graft from another part of your body, you’re augmenting with a device. That’s not really healing your native tissue.

We know that it’s always better to retain or restore your own tissue in the long term. And I think that’s the goal of a lot of companies, and they will ultimately move in that direction.

You started your commercial launch at the end of 2021. Were there opportunities or challenges that came up that maybe were unexpected?

Shadan: We have far exceeded what we expected. We’re seeing 400% growth quarter over quarter. We’re 300% ahead of what we forecasted. We have brought on about 50% more physicians than we expected.

Our ASP is much higher than we expected. I think part of that is because the technology is so disruptive; it’s so new and exciting for surgeons. We’re able to get that kind of premium for the device.

Martha Shadan, President and CEO, Miach Orthopaedics

So is your growth credit to the technology, or do you think organizationally you were also well positioned to exceed your goals?

Shadan: We are highly disciplined. We are highly disciplined in how we target and select physicians. We are highly disciplined in training our surgeons and our messaging.

The other thing is, that we use PR in a very helpful way to educate patients and create awareness in markets where we have established surgeon users.

So that, combined with the fact that we’re hiring what I consider to be best-in-class sales reps. Our model, the criteria we use to select our reps, is not necessarily the same as what others might use. We’re looking for a certain individual that can communicate the science, rather than just talk about a procedure. That certainly makes a difference.

It’s the same playbook that we used for Rotation, with some modifications. In every situation, you hope that you get better. We’re using what worked at Rotation and improving on it.

One of my questions to you was going to be, what lessons learned from leading Rotation have you used at Miach?

Shadan: Yes. Because we have experience with Rotation in how to roll out a disruptive technology efficiently, we are using that.
We’ve got a three-legged stool. We’ve got excellent direct sales reps; we’re using PR; we’re using medical education. So we’re very efficient in the way we spend our money.

What are your priorities for 2022?

Shadan: We’re going to be focused on executing commercially. Continue to execute on enrollment in some of our clinical trials, get our Bridge registry started, and execute our commercial plans, including medical education and our PR. And those are our priorities. We’re having a lot of fun.

We’re a group of very high-energy, passionate, engaged people. We’re building a culture of inclusivity. As a woman CEO, I am passionate about making sure that we have a diverse organization with everyone feeling like they have an equal voice.

I’m the chair of the Diversity and Inclusion Committee for AdvaMed, and our goal is to make the medtech industry the industry of choice for diverse candidates. We are doing a lot to help develop that in the industry.

I think orthopedics has a little catching up to do. I don’t know how many female CEOs spoke today.

You were the only one I heard.

Shadan: Which is not right. We want more women up there. Our goal is to develop and mentor and become strong proponents.

As you said, I imagine it will take time and focused initiatives–mentoring, marketing.

Shadan: It’s not just something that’s going to happen overnight. But I’m pretty passionate about it.

You’ve worked for companies of all sizes — Zimmer, Covidien, Smith+Nephew, Rotation Medical. What excites you the most about working at a startup?

Shadan: At startups, we get to build from the ground up. We can be very nimble. Not that you can’t be nimble in big companies, but it’s a slower pace. I really like the fast pace, building the culture and creating a dynamic, fun culture where people are happy to come to work.
We’re in a market where companies are having problems attracting talent. We haven’t had any issues.

I think part of it is, the success we’re having, but also, we really mean it. We mean it when we say we’re building an inclusive, engaged team of people who feel like they’re owners of this company.

You have a platform technology. While you’re focused on the ACL right now, what’s next for the company?

Shadan: It’s a good question. One of the things that I am very disciplined about is focus, and making sure that we’re excellent and best in class at everything we do. The ACL market is big, and there’s a lot to do. So we are extremely focused there right now. As we gain traction, we’ll start looking at other opportunities.

But, I think that the best companies, the excellent companies, learn how to focus, and they know how to drive value. They know what the three or four or five things are that will drive value.

CL

Carolyn LaWell is ORTHOWORLD's Chief Content Officer. She joined ORTHOWORLD in 2012 to oversee its editorial and industry education. She previously served in editor roles at B2B magazines and newspapers.

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