Martha Shadan has more than three decades of experience in the life sciences industry, leading teams at the largest medtech companies, as well as the smallest start-ups. Right now, she’s president and CEO at Miach Orthopaedics, a medtech company dedicated to developing bio-engineered surgical implants for connective tissue restoration. But her work doesn’t stop there. Martha is a member of AdvaMed’s Board of Directors, a member of AdvaMed Accel’s Board of Directors, and the Chairwoman of AdvaMed’s Inclusion and Diversity Committee.

Martha recently sat down with Tracy MacNeal, President and CEO of Materna Medical and national Chair for AdvaMed’s Women’s Executive Network, to talk about the state of the medtech innovation ecosystem now – and predict where it might go next.

You’ve worked with some of the largest medical technology manufacturers and you’ve worked with small and start-up companies. Can you help readers understand the importance of both kinds of companies to the medtech innovation ecosystem?

The word ecosystem itself implies a sense of interconnectedness. Both large, multinational companies and small, start-up companies are essential within our medtech industry. And each group has unique capabilities and specialties that can complement and enhance each other’s ability to be successful.

There are exceptions to this, but generally speaking, small and start-up medtech companies can be more nimble, which sometimes allows them to innovate faster. They’re not constrained by certain expectations that larger companies are subject to, like quarterly or yearly performance goals and revenue goals. They’re allowed to be a little more creative and free and flexible in the way they look at problem solving. As a result, small and start-up medtech companies are ideally suited for developing some very transformative, very disruptive technologies.

On the other hand, large companies, because of their robust organizational infrastructures and their large distribution networks, are ideally suited to take those transformative, disruptive technologies and get them to customers in a broad way, both at home and internationally.

So, bottom line, the medtech industry will be most successful by leveraging the strengths of both small and large companies.

What, in your view, are the top one to three issues facing small and start-up medical technology companies today?

The first and most obvious challenge for small and start-up medtech companies is access to capital. There’s a big conflict that exists: Investors want performance data before they put significant money into a new project, but innovators need significant money to collect performance data. When a company first starts out, of course, they’re spending money; but once it’s time to test the product in people, that’s when the spend grows to its largest. And government grants, generally speaking, aren’t going to support that kind of human testing – companies need outside investors for that. It’s not an easy task.

The second challenge: Reimbursement. Although the regulatory process with FDA isn’t perfect, it has come a long way. FDA’s expectations for product clearances and approvals are mostly well-understood. In fact, in recent years, FDA has published a series of guides or roadmaps for specific device types that outline how innovators should approach their applications, giving those innovators specific examples of the kind of information they should gather, how they should format that information, and what the final submission should look like. And additionally, the conversations between companies and FDA have become much more fluid. It’s easier than ever to interact with FDA and get feedback quickly. But, with reimbursement, the process isn’t as transparent. Innovators – especially small and start-up innovators – are having trouble understanding the level of evidence support they need to receive coverage. And, even further, the industry has questioned whether the level of evidence support required to receive coverage is reasonable. So, AdvaMed has been working with CMS to achieve alignment about how medtech companies demonstrate our technologies’ value.  

AdvaMed has also been working on defining value within our own companies – That’s the third challenge facing small and start-up medtech manufacturers. What is meaningful value? AdvaMed, in partnership with Deloitte, created a value framework that helps us think through important value variables. As we develop products, companies can use the framework to consider all the different stakeholder perceptions of meaningful value. For a patient, value might be getting back to work sooner. For a physician, value might be being able to do ten procedures in a day versus only six. For a provider, value might mean lower operating room costs. For insurers, value might mean less physical therapy required after a surgery or lower hospital readmission rates. We must consider every perspective. Better vigor around how we’re analyzing and assessing the value of our technologies – and better translation of evidence to prove that value – will make us more efficient and more effective as an industry.

So many companies, no matter the size or industry, are working toward better inclusion and diversity standards. Based on your experience, what advice can you give them?

As we’re thinking through strategies to advance inclusion and diversity standards, we have to keep in mind that every company is at a different starting point. Some companies are deep into their I&D journey, and other companies are just starting to think about it. Both of those realities are OK. What’s important isn’t where exactly you are on the I&D continuum, but your ability to honestly recognize where you are and act from there. That’s what AdvaMed’s Inclusion and Diversity Maturity Model is all about. I’d encourage medtech companies to use the Maturity Model as a roadmap to thoughtful action.

I’d also remind companies that we’re not going to achieve optimal inclusion and diversity standards overnight, or within a year, or within two years. Focus on making progress and moving in the right direction. Act from a sincere interest and desire to effect change. And seek alignment in your efforts through every level of management. Every single person in your company must see improving inclusion and diversity as an individual responsibility that they will be accountable for. AdvaMed Advance has some great conversation facilitation and awareness building resources that are a great place for companies to start on all fronts.

What can we do to improve the number of women in the medical technology industry and, specifically, in executive roles?

In order to improve the number of women in the medical technology industry and in executive roles within the medical technology industry, we first have to understand why it’s important to do so. Our companies must seek out diversity – whether it’s gender or race or ethnicity or any another identifier – because we need diversity of thought to succeed. Diversity of thought allows us to make the best decisions with the best information available. The data shows us that the more diverse your workforce is, the more engaged your employees are, the higher your innovation output is, the better your retention is, and, ultimately, the more successful you are financially.

So, we can start by building that awareness and, eventually, creating an understanding. Then, we act on that understanding. We need to look at how we’re recruiting and where we’re recruiting for new talent. We need to analyze how our job descriptions are written to ensure they’re not unconsciously biased. We need to ensure every hiring process includes a diverse slate of candidates, and that our interview questions are fair and equitable. All of these tactics will help us hire more women into our industry.

Then, we can turn to retaining those women into our industry. We can form mentorship programs and host networking opportunities. We can ensure qualified women employees can access the same growth opportunities as their male counterparts. We can create leadership opportunities for women, like piloting new programs or spearheading new projects.

Right now, as an industry, medtech lags behind on gender diversity. But I’m confident that the work we’re doing within our companies and the work we’re doing as an industry through AdvaMed Advance will help us move the needle in the right direction.