Bridging the Gap Between Clinical Trials and Commercial Success

Interview With Rob Ball, CEO of Shoulder Innovations

Rob Ball, the CEO of Shoulder Innovations, has dedicated more than two decades of his professional life to advancing medical device technologies, making a significant mark in the field of orthopedics. 

His journey began in the city of Kalamazoo, Michigan. Having a proclivity for engineering, Rob pursued his Bachelor's and Master's degrees at Kettering University, formerly known as the General Motors Institute (GMI). In Rob’s early career days, he was engaged in the automotive industry, working with SPX Corporation, where he was instrumental in building a large-scale casting and machining facility in Warsaw, Indiana.

Rob’s career took a dramatic turn when he crossed paths with Dane Miller, the founder of BioMet, and Rob’s neighbor in Warsaw. Dane, a GMI alumnus himself, introduced Rob to the striking differences in profit margins between the automotive and medical device industries. This realization spurred Rob to transition into medtech, marking the beginning of an exceptional journey.

Rob initially joined DePuy, a division of Johnson & Johnson, as a product development engineer in the extremities group. During his time there, he developed significant relationships and gained critical insights into product development and the inner workings of the medical device industry. Rob then transitioned to a small startup in Southern California called Kinetikos Medical, where he applied the skills and knowledge he had amassed at J&J.

After a few years, an opportunity presented itself through Warburg Pincus, who invited Rob to join the Tornier team, where he worked for about eight years. At Tornier (now Wright Medical), Rob led research and development and managed clinical and regulatory functions. Under his tenure, Tornier witnessed a significant boost in revenue, growing from $40-50 million to $300 million, mostly through organic growth.

During his time at Tornier, Rob had the opportunity to live in France for five years, an experience that broadened his global perspective. In 2013, Rob returned to the United States and co-founded Genesis Innovation Group together with Jeff Onderla and Don Running.

Genesis was founded as an early-stage advisory firm for medical device technology. Today, its operational capacity encompasses R&D, engineering, regulatory, quality systems, financial operations, and governance. It also operates a separate subsidiary, Genesis Software Innovations, focused on software development, and Revelation Medical Devices for small-scale manufacturing and prototyping.

Rob eventually transitioned to Shoulder Innovations, one of the portfolio companies under Genesis, where he took on the role of CEO. Shoulder Innovations is known for its inset glenoid fixation technology, one of the most robust and stable glenoid platforms in the industry. Under Rob’s guidance, Shoulder Innovations has made significant strides in rectifying a major problem in shoulder arthroplasty – unreliable fixation of the glenoid implant.

Over the past two decades, Rob has been dedicated to bringing medical device technologies to market, and holds more than 30 issued or pending patents. His vast experience, ingenuity, and commitment to excellence have made him a pivotal figure in the medtech space.

Key Learnings From Rob’s Experience

  • Engineers naturally excel at spotting technical problems and finding solutions for them. However, entrepreneurs should always try to balance their technical focus with the commercial aspects when developing a new product. 
  • Clinical trials are crucial, so set them up in a way in which they answer pertinent questions from clinicians while aligning with the key regulatory requirements.
  • Capital efficiency is critical during a startup’s early stages. If done the right way, you can both attract further investors and ensure early-stage financial partners a good return on their investments.
Guest
Rob Ball
CEO of Shoulder Innovations

Rob Ball, a graduate of Kettering University with a deep-rooted passion for engineering, has dedicated over two decades of his professional life to medical device technologies. He currently serves as the CEO of Shoulder Innovations, a leading orthopedic device company recognized for developing one of the most robust and stable glenoid platforms in the industry. Rob has over 30 issued or pending patents and has been instrumental in the growth of several organizations, most notably Tornier, where he drove the company’s revenue from $40 million to an impressive $300 million within a handful of years. 

Balancing Technical Solutions With Commercial Realities

As a startup entrepreneur, one might often find themselves caught up in the details of a technical problem that their venture is poised to solve. And while their solution might be sound from an engineering perspective, its commercial viability can often be underestimated or entirely overlooked. Rob’s experience serves as an important reminder of this common pitfall.

Rob candidly admits that there have been times when he’s been too engrossed in the technical details of his professional journey: “It's very easy to get tied up in how we, as engineers, are trained to articulate a problem we're solving. But I think we can get a little too caught up sometimes in the technical aspect of the problem when trying to come up with a solution.”

Rob points out that regardless of how great your product’s technology is, if the commercial aspects aren’t given the proper attention, it could spell the end for your business. He advises clearly articulating the idea behind your solution, matching it with the business model, and ensuring the product fits the industry norms.

But the success of an early-stage venture often lies in its deep operational engagement, which is not only about mere advisory or financial support, but involves actual participation in the startup's day-to-day operations. 

Rob emphasizes: "We literally have people packing boxes for Genesis companies." This hands-on involvement affords startup employees a practical understanding of the business's inner workings, ultimately driving capital efficiency.This direct involvement in every aspect of the business is what differentiates Genesis portfolio companies from others.

Setting Up Clinical Trials to Address Clinicians’ Needs, Regulatory Requirements, and Market Demands

An efficient clinical trial set-up is crucial for early-stage startups. Rob underscores the importance of answering specific questions that clinicians may have and balancing this with regulatory requirements.

Rob highlights a common oversight in the realm of orthopedics: when designing a product, there’s a gap of up to five years before the outcomes present themselves. The resulting challenge is not only about gathering data, but ensuring the collected data focuses on the right questions clinicians are most interested in.

Still, addressing these problems is just one facet of trial designs. Startups also need to align their clinical studies to both meet regulatory standards and hold up to commercial scrutiny. Rob notes that this isn’t always the forte of clinical and regulatory partners, who might often design trials around objectives that aren’t commercially relevant. As he points out: "Frequently, clinical data is designed around indications that are not necessary. You end up collecting more data and spending more time as compared to doing the minimum of what's necessary to be commercially successful."

Rob’s experience serves as a reminder for startups to be careful when designing a study with too many voices at the table. Instead, identify key opinions that matter and tailor the study design to address the right questions. This approach enhances efficiency and positions the company on a path to commercial success

The Value of Prudent Capital Management

For a startup, securing initial funding is a win to be celebrated, but it’s also just the first step of many. How you manage this capital actually determines your future success. This is especially pertinent when planning for subsequent funding rounds. Rob recalls: "We would have never gotten our Series D done had we not been so efficient in the earliest stages of our company, because the cap table just wouldn't have supported the type of financing that we did."

While capital efficiency is not the sole determinant of success, it is an essential factor that startups should take into account as they approach their fundraising process. It's not about bootstrapping or achieving positive cash flow at the onset but about making judicious decisions about spending. Rob advises: "Don't start with five executives around the table."

The issue of mismanaged capital becomes even more pronounced in later funding rounds. Rob warns: "If your cap table is too dysfunctional, for lack of a better description, it's going to be extremely tough." In other words, a poorly managed cap table can lead to unappealing valuations that deter new investors and disappoint early-stage partners.

Moreover, startups should be wary of overinflated valuations that cannot be substantiated by their progress or product. Such ungrounded valuations, as Rob points out: "introduces an existential risk that's hard to combat."

This highlights the importance of mindful capital management from the earliest stages of a medtech startup. Rob’s experience serves as a cautionary tale for founders and CEOs, and he urges them to strike a balance between spending on essential activities and maintaining an appealing valuation for future fundraising rounds.

In this regard, Rob is quite excited about Shoulder Innovations' potential over the next 12 months. After ensuring sufficient resources, large part due to the company’s capital efficiency,, the startup is now in a position to build a commercial organization, backed by strong operations, finance, and R&D teams, to create a standalone orthopedic company with a phenomenal future.

Download a copy of the interview transcript right here.
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Rob Ball, the CEO of Shoulder Innovations, has dedicated more than two decades of his professional life to advancing medical device technologies, making a significant mark in the field of orthopedics. 

His journey began in the city of Kalamazoo, Michigan. Having a proclivity for engineering, Rob pursued his Bachelor's and Master's degrees at Kettering University, formerly known as the General Motors Institute (GMI). In Rob’s early career days, he was engaged in the automotive industry, working with SPX Corporation, where he was instrumental in building a large-scale casting and machining facility in Warsaw, Indiana.

Rob’s career took a dramatic turn when he crossed paths with Dane Miller, the founder of BioMet, and Rob’s neighbor in Warsaw. Dane, a GMI alumnus himself, introduced Rob to the striking differences in profit margins between the automotive and medical device industries. This realization spurred Rob to transition into medtech, marking the beginning of an exceptional journey.

Rob initially joined DePuy, a division of Johnson & Johnson, as a product development engineer in the extremities group. During his time there, he developed significant relationships and gained critical insights into product development and the inner workings of the medical device industry. Rob then transitioned to a small startup in Southern California called Kinetikos Medical, where he applied the skills and knowledge he had amassed at J&J.

After a few years, an opportunity presented itself through Warburg Pincus, who invited Rob to join the Tornier team, where he worked for about eight years. At Tornier (now Wright Medical), Rob led research and development and managed clinical and regulatory functions. Under his tenure, Tornier witnessed a significant boost in revenue, growing from $40-50 million to $300 million, mostly through organic growth.

During his time at Tornier, Rob had the opportunity to live in France for five years, an experience that broadened his global perspective. In 2013, Rob returned to the United States and co-founded Genesis Innovation Group together with Jeff Onderla and Don Running.

Genesis was founded as an early-stage advisory firm for medical device technology. Today, its operational capacity encompasses R&D, engineering, regulatory, quality systems, financial operations, and governance. It also operates a separate subsidiary, Genesis Software Innovations, focused on software development, and Revelation Medical Devices for small-scale manufacturing and prototyping.

Rob eventually transitioned to Shoulder Innovations, one of the portfolio companies under Genesis, where he took on the role of CEO. Shoulder Innovations is known for its inset glenoid fixation technology, one of the most robust and stable glenoid platforms in the industry. Under Rob’s guidance, Shoulder Innovations has made significant strides in rectifying a major problem in shoulder arthroplasty – unreliable fixation of the glenoid implant.

Over the past two decades, Rob has been dedicated to bringing medical device technologies to market, and holds more than 30 issued or pending patents. His vast experience, ingenuity, and commitment to excellence have made him a pivotal figure in the medtech space.

Key Learnings From Rob’s Experience

  • Engineers naturally excel at spotting technical problems and finding solutions for them. However, entrepreneurs should always try to balance their technical focus with the commercial aspects when developing a new product. 
  • Clinical trials are crucial, so set them up in a way in which they answer pertinent questions from clinicians while aligning with the key regulatory requirements.
  • Capital efficiency is critical during a startup’s early stages. If done the right way, you can both attract further investors and ensure early-stage financial partners a good return on their investments.
Guest
Rob Ball
CEO of Shoulder Innovations

Rob Ball, a graduate of Kettering University with a deep-rooted passion for engineering, has dedicated over two decades of his professional life to medical device technologies. He currently serves as the CEO of Shoulder Innovations, a leading orthopedic device company recognized for developing one of the most robust and stable glenoid platforms in the industry. Rob has over 30 issued or pending patents and has been instrumental in the growth of several organizations, most notably Tornier, where he drove the company’s revenue from $40 million to an impressive $300 million within a handful of years. 

Balancing Technical Solutions With Commercial Realities

As a startup entrepreneur, one might often find themselves caught up in the details of a technical problem that their venture is poised to solve. And while their solution might be sound from an engineering perspective, its commercial viability can often be underestimated or entirely overlooked. Rob’s experience serves as an important reminder of this common pitfall.

Rob candidly admits that there have been times when he’s been too engrossed in the technical details of his professional journey: “It's very easy to get tied up in how we, as engineers, are trained to articulate a problem we're solving. But I think we can get a little too caught up sometimes in the technical aspect of the problem when trying to come up with a solution.”

Rob points out that regardless of how great your product’s technology is, if the commercial aspects aren’t given the proper attention, it could spell the end for your business. He advises clearly articulating the idea behind your solution, matching it with the business model, and ensuring the product fits the industry norms.

But the success of an early-stage venture often lies in its deep operational engagement, which is not only about mere advisory or financial support, but involves actual participation in the startup's day-to-day operations. 

Rob emphasizes: "We literally have people packing boxes for Genesis companies." This hands-on involvement affords startup employees a practical understanding of the business's inner workings, ultimately driving capital efficiency.This direct involvement in every aspect of the business is what differentiates Genesis portfolio companies from others.

Setting Up Clinical Trials to Address Clinicians’ Needs, Regulatory Requirements, and Market Demands

An efficient clinical trial set-up is crucial for early-stage startups. Rob underscores the importance of answering specific questions that clinicians may have and balancing this with regulatory requirements.

Rob highlights a common oversight in the realm of orthopedics: when designing a product, there’s a gap of up to five years before the outcomes present themselves. The resulting challenge is not only about gathering data, but ensuring the collected data focuses on the right questions clinicians are most interested in.

Still, addressing these problems is just one facet of trial designs. Startups also need to align their clinical studies to both meet regulatory standards and hold up to commercial scrutiny. Rob notes that this isn’t always the forte of clinical and regulatory partners, who might often design trials around objectives that aren’t commercially relevant. As he points out: "Frequently, clinical data is designed around indications that are not necessary. You end up collecting more data and spending more time as compared to doing the minimum of what's necessary to be commercially successful."

Rob’s experience serves as a reminder for startups to be careful when designing a study with too many voices at the table. Instead, identify key opinions that matter and tailor the study design to address the right questions. This approach enhances efficiency and positions the company on a path to commercial success

The Value of Prudent Capital Management

For a startup, securing initial funding is a win to be celebrated, but it’s also just the first step of many. How you manage this capital actually determines your future success. This is especially pertinent when planning for subsequent funding rounds. Rob recalls: "We would have never gotten our Series D done had we not been so efficient in the earliest stages of our company, because the cap table just wouldn't have supported the type of financing that we did."

While capital efficiency is not the sole determinant of success, it is an essential factor that startups should take into account as they approach their fundraising process. It's not about bootstrapping or achieving positive cash flow at the onset but about making judicious decisions about spending. Rob advises: "Don't start with five executives around the table."

The issue of mismanaged capital becomes even more pronounced in later funding rounds. Rob warns: "If your cap table is too dysfunctional, for lack of a better description, it's going to be extremely tough." In other words, a poorly managed cap table can lead to unappealing valuations that deter new investors and disappoint early-stage partners.

Moreover, startups should be wary of overinflated valuations that cannot be substantiated by their progress or product. Such ungrounded valuations, as Rob points out: "introduces an existential risk that's hard to combat."

This highlights the importance of mindful capital management from the earliest stages of a medtech startup. Rob’s experience serves as a cautionary tale for founders and CEOs, and he urges them to strike a balance between spending on essential activities and maintaining an appealing valuation for future fundraising rounds.

In this regard, Rob is quite excited about Shoulder Innovations' potential over the next 12 months. After ensuring sufficient resources, large part due to the company’s capital efficiency,, the startup is now in a position to build a commercial organization, backed by strong operations, finance, and R&D teams, to create a standalone orthopedic company with a phenomenal future.

Download a copy of the interview transcript right here.
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