Carlsmed CEO, Mike Cordonnier, on Building the World’s Only Bespoke Medical Device Company

Mike, what medical device is Carlsmed creating?

Carlsmed is a San Diego-based medical technology company that leverages science, data and digital technologies to personalize the treatment of complex adult spinal deformities. I founded the company along with Niall Casey in 2018 and established our headquarters in Carlsbad, California. Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond.

Carlsmed’s proprietary aprevo® solution makes surgical plans and devices tailored to the precise medical situation of each patient. We are the only bespoke medical device company in the world. Every device that we manufacture is intentionally made for a specific patient.

aprevo® devices are FDA cleared and have been granted FDA Breakthrough Device status. In addition, aprevo® devices are classified as Medicare Transformative New Device. This is an industry first in both categories for any implanted device.

Can you give us a bit of background on yourself?

I grew up finding unique problems to solve and ultimately graduated with a degree in Mechanical Engineering.  I quickly transitioned from engineering to leadership roles in diagnostics and medical device companies.  I have solved problems and launched products at successful startups and market leaders, including YSI (now Xylem), X-Spine Systems (now X-tant Medical), Orchid Orthopedics, Zimmer Biomet, and Ellipse Technologies (now NuVasive).

What inspired you to launch Carlsmed? What problems in the industry were you seeing?

I was inspired by my father to start this company. He suffered from back pain for many years. When his condition became severe enough that he decided to have spine surgery, he asked me if I could develop customized implants to treat his specific condition. I was working as an engineer for a medical device company then and knew the technology did not exist to accomplish his request at that time. The current business model for spinal device manufacturers is to provide “one size fits all” stock devices for surgeon to implant into patients during surgery.

My father’s plight resonated with me, though. I believed in this vision and decided to leave the corporate world and build a completely different kind of company: a company that starts with a patient – and not with a product. One that would never make the same thing twice. A company that uses data to provide the surgeon the best personalized devices for the patient. Carlsmed and our aprevo® devices are the result of that vision.

Where do you see the medical device industry headed? 

The medical device industry is under great pressure to deliver better outcomes while still lowering the overall cost of care. As such, I believe the industry will continue to move toward more sustainable manufacturing processes as well as leverage the use of data and technology to improve the current standard of care. At Carlsmed, we have built a digital-to-device business that embraces the principles of lean manufacturing and applies them to the emerging world of Industry 4.0.

The tenets of Carlsmed are to utilize digital technologies to optimize surgical planning, then utilize additive manufacturing to create personalized implants. This zero-inventory approach is nearly unheard of in the medical device industry, but definitely where the industry needs to go.

I believe our technology will enable decentralized production of precision implants that will continue to decrease the cost of healthcare, advance the treatment options for surgeons, and improve the results for patients. In the future, this technology will produce the data required to optimize the continuum of care for patients, healthcare providers and payors.

What has been the biggest challenge and the greatest reward of building Carlsmed?

One of the biggest challenges in creating a startup is knowing what problems to prioritize.  What has been helpful for me in building the company has been to maintain our true north through the challenges of building a fast growth startup.  We are patient obsessed so that we are always making the right decisions day to day that will best serve the patients.

The most rewarding part about creating a truly meaningful medical device startup is the impact on people that you can have.  As a patient specific medical device manufacturer, we make personalized devices that improve lives every day.

What did you find to be the most significant take-away of joining the EvoNexus incubator?

Even for a great business, building a startup to scale is hard.  EvoNexus provides a community of founders that have scaled their businesses successfully.  One of the greatest lessons that I learned from the team at the EvoNexus incubator is to continuously evaluate what outcome you are optimizing for your business and how to measure progress towards outcomes to hold yourself accountable.  This makes sure that you are running your business in alignment with your true north and prioritizing time and energy appropriately.

To learn more about Carlsmed®, head to their website:

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