Bill Colone’s Proven Playbook for Bringing Innovative Medical Devices to Market

Having led multiple successful startups, there’s never a shortage of innovative medical device ideas that cross Bill Colone’s desk. His unprecedented depth of knowledge for bringing life- and time-saving ideas to fruition, and his proven playbook for getting them to market, can make all the difference for inventors and investors alike.

Colone’s expertise in medical device R&D—specifically vascular peripheral technologies—is extensive. Among his many current roles, he serves as the CEO of Single Pass, an innovative disposable electrocautery device designed to support swift, easy and safe biopsy procedures. He also is the co-founder of three additional companies, serves on the boards of directors of an additional seven, and maintains a thriving consulting practice. Colone also holds 13 U.S. patents with another five or six pending, and more than 30 worldwide.

Paving the Way to Startup Success

Immediately following his graduation from Arizona State University with a degree in chemical engineering, Colone took a job with a Tempe-based surgical vascular manufacturing company as a process engineer. There, he received invaluable hands-on learning that he has used to build a long and storied career in the startup space.
“I was given really good advice early on, which was to make sure you network, make sure you build relationships, and make sure you nurture those relationships, which I did for over eleven years,” Colone recalls. “And that advice led, literally, to everything else.”

After more than a decade with the manufacturing company, Colone launched his first company startup, Endomed. It was during his time with Endomed that Colone learned the mechanics of running a medical device business, enabling him to set a vision for future company exit strategies.

“With Endomed, we also did some R&D, licensed some technology, did our own manufacturing, and, when we got to CE mark, we were selling in Europe,” he explains. “We made a lot of money, but when we got to market, we kind of missed the acquisition window at the time, so it took a little more time to exit.”

Helping Today’s Medical Professionals Become Tomorrow’s Inventors

Today, Colone uses his expansive experience in the vascular peripheral medical device industry to help guide physicians and other medical professionals who have potential innovations they want to bring to market. As he shares, there’s never a shortage of great ideas, but when viewed through the lens of production realities, it’s easier to see clear winners.

“My initial due diligence is always the same. First, verify that there’s a market that already exists, and that it’s growing. Next, determine that what’s being presented is a clear solution to an unmet need. And, finally, whether we can get IP or that the inventors already have IP,” he explains. “Ninety percent of the opportunities I review won’t pass that diligence.”

There’s also the hurdle of the idea’s potential market value and whether intellectual property rights can be gained. For many innovations, Colone shares, similar IPs may already exist, even if the product hasn’t been manufactured or produced.

“You have to justify that everything you work on has at least $1B market potential—in other words, if you have 100 percent of cases worldwide, that potential is $1B,” Colone says. “That and the IP are very important.”

If the idea clears Colone’s initial due diligence, and he and his partners believe they have the subject matter expertise to add value, they’ll proceed with co-founding a company, work to attain seed investors, and progress until they get to Series A round. And, thanks to Colone’s lean business model, the investments he seeks for seed or Series A capital is often significantly less than what is sought for medical innovations.

The Secret Sauce to Colone’s Unique Business Model

The secret sauce in Colone’s business model? He only has one employee: himself. By hiring outside consulting firms and contractors, Colone eliminates the overhead that can require millions more in investment dollars.

“We never have to lease buildings, create our own quality management systems, or build clean rooms,” says Colone.

“We start every project on second base because we don’t have to do all of that, so we can get to the finish line faster, and for less money.”

Instead, he and his partners use targeted distribution networks within the U.S. to gain commercial traction and collect real-world data, and then proceed to regulatory approvals, solid IP, and commercialization in the U.S. and Europe.

Additionally, Colone veers from institutional investors.

“We look for projects that match the tolerances of high-net-worth investors and investment clubs,” he adds. “They more readily accept the risk associated with seed stage founding. So we look for projects that fit get to treating patients, and that will have some kind of minimal clinical proof of concept with the first dollars in.”

Not only is Colone’s business model time- and capital efficient, it has enabled him to bring innovations to market faster than is often seen. It is this exact model that he has applied to all the companies he has recently started, with two of them already having CE mark and one, Single Pass, also achieving FDA clearance.

“We accomplished what we said we would do with each company,” Colone shares. “And that’s what we think is palatable for our investors. Usually these seed rounds are between $1-2M, and then depending on what the product is, the Series As can be anywhere between $2-5M after that.”

Proof of Concept: Single Pass

When two interventional radiologists in Phoenix had an idea for an electrocautery device for biopsy procedures, a physician friend referred them to Colone. Applying his usual due diligence protocols, he was able to establish that the radiologists already had issued IP and had a functional prototype. Colone and his partners used their network to raise money, source R&D teams, vendors, contract manufacturers, clinical and regulatory consultants and began the work and testing to get the product to regulatory submission and initial commercialization.

“Single Pass came to me via a doctor that I created an orthopedic product for that we sold to Stryker,” explains Colone. “Single Pass is electrocautery, but it’s used by interventional radiologists, and our team has done a lot of interventional radiology products, which is why I took that one in.”

Colone’s lean business model ensured that less seed or Series A capital was needed to bring Single Pass to market.

“Less than $5M has been invested in Single Pass so far,” he explains. “It took us 36 months from the date of the first investor check to obtain CE mark and FDA clearance. Thus we don’t need a giant exit number to get a really nice ROI for our investors.”

Today, Single Pass has received clearance from the U.S. Food and Drug Administration, and has its CE Mark under EU MDR regulations, making it commercially available worldwide.

“As engineers and developers, my colleagues and I know the biggest value driver is getting both regulatory approvals. Once you have CE mark and FDA clearance, you become an easier acquisition target because for the strategics; all you have to do is sell. There’s no more clinical risk, there’s no more regulatory risk, there’s no more wondering about timelines,” he explains.

The Value of Orange County

So why did Colone choose Orange County as the hub for his investing operations? As he puts it, Orange County has everything he needs to build successful deals.

“Orange County has over 58,000 medical device employees, so there’s a lot of talent here. Also, all the service providers and facilities are here, and there is a large pool of potential investors,” he explains. “Depending on the product, there are different groups or different consultants I can reach out to.”

“The Why” Behind Every Deal

Raising money for ambitious ventures requires continuous care and constant attention. But it’s the “why” that keeps Colone going.

“The professional satisfaction I gain from my work is extremely high,” he explains. “I enjoy knowing that the technologies we make helps people. And I especially enjoy when there’s success that we can share with others—not only the people who are involved, who are making money from the project and are employing people because they’re working on the project—but also the investors having trust and faith in us.”

Lori Wildrick, Special to California Business Journal