The 3 Pillars of a Successful Medical Device Startup

Interview With Clarius CEO Ohad Arazi

Clarius is a Canadian health technology firm that aims to provide medical professionals across various specialties and settings with accurate, easy-to-use, and affordable ultrasound tools. The company’s platform employs high-performance ultrasound imaging, cloud data, and artificial intelligence to enhance patient care and medical imaging.

Ohad Arazi, the President and CEO of Clarius, has an extensive technology background with over 20 years of experience in the digital health, medical device, and telecommunications industries as an entrepreneur, public company executive, and CEO. 

In this interview, he shares Clarius’ innovative ultrasound technology and how he’s leveraged his startup technology experience to continue the company’s impressive growth three years in a row.

Key Learnings from Ohad’s Experience

  • To build a product that truly meets the needs of your target market, it’s critical that you understand its must-have features from a functional, clinical, and financial perspective.
  • Have a clear understanding of the regulatory and reimbursement pathways and be able to effectively communicate them when pitching to investors. Also, understand the surrounding tools and infrastructure that make it easy for your target audience to adopt your product.
  • Your channel strategy is crucial and needs to be approached soberly and with intellectual honesty. As a startup, you sometimes need to leave the beaten path and disrupt the legacy market to generate revenue quicker.
Guest
Ohad Arazi
CEO of Clarius

Ohad is the CEO and President of Clarius, a leading provider of high-definition wireless ultrasound systems. With his extensive experience in the technology industry, ranging from the Israeli military to industry leaders like McKesson, Telus, and Zebra Medical, Ohad's impact on Clarius' persistent growth is undeniable.

Cracking the Code: Creating a Product that Your Market Can't Live Without

Product-market fit is is key to the success of any startup, but it’s a challenge with a lot of nuance. You need to understand how your product is necessary in terms of clinical function, but also whether it makes sense for users financially. Only then you can come up with a must-have solution with an opportunity to disrupt the legacy market, and change it for the better. 

Since Ohad didn't have a background in medical imaging when he started his career in the medical device space at McKesson, he spent two years immersing himself in radiology dark rooms and cardiology labs, observing and asking questions to understand their workflows and pain points.

“To convince them to make a replacement decision or to buy into a new technology [and] change their workflow, which is a very difficult thing to do in a medical setting at the point of care, we had to really understand how they work,” recalled Arazi.

So, when developing Clarius’ technology, the first goal was to generate image quality that was on par with what specialists were already using. But, as Arazi notes, that wasn’t enough. 

“By observing them, we saw that what they really need is voice controls. They need to be able to say increase zoom, increase gain, take a snapshot. Our AI automatically detects the optimal image as the key image that they use for reimbursement because if they're billing for an image-guided code, they need to retain the record to show the needle in an ultrasound view, because if CMS then audits them for their reimbursement, you have to be able to provide that evidence. So things like that all stem from really observing the workflow and understanding where you can add value.”

According to Ohad, getting to know the problems users face is, ultimately, how a company can ensure that its product is not just generally aligned with user needs, but also very specific in addressing the unique challenges they face in a particular setting.

The Role of Regulatory and Reimbursement Strategies in Medtech

Getting regulatory clearance in the medical industry can be a huge challenge. Clarius serves as an excellent illustration of a company that has been successful in acquiring regulatory clearances in 74 countries from the EUMDR, TGA, and FDA. 

 To achieve such global milestones, it’s important to identify clinical gaps that have not yet been addressed. “Sometimes you walk into an environment where you've identified a clinical gap that isn't yet supported by reimbursement, and that's okay as well. There are pathways to do that.”

Ohad advises entrepreneurs not to get hamstrung if there is no pathway for reimbursement and to create one instead by being clear on the clinical value of their product.

Ohad adds: “Once we identified things that were not being addressed, we didn’t try to replace or disintermediate radiologists, but actually complement them by offering things they weren't doing today. We leveraged AI to stratify risk for a variety of conditions and we found out there's clinical value, but there's no reimbursement yet. We created a reimbursement case, and we ultimately got two category 3 CPT codes for imaging.”

Apart from understanding reimbursement globally, Ohad emphasizes the importance of having a business-oriented regulatory team that facilitates the entire compliance process.

“First of all, it underscores that in the life of a medical device company, the regulatory team is so important, and it's incredibly important that they're also business-minded. They should understand the drivers behind [business decisions]. Generally, as you build out your company, I've always been very cautious to make sure that the regulatory team is not the gatekeeper. Actually, they should be the facilitator.”

Breaking the Mold: Clarius' Disruptive Channel Strategy for Global Success

Ohad explains that a successful commercial strategy requires not only having the right product, but also innovation in the channel and go-to-market strategy. 

At a high level, Ohad advised to ask yourself, “[W]hat is my channel, and how will that channel be successful relative to the challenges of the buyer base I'm selling into?”

For Clarius, their strategy focuses on specialists who work in a private office setting, which accounts for 75% of their sales. Instead of going after enterprises, they’ve channeled their marketing strategy towards users, that is, the medical practitioners themselves. The company created a virtual experience for end users to show them how Clarius’ ultrasound device can change their workflow for the better and improve the patient’s overall satisfaction.

Ohad cautioned against selling into an enterprise, as the sales cycle might take between 12 to 18 months, and the cost of customer acquisition could be high. 

Instead, Clarius’ sales process is largely executed digitally, with 25% of sales occurring online and 83% of all sales happening within 30 days of acquiring a lead. They don't send trial devices; instead, they educate potential customers remotely, just like someone would research before buying a new MacBook Pro. Even though Clarius is selling to a highly sophisticated audience who’s used to purchasing products the traditional way, their strategy appears to be working extremely well as evidenced by the company’s exceptional growth.

In summary, it comes down to really believing in your product’s value and convincing investors you know how to drive execution in  the market. Ohad advises to try and find innovative ways to pitch your product to the right audience, which often requiresdisrupting legacy incumbents: “As a startup company, you're always disrupting. You have to be blind, deaf, and dumb because if you listen to anyone and if you saw everything, you would never do what you're doing because the odds are impossible.”

Download a copy of the interview transcript right here.
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Clarius is a Canadian health technology firm that aims to provide medical professionals across various specialties and settings with accurate, easy-to-use, and affordable ultrasound tools. The company’s platform employs high-performance ultrasound imaging, cloud data, and artificial intelligence to enhance patient care and medical imaging.

Ohad Arazi, the President and CEO of Clarius, has an extensive technology background with over 20 years of experience in the digital health, medical device, and telecommunications industries as an entrepreneur, public company executive, and CEO. 

In this interview, he shares Clarius’ innovative ultrasound technology and how he’s leveraged his startup technology experience to continue the company’s impressive growth three years in a row.

Key Learnings from Ohad’s Experience

  • To build a product that truly meets the needs of your target market, it’s critical that you understand its must-have features from a functional, clinical, and financial perspective.
  • Have a clear understanding of the regulatory and reimbursement pathways and be able to effectively communicate them when pitching to investors. Also, understand the surrounding tools and infrastructure that make it easy for your target audience to adopt your product.
  • Your channel strategy is crucial and needs to be approached soberly and with intellectual honesty. As a startup, you sometimes need to leave the beaten path and disrupt the legacy market to generate revenue quicker.
Guest
Ohad Arazi
CEO of Clarius

Ohad is the CEO and President of Clarius, a leading provider of high-definition wireless ultrasound systems. With his extensive experience in the technology industry, ranging from the Israeli military to industry leaders like McKesson, Telus, and Zebra Medical, Ohad's impact on Clarius' persistent growth is undeniable.

Cracking the Code: Creating a Product that Your Market Can't Live Without

Product-market fit is is key to the success of any startup, but it’s a challenge with a lot of nuance. You need to understand how your product is necessary in terms of clinical function, but also whether it makes sense for users financially. Only then you can come up with a must-have solution with an opportunity to disrupt the legacy market, and change it for the better. 

Since Ohad didn't have a background in medical imaging when he started his career in the medical device space at McKesson, he spent two years immersing himself in radiology dark rooms and cardiology labs, observing and asking questions to understand their workflows and pain points.

“To convince them to make a replacement decision or to buy into a new technology [and] change their workflow, which is a very difficult thing to do in a medical setting at the point of care, we had to really understand how they work,” recalled Arazi.

So, when developing Clarius’ technology, the first goal was to generate image quality that was on par with what specialists were already using. But, as Arazi notes, that wasn’t enough. 

“By observing them, we saw that what they really need is voice controls. They need to be able to say increase zoom, increase gain, take a snapshot. Our AI automatically detects the optimal image as the key image that they use for reimbursement because if they're billing for an image-guided code, they need to retain the record to show the needle in an ultrasound view, because if CMS then audits them for their reimbursement, you have to be able to provide that evidence. So things like that all stem from really observing the workflow and understanding where you can add value.”

According to Ohad, getting to know the problems users face is, ultimately, how a company can ensure that its product is not just generally aligned with user needs, but also very specific in addressing the unique challenges they face in a particular setting.

The Role of Regulatory and Reimbursement Strategies in Medtech

Getting regulatory clearance in the medical industry can be a huge challenge. Clarius serves as an excellent illustration of a company that has been successful in acquiring regulatory clearances in 74 countries from the EUMDR, TGA, and FDA. 

 To achieve such global milestones, it’s important to identify clinical gaps that have not yet been addressed. “Sometimes you walk into an environment where you've identified a clinical gap that isn't yet supported by reimbursement, and that's okay as well. There are pathways to do that.”

Ohad advises entrepreneurs not to get hamstrung if there is no pathway for reimbursement and to create one instead by being clear on the clinical value of their product.

Ohad adds: “Once we identified things that were not being addressed, we didn’t try to replace or disintermediate radiologists, but actually complement them by offering things they weren't doing today. We leveraged AI to stratify risk for a variety of conditions and we found out there's clinical value, but there's no reimbursement yet. We created a reimbursement case, and we ultimately got two category 3 CPT codes for imaging.”

Apart from understanding reimbursement globally, Ohad emphasizes the importance of having a business-oriented regulatory team that facilitates the entire compliance process.

“First of all, it underscores that in the life of a medical device company, the regulatory team is so important, and it's incredibly important that they're also business-minded. They should understand the drivers behind [business decisions]. Generally, as you build out your company, I've always been very cautious to make sure that the regulatory team is not the gatekeeper. Actually, they should be the facilitator.”

Breaking the Mold: Clarius' Disruptive Channel Strategy for Global Success

Ohad explains that a successful commercial strategy requires not only having the right product, but also innovation in the channel and go-to-market strategy. 

At a high level, Ohad advised to ask yourself, “[W]hat is my channel, and how will that channel be successful relative to the challenges of the buyer base I'm selling into?”

For Clarius, their strategy focuses on specialists who work in a private office setting, which accounts for 75% of their sales. Instead of going after enterprises, they’ve channeled their marketing strategy towards users, that is, the medical practitioners themselves. The company created a virtual experience for end users to show them how Clarius’ ultrasound device can change their workflow for the better and improve the patient’s overall satisfaction.

Ohad cautioned against selling into an enterprise, as the sales cycle might take between 12 to 18 months, and the cost of customer acquisition could be high. 

Instead, Clarius’ sales process is largely executed digitally, with 25% of sales occurring online and 83% of all sales happening within 30 days of acquiring a lead. They don't send trial devices; instead, they educate potential customers remotely, just like someone would research before buying a new MacBook Pro. Even though Clarius is selling to a highly sophisticated audience who’s used to purchasing products the traditional way, their strategy appears to be working extremely well as evidenced by the company’s exceptional growth.

In summary, it comes down to really believing in your product’s value and convincing investors you know how to drive execution in  the market. Ohad advises to try and find innovative ways to pitch your product to the right audience, which often requiresdisrupting legacy incumbents: “As a startup company, you're always disrupting. You have to be blind, deaf, and dumb because if you listen to anyone and if you saw everything, you would never do what you're doing because the odds are impossible.”

Download a copy of the interview transcript right here.
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