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Orthopedic device companies often first look to the United States and Europe when launching a new device. That frame of mind is understandable, knowing the size of the markets. ORTHOWORLD estimates that the U.S. accounts for nearly 60% of the orthopedic market, while Europe, the Middle East and Africa combined account for about 25% of the market. However, there are other countries worth considering early in your worldwide expansion due to ease of their regulatory and reimbursement processes.
What criteria make a new market ideal for successful medical device commercialization? At the Virtual MedTech Conference’s session “Considering Untapped Markets for Innovative Product Introduction: Where to Go?” Frederic Rupprecht, Worldwide Vice President, Health Economics and Market Access, Johnson & Johnson, discussed the crucial qualities companies should look for when exploring new countries.
Strong Domestic Competition
Companies should proactively seek out markets with a strong domestic competition, since it’s a sign the framework is in place for successful commercialization strategies.
“Going where you have competition can seem counterintuitive, but it would mean that there’s an appetite for your technology, for your domain,” Mr. Rupprecht said. “There’s also a strong willingness to pay for this market, for this technology, and the market has already been created.”
Having a strong, competitive market is also a sign of a robust culture of innovation, which is another sign of a promising untapped market. After all, innovative companies thrive in (and are drawn to) places that encourage firms at the forefront of cutting-edge technology. As an example, Mr. Rupprecht cites Brazil, which has supported more than 500 health technology startups in the last four years and has an active venture capital market.
Look for Solid Market Access
Mr. Rupprecht points out that getting regulatory approval for a medical device is just the start, as companies also need to have a clear pathway to market access to sell the product. “Which comes back to why it can be good to look at what is the local competition doing,” he said, “because the local competition may have already overcome this access problem for us.”
He recommends companies look for countries with aligned healthcare incentives for providers, physicians and industry. Such alignment is a sign of a country that’s figured out how to navigate market access hurdles.
The U.S. can be used as a model for this, he noted, as it possesses conditions that are “amenable to innovation. Because providers compete, suppliers compete, but their incentives are for the most part going the same way.” This alignment is important, he added, as it makes entering markets a smoother process: “You don’t want to go somewhere where the healthcare system is learning with you. You want to go to markets where you know the rules of engagement. If they change as you try to enter the market, you’re up for a very long and very painful pathway.”
Data is Accessible
Countries where it’s possible to generate data, which Mr. Rupprecht said can be used to measure the quantitative value of a technology and help facilitate market access, also have a major advantage.
“[The] electronic medical records and IT infrastructure in South Korea is state-of-the-art,” he said. “It’s one of the best systems in the world in terms of access to data and possibility to generate real-world evidence.” South Korea also has clearly defined guidelines around reimbursement, which is another plus. “Most medical devices can be reimbursed on top of the regular funding of hospitals,” Rupprecht said. “It’s a market where you know what you need to do, it’s pretty stable and there is possibility to get data there.”
With the looming stricter European Union Medical Device Regulation and the packed competitive U.S. market, medical device companies must consider exploring other markets, said industry experts that spoke alongside Mr. Rupprecht. In addition to Brazil and South Korea, they mentioned Australia and Canada as two strong suggestions for expansion. They concurred that the three considerations of domestic competition, market access and data accessibility will lead to a higher chance of success.
Orthopedic device companies often first look to the United States and Europe when launching a new device. That frame of mind is understandable, knowing the size of the markets. ORTHOWORLD estimates that the U.S. accounts for nearly 60% of the orthopedic market, while Europe, the Middle East and Africa combined account for about 25% of the market....
Orthopedic device companies often first look to the United States and Europe when launching a new device. That frame of mind is understandable, knowing the size of the markets. ORTHOWORLD estimates that the U.S. accounts for nearly 60% of the orthopedic market, while Europe, the Middle East and Africa combined account for about 25% of the market. However, there are other countries worth considering early in your worldwide expansion due to ease of their regulatory and reimbursement processes.
What criteria make a new market ideal for successful medical device commercialization? At the Virtual MedTech Conference’s session “Considering Untapped Markets for Innovative Product Introduction: Where to Go?” Frederic Rupprecht, Worldwide Vice President, Health Economics and Market Access, Johnson & Johnson, discussed the crucial qualities companies should look for when exploring new countries.
Strong Domestic Competition
Companies should proactively seek out markets with a strong domestic competition, since it’s a sign the framework is in place for successful commercialization strategies.
“Going where you have competition can seem counterintuitive, but it would mean that there’s an appetite for your technology, for your domain,” Mr. Rupprecht said. “There’s also a strong willingness to pay for this market, for this technology, and the market has already been created.”
Having a strong, competitive market is also a sign of a robust culture of innovation, which is another sign of a promising untapped market. After all, innovative companies thrive in (and are drawn to) places that encourage firms at the forefront of cutting-edge technology. As an example, Mr. Rupprecht cites Brazil, which has supported more than 500 health technology startups in the last four years and has an active venture capital market.
Look for Solid Market Access
Mr. Rupprecht points out that getting regulatory approval for a medical device is just the start, as companies also need to have a clear pathway to market access to sell the product. “Which comes back to why it can be good to look at what is the local competition doing,” he said, “because the local competition may have already overcome this access problem for us.”
He recommends companies look for countries with aligned healthcare incentives for providers, physicians and industry. Such alignment is a sign of a country that’s figured out how to navigate market access hurdles.
The U.S. can be used as a model for this, he noted, as it possesses conditions that are “amenable to innovation. Because providers compete, suppliers compete, but their incentives are for the most part going the same way.” This alignment is important, he added, as it makes entering markets a smoother process: “You don’t want to go somewhere where the healthcare system is learning with you. You want to go to markets where you know the rules of engagement. If they change as you try to enter the market, you’re up for a very long and very painful pathway.”
Data is Accessible
Countries where it’s possible to generate data, which Mr. Rupprecht said can be used to measure the quantitative value of a technology and help facilitate market access, also have a major advantage.
“[The] electronic medical records and IT infrastructure in South Korea is state-of-the-art,” he said. “It’s one of the best systems in the world in terms of access to data and possibility to generate real-world evidence.” South Korea also has clearly defined guidelines around reimbursement, which is another plus. “Most medical devices can be reimbursed on top of the regular funding of hospitals,” Rupprecht said. “It’s a market where you know what you need to do, it’s pretty stable and there is possibility to get data there.”
With the looming stricter European Union Medical Device Regulation and the packed competitive U.S. market, medical device companies must consider exploring other markets, said industry experts that spoke alongside Mr. Rupprecht. In addition to Brazil and South Korea, they mentioned Australia and Canada as two strong suggestions for expansion. They concurred that the three considerations of domestic competition, market access and data accessibility will lead to a higher chance of success.
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Carolyn LaWell is ORTHOWORLD's Chief Content Officer. She joined ORTHOWORLD in 2012 to oversee its editorial and industry education. She previously served in editor roles at B2B magazines and newspapers.
