OSP Advisors, formerly known as Ortho Spine Partners, has had the opportunity to work with multiple start-ups in the musculoskeletal and wound care specialties of the medical device industry. OSP Advisors has developed a unique approach and established some of the best relationships in the industry with surgeons, distributors and hospital executives allowing us to apply our knowledge and expertise to shorten the sales cycle when launching a company or product. Below is an example of how we did it.
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A German company launching its spinal implants in the United States faces several challenges due to differences in regulatory requirements, market dynamics, and healthcare systems. Firstly, the regulatory landscape in the United States, particularly regarding medical devices like spinal implants, is governed by the FDA, which has its own set of stringent approval processes and standards. Navigating these requirements can be complex and time-consuming, requiring the German company to invest significant resources in regulatory compliance and clinical trials tailored to US market needs. Additionally, the US market for spinal implants is highly competitive, with established American companies holding a significant market share and strong relationships with healthcare providers. This makes it challenging for a foreign entrant to gain traction and market acceptance, necessitating effective market entry strategies, partnerships, and differentiation based on innovation or unique value propositions. Moreover, understanding the nuances of the US healthcare system, including reimbursement policies and payment models, is crucial for the German company to ensure successful commercialization and sustainable growth of its spinal implant products in the United States.
Note : Each company has its own characteristics and considerations before launching a product. This represents an example but it is important to know that there is no copy/paste solutions for any company.
1. Know the market, and price competitively
One of EIT’s founders, Guntmar Eisen was introduced to the OSP Advisors team by mutual connections. He is a visionary leader that had some previous experience in commercializing products in the United States before and he knew he wanted to approach the market differently this time around.
In the summer of 2013 I was feeling the need to go in a new direction, and thus began looking at new technologies and manufacturingmethods. When I was offered the chance to visit the Fraunhofer Institute for Laser Technology, a nonprofit entity that commercializes new technologies, the chief engineer showed me prototypes of their 3D printing via selective laser melting. I actually felt cold shivers run down my spine as I thought, ‘What can we do with this?!– Guntmar Eisen
2. Build and Execute the Strategy
Guntmar Eisen worked with the OSP Advisors team to build out the disruptive commercialization plan. The first meetings occurred at one of the best spine meetings every year, Selby Spine in Park City, Utah. The key distinctive traits that we agreed we wanted EIT to look like in the United States included:
3. Road Shows
OSP Advisors realized that Guntmar brought the passion and technical know-how that was extremely compelling to surgeon partners. With that kind of a weapon, the OSP Advisors team was able to create multiple week long road-show styled meetings with surgeons and distributors throughout the country.
These meetings occurred for a full week once per month and we focused on providing consistent audiences for Guntmar and Josh to work together to explain the value of partnering with an innovative start-up like Emerging Implant Technologies.
4. Market Access
Like is the case for all early stage companies commercializing in the United States, market access was initially a challenge. However, with the help and relationships provided by OSP Advisors, EIT was able to make significant progress including the accomplishment of a National HCA Contract issued within the first few months of our commercialization process.
5. Market Demand Created
By helping EIT achieve a run rate of $3.5M in sales in the first 10 months of commercialization, the market was noticing the success of the products and sales success. Three of the top four strategic spine companies took notice and entered into a process.
It was incredibly important to the EIT leadership team that the partner that was chosen would invest into truly accelerating the early commercialization success and that they would remain committed to the platform.
6. Johnson & Johnson
By mid-2018, it was becoming increasingly clear that DePuy Sythes Spine, which is a Johnson & Johnson company, was the right partner. After a thorough due diligence process, the acquisition was announced at the 2018 EuroSpine meeting in Barcelona.
It was overwhelming, and it all went so fast,” says Eisen. “It was very hard work, but we had the right people at the right time. While there are other companies doing 3D printed cages, none had our level of spine focus—we did nothing else. And because we had no existing product line or messaging, we could afford to be somewhat radical.– Guntmar Eisen