Navigating US market complexities with expert- & data-driven validation

Summary:
Powered Orthotics partnered with Peak Spirit to conduct a structured market validation process, focusing on standard of care (inpatient, outpatient, at-home), reimbursement assessment, competitive intelligence, Go-To-Market strategy, & distribution collaborations.
Peak Spirit organized and led expert interviews with neurologists, occupational therapists, sales professionals, and executives from leading exoskeleton companies. In parallel, extensive desk research provided insights into reimbursement strategies, market trends, and competitor positioning.
Results
Delivered a comprehensive market validation report, outlining key reimbursement considerations, market entry strategies, and competitive positioning.
Secured high-quality expert interviews and early connections with key opinion leaders and potential distribution partners.
Provided expert- & data-driven insights that enabled Powered Orthotics to refine its commercialization approach and anticipate challenges.

We expected high-quality work, but Peak Spirit’s expertise and strategic approach exceeded our expectations, providing us with invaluable insights into the US market.
Background
Powered Orthotics is a successful MedTech spin-off from the University of Heidelberg, Germany, specializing in powered hand exoskeletons that assist individuals with impaired hand function. With a strong foundation in engineering and medical research, the company is developing a device designed to enhance mobility, improve independence, and support rehabilitation. Given the size and potential of the US market, Powered Orthotics aimed to validate its market entry strategy before committing significant resources.
The Challenge
Entering the US healthcare market is complex due to strict regulations, a fragmented payer system, long reimbursement processes, and high competition, requiring strategic navigation, compliance, and many more reasons. To succeed, Powered Orthotics needed to validate key assumptions regarding the standard of care, stakeholder dynamics, reimbursement feasibility, and competitive intelligence. Understanding who influences adoption, how reimbursement pathways work, and how to position the technology within existing inpatient and outpatient treatment practices was critical.
Rather than relying on trial and error, Powered Orthotics partnered with Peak Spirit for a structured market validation approach, ensuring a data-driven foundation for decision-making.
Preparation for Market Validation
To kick off an insightful market validation, Peak Spirit reviewed Powered Orthotics' existing marketing material and strategy and conducted an in-depth workshop, discussing all critical assumptions related to the US market. The discussions focused on the standard of care, identifying key stakeholders involved in prescription and usage, evaluating the perceived benefits and competitive positioning, and mapping out potential reimbursement options and barriers. From these discussions, a comprehensive list of questions was developed for validation through direct market engagement and desk research.
The validation areas and key focus points included:
Standard of Care: Gaining a detailed understanding of current treatment practices and the role of powered exoskeletons.
Value Proposition: Identifying key factors that drive recommendations from healthcare professionals & factors that might lead to objections.
Go-To-Market Strategy: Exploring different market entry strategies and gathering insights from competitors.
Reimbursement Feasibility: Assessing the potential for reimbursement, including existing coding and payment pathways or the need for new coding.
Pathways to Market: Understanding differences in outpatient, inpatient, rehabilitation, and at-home usage scenarios.
Competitive Intelligence: Examining competitor products, their commercialization strategies, and potential differentiators for Powered Orthotics.
Market Validation & Expert Interviews
With a structured framework in place, Peak Spirit researched, contacted, and led in-depth interviews with key stakeholders. Neurologists and occupational therapists provided insights into clinical needs and rehabilitation pathways, helping to clarify how powered exoskeletons fit into current treatment practices. A salesperson from a well-known company in the area shared perspectives on commercial collaboration and distribution challenges in the medical device industry. Additionally, a management board member from a leading lower-limb exoskeleton provider detailed their US market entry strategy, reimbursement efforts, and potential collaboration synergies.
Accessing relevant interview partners is often a significant challenge in these types of projects, but thanks to Peak Spirit's network and expertise, we were able to secure many high-quality interviews that contributed valuable insights to the project. Securing these interviews required persistence and multiple follow-ups, but the effort ultimately yielded invaluable information.
In parallel to the interviews, Peak Spirit conducted extensive desk research on reimbursement pathways, market trends, and competitor intelligence. Reimbursement was identified as a challenge due to the lack of existing coding. However, our research revealed existing codes for similar solutions targeting the lower limbs and provided insights into how direct competitors successfully navigated commercialization despite these obstacles.
Results
Within a few months, Peak Spirit successfully conducted numerous expert interviews and extensive market research for Powered Orthotics. The insights gathered were summarized in a comprehensive report which allowed for a detailed understanding of inpatient and outpatient care dynamics, the US reimbursement system, and key coding considerations. The analysis of the competitive landscape helped define differentiation opportunities, while early connections with key opinion leaders and potential distribution partners strengthened Powered Orthotics' positioning for future commercialization.
These expert- and data-driven findings enabled Powered Orthotics to refine its market entry approach, anticipate challenges, and engage with the right industry stakeholders in the future to support its commercialization efforts. Additionally, Peak Spirit managed to connect Powered Orthotics to high-quality leads which will help to accelerate their successful market entry further.
Conclusion & Recommendation
This collaboration highlights the importance of expert-driven market validation before entering a complex market like the US. By systematically testing key assumptions, Powered Orthotics gained a clear perspective on the landscape, enabling informed strategic decisions. Partnering with specialists like Peak Spirit ensures that companies can efficiently gather critical insights, refine their approach, and increase their chances of success.

Peak Spirit delivered a well-structured and efficient approach that provided us with invaluable insights for our US market entry. Thanks to their expertise, we were able to achieve a quality and speed for this project that would have been impossible for us to match on our own. Ryan Alicea, Founder & CEO of Powered Orthotics
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