The U.S. may be home to one of the most productive and profitable healthcare sectors in the world, but many medical device companies are expanding their reach to other markets that also offer attractive business opportunities. However, despite the potential for accelerated sales growth, the rules for commercialization change drastically when a company broadens its horizons beyond the U.S. landscape, facing countless new roadblocks on the path to successful global expansion.
Top Three Hurdles to Global Expansion
Launching a device in a new market is a monumental undertaking, even for the most experienced medical device company, due to:
- Regulatory diversity. Far and away, the largest hurdle to expansion is tackling the mountain of new regulatory compliance requirements and guidelines. Each country has specific regulations for medical device commercialization, ranging from product registration and labeling to quality standards and post-market surveillance. Companies seeking to commercialize in the European Union (EU), for example, must align their clinical investigation, manufacturing protocols, and ongoing research protocols to comply with the Medical Device Regulation (MDR). Despite the added complexities, achieving compliance with these regulations is non-negotiable, and often requires substantial amounts of time and resources to meet these requirements.
- Market unfamiliarity. Beyond regulatory challenges, medtech companies must also navigate the unfamiliar landscape of a foreign market. Cultural differences, healthcare workflows, provider requirements, and patient expectations can heavily influence buying behaviors and product adoption. To ensure a successful launch, companies should gain a deep understanding of each country’s healthcare market and align their commercialization initiatives to those requirements to, ultimately, avoid a failed market entry attempt.
- Limited agility. Scaling medical device manufacturing operations is difficult enough for domestic sales — expanding to international markets introduces a host of new challenges for even the most efficient manufacturing procedures. Scaling to meet the demands of global expansion requires a much higher level of agility and adaptability to quickly pivot to capitalize on new opportunities or overcome unexpected challenges. Without the necessary infrastructure and optimizations in place, companies struggle to effectively respond to shifting market conditions, resulting in slower sales and a lower return on investment.
The Roadmap to Successful Commercialization
How can a medical device company swiftly tackle these challenges while driving successful global adoption? The key is leveraging an expert partner who understands the complexities of global commercialization. With an OEM medical device and contract manufacturing partner like Ranfac, medtech innovators can focus solely on enhancing their device design and capabilities, while the outsourced manufacturing team handles every other task necessary to drive a successful launch. Ranfac serves as the ideal global expansion partner by providing:
- In-house regulatory and product expertise. To prevent gaps in regulatory compliance, Ranfac leverages a cloud-based quality management system backed by a fully staffed in-house regulatory and quality assurance team. Instead of handling regulatory functions prior to launch, we embed compliance into every step of the process. Our finished device capabilities ensure our manufacturing workflows and finalized products fully align with the specifications of each market, from FDA approval to MDR and beyond. Ranfac holds MDSAP, ISO 13485, and EU Quality Management System certifications to help our customers obtain every necessary clearance on time for their desired markets.
- Strategic market analysis. As a patient-centered manufacturer of custom medical device solutions, Ranfac always has a finger on the pulse of what key stakeholders demand from their devices. A core component of this approach is conducting strategic market analysis to identify and prioritize the target markets with the greatest potential for product adoption. Through comprehensive research, Ranfac bolsters globalization initiatives by assessing market dynamics, competitors, and customer needs to position market entry strategies for success.
- Upfront planning and scaling. To provide comprehensive value to our customers, Ranfac invests in meticulous upfront optimizations, including lower-level planning and regulatory compliance with entry-level quantities, to empower scalability and agility to adapt to surges in demand. Laying a foundation of scalable production early on is crucial for international expansion, as companies can take advantage of market disruptions and emerging opportunities to further penetrate global markets. This level of scalability is made possible by our vertically integrated facility that houses every process under one roof, allowing every department to work as one team to rapidly change course when needed.
