For biotech and medtech companies, strong innovation is only part of the equation when expanding internationally. The ability to commercialise at scale and the right leadership is essential. Learn the key readiness signals and leadership needed to turn local R&D into global impact.
For start-up biotech and medtech companies, maturing beyond their R&D and clinical pipelines requires more than just a validated product. It demands strategic readiness, robust infrastructure, capital efficiency, and perhaps most critically, exceptional leadership.
At Hunton Executive, we spend a lot of time working with companies – alongside our partners Axis Health Co. – to make sure that company founders and boards have everything they need in place for successful commercialisation, including product readiness, capital runway, regulatory strategy, and market pull.
Here is how to ensure a start-up looking has the right leaders to bring strategy to life in a global context.
Commercial readiness is not a checklist, but a series of steps that must be in place before a company considers its first overseas office, regulatory filing, or commercial agreement. To effectively scale internationally, organisations must assess their commercialisation readiness and build internal capability across key domains. This is where structured talent planning becomes essential.
These signals are:
1. Validated product-market fit
The product must have solved a real, recognised problem in its home market. Local regulatory approval, early clinician adoption, and payer feedback are critical indicators. Without domestic traction, assessing the global audience is just speculation.
At the same time, companies need to conduct strategic talent planning before planning global growth. For more information see the ‘Strategic Talent Planning for Global Growth’ section of this checklist.
2. Regulatory & reimbursement intelligence
Having a mapped and tested strategy for US FDA approval, EU MDR compliance, or regional market access should be the foundations of any strategy, not an afterthought. Engaging with international advisers early on is essential.
Also essential is having leaders who understand regulatory landscapes and reimbursement mechanisms.
3. Scalable infrastructure
Before going global, a business must be able to support scale—logistically, operationally, and legally. This includes supply chains, distribution agreements, data compliance, and after-sales service models fit for each jurisdiction.
As part of this, organisations must build scalable leadership ecosystems, including leaders who can drive cross-border decision-making and data-driven insight.
4. Capital strategy & financial maturity
It’s important for a business to have the funding to sustain expansion without compromising core business health. Global commercialisation is capital intensive, and ROI is often delayed, so a financial runway gives a scaling business the space to adapt, iterate, and grow.
The organisation must also have leaders who are equipped to handle financial volatility and market shifts, and be able to build organisational resilience.
5. Market Pull
If overseas investors, clinicians, or partners are reaching out, then this is a leading indicator that the innovation has translatable value and is resonating beyond borders.
This is also key for talent acquisition and retention, especially for attracting international talent who understand global market demands.
Yet even when a company meets these signals, realisation of commercial goals depends on leadership – on executives who can navigate market nuances, rally cross-border teams, and deliver results under complex and competitive conditions. This leadership must be culturally fluent, market-literate, and strategic. Read this checklist for more detail.
At Hunton Executive, we’ve worked extensively with ambitious biotech and medtech organisations scaling into the US., Europe, and Asia-Pacific. A common thread among those who were successful is they invested carefully in the executive search process, taking a proactive and strategic approach to find the best leaders to suit their business in its particular stage of development.
In our experience, scaling globally requires leaders who are:
There’s also an X-factor of sorts when finding these leaders – it’s those who can be translators between vision and reality, bridging the gap between local innovation and global adoption, and inspire others along the way.
Sometimes, leadership is the last consideration in commercialisation planning, when in fact it should be the first. Because without the right people at the helm, even the best strategies can stall. Scale-ups contending with tight capital, rising global competition, and escalating regulatory expectations, can’t afford to get leadership wrong. They must build leadership ecosystems that align with their global vision, strategy, and values.
As well as the attributes of suitable leaders, we often get asked about some of the key functions that are required for commercialising innovations globally. These include:
However, we also emphasise that it is not just about filling key roles now, but strategic planning for future needs, and succession planning in order to ensure business continuity. For a structured path to identifying and strategic planning for mission-critical roles such as CEO, CCO, Global Market Access Director, and Regulatory Leaders, download this useful checklist.
For organisations who’ve evaluated across the five signals mentioned above, there are a few steps they can take to move forward.
Biotech and medtech companies looking to go global should also seek professional help, both in finding the best leaders and making sure they’re market ready.
That’s why Hunton Executive’s partnership with Axis Health Co is so impactful. Hunton Executive sources and places the executives and leadership teams capable of delivering on that strategy, with a track record of global success. Axis Health Co brings unmatched insight into policy direction, commercialisation strategy, and the regulatory landscape.
Together, we support business across the entire commercialisation lifecycle from strategic readiness assessments to leadership gap analysis, executive search, talent integration and succession planning.
Hunton Executive’s partnership with Axis Health Co is designed to deliver:
Successful global expansion takes more than innovation. It requires strategic leadership, readiness, and the right support. By aligning commercial strategy with executive capability, biotech and medtech companies can scale with confidence.
Hunton Executive and Axis Health Co have joined forces to equip growth-stage companies with both the strategic advisory and executive leadership they need to expand with confidence. With the right talent, leadership, and strategic planning, your organisation is ready to bridge the gap from R&D to global impact.Contact us to learn how the Hunton Executive + Axis Health Co partnership can help your organisation commercialise globally with confidence, clarity, and capability.
Master the Art of Interviewing: How to Listen, Connect, and Hire Exceptional Leaders
In today’s competitive market, finding and securing top-tier leaders isn’t just about asking the right questions—it’s about listening deeply and understanding who they truly are.
Hospital Leadership Is Changing—Is Your Executive Team Ready?
Hospitals in 2025 are redefining what it means to lead. The past five years have brought extraordinary disruption—and the next five promise even more profound
How You Are Viewed by Key Stakeholders Matters More Than You Think
In the complex landscape of leadership and executive presence within the healthcare and life sciences sectors, your reputation is not just built in the boardroom
Leading with Purpose: The Journey to Extraordinary Leadership in Healthcare and Life Sciences
Leadership in healthcare and life sciences is unique—it’s not just about driving results; it’s about impacting lives, advancing innovation, and navigating complexity with unwavering resilience.
We want to get to know you and understand how we can help you. Take the next step and schedule an appointment with Hunton Executive to start the conversation.
P. +61 1300 121 057
E. enquiries@huntonexecutive.com
Sydney, Australia
© Hunton Executive Recruitment and Consulting
