Expanding to the United States: The Capability Decisions Australian and New Zealand Biotech and MedTech Companies Often Underestimate

The discussion may begin around commercialisation, investment, licensing opportunities, strategic partnerships or market entry. The catalyst varies from organisation to organisation, but the question is usually similar.

What needs to happen for this business to succeed in the United States?

Interestingly, the conversation often turns to recruitment surprisingly quickly.

The organisation begins discussing a US General Manager, a commercial leader, a business development executive or a local leadership team. The assumption is understandable. If the United States is strategically important, surely the first step is appointing someone there.

What we often see, however, is that organisations are not actually making a hiring decision at this stage.

They are making a capability decision.

The distinction matters because many of the challenges associated with US expansion have less to do with who is appointed and more to do with understanding what the organisation is trying to build.

A company cannot determine the capability it needs until it has a reasonable degree of confidence about the pathway it intends to follow.

For example, an organisation pursuing licensing opportunities will often require different leadership and capability to an organisation establishing a direct commercial presence. A company focused on partnerships may need deep business development expertise long before it requires a large local team. An organisation approaching commercialisation may believe it needs a US commercial leader only to discover that market access, reimbursement strategy or regulatory capability will influence success far more significantly over the next two years.

From the outside, these businesses may look remarkably similar. They may operate within the same therapeutic area, have comparable funding and be pursuing the same market.

The capability they require can be completely different.

This is one of the reasons organisations occasionally become frustrated with early US appointments.

The individual joins with excellent credentials, significant market experience and a strong network. Everyone agrees they are the right person. Twelve months later the organisation is disappointed because progress has not matched expectations.

The problem is rarely the calibre of the individual.

More often, the organisation has recruited somebody to execute a pathway that has not yet been fully defined.

The person has been hired to build the future before the organisation has agreed what that future looks like.

This becomes particularly challenging because success in the United States is often built upon a series of interdependent decisions. Commercial strategy influences reimbursement. Reimbursement influences market access. Market access influences adoption. Adoption influences investment decisions. Investment decisions influence organisational structure.

The sequence matters because each decision affects the next one.

The strongest organisations recognise this and spend considerable time understanding which questions still need answers before deciding which capability should be introduced.

A useful way to think about this is to separate US capability into three phases.

The first phase is understanding the market.

At this stage the organisation is learning. It may be evaluating commercial pathways, understanding reimbursement dynamics, exploring partnerships, assessing competitors, speaking with potential customers or building relationships with investors and advisers. The objective is not primarily execution. The objective is reducing uncertainty around important decisions.

Many organisations discover that the capability required during this stage is quite different to the capability required later. They may require highly experienced people, but those people are often helping the organisation make strategic choices rather than build infrastructure.

The second phase is establishing a presence.

The organisation has reached greater clarity around its pathway and now needs capability capable of turning that strategy into reality. Relationships need to be built. The market needs to be engaged. Decisions that previously existed on presentation slides need to be translated into day-to-day activity.

What becomes important here is that accountability begins to matter more than advice.

The organisation may still use fractional capability, external advisers and strategic partners, but somebody increasingly needs ownership of outcomes.

The third phase is scale.

The organisation understands where it is going, has evidence that the model works and now needs leadership capable of building a sustainable business. This is often where organisational structure becomes more important because additional capability, management layers, reporting relationships and specialist expertise begin to emerge around the initial leadership team.

One of the patterns we see repeatedly is organisations recruiting scale capability when they are still solving learning-stage questions.

Equally, we see organisations remain in learning mode long after enough information exists to begin execution.

Neither position is ideal.

The challenge is recognising which stage the organisation is genuinely operating within rather than which stage it hopes to be in.

This also changes how organisations think about location.

Many businesses begin with the assumption that US capability should be physically located in the United States. That may be true. Sometimes it is not.

The more useful question is where important decisions need to happen.

If market relationships, partnerships, investors and customers all require continual local engagement, capability should probably sit within the market. If the organisation is still testing commercial pathways and developing strategy, some capability may continue to sit effectively within Australia or New Zealand while drawing on US expertise where needed.

The distinction appears subtle but often has an enormous impact on cost, organisational complexity and decision-making.

A US operation should not exist because an organisational chart says it should.

It should exist because capability genuinely needs to be there.

This is why experienced Boards often spend as much time discussing structure, accountability and capability as they do discussing recruitment itself.

They understand that a US leader inherits whatever organisational clarity currently exists.

If reporting relationships are unclear, if authority remains ambiguous or if critical strategic decisions are unresolved, those challenges become part of the appointment whether they appear in the position description or not.

The most successful US expansion strategies therefore tend to begin with a different question.

Not “Who should we hire?”

But “What capability does the organisation need next to reduce risk, create momentum and move towards the next stage?”

The answer may be a Board appointment.

It may be commercial expertise.

It may be market access capability.

It may be business development leadership.

It may be a US General Manager.

The role itself is often the outcome of good organisational thinking rather than the starting point for it.

That is why the strongest organisations rarely build their US presence by following a predetermined organisational chart. They build capability in response to the decisions they need to make, the uncertainty they need to reduce and the growth they are trying to create.

Over time, those capability decisions become a leadership structure.

The organisations that understand that distinction tend to arrive at a stronger structure and reach it with far less wasted effort along the way.

Start with the capability required for the next stage

Whether you are considering partnerships, licensing, commercialisation, investment or establishing a direct US operation, the first discussion is not always about who should be hired. It is often about understanding what capability the organisation needs next, where it should sit and how it should evolve as the business grows.