Rethinking Drug-Device Combination Product Partnerships

Why drug-device combination products need a new model

Drug-device combination products are becoming strategically critical. They enable differentiation, improve patient experience, and support complex therapies.

Yet collaboration models between CDMO and pharma have not kept pace.

Most partnerships still rely on volume-based manufacturing logic — built for predictability. That assumption no longer holds:

• Drug development is longer, costlier, and more uncertain
• Approval success rates remain low
• Device volumes are often limited

The result is a structural mismatch: high uncertainty meets fixed commercial expectations.

Where traditional models break down

Drug and device are often not developed in parallel and lack integration into the others process. This leads to recurring issues:

• Missed regulatory alignment
  Device development fails to match key drug milestones
• Late-stage redesigns
  Technologies are not ready when needed
• Misaligned incentives
  CDMOs bear early risk without visibility on future demand
• “Chicken-and-egg” dynamics
  Pharma expects a proven device; CDMOs expects reliable demand

At the same time, a contradiction persists: Platforms are marketed as “ready-to-use,” yet require significant customization investment later.

The result: delays, stalled decisions, and lost value.

What leading companies do differently

Leading players treat drug-device combination products as a joint development journey, not a handover.

Three shifts stand out:

1. Early integration

Device partners are involved as soon as key decisions are made — such as route of administration.

This drives:

• early regulatory alignment
• fewer late-stage changes
• faster development

2. True partnership models

Relationships move beyond transactional setup:

• risk is shared
• expertise is combined early
• value is created jointly

The CDMO becomes a co-development partner, not just a supplier.

3. A new way of sharing value

The biggest shift is in the commercial model. Instead of relying only on production revenues, companies introduce multi-phase value sharing:

• Compensation for early advisory work
• Funding across development milestones
• Participation in long-term commercial success

This aligns incentives across the full product lifecycle.

A practical playbook for change

Successful companies focus on a few critical levers:

• Adopt multi-phase commercial models
  (early compensation, milestones, long-term participation)
• Align regulatory strategies early
  Integrate drug and device pathways from the start
• Engage CDMOs earlier
  Leverage expertise before manufacturing begins
• Establish clear governance
  Define roles, decision rights, and risk-sharing mechanisms

What this means for pharma and CDMOs

The shift is both structural and cultural.

For pharma:

• stronger regulatory alignment
• lower development risk
• faster time-to-market

For CDMOs:

• expanded role in innovation
• deeper, longer-term engagement
• participation in downstream value

Both sides benefit from better alignment and improved outcomes.

Looking ahead

Drug-device combination products will continue to grow in importance.

Success will depend less on technology — and more on aligned incentives across uncertainty.

The partnerships that win:

• integrate early
• share risk
• share in success

How a-connect supports

We help pharma companies and CDMOs design and implement partnership models that work in practice.

About the author

Amir Tahric, Independent Consultant with a-connect, advises life sciences companies on business model innovation, supply chain strategy, and strategic partnerships. His focus lies on building resilient, value-driven collaboration models in complex innovation environments.

Ralf Halbach, Client Services Partner at a-connect, focusing on Life Science clients, supporting senior executives across sales & marketing, commercial operations, market access, P&L leadership, and strategic transformation.