Case Study

Design and Development Pivot

The Situation

Company: A clinical-stage biotechnology company developing therapies for metabolic disease was advancing its lead asset through Phase 2 clinical development.

Issue: The internal development team had deep experience in early-phase drug development but limited exposure to combination product programs – The broader organization had not previously managed the full scope of medical device development within a drug program.

The team had selected a commercially available auto-injector platform for the therapy and had begun initial engagement with the device supplier. However, foundational device development infrastructure had not yet been established. The program also faced aggressive clinical timelines driven by leadership’s desire to maintain development momentum.

Project: 

The work began with a series of short-term engagements focused on resolving immediate program barriers and the most pressing requirements needed to initiate device development.

During this period, Suttons Creek supported:

  • Development of the Design Input Requirements (DIR) documentation required by the device supplier
  • Creation of design control and risk management procedures necessary to begin formal development work
  • Structured documentation support

Challenges Expressed:

The internal team had deep drug-development expertise but had never managed the full scope of a combination product program. A device platform had been chosen, but the operational foundation hadn’t caught up:

  • No design control or risk management framework in place to begin formal device development
  • No device-aligned quality system, with internal quality leadership still taking shape
  • The device supplier required formal design inputs before development could even start

Leadership initially viewed the device work as a narrow documentation task rather than a multidisciplinary development effort — a common misread for teams new to combination products — while aggressive clinical timelines kept the pressure on.

Impact:

  • Lack of development readiness strained the relationship with the device supplier and slowed progress
  • Growing risk that stalled device work would jeopardize clinical momentum

Discovery:

  • Immediate barriers could be resolved through short-term, focused engagements rather than a program overhaul
  • Complex device development needed to be broken into milestones the client team could realistically absorb
  • Vendor tension reflected misaligned expectations, not a broken relationship — recoverable with the right mediation

Solutions Implemented:

  • Developed Design Input Requirements (DIR) and the design control/risk management procedures needed to start supplier development
  • Established recurring working sessions with client stakeholders for accountability, risk visibility, and schedule management
  • Mediated technical and operational discussions with the device supplier, clarifying expectations and aligning on a realistic path forward, while surfacing contingency vendor options to strengthen the client’s negotiating position