Engaging people behind a seemingly impossible vision

Delivering clinical trial excellence for a global medical devices company


The medical device industry is undergoing unprecedented global transformation. One area of dramatic change is the evolving clinical, regulatory and quality conditions that dictate the standards which are a pre-requisite to product launch in any particular market. Expectations for medical devices are now similar to those of pharmaceuticals; demanding consistent quality without compromising speed to market and flexibility.

Our client’s strategy to ‘be close to the customer’ in its distinct regions had aided rapid growth but proved challenging when ensuring consistency of quality, process and speed at a global level. Inconsistent operating procedures across Europe, USA and Asia created inefficiency and variable standards which were exacerbated by a siloed culture, with each region believing it had the “right” approach. This meant delayed clinical trials and sub-standard results, with no collective ambition to resolve the problem or transform quality at a global level.


3 critical components:

1. Group Workshops to re-invent ambition and build leadership capability

Achieve Breakthrough designed a transformational leadership programme spanning 12 months. It included several face to face interventions, firstly developing the leadership team in Breakthrough Thinking and Performance before extending this to the wider teams. The size of the gap was acknowledged by all, creating an overarching vision that captured the speed and size of the shift required and the appetite for change.

The Leadership team uncovered that their conventional wisdom was holding them back. New Breakthrough capabilities were developed, enabling delegates to apply the breakthrough thinking tools and methodologies to the critical projects that underpinned the vision and organisational strategy as vehicles for success.

2. Breakthrough Project Methodology

There were dedicated project leaders and a self-selected project team. The project scope included a 100% revision of all global operating procedures supported by global communication and a team approach.

3. Senior Leadership Development:

  • Alignment behind a single vision in line with being world-class
  • Creation of a cross-functional and geographical leadership team
  • A dedicated development programme to embed a new vision, behaviours and ways of working across all regions


The outcomes required involved structure, processes, quality, innovation, leadership skills and mindset:

  • Repositioning Global Clinical Ops as an industry-leading organisation time and time again – a radical change in their performance with a mindset of winning and leading the way in World Class Clinical Operations.
  • Repeatedly delivering extraordinary results as ‘one team’ – quality and speed; consistency; employee engagement.
  • Transforming the function’s reputation and own perception of what they could contribute to the organisations strategy. 
  • A Leadership team capable of leading and inspiring with the skills to shift context
  • Establishing ‘one global clinical operations team’ – 100% alignment and empowerment across Global Clinical Operations.
  • A single performance dashboard that provides transparency and facilitates early identification of issues and corrective measures.
  • Coaching and supporting each other is commonplace, working towards the collective aim.
  • One team; one vision; open communication and trust. If setbacks occur, these are owned by the whole team and creative solutions are found and used
"After only 6 months into this programme, the Achieve Breakthrough methodology is so powerful that we are delivering outcomes that are at least 3 times better than I could have predicted. What’s more, this is the first time that I have had a truly 100% empowered team" Vice President, Global Clinical Operations