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  • Janani Liyanage

From compliance to congruence: An agile coaching story


This is story is based on real life experience of an agile transformation coaching enagement which helped anorganization to drive innovation and human centric delivery approach. The story presents key lessons learnt specially in evoking stakeholder alignment during an agile transformation at a highly regulated clinical trials platform development company

Overview of Organization

• It was an organization that develops and markets software platforms clinical trials. Target users are patients, researchers, care givers, physicians and compliance authorities.

• Clinical trials are a means of developing new treatments and medications for diseases and conditions. There are strict rules for clinical trials which are monitored by National Institutes of Health and the U.S food and Drug Administration.

• Clinical trials pass through a series of phases as the trial sponsor gains more evidence around the investigational drug or biologic. Preclinical studies are often conducted in cell and animal models and then are slowly expanded into humans: first in healthy humans in small numbers to test safety, and then to larger sets of humans who have the condition in question to test both safety and efficacy. This organization builds platforms so patients who volunteer to go through clinical trials.


• Software development Teams are distributed across US, UK, India

2. The Challenge

Head of PMO, Head of Product management & Head of Compliance departments requested support from our agile transformation team to help them with some challenges. Initial challenges presented were time to release and some unsatisfactory comments raised in client delight surveys.

3. Forming agile transformation team.

A 5-member team was formed which consisted with Senior client relationship manager, Director Agile Transformation, 2 Enterprise Agile coaches including me and 1 DevOps consultant.

4. Misalignment, Confusions & Conflicts between key Stakeholders

The biggest challenges were misalignment between 5 stakeholders around what is the problem, and what really matters. There was no shared understanding, shared goals around business Agility though they requested to perform agile maturity assessment

· Head of PMO needed more control and predictability hence emphasizing the need of streamlining SDLC (Software development Life Cycle)

· Head of Engineering need a separate initiative on test automation DevOps but no alignment with other teams

· Head of Compliance team complain about poor quality and regard for compliance and lack of corporation by development teams

· Head of Product management team complains about creativity of team as well as poor responsiveness of team when requirements change

· Dev team complains about last minute changes does not allow them to focus on sprint goal and rigorous compliance activities

Head of PMO suggested to do an agile maturity assessment on a standard industry template, identify gaps and initiate trainings.

Agile transformation team brainstormed on this request and came to an agreement that directly performing agile maturity assessment without creating alignment with stakeholders and holistic view around what the problem is and what really matters to the stakeholders could degrade the results of this engagement.


High-level approach proposed:


diagram: highlevel approach proposed

Insights & Lessons learnt in improving stakeholder alignment

Empathize & Analyze Stakeholders Needs, Goals, Pains and Fears

· 1–1 stakeholder interviews really helped to empathize underling challenges, needs, goals pains, fears and frustrations that led to conflicts, and misalignments.


table : Stakeholder analysis

Building Trust through Enhancing Clarity on Agile coach Role and Transparency to Agile coaching engagement process

· 1–1 stakeholder interviews also helped building trust between stakeholders and agile coaching by helping them to create clarity role of agile coaches. We used stakeholder alignment canvas from personal agility institute and Mckynsey 7S model to craft some specific questions.

From Assessment to Discovery

· Measuring agile maturity is not successful unless stakeholders discover business agility means to them and what really matters to them

· “Agile maturity assessments should not simply assess compliance to Agile practice but also discover quality of interactions between different teams and misalignments between strategy, structure, culture, systems, staff and skills. This required going beyond a checklist-based assessment to more holistic approach”

· So agile transformation team recommended a dialogue-based discovery approach where Agile coaches observe, visualize, assess & facilitate discovery dialogues between diverse groups

· These dialogues were followed by team coaching sessions to better reflect & enhance clarity among those groups.

· Stakeholder alignment is a journey that needs to be formed, normed, celebrated and reinforced continuously.

How Stakeholder conflicts were resolved during the inception of transformation by crafting a Shared problem, shared compassion and shared vision. Key Discoveries during Dialogue based Discovery sessions.

· Misalignment in Strategy — Structure and Systems was a huge impediment to improve client delight. This misalignment created competing goals & conflicts between Internal stakeholders (Product, PMO, Engineering & Compliance). We used Mckynsey 7S model to visualize this.

· Below is a sample evaluation (below is not presentation of real data )


Image : McKinsey 7S Model Inconsistency Matrix

· Leadership envisions a Strategy that drives innovation by co-discovering and co-creating solutions with patient focused groups who undergo clinical trials and internal/External stakeholder groups.

· But Structure does not facilitate this as teams are more organized around functions than customer focused

· Process is not helping empiricism to work with customers, stakeholders while inspecting & adapting changes. Process is primarily compliance driven. This is due to heavy compliance activities required to deliver a release. There were several phase gates and rigorous compliance checks

· Before any agile maturity assessment, it was essential to visualize and create clarity on this misalignment in strategy-structure and process which led to some conflicts in stakeholders

· This visualization led to stakeholder to have shared compassion on a Shared compelling problem to resolve urgently. Stakeholders started making sense of what business agility is and what really mattered. This helped them to envision set of common objectives around business agility

Key insights team discovered from group coaching sessions with change agents and development teams

· Compliance team worked as separate team and this distance created tension between development team and them. Compliance teams were deemed as police who come at the last phase of development and find faults and change many decisions.

· Compliance team members were worried about their carrier growth. They are highly specialized team with skills they felt not demanded in software industry except for medical sector.

· Lack of automation in many areas slowed them down to come up with potentially shippable product increment

· Human centric design practices required structure and policy level changes than simply training people.

· Lack of proper job descriptions, carrier paths and performance evaluation frameworks were key impediments to establish ScrumMaster role.

From Compliance to Congruence of siloed teams to improve patient centricity: Key Improvements teams implemented across multiple departments

Agile coaches and coaching sessions with multiple groups and departments ( HR, Learning & development, PMO, Compliance, Product Management & Engineering)

· Define NorthStar metrics to measure definition of awesome of vision and arrived tracking and reporting and evaluating mechanics

· Introduced Patient centered discovery, and delivery product development process influenced from Design thinking, Scrum and Disciplined Agile.

· Re-align teams around value stream in patient enrolment value stream. There are 3 more value streams were identified, due to complexity of organization only 1 value stream was focused in first phase of Agile transformation.

· Formed product discovery team in patient enrolment value stream to enhance collaboration in all stakeholders during product discovery or release inception

· Integrated the compliance activities into agile product development lifecycle than confining to phase gates

o In 2012, the Association for the Advancement of Medical Instrumentation (AAMI) released the technical information report (TIR45 guidance document) to steer medical device design and development companies on how to work agile within a regulated process US FDA explicitly recognized agile as an acceptable standard in January of 2013, referring to AAMI TIR45 guidance document and added it to its list of the approved standards to be used by the manufacturers

o We used above standards and guidelines to improve product development lifecycle more agile & human centered without compromising the Safety and Security.

o Series of team coaching sessions were facilitated to create better collaboration between compliance teams and development teams which required changes in team structure and design.

o Introduced an RPA solutions to minimize repetitive complex compliance activities and it helped to improve definition of done of sprint to realize potentially shippable product increment

· It was essential to develop coaching culture and coaching mindset to drive sustainable change and reinforce the need for patient centric discovery and delivery. Teams showed considerable resistance to take up ScrumMaster role due to poor recruitment process, job descriptions, carrier paths and performance evaluation frameworks for ScrumMaster role.

· Agile coaches worked with HR and PMO to reimagine and redefine ScrumMaster role. Introduced Delivery excellence team coach role with enhanced job descriptions, carrier paths and performance management frameworks.

Stakeholder alignment plays vital role in agile transformation. Its a journey where alignment requires to be continously discovered, nurtured and reinforced through out the transformation
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