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How can you lead Agile teams in a highly regulated industry?

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Agile methodologies are widely used in software development and other fields to deliver value to customers faster and more efficiently. However, if you work in a highly regulated industry, such as healthcare, finance, or defense, you may face some challenges in leading agile teams. How can you balance the need for flexibility, collaboration, and innovation with the requirements for compliance, security, and documentation? In this article, we will explore some strategies and tips to help you lead agile teams in a highly regulated industry.

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1 Understand the regulations

The first step to lead agile teams in a highly regulated industry is to understand the regulations that apply to your domain and your projects. You need to know the legal and ethical standards, the risks and liabilities, and the best practices and guidelines that govern your work. You also need to communicate these regulations to your team members, stakeholders, and customers, and ensure that they are aligned on the expectations and the goals. You can use tools such as compliance matrices, checklists, and audits to map the regulations to your agile processes and artifacts, and to monitor and report your progress.

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Aleksander Cyrkulewski

Engineering manager with focus on underperforming teams | Engineering Team Lead at Kindred Group
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Agile is agnostic to industry: regulated or not. For instance, if one of your steps in development is to get an approval from regulator — just include it in your process. Simple as that.

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2 Adapt your agile framework

The second step to lead agile teams in a highly regulated industry is to adapt your agile framework to suit your context and your needs. You may not be able to follow a pure or prescriptive agile approach, such as Scrum or Kanban, but you can still adopt the core principles and values of agile, such as customer focus, feedback, iteration, and empowerment. You can customize your agile framework by choosing the most appropriate roles, ceremonies, artifacts, and tools for your team and your project. For example, you may need to add more documentation, testing, or approval steps to your agile workflow, or you may need to use more formal or structured communication channels with your stakeholders and customers.

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3 Build trust and transparency

The third step to lead agile teams in a highly regulated industry is to build trust and transparency among your team members, stakeholders, and customers. You need to foster a culture of openness, honesty, and accountability, where everyone can share their ideas, opinions, and concerns, and where everyone can access the relevant information and data. You also need to demonstrate your competence, credibility, and reliability, by delivering high-quality products and services, by meeting the deadlines and the budget, and by complying with the regulations. You can use tools such as dashboards, reports, demos, and reviews to showcase your work, to collect feedback, and to validate your assumptions.

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Sabrina Mbaba

Project Manager|CSM|Therapist |MS in CMHC| Helping women position themselves for their career choice, and make the pivot.
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As a project manager, establishing clear communication channels and ensuring all team members are well-informed about project goals, progress, and challenges is key. Encourage open and honest communication, foster an environment where team members feel comfortable sharing concerns and ideas. Promote transparency by involving the team in decision-making processes and providing visibility into key discussions. For example, in a healthcare project, trust can be built by actively involving regulatory experts in decision-making and ensuring the team understands the importance of complying with patient safety and data privacy regulations. Prioritizing trust and transparency creates a cohesive and empowered team working towards project success.

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Anurag Shagun

Healthcare | Insurance | EHR | HIPPA | Agile| Event driven | Microservices | Azure Cloud| AWS |SQL |H1-B
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Absence of Trust is a major factor for ineffective and timely communication. Steps to resolve this could be- - build relationships -open discussions -have a process to ask questions feelings without fear of retaliation - Failure is not punished, but to learn from - In virtual meeting, have cameras turned on - Appreciation, during stand up meets

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4 Embrace change and learning

The fourth step to lead agile teams in a highly regulated industry is to embrace change and learning as opportunities for improvement and innovation. You need to be flexible and adaptable, by responding to the changing needs and expectations of your customers, stakeholders, and regulators. You also need to be curious and proactive, by seeking new knowledge and skills, by experimenting with new ideas and solutions, and by learning from your successes and failures. You can use tools such as retrospectives, surveys, and metrics to evaluate your performance, to identify your strengths and weaknesses, and to plan your actions for the next iteration.

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Linda Whitesell, SPC, CSM, PMP, SSAC

Accelerating agile maturity in business and IT teams at Humana
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Agile teams require knowledge and experience to improve flexibility, dexterity, and speed. Therefore, ensure all team members are trained and periodically refreshed on the regulations and the regulatory landscape. ? What are the non-negotiables? ? What are the penalties? ? What are the user experience trade offs? These are just a few of the questions team members should be able to answer so they can design the best solutions and respond to local needs and changes quickly and easily.

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Anurag Shagun

Healthcare | Insurance | EHR | HIPPA | Agile| Event driven | Microservices | Azure Cloud| AWS |SQL |H1-B
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Always try to keep a learning/research user story in a sprint. Constant learning and sessions like 'lunch and learn' helps empower a team. Research stories give a constant learning opportunity for team

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5 Empower your team

The fifth step to lead agile teams in a highly regulated industry is to empower your team to make decisions, to solve problems, and to collaborate effectively. You need to provide your team with the necessary resources, guidance, and support, but also with the autonomy, responsibility, and recognition. You need to delegate tasks, to encourage initiative, and to facilitate communication. You also need to coach, mentor, and develop your team members, by providing them with feedback, training, and career opportunities. You can use tools such as goal setting, team building, and recognition programs to motivate, engage, and retain your team.

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Anurag Kusuru

DevOps/SAFe Practitioner | Design Control | MedTech | Leveraging Digital Twin & Digital Thread to Drive Innovation in Medical Manufacturing | Passionate about Product Lifecycle Management | ALM - Polarion
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In the highly regulated life sciences industry, as an Agile practitioner with two years of experience, balancing agility and compliance is crucial. Tailor Agile frameworks to meet FDA guidelines, emphasizing documentation, risk management, and cross-functional collaboration. Regularly engage regulatory experts, incorporate compliance into sprint reviews, and maintain adaptability to evolving regulations. Foster a culture of continuous improvement, provide ongoing training, and establish relationships with regulatory bodies. Successfully leading Agile teams in this context requires a approach that ensures both efficiency and adherence to industry standards.

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6 Collaborate with stakeholders and customers

The sixth step to lead agile teams in a highly regulated industry is to collaborate with your stakeholders and customers throughout the project lifecycle. You need to involve them in the planning, design, development, testing, and deployment of your products and services. You need to understand their needs, expectations, and preferences, and to deliver value to them. You also need to manage their expectations, to negotiate the scope and the priorities, and to handle the conflicts and the changes. You can use tools such as user stories, personas, prototypes, and user testing to elicit, validate, and prioritize their requirements, and to deliver solutions that meet or exceed their satisfaction.

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Anurag Shagun

Healthcare | Insurance | EHR | HIPPA | Agile| Event driven | Microservices | Azure Cloud| AWS |SQL |H1-B
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Constant feedback in necessary to shape your application. Following process can help better collaboration with stakeholders and other related parties- - Demo: processes like "show and tell", "lunch and Learn" can help demo your work and get early feedback - Retrospective: Feedback and retrospective meeting after every agile sprint, help to rectify mistakes and learn from mistakes

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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How can you lead Agile teams in a highly regulated industry?

1

2

3

4

5

6

7

1 Understand the regulations

2 Adapt your agile framework

3 Build trust and transparency

4 Embrace change and learning

5 Empower your team

6 Collaborate with stakeholders and customers

7 Here’s what else to consider

Agile Methodologies

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How can you lead Agile teams in a highly regulated industry?

1

2

3

4

5

6

7

1 Understand the regulations

2 Adapt your agile framework

3 Build trust and transparency

4 Embrace change and learning

5 Empower your team

6 Collaborate with stakeholders and customers

7 Here’s what else to consider

Agile Methodologies

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