Building and maintaining capability to deliver innovative solutions to customers and patients is not easy. A clear innovation strategy guides investments in new technologies and solutions, and creates a balanced frame for trade-offs between short and longer term priorities. How robust is your product delivery system? Is it delivering the outcomes you need? Request a free consultation to map out your own transformation path.
Governance focuses on delivering the best portfolio outcomes and project value short- and longer term. Portfolio management helps clarify priorities for the organization, which enables faster execution by staffing active projects for success. The phase gates are used to evaluate and support individual projects. Flexible governance enables scalability and timely decisions based on complexity, risk and value.
Med Tech companies are immersing themselves in learning more about their end users and their eco-systems in order to build solutions that can address patient and physician needs more holistically. The best customer solutions bring together technology and behavioral science to address needs and enable new workflows, habits and collaborations. Moving from products to solutions is a strategic decision that requires thoughtful planning and often results in changes to business model, structure and skills.
Having a well-defined product delivery process gives product development teams a common frame with clear expectations and vocabulary that enables effective collaboration and outcomes. An integrated PDP sets the clear expectations for product design and development, industrialization and commercialization, and clarifies accountability within and across teams. The PDP is the bridge between governance and execution, fit-for-purpose, allowing for flexibility in choosing the best approach and methodologies for execution based on product and project type.
Design Controls ensure the safety and effectiveness of medical products -- establishing clear traceability and evidence to show that the products meet user needs. Upfront clarity of required documentation contributes to straight-forward submissions, and creates the foundation for value-adding product support and life cycle management. Aligning critical quality management system (QMS) elements -- Design Control and Risk Management -- with the overall PDP, and incorporating critical training to practitioners and management, ensures agreement on "what good looks like" and improves both customer satisfaction and compliance to global regulations.
Agile development methodologies are used increasingly in Life Sciences projects, beyond just software
development. Through this iterative development approach, requirements, plans and solutions evolve over time
based on frequent engagement and feedback from customers. Understanding agile development in context of the
overall product development process and design controls, is key to ensuring the right cross-functional buy-in and