Success Story
The Challenge
Senior leadership at J&J Medical Devices needed to conduct a detailed assessment of their entire new product development (NPD) portfolio to ensure strategies and budgets were appropriate and aligned across business units.
When they started the assessment, they discovered that the unique NPD processes in use at each business unit made it nearly impossible to get a clear, franchise-level view of what was happening.
The stark differences in NPD systems and stage-gate processes had arisen as a natural consequence of multiple mergers, acquisitions, and organic growth at each business unit. Each business unit had differing definitions and requirements for each stage of the NPD process, making it impossible to perform cross-portfolio comparisons of new products. But this inefficiency had an impact well beyond the decision-making capabilities of senior leadership.
Because of fundamental differences in their approaches to NPD, business units were having problems with interdependent working, which was becoming increasingly common, particularly for functional shared services. For example, labelling was managed at a franchise level, but the input process differed between business units, causing delays and forcing work to be redone.
Communication between business units was a particular challenge. Because each business unit used different terms, definitions, and sub-process steps, they had to pause to interpret each other’s processes when they worked together. A time-consuming, and thus costly, step.
The deadline to harmonise NPD processes across 7 business units was set at 12 months. This would include writing new, universal processes, getting buy-in on the new processes from business-unit leaders, and implementing the new processes and training stakeholders within each business unit.
A daunting project with the potential for immense benefits, including streamlined portfolio management and consistent, efficient working practices. With all projects working under the same stage-gate and NPD processes, it would become far easier for leadership to understand the progress of projects, their risks and benefits, and the proper allocation of resources.
An additional challenge was persuading each business unit to change its process. Each was, unsurprisingly, wedded to their own ingrained process. Such a fundamental change to their day-to-day work promised significant disruption to operations. This instigated a high level of internal resistance to the initiative.
The Choice
Despite their resistance to changing their NPD processes, each business unit had anecdotal experience that made it clear that harmonisation was necessary. So the task became less about convincing them of the need for the project, and more about finding someone who could manage stakeholders and get the job itself done.
Senior leadership again called on Stuart Grant to lead the initiative. His extensive experience and knowledge of NPD processes and product innovation theories plus his proven ability to collaborate with multiple business units, made him the top choice.
Stuart’s decadelong role in establishing and leading the design control committee for the joint reconstruction business was a particularly important to his selection. In that role, he had maintained the procedure ecosystem and ongoing training. The consistency of his approach and the depth of his knowledge had markedly improved the efficiency of the joint reconstruction NPD team during his tenure.
Because he not only owned NPD procedures, but used them every day, he had a deep understanding of how each element was created and integrated with other requirements. For instance, the relationship between the design history file (DHF), risk management, and usability engineering.
Because each procedure has its own inputs and outputs, aligning them to the overall NPD process ensures an effective flow of data during the process, which prevents chicken-and-egg situations that cause conflicts and delays.
The Solution
Stuart began at the beginning by examining fundamental governing standards. He then reviewed the existing procedures across each business unit. He benchmarked the standards and compared how each unit executed those standards.
Above all, the goal was to avoid creating a “Frankenstein’s monster” that mashed together the different processes of each business unit. It had to be a simple process that included only what was essential.
Stuart chose a bottom-up approach, starting with design control procedures. Design control procedures are required for compliance and must be in place and correct before anything else.
From there, he moved on to the NPD process, because design-control outputs feed the NPD process. Getting this stage right increases the efficiency of each development project and is outside of compliance requirements.
After developing the design control and NPD processes, Stuart developed the stage-gate process. The stage-gate process, at the top level, is a business process and primarily manages the project portfolio and governs all active development projects.
Working with each business-unit leader, Stuart generated questions for each gate, then verified and validated the questions to ensure they met relevant regulations and standards.
Once the entire process was developed, there was a negotiation and review period with each business unit leader. This involved addressing and clarifying all queries and resolving any issues they raised to ensure they were aligned with the new process.
Strategically, the goal was to create a revised NPD process that would be simple for all stakeholders to quickly understand and effectively use. This would ensure a nominal learning curve and thus minimize disruption to in-progress projects. Extensive delays caused by instituting a complex new process would delay product launches and damage business unit performance, an unacceptable result.
One surprise challenge was an outlier business unit that refused to implement the new process. Because it was the smallest of the 7 business units with few active development projects, they felt it was unnecessary to use a stage-gate process to manage their portfolio. Stuart and team decided to proceed with the other 6 business units with the hope that they would adopt the new process after seeing it work.
Eventually, they decided to adopt the process for all new product development but keep their existing process for in-progress projects, which was an acceptable workaround.
Another challenge Stuart faced was convincing regulatory compliance and quality management teams that the new process was compliant. This was a difficult discussion; much of what compliance and QM teams do is based on their interpretations of regulations and standards, which are based on their own unique experiences, company cultures, device specialty, and audit experience.
To cut through the layers of interpretation at each business unit, Stuart returned to the text of standards and regulations to have a clear understanding of their intent, allowing him to challenge interpretations and assumptions. Again, this allowed him to avoid creating the Frankenstein’s monster that would have resulted if he cobbled together each team’s regulatory interpretations.
The Impact
The results were excellent. The NPD and stage-gate processes enabled the organisation to have a clear picture of the projects, improving senior leadership’s ability to assess the entire NPD portfolio and enabling speedy decision-making and resource allocation.These processes helped efficiently evaluate the risks and benefits of each innovative MedTech product in development and ensured that the necessary resources were available to the products that most aligned with the company’s overall strategy.