Plan Now Pays Later
Typically, initial planning neglects to account for potential failures in manufacturing, clinical testing, or handling post-marketing complaints. This oversight can lead to significant setbacks. Prioritizing planning for success over acknowledging potential setbacks isn’t the most optimistic approach; instead, understanding the deliverables across the organization is paramount.
While regulations often lag behind, organizations prioritizing business-centric processes in product development, supplier quality, or elsewhere have the potential to excel. Effective risk management, when embraced, can serve as the primary driver in such scenarios, empowering you to navigate the path to success.
Developing a sustainable process is the backbone for successful product development, adapting to changes in business and regulatory needs throughout the product’s life-cycle. A swimlane process, shown below, was created in 2005 for a client’s new product development, a Drug-Device combo device. Over time, it underwent modifications primarily aimed at satisfying Global regulatory requirements without minor impact on the project, providing significant improvements in cycle time, reducing risks and failures during development and regulatory approval phases, and providing clear cross-functional deliverables. The importance of establishing sustainable processes for Product Lifecycle Management cannot be overstated, regardless of the project’s size or complexity.
Fortune cookies are an arbiter of truth when you understand their real meaning…Planning is great, but the real key lies in understanding consequences and risks. The journey of product and/or individual development presents ‘forks in the road’ requiring sound judgment and decision-making when deciding on a new path that may not have been in the original plans. Integrating risk management and consequential decision-making into your plans with clear communication keeps you moving forward, providing clear documentation for the technical files. As Dr Steve Covey highlighted, begin with the end in mind. Clear communications with ‘road signs’ keep you and your projects on the right path.
“It is better to travel than arrive.” Another cookie wisdom provides the sustainability of the journey for continuous improvement in ourselves, our products, and our organizations. As a trusted partner, Consult Wing LLC has been instrumental in helping organizations and individuals align to achieve their goals by providing sustainable business-centric solutions. Contact us for further information on how we can align, achieve, and sustain your products and services…
