Development requires understanding both the product technology and the biology of the disease.
Successful development requires a complete understanding of the variables imposed on the development process from specimen acquisition through to final result.
Finally, development requires having the expertise to design a product that can be successfully transferred to a manufacturing setting. Doing this takes patience and specific experience applying relevant standards and meeting requirements imposed by the regulatory and market strategy.
Research and Development
Though they are overlapping scientific disciplines, research work and development work do not use the same skill set. Product development is a distinct specialty that combines traditional lab bench science with expertise in engineering, manufacturing and business requirements.
Many early-stage companies invest heavily in research but are unable to create adequate capabilities in development. As a result, talented researchers are often taken off-task and asked to move a product into development without much development experience.
Key development questions include:
- Do my development scientists have a deep understanding of manufacturing issues for my type of system?
- Have I involved experienced developers during the requirements process when their input is critical?
- Does my development team understand how to balance product and manufacturing requirements with relevant standards and business strategies?