It is unfortunate that this scenario occurs in many organizations but the good news is that things can change. The following are lessons learned that should be implemented to improve the organization’s effectiveness in design and development planning:
- Management should convey a culture of compliance. This can only happen if management puts compliance as a first priority in word, action, and procedure. The product should be developed “the right way” as a first priority and then on time as a second priority.
- Adequate planning time should be given to the product development team so they can provide realistic timeline and resource requirements prior to management committing to revenue promises (or other similar business projections).
- Management should not put undue pressure on the development teams to go back and “re-assess” design decisions (a.k.a taking short cuts or risks). The establishment of the development team with independent reviewers acts as a “checks and balances” system which minimizes the biased influenced from some stakeholders to influence decisions based on pressure to meet financial goals. This undue influence is often against an organizations procedure and borders on unethical business practices.
- The project manager is responsible to push back to management if unrealistic timelines are set which may compromise the safety and effectiveness of the product. Short cuts in developing design and development documents should not be used to just “check the regulatory box”. The effective use of a Design and Development plan is a useful tool that increases the likelihood of developing a safe and effective product and should be used in compliance with FDA regulation.