So, your life science organization has made a resolution to improve your product development activities in the new year. Now what? Many factors need to be taken into account, and stakeholders from all facets of development need to be involved. Determining how to meet your organization’s directives while finding solutions that optimize your current capacities and resources can therefore be difficult. If you find yourself stuck trying to improve your organization’s product development in the coming year, there are a handful of approaches that can help.
Figuring out what to review can be difficult, however. While it might be tempting to look at the whole product design, this might not be feasible, especially with more mature projects. Instead, you might want to do design reviews based on:
Whatever approach you take for this new year review should be achievable based on your current capacities and resources. Determining that is not the easiest task, but it’s necessary in order to optimize effort while minimizing burden. Long, drawn-out reviews can force delays in project timelines, so adequate planning and preparation are key.
FDA and other regulatory bodies are constantly updating regulation and their positions on product safety and effectiveness, and it’s important to be well-informed on any changes. While your regulatory affairs personnel systematically monitor activity from regulatory bodies, the new year provides an opportunity for more defined compliance updates.
When enacting these updates, keep the rest of your development in mind. Often, working groups within your larger team—design, risk management, quality, regulatory, etc.—stay in their own silos; this can sometimes force design issues in later stages. While it is important to let your individual groups focus on their discipline, arming them with regulatory knowledge can bolster their work.
Therefore, consider running compliance updates jointly in the new year. Collaborative regulatory updates allow you to align your team’s design principles, as well as communicate your product’s compliance needs. These updates also offer a forum for personnel less familiar with applicable regulations and standards to obtain more information about them. This can promote a greater understanding of the organization’s compliance imperatives throughout your team.
Finding time to analyze and evaluate current development processes can be difficult. However, it’s necessary, especially since ISO 13485:2016 and other quality management system regulations encourage continuous process improvement.
For any efficiency you identify, your goal should be to continue supporting it and augmenting it when possible. This could entail anything from providing training refreshers to incentivizing greater levels of development progress, or even just giving your teams more managerial distance to do their work.
Likewise, investing in solutions for improvements should be prioritized. Sometimes this may involve greater levels of training, hiring additional personnel, or entirely retooling processes altogether. Resolving serious issues and critical gaps is important, so making the necessary investments is worthwhile. However, keep in mind that time and resources used in addressing improvement areas can and should be optimized to minimize cost and burden while maximizing outcome.
Remember that there is always room across your processes for improvement, regardless of when you conduct evaluations. Efficient processes aligned with regulatory requirements assist your teams in boosting their compliance efforts. Plus, organization-wide concerns—cost, time to market, etc.—are easier to meet.
Improving your processes is not an easy task. Compliance software can help, as can process evaluation, regulatory requirements updates, and design reviews, but there’s no singular solution that can act as a cure-all. Instead, mix and match your approaches and initiatives, and do this in an iterative fashion. Long-term improvement is more gradual than it is immediate, and quick fixes don’t always help. But, with some effort, you can find what works for your organization and bolster your development activities for years to come.