The year has begun and it’s only a question of time before your executive team asks you about the progress of your program. Is this your year for a thoughtful, well-executed program? In our experience in medical device, biotechnology and pharmaceuticals in the area of software product development and regulatory, we have identified a few tips that might be helpful for you:
1. Build a technical framework
By building a technical framework, your software development team can proactively avoid technical debt. In software product development, technical debt can occur due to commercial needs. Over time, the technical debt can become costly and challenging. If you are in a situation with high technical debt or would like to build a technical framework, BeanStock Ventures can help. However, the ideal situation would be to ensure writing code that does not violate good architectural or coding practices.
2. Scale Your Team
Scaling your team is often thought about in terms of size. However, best practice includes identifying the needed skillsets for your project as well. If your team is currently stretched and timelines have been escalated or more products have been handed to you to develop, you are probably considering a larger team. Alternatively, or in addition to, your team may need to execute on a project where they need additional skillsets. It may be helpful to have a product development organization bridge the gap until your team is up and running. This is especially so currently where skilled software professionals are in increasing demand.
3. Understand the Regulatory Landscape
With the introduction of Software as a Medical Device (SaMD), EUMDR and other compliance, leaving regulatory requirements to the last stage of product development could result in rework and an increase in costs and a delay.
4. Develop a Strategic Program Framework
When does your organization expect to start selling the product? Do you have a Strategic Program Framework to meet the goals at the desired time?
BeanStock Ventures is a third party approved (3P510k) FDA accredited organization.
We have a good understanding of how long a clearance can take and the type of requirements needed. Ensure you have mapped the program with sufficient time for execution and for the product to be cleared.
5. Extending Your Expertise
Does your team have the skillsets needed for the software product development and regulatory concerns? In our experience working with large and small organizations, we’ve observed a gap in the modern software engineer skillset. You may decide to integrate training into their 2022 performance management to ensure that your team is ready to execute. The Software Online Agile Regulatory (SOAR®) Training may be a helpful overview.
Click here for more information about SOAR®.
We wish you a successful and efficient 2022! BeanStock Ventures is here to support your software product development and quality needs if you have identified any gaps in any of those tips. For more information, contact us at: marketing@beanstockventures.com
