December 22, 2015
Balancing the Development Process
Is your development process balanced? Are you meeting the needs of your engineering, software development, quality assurance (QA), and regulatory teams? If so, you’re ahead of 90% of the medical device development industry. As we reported in State of Medical Device Development 2015, very few respondents found this balance easy to achieve. Out of more than 900 respondents, less than 10% met the business needs of all groups without difficulty. [caption id="attachment_18076" align="aligncenter" width="650"] How difficult is it to balance the business needs of Engineering, Software Development, QA, and Regulatory?[/caption] When a company is out of balance, they either lose the ability to innovate or experience a decrease in quality, depending on which team has more weight. If you lean too far toward regulatory, for example, you become so focused on regulations that you’re hesitant to explore greater communication or development efficiencies. Innovation takes a nosedive. If a company puts too much emphasis the software development side, quality may slide. Risk goes up.Email sign up
Many Moving PartsOne of the reasons it’s so difficult to achieve balance is because the development process has a lot of moving parts. When you add regulatory compliance into the mix, it adds a whole new level of complexity. We asked our survey respondents to name their most difficult areas to balance, and they identified delivery expectations, verification and validation (V&V), and documentation as the top three. [caption id="attachment_18079" align="aligncenter" width="611"] What are the three most difficult areas to balance in the development process?[/caption] When you look at the graph above, you can see that most of these categories can be broken down further, adding even more elements that need to be monitored, managed, and traced.
Is Balance Even Possible?Is it possible to balance all of these spinning plates? That is, can you strike a balance that meets your business goals? The short answer is, “Yes.” The longer answer is, “Yes, but it takes a some work—and possibly some additional tools—to get there.” Many companies adopt tools to help foster communication between the core teams involved in product development—engineering, software development, QA, and regulatory. Improved communication is a good starting point, but to satisfy the unique needs of these groups, it’s important to understand their key desires and goals.
Where Do You Begin?Our white paper, Balancing the Product Development Process: 3 Functional Areas to Consider, is a good starting point. It takes a look at how balancing these core functional areas will help lower production costs and get products to market faster, while maintaining a high degree of product quality. In addition to examining these areas, the paper also offers tips for striking a balance between them, including:
- Find the existing similarities between the groups.
- Evaluate what works and what doesn’t.
- Meet with each team lead individually to discuss how their team works.
- Find a neutral party to arbitrate the discussions to overcome internal politics.
- Create an action plan after reaching a consensus.