It is no secret that an ideal medical device development team structure includes being co-located and multi-disciplined, with every product development lifecycle role included within that team.
The reality, however, is quite different: we are often a mix of integrated teams and silos in collaboration, striving to achieve the best product for our clients.
Silos can take many forms. They can be comprised of organizationally structured groups, product line divisions, contract workers, and even external partners. The challenges with these silos—including the burden of orchestration, disjointed traceability, and unaligned cadences—add up to a chaotic process with too many moving parts.
Some practices that have helped address the silo issue are tried and true, such as improving visibility to requirements and traceability, where the team agrees on traceability strategy early. Providing shared access to working and released documents as well as maintaining an up-to-date trace matrix throughout the life cycle are essential. Using an enterprise product life cycle management tool can also be helpful.
Creating cross-functional teams that include representatives from the various functions is key. These representatives have a dual purpose: They are ambassadors for their functional area, bringing information from their department or group to the product team, and serve as representatives of the product, communicating back to their department.
Be sure to choose representatives that are knowledgeable about the product and/or market, passionate about what the company does, and have influence within their own department. The members can then coordinate with the product team and their functional groups so that every member is involved in all requirement and design reviews. Combined with the use of collaboration tools, this critical step helps with the orchestration process and allows the systems engineering role to have ultimate oversight and authority.
As we synchronize across silos, cross-team planning cannot be emphasized enough. Key milestones and dependencies must be defined between teams and planning how teams will address dependencies requires frequent integration and cadence alignment. Also, consider an Agile framework for the system and use web-based productivity tools like Jira or Asana.
Team coordination and collaboration is not only desirable, but essential for the successful development of medical device products. Consistently giving this important issue the appropriate amount of foresight will ensure this goal is attained.