3 Tips to Fast-Track Your Medical Device Development

By Megan Kuhn

The medical device development cycle can be a continuous iteration of progress and setbacks, but the competition for releasing the product to market puts the pressure on medical device companies to expedite a quality delivery and minimize delay. Pushing the project at breakneck speed results in cutting corners in the name of expediency and can have the consequence of forcing the team to compromise on quality if not properly managed. But, the good news is that the fast-track does not need to mean compromising quality for time. When applied artfully, fast-tracking your product development ensures product quality while maximizing the time and efforts of the team. The next time you want to effectively fast-track your product development, consider these few tips:

Learn how to design next-generation medical devices at the MD&M East conference, June 9–12, 2014 in New York City.

1. Settle on a solid project definition.

With the excitement of a new project, it’s easy to the let the team scatter and work on their respective areas. Everyone seems to understand the final objective but may not agree on how to get there.

The earliest phase of product development can often be the most uncomfortable because it inherently lacks structure The key here is to embrace it! This phase can be the most exciting since this is when you have the opportunity to incorporate fresh ideas. However, under an aggressive timeline, a frenzy can sweep the team into a spree of misaligned efforts.

To avoid this, focus the team’s early efforts on hammering out the project definition and requirements, and honing the technical approach. Teams are often anxious to add value, but without a structured approach and consensus on that approach, they lose momentum. You will know your team is on the fast-track when they can each provide the primary objectives and technical approach verbatim.

2. Establish a smart scope.

To meet an aggressive product development cycle, the scope of the project could be your opportunity to fast-track product development. When the schedule is king, unidentified elements of the project may need to bow out.

Work with the team to define the product elements and features that are in and out of scope. An easy way to clearly illustrate this is to draw out the must-have items from the nice-to-have items. When working under an aggressive timeline, it’s imperative to understand the purpose and fidelity of each milestone. The purpose and fidelity will inform the complexity of the feature set, the required effort, and documentation appropriate for each milestone. This will ultimately allow the team to navigate the schedule while maximizing their efforts.

When taking this approach, remember that items that have been removed temporarily from the project scope can be revisited and possibly reintroduced into the project for the next milestone or target. Identifying the proper timeline and strategy for reintroduction of such items can be the difference between staying on track and falling behind the product development schedule.

3. Plan for the fast-track.

Product development requires trial and error to meet the best outcome. It’s a process of learning and improving, and what is product development without the occasional fumble before triumphant discovery? So how do you fast-track a process that requires unplanned errors along the way?

Product development risk and error are unavoidable, so plan for project catalysts to offset the undesirable outcomes (i.e. scope creep, technical setbacks, delayed schedule, etc.). An aggressive product development cycle comes at a cost, but these costs can be minimized to accelerate the schedule if spent strategically. Here are a few tips depending on the project budget:

$$–$$$. Implement a Phase Zero effort prior to launching a full, aggressive product development effort. The intent of Phase Zero is to understand the technology and regulatory strategy, and build the business case necessary for mapping an effective product development cycle (see “From Phase Zero to Product Development Hero: A How-to Guide”). The length of Phase Zero varies but can take as little as a few weeks depending on the complexity of the product. Note: The Phase Zero should not be confused with a Planning Phase, as the objective here is to build confidence for successful product development and not map the milestones for the project.

$–$$. Employ the aid of a subject matter expert at the critical planning stages of the project. There is no substitute for experience when it comes to identifying countermeasures specific to the project at hand.

$. Recommend form factor models and/or fit-check prototypes. With the plethora of fabrication houses, form factors and fit-check prototypes are convenient ways to mitigate risks on a tight schedule. These options require a relatively low investment for the time they can save on the tail end of a project sprint.

The next time you want to fast-track your product development or you’re simply on an aggressive schedule, kick your project into high gear by incorporating the tips above.

Learn how to design next-generation medical devices at the MD&M East conference, June 9–12, 2014 in New York City.

Megan Kuhn is a project manager for Stratos Product Development. She is a versatile project manager with experience uniquely honed through a leadership rotational program allowing her to manage teams and projects through the full product lifecycle: concept and detailed design, manufacturing hand-off, supply chain operations, and field service and end-of-life support. Kuhn's experience includes the development of class II medical devices, and working within FDA and ISO requirements for medical quality management systems. Prior to joining Stratos, she worked at ARCCA Inc. as a biomechanical engineer and at Philips Ultrasound as a part of their Leadership Development Rotational Program in Ultrasound. Megan holds BS and MS degrees in mechanical engineering from the University of Washington. She can be reached at mkuhn@stratos.com.


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