At what point in the process of developing a new device does your team start formally managing requirements and risk?

In talking with medical device companies, the most common answer we hear is “we don’t start worrying about that until the product is actually under design control.” That kind of time frame works great for the engineering side of the business, but often leaves marketing and product management in the lurch. The issue is that product management and marketing do the bulk of work on the front-end understanding the market need, defining a concept, and building a business case for the new product, including:

  • Capturing voice of the customer (VOC) feedback
  • Determining market/user needs and researching competitive offerings
  • Conducting cost and reimbursement analysis

Trace requirements starting at idea origination

Once a product idea makes it out of the concept phase, it goes through feasibility studies. If those studies go well, the idea ultimately makes into the development process. But what about the work your team did during concept and feasibility? In an ideal world, you should be able to link downstream product and technical requirements and risk artifacts with the front-end work that was done in gathering VOC and defining marketing requirements. Unfortunately, many teams use Microsoft Word or email to collect and distribute that early work. When it comes time for engineering to start developing the product, all of that early work is completely disconnected from the product development tools that engineering is using.

Our customers who use TestTrack in their marketing and product management teams have seen the following two key benefits from that setup.

Shift product design from a development-centric view to focus more on voice of the customer feedback. With VOC captured and better connected with the work that engineering is doing, it’s easier to design and build products that meet user needs. Stop relying on the development team’s ideas of what a user needs, and better incorporate actual user feedback into the design and development process.

Increase the chances of a successful product launch. When marketing requirements are clearly linked to design elements, technical product requirements, and risk artifacts it’s much easier to check into the product development process. If a key marketing requirement isn’t being fulfilled, or risk analysis and mitigation hasn’t been handled properly, the product manager or product marketer can quickly see that issue and raise it with the engineering team lead.

Check out our white papers and videos on improving medical device development to learn more.

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