Medical Device Benchmarks & Key Performance Factors

 

Situation: You're developing a medial device and need to know where to focus your efforts.

Producing medical devices is a challenging business. You face huge compliance hurdles and constantly changing requirements in a field where innovation and speed are everything. With all of that going on, it’s difficult to take a breath and understand what your peers are doing. Here is a quick and easy way to identify best practices and better understand how you are performing against a standard set of benchmarks.

The 2013 Medical Device Development survey delves into the product development process, examining key metrics used to track progress and the management of tasks that can be a heavy drag on your project. Respondents are asked to identify areas they wish they could gain better visibility into, as well as the roadblocks damaging their success rates. The survey explores design, risk, and quality control topics—how these areas are managed, analyzed, and traced—before turning to the commercial tools used in the development process.

Requirements, test cases, and artifacts are also covered—how they are managed, which ones are tracked, and which are the most difficult to manage. Also, respondents are asked about proving compliance. What is the most difficult item to prove? How do you provide objective evidence with test cases, or verify that they were completed? This leads into questions about traceability matrices, including how they are created, what is traced, how they are kept updated, and more.  You can find the survey here.

Note: This survey is being conducted by Seapine Software, who is a sponsor of ProjectManagement.com .