When to Ask Questions

When to Ask Questions

Solving Problems

Another great “soft skill” I learned from a mentor early in my career was knowing when to ask questions. You know, how long should I dig, research and investigate, before seeking the help of others? Some may gravitate toward spending too much time trying to find answers or solutions when it would have been more expedient to have asked questions from those more knowledgeable or familiar with the design or the task being performed. Others may be too quick to ask questions and do very little or no research or investigation. In the the engineering field, that latter would be least desirable since one learns through research and discovery.

My Suggestions

  1. Approach it systematically – make sure you pace your approach so as to complete your first pass of research and investigation within the time constraint. Ask your lead or manager their advice on how much time – my advice is about 8 hours. Great rhythm to spend a day educating yourself and good point to touch base with lead.
  2. Also systematically “circumnavigate” the problem. That is, consider, as best you can, all angles and views to the design or task. Consider users, user types, use cases, timing, capacities, faults/error conditions, general cases, specific cases, re-use, etc. Make a list of what you considered. When you review and ask questions from your lead, write down what they thought of that you did not. Add it to your list.
  3. Ask “dumb” questions. My mentor surprised me many times when I would hear him ask a question that I knew that he knew the answer to. I asked why he did this … his answer, “to confirm my assumptions.” That alone is gold my friend.

Onward! Let’s build safe, robust, and secure software for medical devices.

About the author

Partner and General Manager, Brian Pate is ISO 1385:2016 Lead Auditor certified for Medical Device Quality Management Systems (MD), and ISO 19011:2018 Management Systems Auditing (AU) and Leading Management Systems Audit Teams (TL). Brian started his medical device career in anesthesia clinical research in 1985 and has since worked both academia and industry including many years with Johnson & Johnson, Baxter Healthcare, and GE Medical. Brian’s roles have included software engineering, systems engineering, quality assurance, and regulatory affairs. Brian has served on multiple AAMI TIR working groups, including TIR32-2008 (Application of ISO 14971 Risk Management to Software; now IEC 80002-1) and TIR45-2012 (Guidance on the use of Agile practices in the development of medical device software) and served as a reviewer for the 2nd edition of TIR45. Brian serves on the AAMI Software Committee and as an AAMI instructor for the software, design controls, and agile methods courses. Brian also is a member of the Underwriters’ Laboratories (UL) Standards Technical Panel for UL1998 (Software in Programmable Components) and or UL5500 (Remote Software Updates).

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