Star Medical Device Engineer – Specification and Test Development

Technically creative product designs stoke engineering pride. Most medical device engineers are happiest when flexing their technical muscle – developing elegant mechanisms, designing clever electrical circuits, and writing creative code. Technical muscle grows stronger with every new product developed.

Strong technical muscle alone doesn’t make a medical device engineer a star. A great attitude is necessary too, but still not sufficient. Star medical device engineers also develop several other muscles needed to bring great products to market. One critical strength is the ability to develop great engineering specifications and tests.

Specification and test development gets no glory. I’ve never heard someone say “Nice specs!” or “Hey Jay, that’s a really awesome test you developed!” Specification development and test development are hardly taught in schools, so engineers typically start off weak in this area. (If engineering schools taught us everything we needed to know to develop products better, faster, and cheaper, we’d all start off as principle engineers.) When it’s not a strength, turning amorphous user requirements into a set of measurable product attributes can be intimidating. Most engineers shy away from this task and never become strong in this area.

Star medical device engineers, on the other hand, develop strong “specification and test development” muscle, and they build this muscle with every new product they develop. Star medical device engineers learn from more senior engineers, study specs and tests of existing products, and exercise this skill every chance they get. Star medical device engineers (and great contract development firms) allocate significant time to specification and test development at the beginning of every product development project. Why?

  • Test-driven development enables faster product development iteration. 
  • Good specs and tests drive the development process towards meeting user and business requirement and reduce the number of iterations. Clear specs reduce “design flail,” where an engineer or a team keeps trying different designs until someone (management, clinician) says “stop, just ship it.”
  • Well-specified bench tests are more reproducible and much cheaper than animal models. Bench tests can measure small but clinically meaningful differences between designs.
  • Good specs and tests ensure all elements of system work well together and help ensure future design changes don’t degrade product performance.

Just imagine how much longer it would take to develop new cardiovascular catheters without ISO standard specifications, glass model test fixtures (e.g. fromFinkenbeiner, Farlow Scientific, Malchow Glass, Glass Anatomy and Vasodyn), and standard pushability and trackability fixtures. Specs and tests accelerate timelines – it’s that simple.

Unfortunately, only a few specs and tests are available for purchase, so star medical device engineers roll their own. They pull, they push, they twist, they time, they flex, they kink and they pressurize. They quantify anatomy, characterize predicate devices, codify squishy user requirements and attack the task with the same ingenuity and effort that they’d apply to product design. Star medical device engineers set great specs and great tests to speed their path to product glory.


3 thoughts on “Star Medical Device Engineer – Specification and Test Development

  1. Jay, Thanks for this excellent commentary. The product you played a crucial role in designing and developing has now been used in over 3,000 patients and is obtaining excellent results.

    Jim Muller, MD

  2. Jay,

    I am really enjoying your posts on Star engineers, particularly your perspective on attitude. Folks with good attitude have a commitment to the team (which is much more capable than any one person) and a commitment to effective communication (that facilitates so much problem solving). Folks with good attitude positively impact team/company morale and, just as you point out, product development (e.g., time-to-market, quality). I’m looking forward to more Star posts.

    Kendall Waters

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