Selecting the Right Medical Device Software Company – 3 (more) Crucial Questions

Ok I was wrong… In a previous blog, I shared my thoughts on the “5 Crucial Questions to Ask” when selecting a medical device software company.  Well, it turns out I was wrong – about the number of questions to ask, that is.

To be sure you are selecting the right vendor, there are actually 8 crucial questions.

My firm, Syncro Medical, has been in the medical device software development business quite a long time – more than 30 years.  In that time, many clients have shared tales of prior outsourced projects that didn’t go so well.  Some common themes frequently show up when a project fails.  These 8 crucial questions are intended to smoke out early warning signs.  By pressing for satisfactory answers to these 8 crucial questions, you’ll sidestep potential problems and instead, enjoy a successful vendor relationship and project outcome.

As a quick review, here are the questions I discussed in “How to Select the Right Medical Software Engineering Company – 5 Crucial Questions“:

  1. Does the vendor offer sufficient staff size and stability?
  2. How many long-term clients do they have?
  3. Do they ask good questions?
  4. Where will the software development be done?
  5. Do they project a culture of opennenss and integrity?

I have had the opportunity to discuss these questions with some of our clients, and I recommend you consider these three additional questions when qualifying a medical device software company:

Q1: Does the vendor specialize in software?

Does the vendor focus exclusively on providing software engineering services?  If so, you’re much more likely to receive best-in-class capabilities.  You can be justifiably skeptical of the one-stop shopping vendor that claims to be an expert in software and other disciplines such as hardware design, industrial design, or regulatory.  Would you select a general surgeon for your heart transplant or a renowned cardiac surgeon?  The same logic applies to software – insist on best in class.

Q2: Does the vendor specialize in medical product development?

This may seem to be an obvious question to ask, but when newer technologies are involved, specific experience in the medical product arena can appear to be less important.  But in fact, medical experience is even more so.

A recent example is mobile medical app development.  My firm was engaged to repair, and in some cases completely rewrite mobile apps developed by firms that offer expertise in mobile technology, but have little, if any complementary experience in the regulated medical space.  Inexperience in medical software process and unawareness of the nuances involved in UI and workflow for medical apps will negatively impact your product development.  Yes, it’s harder to find a vendor with both medical and mobile experience.. but it’s well worth the extra effort.

Q3: Will the vendor assign team members that have the deep experience you expect?

It’s very important to explore the firm’s staff profile.  Ask for the average years of relevant experience of their technical staff.  More importantly, what’s the experience level of the team that would be assigned to your project?  While it may benefit the vendor to populate your team with less-experienced, junior engineers, it certainly won’t benefit your project.  In fact, with less experienced staff on your project, costs and time frame will typically expand.  You absolutely want your assigned team to have a high degree of relevant experience in order to meet your time and quality targets.  Don’t hesitate to press for answers about the vendor’s staff profile, and ask to meet the team upfront.

I was about the number of questions to ask when evaluating a medical device software company.  But I can assure you that I’m correct about the need to press for answers.  If a firm cannot provide satisfactory responses to these 8 questions, keep looking!


Patrick Carr is President and CEO of Syncro Medical, a software engineering firm serving medical product manufacturers. Pat brings a wide range of experience from his prior management roles in medical technology companies. Pat focuses on optimizing both sides of the Syncro-Client equation: creating a stable, stimulating environment for elite engineering talent, and delivering top-quality results to clients. Pat is a strong proponent of the mutual benefits of developing long-term client relationships. He is a graduate of Harvard Business School. Outside of the office, Pat is president of an open space preservation organization. He also serves as a volunteer on various boards in the historic borough where he and his wife reside.

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