CERTIFIED: ISO 9001 | ISO 13485 | ISO 27001
CERTIFIED: ISO 9001 | ISO 13485 | ISO 27001

How to Select the Right Medical Device Software Development Firm – 8 Crucial Questions

How to Select the Right Medical Device Software Development Firm – 8 Crucial Questions

My firm, Syncro Medical, has been in the medical device software development business quite a long time – nearly 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 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.

Q1: Does the provider offer a stable staff of sufficient size?

A key thing to know is whether the firm has the critical mass to fully support your project throughout the development cycle. Smaller firms (staff less than 10) frequently find it difficult to support multiple client projects and meet deadlines.

Critical mass is also important in terms of what we call “bench strength” — having experts in several specific technical areas. Larger firms are able to tap these internal experts as needed to expedite your project.

Finally, the stability of a firm’s staff is important if you’re looking to establish a long-term relationship. What’s the average tenure of their staff? What’s their employee turnover rate? Are they available to handle issues after your product is released to market? Can you be assured that the same engineers (once spun up on your products) will be available to assist with future development needs?

Q2: How many long-term clients do they have?

This is an excellent surrogate indicator for a number of factors. Repeat business over many years with multiple clients provides a strong indication of the vendor’s track record for:

    • Meeting deadlines
    • Providing realistic estimates
    • Delivering high-quality results

Press for answers about how many of their clients have returned for multiple projects. Ask how long is “long-term”? Only two-three years? 10 or even 15 years is a much better answer.

Consider your own purchasing behavior outside of work. The service providers (auto mechanics, electricians, plumbers) you continue to use year after year are the ones that deliver quality results at a fair price. On those rare occasions when things don’t go exactly as planned, they act responsibly and make things right. It’s no different with a medical software engineering firm.

Q3: Do they ask good questions that help define the effort?

As in any hiring process, a key factor that can tip the scales in favor of one candidate – or in this case vendor – over another is whether they ask good questions. Do they really want to understand your project details pre-sale? It’s a very good sign if a vendor raises questions or topics that the other vendors didn’t … or if they surface issues you hadn’t yet considered.

The degree of thoroughness evidenced during the proposal process is invariably a part of the vendor’s corporate culture. In other words, you can expect to see the same attention to detail during the project itself that you experienced during the courting phase. This vendor would likely identify missing, incomplete, or possibly conflicting requirements early in the development process – when the cost of change is the lowest.

Q4: Where will the medical software development be done?

You’ll want to be assured that the engineers assigned to your project are all co-located at the same development center – and ideally within the same workspace. Some firms use a distributed model, whereby individual developers do their work in various remote locations. While touted as “efficient”, this approach is in effect quite the opposite, and prone to failures due to communication breakdown. Don’t accept evasive answers – make sure you know where the work will be done!

However tempting the offshore option may be, this trend now seems to be losing momentum. Based on our myriad experiences being hired to clean up offshore development failures, we advise caution — lots of it. Consider carefully whether the theoretical cost savings will play out. How much additional bandwidth will you need to apply in order to oversee progress? How much will slip through the cracks due to language, cultural, or time zone differences? What are the financial implications of missing the launch deadline due to software completion or quality issues? How safe is your company’s intellectual property on the other side of the world?

Q5: Do they project a culture of openness and integrity?

To get a sense of a vendor’s corporate culture, a site visit is strongly recommended for those on your short list. If you sense any hesitancy from your vendor about hosting a site visit, that’s a clear warning sign. You’ll learn quite a bit by being on their home turf. When you visit, try to engage some of the staff in conversation, even those not involved in your discussion. If you’re dissuaded from doing so, wonder why. A site visit is a great opportunity to get a sense of the personnel that could be assigned to your project. Are they articulate? Responsive? Knowledgeable? Is the culture compatible with yours? You should leave the visit feeling comfortable that the vendor will be easy to work with.

When it comes time to discuss the estimate, this is an opportunity to assess the vendor’s integrity. Do you feel the vendor’s estimate and proposed timeframe fairly represent the effort required? Are you being lowballed in order to get the business? Now’s the time to sniff out whether you’re getting an honest estimate, or whether it’s a “bargain” only to be followed by higher estimates later when you’re over the proverbial barrel .

An earnest vendor won’t be afraid to present a realistic estimate – even if it’s higher than what you expected – if they can demonstrate in sufficient detail how the time will be used. They understand that in the long run the client is better served by receiving an honest assessment upfront, even at the risk of losing the opportunity. An established vendor’s reputation is paramount, and they’ll be loath to risk it in order to close a single deal.

Q6: Does the provider specialize in software?

Does the provider 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.

Q7: Does the provider 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 has been engaged to repair, and in some cases completely re-write mobile apps developed by firms that offer expertise in mobile technology, but have little, if any, complementary experience in the regulated medical device 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.

Q8: Will the provider assemble a team with deep experience and commitment to quality?

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 up front.

Recap: Selecting the Right Medical Device Software Company

Asking these 8 crucial questions will greatly improve your evaluation process. You should expect a solid answer to each question. Once selected, the right medical software company will bring you an experienced development team – with the expertise needed to accelerate your time frame and ensure that your ship dates (and project objectives) are met.