Medical Device Engineer Jobs Hard to Fill?
The 2022 medical device talent shortage is coming. If you haven’t noticed it already, and you likely have, the medical device industry is facing a shortage of experienced medical device software development engineers and test professionals. Unfortunately, a shortage of key talent can stifle innovation and productivity which means you could miss key product development deadlines, or worse fall behind in the competitive arena of medical device companies. Here are a few of the reasons why this is happening and what you can do to help mitigate this situation so you can keep on track with your medical device development, FDA approval, and launch plans.
Shortage of Software Developers
The pandemic took a toll on the supply of technologists, and software developers in particular. Due in part to travel embargos, limited access to educational loans, and delays in student visa processing, US colleges and universities observed declines in graduate-level enrollments in computer and information science. These declines are translating into one-year enrollment deferrals, meaning a temporary, but significant reduction in expected 2021 graduation rates which will have an impact into 2022 and perhaps beyond. 
Growth in the Medical Device Software Market
There has been a shift in increasing demand for high end technical roles among medical device companies, particularly in software development and engineering. A lot of this is driven by a very hot market for medical device software which demands software developers and engineers with relevant industry experience. In 2020, some of the biggest technological developments in the medical world came in the form of software. We are seeing that more traditional medical device companies are adding software, known as Software in a Medical Device (SiMD) as well as an emerging trend toward creating Software as a Medical Device (SaMD). Software that is run on or helps run things like an MRI, EKG, EHR, X-ray, insulin pump, etc., qualifies as SiMD. SaMD software functions independently of the existing device though most often in conjunction with it by helping to process data and improve patient outcomes. Telehealth and a growing consumer and physician interest in remote monitoring during the pandemic has helped catalyze growth in these areas. The global medical devices market is projected to grow from $455.34 billion in 2021 to $657.98 billion in 2028 at a CAGR of 5.4% in the forecast period.
Heavy competition for software development roles
Medical device companies, particularly startup or early stage growth need to keep in mind that they are not only competing with their competitors in the medical device industry for technology talent, but also what is commonly referred to as Big Tech or the FAANG companies (Facebook, Amazon, Netflix, and Google) who hire volumes of software developers and software engineers, offering impressive hiring packages and salaries. All of these things can mean that your software developer and engineer roles can go months unfilled. Rather than push plan further out, what can you do?
3 ways for medical device companies to bridge the resource gap
We recommend 3 things that you can do to help your medical device company stay on track when medical device software development talent is hard to find.
- Be flexible in your requirements but don’t settle for lack of medical device experience
- Consider outsourcing
- Find an interim solution
Let’s go through these one by one.
Don’t settle for lack of medical device software experience
Medical device development presents an array of challenges that engineers and developers used to traditional embedded development may not be familiar with. According to Sedgwick’s Q3 recall index , after falling for four straight quarters, medical device recalls jumped from 173 events to 235 events quarter-over-quarter, representing a 35.8% increase. And the number one reason for recalls was software issues. While larger companies with a little more flexibility and time might have the option to train to the unique traits presented by an FDA regulated industry where software issues at best could result in a recall, or worst life or death scenarios, startups and early stage companies would be best advised to leverage only software developers and engineers with years of industry experience.
Consider outsourcing medical device software development
Rather than spending months searching for qualified medical device IT talent, one option might be to outsource your software development, engineers, or testers to experienced professional teams who can easily step in and handle critical development projects, keep your product launch on time, and ensure that you get through your pre-market requirements, the first time.
Use interim medical device software expert resources
Maybe you don’t want to outsource, that you’d prefer to have your team all inhouse, for convenience, confidentiality or other reasons. That doesn’t mean you have to put your plans on hold. One option to consider is to use interim medical device software experts to bolster those areas where you have gaps. An expert team with years of experience in the detailed regulatory environment and medical device quality management can not only keep you on track but can accelerate your projects and take the load of your existing team, freeing them up for important internal development work, so they don’t have to be bogged down in the day to day detail work. As the FDA increases their oversight of medical device software (SiMD and SaMD), having a resource who knows the latest requirements can make the difference. In the past several months, the FDA has expanded its risk-based approach by requiring more documentation for premarket submittals, (focused on device software function safety), with 4 risk-based factors used to help determine the documentation level –either Basic or Enhanced. The documentation level is based on the device’s intended use, not the individual device function(s). Working with seasoned medical device professionals with a long history of FDA submissions will ensure a quality product and shrink your time to market.
If you are facing these challenges, call Advantu today to explore leveraging our outsourced or interim managed services to keep your company on track. We help clients build medical devices & instruments their customers can trust with QMS process support that’s fully FDA compliant, along with a host of software development and verification & validation services.
