Why Can’t You Find A Qualified Medical Device Software Project Manager?

Waddell Group has seen increased demand for Software Project Managers for Medical Devices over the past several months. In our searches, these people are hard to find and extremely valuable when it comes to projects. Because they are scarce, there is a significant demand for their time, adversely impacting many medical device projects. Let’s understand why finding a good Medical Device Software Project Manager is difficult and potential solutions to combat it. 

The Importance Of A Medical Device Software Project Manager

Information technology is advancing in leaps and bounds, and the medical device industry has left no stone unturned to leverage these advances for better healthcare. These days, very few medical devices consist solely of hardware. Most have software that controls, operates, or drives the core modalities of the device in question. 

And just like most software, medical device software also requires constant updates, management, and debugging. The lack of this can drive a project over time and budget. Making the requirement for a qualified software project manager a matter of some urgency.

However, just any software project manager won’t do. The medical device industry is a high-stakes, highly regulated industry, where one misstep can endanger patient safety or open the stakeholders to a host of legal issues. That’s why having a qualified medical device software project manager working with you is important. This means a project manager who is:

• Learned in software development and software lifecycle management. 
• Aware of the applicable product safety standards and market regulations for medical devices.
• Able to adapt to the latest project management tools and techniques used in the medical device industry.

Let’s elaborate on these below.

The Roles And Responsibilities Of Medical Device Software Project Managers 

According to the FDA, medical device software can be classified into three types: 

• Software as a Medical Device (SaMD): software intended to be used for one or more medical purposes without being part of a hardware medical device. For example, the CAD software that performs image post-processing to help detect breast cancer.
• Software in a Medical Device: software that is integral to a hardware medical device. For example, the software that controls the pumping of medication in an infusion pump.
• Software used in the manufacture or maintenance of a medical device. Like ERP systems and software used for Quality Control and Analysis. 

Depending on what software they are working on, the Medical Device Project Manager’s role varies. They are generally responsible for:

• Defining key project objectives such as scope, schedule, resources, and risks.
• Collaborating with software technical leads, engineers, and functional managers on planning and executing the medical device software project.
• Risk analysis and crisis management.
• Developing, tracking, and analyzing key performance indicators of the medical device software and project.
• Communicating effectively with software engineers and cross-functional teams that may or may not have a technical background.
• Managing a hybrid team of remote and on-site software engineers.
• Incorporating patient safety and ensuring compliance with codes and standards like FDA Part 820, IEC 62304, ISO 13485, ISO 14971, MDR, and MDSAP.

Consequences Of Not Finding A Suitable Project Manager For Your Medical Device Software Project.

Working with a software project manager who is unaware of the medical device industry, its norms, and rules can lead to: 

• Possible errors that affect patient safety and cause legal issues.
• Delays with product releases due to incompatibilities between hardware and software.
• Compliance and regulatory issues which can halt production or cause product recall.

All this can have long-term and short-term repercussions that ultimately impact the bottom line, profit margins, and company reputation. 

But finding a qualified medical device software project manager is not that easy.

Why You Can’t Find A Qualified Project Manager For Your Medical Device Software

The Need For Very Specific Skillsets To Deal With Very Specific Challenges

As medical devices become increasingly advanced with each passing year, so too do their accompanying software applications – techniques once thought revolutionary quickly become obsolete as innovation drives forward at breakneck speeds. 

As a result, any Medical Device Software Manager worth their salt should have both:

• experience with highly specialized software systems and processes necessary for medical device development
• and the skills to keep up with the constant technological advancement in the field. 

They should understand the complexities of healthcare regulations, standards, and protocols. And must be well-versed in established project management processes and methodologies (Waterfall, AGILE, SCRUM, hybrid), along with core healthcare competencies like:

• Risk management
• Project planning
• Quality assurance
• Process optimization 
• And more. 

That also means having special knowledge of risk categorization, Quality Management Systems, and clinical evaluation for Software as a Medical Device

Plus, with more and more IT work going remote, they must also possess the capability to manage remote or hybrid teams. This is on top of effective leadership, communication, and problem-solving skills essential for any project manager.

With software going borderless, and new concerns for privacy and public safety, IT laws also change quickly. A medical device company needs someone who stays on top of domestic and international IT laws like GDPR.  

Being a Medical Device Software Project Manager requires a combination of hard and soft skills to take complete ownership of the project and team.

Here’s a diagram that’ll explain more. 

Medical Device Software Project Managers Are Expensive

If you think Technical Project Managers for medical devices are difficult to find, try looking for a medical device project manager experienced in software as well.

Software is specialized and expensive, and people who work on it are even more so. So it’s a challenge to find someone with all the above skills who can manage it without exceeding the budget. And if they are so qualified, they will – and can – charge big bucks. 

Not many companies are willing to part with that kind of money. But if you are playing the long game and want to keep up in the race to the top on time and on budget, you need to start looking for that candidate yesterday.

Another reason they’re expensive; the law of supply and demand. 

The Law Of Supply And Demand

As the industry starts moving towards more technologically advanced medical solutions, the demand for Medical Device Software Project Managers increases. Currently, this demand exceeds the supply. One of the things driving demand is that insurance companies require proof that SaMDs and Software in Medical Devices actually work and are in use.

For example, one of our Project Managers is working with a company that provides physical therapy machines with specialized software to people in rehab. Insurance companies supporting the centers or the individuals in rehab need to ensure that people are actually using these machines before reimbursing them. And this is just one example of many. For this includes a host of software-related issues like:

• Data security issues, 
• HIPAA security issues
• Managing data in the cloud
• Presenting the data to people in layman’s terms
• Data anonymity for the insurance company. 

All this requires a medical device project manager that’s also an expert in that (or related) software management.

Which is why we have to explore the potential solutions. 

Exploring Potential Solutions

Finding a Medical Device Software Project Manager who fits all the above criteria would be like finding a needle in a haystack. We are not looking for a unicorn here; we just need someone who understands the necessary aspects of medical device software plus project management. 

Here are potential solutions to bridge the gap between demand and supply for the same. 

Change Your Approach To Find People Who Meet The Criteria For Your Project

Before looking for the right fit Medical Device Software Project manager, you need to:

1. Understand your project and its needs
2. Know your team members, their working style, and leadership needs. 
3. Figure out what will be required from the medical device project manager to bring the project to completion with the existing team seamlessly.
4. List the criteria
5. Look for someone with integrity who is willing to learn and fits most of the criteria.

You can also explore other alternatives to direct hiring and recruitment. 

• Leverage your network.
• Collaborate with educational institutions to gain access to their expertise and resources. 
• Hire a recruiter that specializes in the medical device industry.
• Develop incentives to attract new talent or encourage existing talent to upskill.
• Think of bringing in an external contractor or project management consultant.

Train Existing Employees

Someone once said if a team runs itself for six months while you hire a manager, you shouldn’t be hiring; you should be promoting.

The same holds true for any new requirement. Who better to know a project or your company than an existing employee? If a software engineer in your team displays leadership abilities, aptitude, and willingness to learn project management, train them to step up as a Medical Device Software Project Manager.

Hire Qualified Contractors Or Project Management Consultants Instead Of Full-Time Employees

Sometimes, hiring external consultants who are qualified as medical device software project managers saves you a lot of time, money, and aggravation. You just need to find the right fit consultant. Our project managers (who have an average of at least 10 years of experience in the medical device industry) have worked full-time or on a fractional basis, with contracts measured from weeks to years.

You can read some of our success stories here. 

You can also get in touch if you’re looking for a medical device project manager to help you with your project management needs. 

Look To Other Industries

Until the shortage of qualified software project managers for medical devices is filled, companies should start looking to software project managers from other industries with similar environments and requirements. Are there any transferable skillsets, education, and experiences? 

For example, industries like aviation, pharmaceutical, energy, etc. are as highly regulated as the medical device industry. Project managers from these industries can work in a high-pressure, high-stakes environment, making it easier for them to work in the medical device industry. 

Additionally, these potential hires may bring an expanded set of skills and knowledge that could benefit the organization in new ways. 

The only catch, you should be prepared to provide these individuals with more training to ensure they are up-to-date on all relevant regulations related to medical device software development before taking on the responsibilities of managing projects.

Benefits Of Finding A Suitable Project Manager For Your Medical Device Software Project.

Once you have found, trained, or hired a Suitable Software Project Manager For Your Medical Device Project, you’ll be able to breathe easy knowing your project will:

• Have reduced regulatory risks and delays. 
• Run more smoothly because of greater flexibility in choosing methods and techniques of product development that suit your project and company needs. 
• Have a better timeline and bottom line, as potentially costly errors will be prevented.

Medical device software development requires specialized knowledge and experience that few modern professionals possess in one comprehensive package. Plus, different projects require different types and levels of technical knowledge. It’s up to you to understand what your project needs and match the right knowledge and experience with the right person. If you need any help with that, Waddell Group will be happy to step in. 

We can be your resource if you’re looking for a Medical Device Software Project Manager. If you are a project manager who knows medical device software and is interested in consulting, we definitely want to talk to you. 

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Credits: in order of appearance, illustrations by katemangostar and pch.vector and on Freepik