According to a survey conducted by the Project Management Institute (PMI), 97% of organizations believe that project management is critical to business performance and organizational success. The same survey found that 80% of high-performing organizations attribute their success to the use of standardized project management practices. Now that we have established the importance of hiring a project management consultant for your medical device company let’s move on to exactly how you can do that. 

Hiring a medical device project consultant: What you need to know, will go into detail about:

It will also provide you with additional resources to make the process as simple and painless as possible, helping you make the right choice for your project. 

Hiring a medical device project consultant: What you need to know

What is a medical device project management consultant?

Medical device project managers and management consultants help companies navigate the complexities of the medical device industry and achieve successful product development and market entry. 

And good project consultants do that on time and budget, keeping the company and product goals in mind. They manage projects across multiple functional areas while working with applicable product safety standards and market regulations for medical devices and healthcare. 

Experienced project consultants in the industry know how to adapt the latest project management tools and techniques for medical device development and process improvement. They then implement these techniques to control costs, speed outcomes, and manage risks in a healthcare environment. Making their contribution to your medical device project almost invaluable. 

Want a peek into what kinds of projects your medical device project management consultant can help you with? Take a look at this article >>8 types of medical device projects Waddell Group consultants work on 

Identifying Your Project Management Needs

Different medical device projects have different needs. Some projects may require someone to reintroduce their projects to market successfully. While others may need help with getting a medical device project back on track.  Some others may need a medical device project manager to build a manufacturing plant internationally. 

Before looking for a medical device project consultant for your needs, keep the following in mind:

• Project and company budget: This will help you identify consultants or consulting firms that align with your financial constraints. Remember, a consultant with experience may charge a higher fee, but their expertise is invaluable.
• Type of project:  Is it a marketing project? Does it require someone with regulatory expertise? Is it a recall management project? Or perhaps a restructuring project? The right fit consultant should have the education and experience necessary to match your project type.
• Type of device: A medical device may include a combination of electrical, mechanical, biomechanical, software, or pharmaceutical components. What component/s does your device include?
• Regulatory Knowledge: If regulatory compliance is a significant aspect of your project, ensure that the consultant has a deep understanding of the relevant regulatory requirements in your target markets (e.g., FDA, CE Marking, etc.).
• Timeline: Make sure your project timeline is clearly mapped out and matches with the project management consultant’s availability.
• Location: Is your project remote or local?

Once you identify your project management needs, you can look for a project manager that matches most (if not all) of them.  

Qualities to look for when hiring a medical device project consultant

Your medical device project manager should have knowledge of, or at least be willing to look into, the following (depending on your project requirements):

• The technicalities of a medical device development process.
• Current market, geographical, and industry-specific boundaries.
• Various medical device industry niches and their differences.
• Legal, quality, and regulatory requirements specific to the medical device project.
• Risk management. 
• Design controls.
• Process optimization.
• Quality management systems for medical devices.
• FDA, EN ISO, CE, and other quality and regulatory bodies.

How closely does their experience match what’s needed for your current project? What project management and leadership skills do they have? Can they:

• navigate complex projects successfully?
• understand people?
• effectively communicate with other team members?
• motivate people?
• lead people to individual and team success?
• manage employees across skill sets and performance levels?

A good medical device project manager also needs to have self-awareness, integrity, and accountability in spades. They should know their personal ‘why’ and be able to take decisive action while communicating clearly and timely. 

Peter Drucker, the father of modern management,  believed that business leaders need to embrace the “spirit of performance” by displaying high levels of moral and ethical integrity in their actions, focusing on results, empowering employees, going beyond financial obligations to shareholders, and ultimately serving the common good.

Evaluating their background and experience

A project manager’s skills, specializations, and experience can make or break a project in a highly regulated industry like medical devices. You can get a decent idea about their reputation and the quality of work by looking into their education and experience, interviewing them, and requesting and checking references from past clients.  

Here’s how you can do that.

1. Ask the project manager to provide references (with contact information) from their previous clients or employers.
2. Reach out to the provided references, introduce yourself, and explain your purpose for contacting them. Set a time to get answers to questions related to the project manager’s performance, strengths, weaknesses, and their impact on the projects they managed.
3. Look for any online reviews or testimonials related to the project manager’s work, if available. Websites like LinkedIn and professional networks can sometimes provide insights from past clients or colleagues. You can also evaluate the case studies, if any, provided by the project management consultants.  

As experienced project management consultants of over 20 years, we make sure that our medical device project managers come highly recommended and are a proven fit for your project. You can see our selected case studies here.  

Their project management methodology and approach

Knowing a consultant’s project management methodology and approach will help you understand their thoughts on effective project planning, communication, risk management, and successful project outcomes. You can then match these thoughts with your project management needs and company culture to see if they complement each other. 

Below is an example of the Waddell group project management process. 

Waddell Group’s project management consultants adapt this approach to your project’s specific requirements for predictable success. 

Knowing their project management methodology and approach allows you to make informed decisions, set clear expectations, and collaborate effectively with the ‘right fit’ consultant to achieve your project objectives.

However, to find the right fit project manager for your medical device project, you also need to be aware of the different leadership styles and understand what style would be the best for your project needs. 

For example, If it’s a project in trouble or has tight deadlines, you need a dictator.

If there’s a lot of discovery you need a mentor, someone who works well with research.

Expansive, long-term projects require very high EQ, and a persistent, driving leadership style.

In most cases, a project manager needs to transition across roles and project management styles as needed seamlessly. They need to be the captain, manager, and cheerleader of their team, depending upon the situation at hand. 

Tom Waddell

You also need to consider whether the consultant’s working style and values align with those of your organization. A good cultural fit can lead to more productive collaboration.

Clear communication and expectations

Clear and transparent communication with shortlisted consultant candidates:

• establishes company and project expectations
• ensures alignment with the company’s goals
• promotes accountability

It also allows for measurable progress tracking by setting clear goals and benchmarks.

This can be achieved by clearly articulating your specific project objectives, desired outcomes, and any regulatory or quality standards to be met. You can also ask candidates how they communicate and measure progress. Setting clear and transparent expectations beforehand will lead to a more collaborative and productive working relationship, leading to better results for the project. 

Hiring a medical device project consultant: Pricing and payment

Most of our clients wonder about pricing and payment when they first approach us. We will tell you the same thing we tell them before we ask them about their needs and project details. 

When hiring a medical device project consultant, pricing and payment can vary based on several factors. These factors include, but are not limited to:

• Duration and frequency of a project: Short-term, one-time projects may have a different fee structure than long-term, ongoing consulting relationships or fractional roles. Hourly, daily, weekly, or project-based rates may apply, depending on the consultant’s availability and the project’s scope.
• Project scope and complexity: The more complex a project, the higher the fees. Similarly, the wider the scope of the project (for example, a project involving multidisciplinary teams, regulatory submissions, and systems development will be priced higher as compared to a ‘project initiation’ project)
• Company and project budget: Larger budgets mean more flexibility in hiring experienced consultants, while smaller budgets require companies to consider more cost-effective options.
• Consultant Expertise: Consultants with specialized knowledge or a proven track record in the medical device industry often command higher fees due to their unique qualifications.
• Market Rates: Rates may vary based on geographical location and industry demand for specialized expertise.
• Additional Expenses like travel costs, materials, or software tools can affect the overall cost of the project.
• Payment Structure: Options like upfront retainers, milestone payments, or monthly invoicing allow some wiggle room based on the project timeline and company finances.

Fractional vs. full time needs

Differentiating between fractional and full-time medical device project management needs will help you manage your costs and allocate resources more efficiently. 

Some projects may require only a fraction of your project manager’s time.  When this happens, it’s best to hire a fractional project management consultant for your project needs.  This typically suits smaller or less complex projects, where the project manager’s involvement may be part-time or intermittent. It’s also more cost-effective.

Larger, complex medical device projects often require full-time project managers.  An interim project management consultant who works with you full-time (for the project duration) can ensure continuous oversight, timely decision-making, and effective management of resources, risks, and stakeholders. 

Hiring an external medical device project consultant vs. hiring internally

The eternal debate of hiring internally vs. hiring an external consultant can be put to rest by making a pro-con list. Here are some factors to consider: 

With an internal hire, you get: 

• someone who already has a deep understanding of the organization’s culture, processes, and history. They may require less time to acclimate and can hit the ground running.
• cost savings, especially for positions that require ongoing work or expertise that is core to the organization’s operations.
• the possibility of better collaboration s internal hires are already part of the team.
• the ability to groom employees for leadership roles.

With an external consultant you get:

• expertise in a particular field or industry, which may not be readily available within your organization.
• an unbiased perspective. They can assess problems and opportunities objectively, without being influenced by internal politics, preconceived notions, or favorites.
• flexibility in terms of resource allocation. You can hire them part-time, full time or on a fractional basis which can be cost-effective for specific projects or when expertise is needed intermittently.
• a quick start. As opposed to hiring internal staff, you don’t need to train them.

Once the project is completed, the relationship can be easily terminated. Saving you the cost of a full-time employee. There’s also the possibility of using a combination of both approaches to leverage external expertise for certain projects while nurturing talent from within for ongoing roles and responsibilities.

Hiring a medical device project consultant: Contract and legal considerations

A written agreement or contract clearly states the expectations from both parties (the medical device company and its consultant) and protects their interests. It helps avoid ambiguity, scope creep, and failure to meet obligations. Some important clauses to include in the contract:

• Scope of Work: Clearly define the project’s scope, objectives, deliverables, and timelines. This section should outline the consultant’s specific responsibilities.
• Payment Terms: Specify the consultant’s compensation, payment schedule, and any expenses or additional costs.
• Confidentiality: Protect sensitive information shared during the project. Define what information is considered confidential and how it will be handled.
• Termination: Outline the conditions under which either party can terminate the contract, as well as the notice period required for termination. 
• Change Management: Include procedures for managing changes to the project scope, timeline, or deliverables. Outline how changes will be approved and documented.
• Continuous Evaluation: Establish a process for evaluating the consultant’s performance. Regular check-ins and feedback sessions can help address any issues early and ensure the project stays on track.

Questions to ask potential medical device project managers

Here is a list of helpful interview questions to ask when hiring a medical device project consultant:

1. Tell me about your experience
   1. What are your preferred technical areas/project management specialties with examples?
   2. What’s your project management style?
   3. Describe your approach to project planning and management.
   4. What company culture do you work best inside of?
2. What is your best project and why?
3. What is your worst project and what did you learn from it?
4. When are you available to work? For how long?
5. How do you measure progress and project success, and what key performance indicators (KPIs) do you track?
6. What experience do you have with quality management systems (QMS) such as ISO 13485, and how do you ensure that projects adhere to quality standards?
7. What communication and reporting processes do you implement to keep stakeholders informed and engaged throughout a project?
8. How do you handle changes to project scope, timelines, or budgets during the course of a project?
9. How do you ensure that projects are completed within budget and on schedule?
10. What tools or software do you commonly use for project management and reporting?

Asking these questions, along with questions specific to your project needs(for example, what experience do you have with quality management systems (QMS) such as ISO 13485?) will help you gain valuable insights to make an informed hiring decision. 

There you have it, your complete guide to hiring a medical device project management consultant for your needs. This will make it significantly easier to ensure you find the right fit project manager or management consultant for your medical device project. 

And if you don’t want to go through the entire process, get in touch with us! Let us help you look for a project manager with the right skills, temperament, and aptitude to lead your medical device project to success in a high-stakes, high-risk environment.

About Waddell Group

Waddell Group provides strategic-level project leaders and project management consultants for the medical device industry. Beyond essential project management skills, our highly experienced consultants know how to lead teams, manage in times of crisis, and influence change. Take a look at our work and see how we can help you get on the right track with our project management team. 

Additional resources

Your guide to evaluating and selecting a ‘right fit’ medical device project management consultant.

Scope and plan a new medical device project with ease.

Establishing a viable medical device company

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