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The Fractional Advantage: A Smarter Approach to Staffing for Small to Mid-Size Medical Device Companies

By Staff

Fractional staffing is a staffing model that has

gained popularity in the context of medical

device companies, particularly among small

to mid-size organizations. It involves engaging

part-time professionals with specialized expertise

to fulfill specific roles or functions within the


With fractional staffing, medical device companies

can tap into a pool of experienced professionals

who possess expertise in areas such as regulatory

affairs, clinical trials, quality assurance, and other

specialized functions. These professionals work on a part-time or project basis, allowing companies to access the skills and knowledge they need, precisely when they need them, without the long-term commitment of a full-time hire. 

Fractional staffing is a great way to match your variety of needs with the limited pool of resources you have as a small or even medium-sized company. 

This is particularly critical in today’s market.  The complexity of medical device products has increased and with that the needs for specialized skills to match the complexity of the products.  Trying to match a single candidate for hire to a complex medical device is an almost hopeless task.  However, in a small or mid-sized company there are financial constraints to how many Regulatory, Clinical, and Quality hires that can be made.  However, if you took the same finance resources (or maybe even less) and directly them towards a team of experienced professionals with a variety of expertise, you can optimize your companies overall skillset at a fraction of the price.  


Traditional Direct Hires:


Limitations and Challenges 

Directly hiring staff for Regulatory, Clinical and Quality roles can have several limitations in a small to medium-sized company.   


Hiring full-time employees involves significant financial commitments, including salaries, benefits, and overhead expenses. For small to mid-size companies with limited budgets, these costs can be prohibitive and may strain their financial resources.  You might be only able to hire one or two folks and this sets the foundation for the other potential limitations. 

Limited Expertise:

No one is an expert at everything.  And the more experienced the hire, the more they cost.  The paradox is set, the more one pays for experience the less variety of experience the team will have because the lower the number of teammates.  If a medical device has software, hardware, and optics, it is going to be difficult to staff for all those experience sets.  You will be forced into tradeoffs from the jump if you utilize direct hiring. 

Flexibility and Scaling:

Companies tend to hire fast and are generally reluctant to release hires even if the project has delays that create times of reduced work for certain functions.  Stop and starts are common with product development and even more common with Regulated Medical Device products.  You can be sure when you might not pass a test and have to spend time retesting before moving to the next stage or an unexpected Regulatory burden is introduced as the project is moving.  During these low resource load times, the company is still paying for the full cost of the expertise they directly hired. This situation can be expensive and is obviously not efficient. 

Turnover and Retention:

In a traditional hiring model at small and medium sized companies, turnover can be disastrous for timelines and timelines are measured in cash burn.  With hiring remaining tight, the average turnover at small businesses is around 22% according to Gitnux, an industry leading business newsletter.  And at best it takes companies an average of 3 months to hire and train new employees.  The fewer employees you have the more the risk of turnover disasters.  

Administrative Burden:

Hiring, benefits, managing, retention, payroll, and overall HR processes are time consuming and distract from your business.  Traditional hiring models required all of this. 

Fractional staffing overcomes these limitations by offering a broader talent pool, more flexible, cost-effective, and specialized approach. By engaging part-time professionals with targeted expertise, medical device companies can access specialized skills, optimize resource allocation, scale their workforce as needed, and adapt to changing market conditions. Fractional staffing is efficient and provides great risk management for small to medium-sized businesses. 


Unlocking Transparency and Value:


Comparing Hourly Billing to Fixed Monthly Rates for Medical Device Consultants 

When it comes to medical device consultants, there are typically two common approaches to billing: hourly billing and fractional staffing with a fixed monthly rate.

Hourly billing for medical device consultants involves charging clients based on the actual hours worked. Consultants track their time spent on various tasks and bill clients accordingly. While this approach provides a level of transparency in terms of the specific hours spent on each project, it can lead to uncertainties and unpredictability for both the consultant and the client. Hourly billing may result in billing surprises if a project takes longer than initially estimated or if unexpected challenges arise. Additionally, clients may be hesitant to engage consultants for extended periods due to concerns about mounting costs. Hourly billing may not align the consultants’ interests with the clients’ needs.  There is no benefit to speedy, efficient work if one bills hourly.  


On the other hand, fractional staffing with a fixed monthly rate offers a more predictable and transparent approach. With this model, the fractional team charges clients a fixed monthly fee for their services, regardless of the number of hours worked or the complexity of the project. This fixed fee is agreed upon upfront, providing clarity and eliminating the risk of unexpected expenses. Fractional staffing allows clients to budget more effectively since they know the exact cost they will incur each month.  


Companies can focus on delivering high-quality work without the need to constantly track and bill hours. They can allocate their time efficiently and provide a more comprehensive and dedicated service. Clients benefit from predictable costs, enabling them to plan their budgets more effectively and engage consultants on an ongoing basis with confidence. 

Fractional Staffing billing aligns the fractional teams’ interests in efficient work with the client’s need for efficient work product.  


Fractional Staffing: A Game-Changer for Medical Device Companies:

Fractional staffing emerges as a highly advantageous and transformative solution for medical device companies compared to traditional direct hiring or hiring consultants by the hour. By embracing fractional staffing, companies gain access to specialized expertise on a part-time basis, enabling them to overcome the limitations of limited resources and expertise. The fixed fee arrangement of fractional staffing promotes transparency and eliminates billing surprises, allowing companies to better manage their budgets and allocate resources effectively. 


Moreover, fractional staffing offers flexibility and scalability, empowering medical device companies to adapt to changing market demands without the burden of long-term commitments. Companies can tap into a diverse talent pool of part-time professionals, leveraging their specialized knowledge and experience to drive innovation and enhance operational efficiency. With fractional staffing, companies can establish true partnerships with professionals who are committed to their success and share a common goal. 

As the medical device industry continues to evolve, embracing the advantages of fractional staffing can be a strategic move for companies seeking cost-effective solutions, specialized expertise, and operational agility.

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