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When 2 Heads Equal 10: FTEs in Medical Device Development

Efficient staffing for medical device research and development can be a logistical nightmare, especially if you are trying to build an in-house R&D team. Many start-ups only have funding for two to three staff positions. The breadth of skills needed for the entire medical device development process is not possible to cover with just two or three people. Think about which specialties your project plan requires:

• VP of R&D
• Program manager
• Design engineer
• Technician
• Machine shop specialist
• Injection molding specialist
• Proto-typing specialist
• Quality control engineer
• Clinical engineer
• Regulatory specialist

Not only is the breadth of skill virtually impossible to cover in two to three employees, your plan will often need far more than two pairs of hands… often as many as ten will be needed to meet the timeline for your important milestones.

When that occurs, you have two choices: 1) Add time to your schedule and extend your product development completion date; or 2) Find additional resources, usually contract specialists, to bring on board.

Most companies want to avoid the first – adding time to the schedule is often not feasible, since development milestones are often closely tied to funding milestones. If so, you will need to find contract specialists you can bring on board… at the right time.

At times you may need as many as 10 or 12 full time staff to push through to an important milestone. How well does your project plan lay out exactly when you will need these resources? And when you get to that point, will the contract resources you want be available? If you bring on contractors too soon, you may have to pay them, yet have nothing for them to do; and if you bring them in too late, your project will lose precious time.

At other times, you may only need one person to do what is necessary. For example, during many months of clinical trials or while awaiting regulatory approval, your staff will have periods of downtime, with no deliverables… alternating with periods of far more work than a couple people can possibly do. Will you be able to financially keep on your staff? Will your talented staff want to wait around during periods of downtime, with no deliverables?

When you have the right level and type of staffing throughout the product development lifecycle, you are getting the best efforts of those most suited for the job at hand. Overworked, stressed staff often make errors or miss opportunities. This can once again subject your project to slowdowns or even “do-overs” of critical development phases.

An underestimated consequence of this round-robin through various contract resources is the difficulty of creating a cohesive team. Start-up CEOs often overlook the importance of collegiality between team members. The “we’re in this together” attitude is what invests your team in your product development. And an invested team is one that will go the extra mile to be part of a successful project.

A team atmosphere also engenders collaboration. When you have several experienced people with various backgrounds working comfortably together, they often come up with significant design improvements.

When you are ready to partner with a completely staffed R&D team, call on REV.1 Engineering. We flex the time of our 100% full-time staff to cover the most relevant medical device development experience necessary for your project. Our team was designed to expand and contract to efficiently meet the milestones in your product development plan. If you’re ready to go 2x Faster than building an in-house team, give us a call at (951) 696-3933. We look forward to working with you.

Eric & Phil