Luke Baker, Eimile Oakes, and Beth Meier comprise the senior management within GLOBAL’s Medical Device team. We sat down to get their thoughts on structuring and building a team in the current industry environment.  

‍What do you feel are the top 3 strengths of the Medical Device team when working with clients?
I think our team’s three biggest strengths just so happen to align with some of GLOBAL’s core values:
Collective intelligence - One of the most fulfilling parts of working in the contracting and consulting space is that our team has seen and done just about everything. Because we work together as a team, we can share ideas, experiences, advice, and lessons learned. When our clients work with one GLOBAL writer, they’re really getting the experience of 30+ writers.  
Agility - Our team is full of creative, dedicated writers who can pivot and adjust quickly. We’re often working with clients during some of their most challenging times when resourcing, project scheduling, and scope of work are in flux. Our team is exceptional at speeding up, slowing down, and switching gears to best meet our clients’ needs based on what our clients need in the moment.
Sanctuary - Working with contractors is often not our clients’ ideal situation. Our clients are typically working with us because they need immediate, quality help from people they can trust. By being responsive and trustworthy, and by providing high-quality work and really doing all we can to support our clients’ goals, we aim to be a sanctuary for our clients.  

‍How does GLOBAL stand out as a consulting partner around resourcing?
I think GLOBAL’s real strength is that we adapt quickly and easily to whatever needs our clients have. We of course offer a wide range of contract structures (ex. FTE, flat fee, per-project), but also are able and willing to provide a range of services within the writing space.   We have some clients who prefer to give our writers piecemeal assignments on a predictable schedule; these clients prefer to have our writers in a supporting role to assist their internal team. We also have clients who fully embed our writers in their department and our writers do project management, coordination with other departments, and contribute to other deliverables and inputs as needed. These clients depend on our writers to act as full members of their internal team. We also have clients who exclusively come to us for their emergency projects; they know that GLOBAL has the writers and skills needed for these high-priority, high-urgency projects.   Ultimately, no matter the need, GLOBAL is ready to adapt and provide the support our clients need within our clients’ preferred structure.  

‍What insights do you have around resourcing in this current market?
Resourcing in the current market can be a tricky thing. Although the EU MDR has been in play for almost a decade, manufacturers are still seeing significant fluctuations in writing workload based on their internal team capacity, device portfolio, and certification status. Many manufacturers are looking to build out their internal teams but are struggling to find one or more writers with the ideal experience at the ideal price. This can lead to multiple issues, including: Additional team members are needed, but open positions go unfilled for months The salary and benefits offered are too low for the type of writer needed.  Mismatch between desired writer skills and the person they hire Unhappy writers have lots of opportunities to leave their position Managers feel pressure to add resources and panic-hire the first person who meets enough of the requirements, but ultimately does not truly meet the need   Understanding the risks your team faces based on your organizational resources as well as the challenges and opportunities of the current market, you can make a plan to be proactive around staffing and resourcing. The more we plan and make future-based decisions, the less these challenges and issues can affect our team and our efficiency. You don’t have to get ready if you stay ready!  

‍What would you tell a new team to focus on when building from the ground up?  
Take the time to fully define the goals and identify the tools and skills needed to address the challenge. Outline the criteria and constraints of your final team and if interim goals are necessary, incorporate those as well. The key is to be honest and thorough about everything you need!   For example, if your team is currently overwhelmed and you know you need more writing support, your criteria might include adding someone to the team who can write a CER independently. If that’s your only criteria, you might end up with someone who can absolutely write a CER independently but refuses to follow your team’s strategy and approach for executing documents (i.e. criteria were incomplete). You might also hire someone who can write an okay CER draft independently but needs a lot of review and editing (i.e. criteria were not specific enough). You might hire someone who can write a CER independently, but is not prepared to manage the project, engage with stakeholders, and problem-solve when awaiting inputs (i.e. criteria was incomplete). With robust and specific criteria, you can focus on the entire skillset needed for each team member’s success.  

‍Any final thoughts you would share with our clients?
Many manufacturers are facing resourcing challenges as the MDR wave begins to retreat. It’s important to understand the full context of the resourcing challenge and consider which resourcing tools are most appropriate for your particular situation. And when considering resourcing tools, don’t be afraid to be creative. The idea of a fractional CXO may have sounded strange 15 years ago, but today, a fractional CXO can be a really attractive option for companies looking for deep expertise on a tight budget. Don’t be afraid to investigate creative solutions for complex challenges – the right solution might not be the easiest in the short term but can lead to massive success in the long term.  

We would like to thank Luke Baker, Eimile Oakes, and Beth Meier for their time and gracious sharing of their industry insights and expertise. The team at GLOBAL Regulatory Writing and Consulting is full of experts like them, ready to partner with you and serve your organization's needs. Book a consultation with us today:
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