Combination Product Industry News & Guidance

How to effectively utilize a combination product consultant

Suttons Creek has found there is a significant portion of companies out there that don’t capitalize on the benefits of hiring external expertise, because they simply do not know how to effectively utilize a consultant or don’t realize the cost savings that can come from expert support. (Yes, you generally save more money by spending some in the right places.) 

If you have never considered hiring a consultant, or aren’t sure where to start, here are some alternative use scenarios to help you determine when and why to hire external expertise like Suttons Creek’s drug delivery device specialists.

Subject Matter Experts (SMEs)

• • A common reason for utilizing a consultant is as a Subject Matter Expert (SME) in an area where an individual or team may be relatively lacking in experience. This can aid the team in setting strategy, contending with challenges, engaging with regulators, preparing submissions, or scaling up and commercializing.
  • Suttons Creek (SCI) SMEs interface with a primary function, but may occasionally be involved with other functions, management, etc. Our specialists have specific expertise in drug delivery including separate devices and combination products across a number of disciplines (such as Regulatory, Quality, Development/Engineering, Human Factors, Risk Management, Packaging, Labeling/IFU, Sterility, Project Management, etc.).

Second Opinion

• • To ensure that projects meet various business goals, clients seek second opinions on a given strategy, approach, or deliverable. Consultants can start from an unbiased perspective and review content and/or speak with team members to give an expert opinion on a given matter.
  • SCI is happy to step in to perform assessments and give recommendations to ensure your project is on track from its outset, or at any given point in the combination product’s lifecycle. Our experts provide best practices and hands-on knowledge based on a broader spectrum of industry case studies than an in-house team would have access.

Background Advice

• • Sometimes personnel with a given function (individual contributor) and/or at various levels of the organization (management, executive) may seek individualized advice without visibility to the broader organization when a combination product falls outside of their business experience. This can take the form of strategic guidance, as well as coaching and focused education. The goal is to more quickly increase knowledge and move personnel forward along the combination product maturity curve.
  • SCI is experienced in coaching both functional and leadership team members in how to efficiently execute a combination product program, advocate for the project and/or their division’s needs within the company, and align/collaborate with other departments and partners that have a stake or role in the project’s success.

Supplemental Resource

• • Have you experienced staff turnover, a new project starting up, new project(s) due to M&A activity, or an overburdened and potentially burned-out staff? Also, if you are trying to hire – how long and how much effort does it take to recruit, hire, and onboard a team member, particularly someone in a specialized field like combination products? What if you won’t need that functional support long-term/full time? Hiring external experts as a supplemental resource, over hiring internal staff, can be useful to plug a temporary gap or provide a temporary bonus quantity of resources that may not be needed permanently.
  • SCI has a network of experts in drug delivery devices and combination products across a variety of applicable disciplines and typically have availability to plug in an individual or team of experts to meet your particular needs on short notice. In other cases, for instance where a company may have a single or limited number of combination products, SCI can serve as the entire ‘device team’ which could be a cost & time savings over hiring a brand-new team from scratch. While working in this capacity, SCI follows an “empowerment through education” approach where we seek to transfer knowledge to the client, to leave the client’s internal team more informed and prepared for the future.

Strategic Advocate

• • This use case for consultants is especially useful as backup for internal discussions with management, other functions, and external partners. In this scenario, experts will assess situations, share expert opinion, provide necessary cross-functional education, with the intention of delivering the validation needed to allow decision-making confidence for relevant team members.
  • SCI has found this service important and useful for client teams to avoid unnecessary internal ‘swirl’ or to provide a level of strategic confirmation without having to go to a regulator with a number of relatively minor questions or concerns. We act as educators and advocates for your internal project progress and the success of your program.

Translator/Facilitator/Mediator

• • In combination products, at the intersection of drugs/biologics and medical devices, terminology is critical to successful collaboration between internal departments and external partners. Combination product consultants may serve as a ‘translator’ between the drug & device teams (and related suppliers, CMOs, etc.). Often, many hours are spent with teams trying to understand each other while a ‘translator’ versed in both sets of terminology may help bridge that gap and provide baseline knowledge to the entire team. Other times, internal or external teams may not see eye-to-eye and a relatively unbiased facilitator or mediator may be necessary to ‘unstick’ a project when up against obstacles. In this case, an experienced consultant can help address issues that may be specific to combination products and drug delivery, providing the ‘outsider perspective’ but bringing in crucial knowledge and experience.
  • This is often the case and inherently included in much of SCI’s work for two main reasons. First, with the majority of device design and manufacturing being done by external partners, this becomes ever more important since the interests of the device and pharma companies don’t necessarily align – and certainly the individuals’ backgrounds may not. And, internally, companies are often ‘siloed’ into their respective disciplines, with company politics, personalities, and differences in approaches contributing to inter-functional challenges. SCI has multiple consultants who can bring a cross-functional perspective to the team and assist in moving past obstacles.

Regardless of how SCI is utilized at a given company or in a particular project, we strive to work with you to provide the right type and level of support at the right time. That is why every SCI project includes these three key approaches.

Modular:

We customize the type and scale the level of support needed for a given company or project, including different disciplinary expertise, amount of involvement, duration, and overall size of the project.

Tailored:

Regardless of the client or program, we tailor the support to fit your specific needs and budgets. There is no ‘cookie cutter’ approach to projects, just as each and every combination product or drug delivery device program has unique challenges. SCI commonly works with clients big & small, old & new, experienced & not and looks forward to the variety of project scope each type of client and situation may bring.

Expertise:

Besides the expert consultants assigned to a particular program, behind them stands the entire SCI team – from the assigned Customer Success Manager and Technical Director, to the broader team of experts who can provide collective knowledge and expertise to inform the client.

AUTHOR

Jonathan Amaya-Hodges, Director, Technical Services, Suttons Creek, Inc. – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.