Ask An Expert Before Shredding Your Mobile Device CAPEX

By Brad Grimes, mobile device provisioning and logistics consultant

Largely ignored and desperately needing a scalable solution, the provisioned mobile device space within clinical research has been historically what I refer to as “the old pass-through model.” Someone in the equation took on the risk of purchasing a device based largely on having drawn a short straw for the assignment. In addition to the primary, yet typically incorrect, focus on device unit cost, there are many criteria to consider for device procurement: minimum specification requirements, battery life, resolution, pixel density, operating system and security patch upgrades, end-of-life expectations, warranties, global availability, and more. Oh, and did I mention project scope?

Those tasked with the buying decision might not feel prepared to do so or to do it well.  A good place to start when selecting mobile devices for a clinical trial is seeking expert advice.

“But Can’t We Just Do BYOD?”

I get the initial allure of wanting participants to bring their own devices (BYOD). Since my introduction to this wild technology ride, a long list of reputable data collection apps have sprung into action, most relying on the use of BYOD. In fact, the FDA released Conducting Clinical Trials with Decentralized Elements in September 2024,^1, which focused on the use of digital health technologies (DHTs) by sites and participants and essentially encouraged BYOD to enhance decentralized clinical trials (DCTs). Specifically, it contends, “When a trial permits participants to use their own DHTs, sponsor-provided DHTs should be available as an option to ensure that participants who do not have a protocol-specified DHT are not excluded from the DCT for that reason (e.g., lower socioeconomic groups who cannot afford the DHT).”¹

This is, of course, fantastic, but in reality, utilizing devices will still be part of your game plan. And so, the question remains: How do you choose which device to buy? Or, even should you buy?

Things Change, Then CAPEX Budgets Suffer

I’ve witnessed dozens of sponsors and CROs demand or spec out a specific device make/model for their project(s) with the intention to buy them right away. But then:

• The project scope changed.
• The device no longer met the minimum spec requirements of the project’s apps.
• An import/export deglobalization requirement or rule changed.
• The project delayed start-up or changed ending dates.
• Or even worse, the overall project was cancelled. 

The stacks of expensive devices purchased with precious capital expenditure (CAPEX) budgets — many six-figure sums and higher — were forgotten, aged out, and eventually (literally) pushed into a shredder. No one wants this, but it’s a real story that many of you know all too well.

The Solution? Seek Advice From An Expert

Before you try to solve this on your own (no shade to all you expert project managers and procurement folks out there), my advice is to seek expert opinion and come prepared with the right information. The time and input, not to mention any minimal costs, will be well worth it. Come prepared with full scope details in hand, broaden your scope of understanding and capabilities to enhance your overall strategy. Have answers ready to questions such as:

• What number of projects, sites, subjects, etc. are in scope?
• What’s the duration of your project(s)?
• How many countries do you serve?
• What app(s) will be used?
• How do you want to secure the device with an MDM (mobile device management) solution?
• What’s the data consumption for each app, and what’s your SIM (subscriber identity module) connectivity strategy?  Answers such as “Not very much” or “Isn’t it unlimited?” aren’t acceptable and can lead to change orders and budget surprises.

Proper project input can help you determine the right device for your strategy, as well as decide whether to procure (or not) and leverage the same budget dollars to get an improved return on investment.   

Also, it’s best to presume that procurement resources that perform the device selection process are just sunk costs. These and other hidden costs, like internal finance processes for vendor qualification, contracting, invoicing, warranties, returns/replacements, as well as depreciation management and disposition, are often not included in the calculation. Be transparent with yourself about the value of these resources and what they cost your organization.

Stacking Your Project For Success

Lean into the specifics of your project scope. Other commonly overlooked criteria include:

• MDM solutions and ongoing support
  • Locking down provisioned devices creates efficiency and security while deployed.
• Connectivity and data plans, managing use and avoiding overages
  • Selecting the right data plan tier can significantly improve budgets, reduce rework, and mitigate surprise costs.
• Import/export logistics, including IoR (importer of record) costs, lead times
  • Country specifications change constantly, so securing expert advice is critical to on-time arrival of devices.
• All of the resources your teams may consume along the way
  • Be thorough here and include the effort of anyone involved. Your expert should guide you on ways to minimize or even mitigate surprise resource consumption.

These items can hide in the margins and trip up your budget in a big way.  Alternatively, if you leverage an expert, a potential shift in proposed methodology could introduce improved ROI and efficiencies for you, your project team, and your organization.

References:

1. Conducting Clinical Trials with Decentralized Elements, FDA, September 2024, https://www.fda.gov/media/167696/download
2. Paving The Way For Sites To Use Their Own Tech – Clinical Tech Leader, July 25, 2025, Dan Shell, Chief Editor, Clinical Leader: https://www.clinicaltechleader.com/doc/paving-the-way-for-sites-to-use-their-own-tech-0001

About the Author:

Now with 17+ years of experience in clinical research, Brad Grimes first gained experience in Phase 1 recruitment at a 150-bed facility in the Midwest. Following nearly eight years of successive records in recruitment, process improvement, and overall financial impact, Brad transitioned into global management of Phase 1 EDC systems, including U.S., EU, and India, as well as vendor selection, requirements gathering, reporting, system development, and Systems or Software Development Life Cycle (SDLC) processes. Brad then joined one of the industry’s leading eCOA and eConsent platform delivery teams to directly manage vendor selection and global logistics of mobile device provisioning. After establishing a global supply chain in 2019, Brad and his team successfully delivered tens of thousands of mobile devices to over 75 countries, helping facilitate data collection on some of the world’s largest COVID projects. In 2025, Brad stepped into the role of CEO for Clinexion, a mobile device provisioning services and digital health delivery solutions.