How to run a pilot program to avoid a medtech nightmare

Let’s dive into the key steps to define and optimize your chances of success.

Set expectations for the pilot program

First, create a plan and establish an understanding that each participating member will have to sign off and comply with the pilot’s expectations as terms of participation. Socialize this idea internally to ensure no one is caught off guard, and remind everyone that this is a team sport. The pilot plan must be comprehensive and detailed as this is the core of the operation. As the old adage goes, “Failing to plan is planning to fail.”

The outcome of a pilot will inform many aspects of a product’s lifecycle from development to sales. Get specific with your team about clinical and business trepidations to ensure all are addressed during the pilot. Create a safe space for the dialogue and allow all concerns to be voiced with honesty and integrity.

It may be odd to think of the dynamics when determining which vulnerabilities to address, but this is when the art of medtech science and organizational politics come together. Including your regulatory, compliance and risk partners here is also particularly helpful as bringing them in at the eleventh hour will almost certainly reveal overlooked issues.

Cross-functional collaboration during the pilot program

Once the team is on board, engage them to decide which learnings are top of mind and should be further understood during the pilot. For example, it may be valuable to determine average run time and longest run duration for your product in different clinical settings. Alternatively, uncovering clinical workflow inconsistencies that will impede product usage may allow for design adjustments prior to full-scale launch.

Other examples include understanding the top reasons why a competitive product may have an edge, identifying IT configuration issues that may lead to hospital connectivity challenges, and validating that the product’s translated Instructions For Use (IFUs) are comprehensible for independent use by clinicians.

Next, uniformity and structure in the team’s workflow for capturing insights is key to running a smooth pilot and implementing product changes prior to full-scale launch.

Create product feedback surveys with easy link access for all to complete, but only allow certain reviewed access to those submitted forms. Determine the cadence of feedback from the team to the assigned person who will be compiling all findings. Send out calendar invitations for when each finding will be assessed for severity, likelihood, and potential solution. If findings will be recorded in a quality management system (QMS), quality and risk may be concerned with metrics, so discuss how a pilot environment will be designated within the software.

External stakeholder alignment

Lastly, collaborate with hospital teams ahead of time to identify clinical cases in which the product will be used. Create criteria such as patient acuity levels or exclude emergency cases as applicable to your goals and the logistics of the pilot.

Ask vital questions related to designated points of contact at each pilot site along with clinicians and staff who will partake in the pilot and share robust feedback. Set expectations for survey completion and confirm whether a vendor representative will be present during each case. And ascertain redundant sites as backups to activate in case primary sites are no longer able to participate in the pilot.

Remember that the utility of pilot programs can be expanded beyond product innovation to answer further questions the cross-functional team may have, such as pricing sensitivities and competitive differentiation. There is no substitute for seeing your product side-by-side with the competition and having a dialogue with end users about features they like and dislike. Run your product survey by a handful of clinicians to see what else they would add. Allow internal and external collaborators some flexibility to learn about hidden gems during the pilot process.

At the conclusion of the pilot, implement the product modifications your team has discussed and take the next step towards full-scale launch. Quantify the dollar amount that would have been saved by finding these issues in the field if the pilot had been skipped. Compare this with the cost of the pilot and you’ll find a pretty compelling ROI figure that will have everyone smiling.