Running a device trial at a hospital: setting expectations, collecting feedback and asking for the decision

You left a demo unit on a ward "for as long as they need", and two months later nobody will say yes or no. Before a device goes into a ward, agree four things in writing: who evaluates it, for how long, what a good result looks like, and what happens on the last day. Collect feedback on a short sheet while the trial runs. Then hold the meeting you agreed and ask for the decision. Without these, the unit ends up in a corner, and the clinician who wanted it is on leave when you call.

The trial note, signed before the unit leaves your warehouse

One page, signed by someone who can authorise the trial, such as the medical superintendent or the administrator. Keep it plain.

TRIAL NOTE

Device:            model, serial number, accessories supplied
Department:        ward or unit, and where the device will sit
Dates:             start date; end date OR number of cases, whichever comes first
Evaluators:        clinician (name), nurse in charge (name), biomedical engineer (name)
Judged on:         three to five points, agreed with the clinician, in their words
Training:          who trains whom, on which dates, including night staff
Consumables:       quantity supplied free; price for any used beyond it
If it fails:       service contact and phone number
No obligation:     the hospital is not bound to buy
Last day:          review meeting on (date) with (names); outcomes are
                   order, one dated extension with a reason, or return
Signed for the hospital:              Signed for the supplier:

The "Judged on" line does more work than the rest put together. Without it, the review meeting turns into opinions.

Choosing what the trial is judged on

Sit with the clinician and ask what would make them switch. Write the answers down in their words. Good points are things the ward can observe. Setup time per patient. False alarms on the night shift. How the nurses find cleaning it between patients. Whether it fits beside the bed.

Keep the points about use, not about patient outcomes. A trial on a few patients is not a clinical study, and the results should never be presented as clinical evidence. Collect no patient data beyond what the hospital itself permits. Rules on device use, data and claims differ by device and body and change, so check with your own adviser or the regulator before you design anything that records patient details.

A feedback sheet that fills itself in

Leave a half-page sheet at the nursing station, one line per shift. Four columns are enough: date and shift, who used it, what worked, what did not. Nurses will write a line at handover. They will not fill a two-page form.

Visit on the dates agreed in the note. Read the sheet, fix what can be fixed that day, and write down what you changed. A complaint answered during the trial becomes a point in your favour at the review. The same complaint, unseen until the last day, sinks it.

Asking for the decision on the last day

The review meeting needs the clinician, the nurse in charge and someone from purchase. Without purchase in the room, a yes from the clinician still has to travel. Open with the note, not the brochure.

"The trial ran from (date) to (date) on (number) patients. We agreed to judge it on three things. Here is what the ward sheet says about each.

Does this meet what you wanted to see? If it does, the next step is a purchase request. Who raises it, and what do you need from us for it?

If it does not, what would it need to do differently?"

Then stop talking. If the answer is yes, agree who raises the request and by when, and send the documents that afternoon. If the answer is not yet, agree one dated extension with a named reason. A second open-ended extension is a no that nobody has said aloud.

For example: ICU beds at a Kozhikode hospital

For example, a Coimbatore maker of motorised ICU beds leaves two beds at a 120-bed private hospital in Kozhikode, telling the ICU in-charge to keep them as long as needed. Nine weeks later both beds are in use and the nurses like them. No purchase request has been raised. The in-charge who asked for them has moved to another unit, and two beds worth about ₹4 lakh are tied up in a ward that has no plan to pay for them. Purchase says there is no budget line for beds.

The maker's regional manager starts again, properly this time. The manager writes a trial note with the medical director: three points to judge, an end date two weeks out, and a review meeting with purchase present. At the meeting the feedback sheet carries the case. Purchase explains when the next budget is set and who proposes items for it. The medical director agrees to propose the beds, and the maker takes one bed back until then. Leaving a unit indefinitely had felt generous. It had only made deciding unnecessary. The outcome is partial: the first sale waits for the next budget cycle, months away. The maker, the hospital and the figures are invented for illustration.

When not to run a trial

Decline when the buyer is looking for a free month and has no budget or need in sight. Decline when the device needs trained hands that the ward cannot supply during the trial, because a bad trial is worse than none. And do not leave a unit if nobody senior will sign the note. The signature is the hospital's commitment to decide.

Write the trial note for the unit that is out now

Find the demo unit you have at a hospital today and write the trial note it should have had, then ask for a signature on it. Getting several people to agree to the trial in the first place is a separate step, set out in what a hospital purchase committee asks before it trials a new device, and the medical devices and equipment page covers how hospitals find you before that. If you want the note, the sheet and the review meeting built into how your team runs trials, tell us what you need.