Ask the Vendor Seventeen Questions in Writing Before Shortlisting
No Connectivity, No Purchase Checklist
Companion to Medical Device Connectivity · Updated 2026-09-29
Use this for every institutional device that does meaningful repeated work, before it reaches a shortlist. It tests the presumption that such a device comes with a machine-readable interface, a lifecycle-management strategy, and evidence export, unless a documented exception says why not. Procurement sends it to the vendor, and HTM, information technology (IT), security, and the clinical or process owner review the answers; “Hospitals Should Make Connectivity the Default for Institutional Device Purchases” works it on the automated probe reprocessor. Send the same questions for a CT scanner, a hematology analyzer, an electrosurgical unit, or a smart bed.
Send the seventeen questions to the vendor in writing. Require a written answer to each question. Accept “not applicable” only with a reason. Score each answer in the last column as acceptable, not acceptable, or not applicable with a reason.
The No Connectivity, No Purchase Checklist: seventeen questions the vendor answers in writing before the device reaches a shortlist.
| # | The vendor must explain | Vendor’s written answer | Acceptable? |
|---|---|---|---|
| 1 | What machine-readable data does the device emit? | ||
| 2 | What machine-readable commands does it accept, if any? | ||
| 3 | What device state can the institution observe? | ||
| 4 | How does the device identify itself? | ||
| 5 | How does the device handle patient or specimen context, where relevant? | ||
| 6 | How does the device represent the provenance of each event? | ||
| 7 | Which standards or application programming interfaces (APIs) does the device support? | ||
| 8 | How does offline operation work? | ||
| 9 | How does synchronization work after reconnection? | ||
| 10 | How are updates delivered? | ||
| 11 | How are vulnerabilities managed? | ||
| 12 | How are logs exported? | ||
| 13 | How is fleet inventory maintained? | ||
| 14 | How is end of life handled? | ||
| 15 | What data can the manufacturer access? | ||
| 16 | What data can the institution export? | ||
| 17 | What happens if the vendor’s cloud service disappears? |
A vendor can answer “none” to a capability question and still pass, as long as the answer explains why the work doesn’t need it. When the institution decides to buy a device that doesn’t meet the presumption, the team completes the exception record before the purchase order goes out.
The exception record: completed and signed before the institution buys a device that doesn’t meet the presumption.
| Field | Entry |
|---|---|
| Device class, and the device (type, model, software version, number of units) | |
| Checklist items not met (by number) | |
| Reason for the exception: connectivity isn’t required (the work the device does, and why the institution doesn’t need machine-readable evidence of it); clinical performance outweighs the connectivity gap; or no bidder meets the class minimum | |
| Roadmap commitment, where one applies (the capability, the delivery date, and the remedy if the date slips) | |
| What the institution will rely on instead (paper log, printout, manual entry) and who keeps it | |
| Who approved (name, role, date) | |
| Review date |
A blank answer, or one that points to a sales conversation instead of a document, fails its item. Don’t buy a device with failed items and no signed exception record. With a signed exception record, the institution buys the device with its gaps written down, and the review date brings the question back before the next purchase.