The exoskeleton vendor RFP: questions and red flags

What a spec sheet cannot tell you

An exoskeleton vendor's data sheet will tell you the device's weight, the torque output, the battery life, and the adjustment range. It will not tell you whether the vendor's fit program is adequate for a 300-person shift with high turnover. It will not tell you whether the device can be sanitized with the cleaning agents used in your production environment. It will not tell you what happens to your program if the vendor is acquired, discontinues the model, or goes out of business.

The questions in this RFP are the ones that go beyond the spec sheet. They apply to industrial buyers (EHS managers, operations leaders) and medical buyers (clinic directors, hospital procurement), with sections specific to each. They are designed to surface the information that separates vendors who can support a durable program from vendors who can support a successful demo.

This is not an exhaustive legal procurement document. It is a due-diligence question set for the evaluation stage, before formal RFP issuance.

Section 1: Fit and sizing program

The fit program is one of the highest-leverage variables in program success, and one of the most undersold in vendor presentations.

Questions to ask:

1. What are the device's anthropometric adjustment ranges? (Provide your workforce height, weight, and torso-length distribution and ask for the percentage of your population that falls within range.)
2. What is the vendor's fitting protocol? Does it include individual one-on-one fitting, or is it group orientation?
3. Does the vendor provide a certified fitting technician for initial deployment? Is this included in the purchase price, or billed separately?
4. Is there a certification course for our internal ergonomics staff to conduct fittings independently? What does it cost, and how long is the certification valid?
5. What happens when a worker's body changes (weight gain, weight loss, recovery from injury)? Is re-fitting straightforward?
6. What is the recommended re-fitting interval?

Red flags:

• Vendor cannot provide anthropometric range data, or cannot confirm whether your workforce distribution falls within range without seeing the data sheet
• Fitting described as "workers can self-fit using the instruction guide" — individual fit assessment by a trained person is the standard for programs expecting 80%+ wear rate
• No post-sale fitting support; fitting support is billed separately at a rate that makes ongoing re-fitting cost-prohibitive
• Vendor has no field fitting technicians in your geography

Section 2: Shared use and hygiene

Shared exoskeleton programs (multiple workers sharing one device across shifts) are common and economically rational. They create hygiene requirements that must be addressed explicitly.

Questions to ask:

1. Which components of the device require sanitation between users, and which require sanitation on a scheduled interval?
2. What cleaning agents are approved for use on the device's contact surfaces? Can you provide a list of approved agents with dilution specifications?
3. Is the device compatible with [your specific cleaning agents / your USDA/FDA sanitation standard]?
4. Which components are replaceable hygiene items (pads, straps, liners)? What are the replacement intervals and costs?
5. Can the device be laundered, or only wiped? If laundered, what temperature and cycle settings are recommended?
6. Are hygiene consumables available directly from the vendor, or through third-party distributors? What is the lead time for replenishment?

Red flags:

• No specific cleaning agent compatibility data available; vendor says "wipe it down" without specifying agents
• Contact surface materials are not rated for the cleaning agents used in your environment (e.g., food-grade quaternary ammonium compounds)
• Replacement pads or hygiene consumables are only available from the vendor at high cost with long lead times
• No documented hygiene protocol exists; vendor improvises during the conversation

Section 3: Battery and duty cycle (powered devices)

Questions to ask:

1. What is the rated battery life under the usage conditions matching our task? (If vendor states "8 hours," ask what "usage conditions" that assumes — continuous moderate-torque use vs. intermittent use are very different.)
2. What is the rated battery cycle life before capacity degrades to replacement threshold? What is the replacement battery cost?
3. How long does a full charge take? Can batteries be hot-swapped mid-shift without powering down?
4. What is the charging infrastructure cost? (Docking stations, charging racks, cables)
5. What are the battery storage requirements? (Temperature range, charge state for long-term storage)
6. Does the device have a fail-safe mode if the battery depletes during use? What does the worker experience?

Red flags:

• Vendor cannot provide battery cycle life data, or provides only total charge count without capacity-degradation specification
• Battery replacement cost is a significant percentage of device cost and is only available through the vendor with a long lead time
• Hot-swap is not available and a depleted battery mid-shift requires the device to be removed entirely — creates shift-management friction
• Fail-safe behavior has not been documented or tested; vendor cannot describe what happens at low battery

Section 4: Regulatory clearance and evidence base

This section is especially critical for medical/rehabilitation buyers but also applies to industrial buyers considering powered devices or devices used in safety-sensitive environments.

Questions to ask (medical buyers — all required):

1. Provide the FDA 510(k) clearance number and the specific cleared indication language. (If the device is De Novo authorized, provide the authorization number and predicate device.)
2. Is the device cleared for our intended patient population? (Specify your population: diagnosis, age range, ambulatory status, clinical setting — inpatient/outpatient/home.)
3. Is the device CE-marked under EU MDR? (Relevant if your program operates in multiple geographies or if your clinical governance requires EU-standard documentation.)
4. Provide a list of peer-reviewed clinical studies in the target indication. How many are prospective randomized controlled trials versus observational studies? What are the primary endpoints measured?
5. Are there any active FDA recalls, field safety corrective actions, or device advisories on this product or a prior version?
6. What is the device's adverse event reporting history? (Ask for the number of MDR (Medical Device Report) submissions, not just warranty claims.)

Questions to ask (industrial buyers):

1. Does this device require any regulatory clearance in our jurisdiction for occupational use? (In most jurisdictions, no clearance is required for industrial exoskeletons, but verify for your sector and geography — food-grade environments, healthcare facility use, and some national jurisdictions differ.)
2. What safety testing has been conducted on the device? (ISO, ASTM, or EN standards applicable to exoskeletons or personal protective equipment)
3. Are there any known contraindications for use — worker medical conditions, prior injuries, or physical characteristics that would make use inadvisable?
4. Has the device been evaluated for electromagnetic interference (EMI) in environments with welding equipment, RF equipment, or high-voltage lines?

Red flags (medical):

• Vendor cannot provide a clearance number on request, or clearance number does not match the intended indication when verified at the FDA's 510(k) database
• Clinical evidence base consists primarily of case series, conference abstracts, or studies conducted by the vendor's own research team without independent replication
• Adverse event history is unavailable or vendor is defensive about MDR disclosures
• Clearance exists for one indication and the vendor implies it applies to a different patient population without a separate clearance pathway

Red flags (industrial and medical):

• Device has unresolved recalls or field safety corrective actions
• Vendor is unfamiliar with the applicable safety standards for your environment
• Known contraindications are not documented; vendor says "it's fine for everyone"

Section 5: Training and clinical support

Questions to ask:

1. What initial training is provided at installation? Who delivers it, and is it included in the purchase price?
2. Is there ongoing training available for new hires or new clinical staff?
3. For medical devices: is there a clinical specialist or applications specialist available in our geography? What is their typical response time for on-site support?
4. What is the vendor's customer support structure? (Phone, email, on-site; hours of availability; escalation path for safety-related concerns)
5. Does the vendor offer a user community or peer network (e.g., calls with other EHS managers or PTs using the same device in similar settings)?
6. Is there a software update process? How are updates delivered, and do updates require a service visit?

Red flags:

• Post-sale support is primarily ticket-based with no named account contact and multi-day response SLAs
• Clinical specialist is shared across a large multi-state territory and can only visit quarterly
• Software updates require sending the device back to the vendor — a device-down event for a program that has no backup unit
• Vendor cannot provide references from programs in your sector or comparable setting

Section 6: Return policy, trial terms, and end-of-life

Questions to ask:

1. Is a trial or pilot lease available before full purchase commitment? What are the terms (duration, cost, buy-out credit)?
2. What is the return policy if the device does not fit the task or workforce adequately after the pilot? Is there a restocking fee?
3. What is the vendor's commitment to parts availability for this model? (Ask for a contractual minimum — "parts available for X years after last purchase" is the industry standard for durable medical equipment.)
4. What happens to a customer's program if the vendor is acquired or discontinues the model?
5. What is the device's rated service life? What defines end-of-life?
6. For powered devices: what is the battery disposal requirement? Is there a take-back program?

Red flags:

• No trial or pilot lease option; vendor pushes for full purchase commitment before any on-site testing
• Return policy is non-existent or restocking fee makes returns prohibitive
• No contractual parts availability commitment; vendor's position is "we intend to support the model"
• Vendor cannot describe their acquisition or discontinuation contingency with specificity

Section 7: Red flags summary checklist

The following, in any vendor conversation, should pause the evaluation:

• Cannot provide FDA clearance number or CE mark documentation on request
• Fit program is self-serve or group-only; no individual fitting protocol
• No documented cleaning agent compatibility or hygiene protocol
• Replacement parts/consumables available only from vendor with long lead times
• Battery cycle life data unavailable or cycle life implies annual replacement at high cost
• Clinical evidence base is primarily vendor-sponsored or observational only
• Unresolved recalls or active field safety corrective actions
• Post-sale support is ticket-only with multi-day SLA
• No trial or pilot option before full purchase commitment
• No contractual parts availability commitment

No vendor will score perfectly. The goal is to identify which issues are deal-breakers for your program versus which are negotiable or manageable. A vendor who scores well on safety documentation and fit program but has slow consumables replenishment is a negotiation target, not an automatic disqualification. A vendor who cannot provide a clearance number is a different conversation.

This article completes the Exoskeleton series. For the full program design framework, start with Why exoskeleton pilots fail to stick, or browse the exoskeleton catalog to see current commercial devices.