Pilot Scale Manufacturing Insurance: What It Covers, Who Needs It, and How to Get the Right Policy
Pilot scale manufacturing sits in the awkward middle ground between R&D and full production. You’re no longer “just testing” in a la…
Telemedicine has moved from “nice to have” to essential infrastructure. From remote patient monitoring devices and connected diagnostic tools to video-consultation hardware and smart kiosks, telemedicine equipment manufacturers are helping healthcare providers deliver care faster, safer, and more efficiently.
But producing medical and health-tech equipment comes with a risk profile that’s very different from general manufacturing. A single defect can trigger patient harm allegations. A software update can create downtime across multiple sites. A component shortage can stall production and breach supply contracts. And because many devices collect or transmit sensitive health data, cyber and privacy risks sit right alongside traditional factory risks.
This guide explains the key insurance covers telemedicine equipment production and manufacturing businesses typically need in the UK, why they matter, and how to structure a policy that stands up when something goes wrong.
Telemedicine equipment manufacturing can include:
Remote patient monitoring devices (wearables, sensors, home monitoring kits)
Connected diagnostic devices (digital stethoscopes, otoscopes, ECG devices)
Telehealth kiosks and consultation booths
Medical-grade cameras, microphones, and peripherals used in clinical settings
IoT gateways and hubs used to transmit device readings
Charging docks, accessories, and consumables supplied with devices
Embedded software/firmware and companion apps (where part of the product)
Many manufacturers also provide installation, maintenance, calibration, or ongoing software updates. Those services can change the insurance you need.
Telemedicine equipment sits at the intersection of healthcare, electronics, software, and data. That means you can face multiple “high severity” claim types at once.
Typical risk drivers include:
Patient safety: Devices influence clinical decisions. If readings are wrong, delayed, or missing, the consequences can be serious.
Regulatory scrutiny: Medical devices are subject to strict standards, documentation, and post-market surveillance.
Complex supply chains: Components may come from multiple countries, increasing quality and continuity risks.
Software dependency: Firmware bugs, update failures, or compatibility issues can create widespread losses.
Data and connectivity: Devices often handle personal data and connect to networks—expanding cyber and privacy exposure.
Contractual liability: NHS frameworks, private hospital groups, and distributors may impose strict indemnities, service levels, and insurance requirements.
Product liability covers claims that your product caused injury or property damage. For telemedicine equipment, this might include:
A device overheats and causes burns
A battery fails and starts a fire
A faulty reading contributes to delayed treatment
A device damages other equipment when connected
Even if the claim is ultimately defended, legal costs can be significant. Many buyers and distributors will require product liability as a condition of supply.
What to check in the policy wording
Territorial limits (UK only vs worldwide)
Whether the policy includes US/Canada exports (often higher premium)
Indemnity limits appropriate to healthcare severity
Whether “medical devices” are excluded or restricted
Public liability covers injury or property damage to third parties arising from your business activities (not necessarily from the product itself). Examples:
A visitor slips in your factory reception
An engineer knocks over equipment during an on-site installation demo
If you attend trade shows, visit hospitals, or host customer audits, public liability is typically essential.
If you employ staff in the UK, employers’ liability is generally compulsory. It covers employee injury or illness arising from work.
Manufacturing environments can involve:
Manual handling injuries
Exposure to solder fumes, chemicals, or cleaning agents
Machinery accidents
Repetitive strain from assembly work
Product recall covers the costs of recalling products from the market due to safety issues or potential defects. For telemedicine equipment, recall costs can include:
Customer notification and call centre costs
Shipping and logistics
Disposal or repair/rework
Replacement units
Regulatory communications and reporting
Some policies also offer product contamination or rectification extensions, which can be relevant if the issue is discovered before injury occurs.
Professional indemnity covers claims arising from professional advice, design, specification, or services. Telemedicine manufacturers often need PI when they:
Provide design services for bespoke devices
Specify system architecture or integration requirements
Provide calibration, testing, or certification services
Offer consultancy around deployment
PI is especially important where contracts include performance warranties or service-level commitments.
If your equipment stores, transmits, or processes patient data—or if your operations depend on IT systems—cyber insurance is increasingly non-negotiable.
Cyber policies can help with:
Ransomware response and recovery
Data breach response (forensics, legal advice, notification)
Business interruption from cyber events
Liability claims from customers and third parties
Regulatory investigations (where covered)
For telemedicine manufacturers, cyber risk can also include:
Compromised firmware updates
Vulnerabilities in companion apps
Supply-chain attacks via software libraries
Vendor compromise impacting your production environment
This typically bundles cover for your premises and day-to-day trading risks, such as:
Buildings (if you own them)
Contents, tools, and stock n- Plant and machinery
Theft and malicious damage
Fire, flood, storm
Given the value of components and finished goods, as well as specialist equipment, property cover is a cornerstone of manufacturing insurance.
Business interruption (BI) covers loss of gross profit and ongoing costs if you can’t trade following an insured event (like a fire or flood).
For telemedicine equipment production, BI can be critical because:
Lead times can be long
Contracts may include penalties for late delivery
Rebuilding clean production areas can take time
Consider whether you need:
Increased cost of working (to keep trading)
Supplier extension (if a key supplier suffers a loss)
Customer extension (if a major customer site loss affects your turnover)
If you ship components or finished devices, you may need cover for:
Damage in transit
Theft from vehicles
Loss during international shipping
This is especially relevant if you import electronics or export finished units.
Manufacturing relies on machinery—pick-and-place machines, test rigs, calibration tools, compressors, and more. Equipment breakdown cover can help with:
Sudden mechanical or electrical failure
Repair and replacement costs
Associated business interruption (if added)
If you have a board, investors, or significant contractual exposure, D&O can protect directors and officers against claims alleging wrongful acts in management.
This can matter in health-tech where:
Regulatory issues can trigger investigations
Contract disputes can escalate
Investors may scrutinise governance
Insurance is only helpful if it responds when you need it. Telemedicine manufacturers should pay close attention to exclusions and limitations.
Common issues include:
Known defects / prior circumstances: If you were aware of an issue before inception, claims may be excluded.
Contractual liability: Some policies won’t cover liabilities you assume by contract beyond common law.
Fitness for purpose guarantees: If you promise outcomes, insurers may treat that as a higher risk.
Software and cyber exclusions on liability policies: Product liability may exclude pure financial loss from software failure.
US/Canada exports: Often excluded unless specifically included.
Clinical trial or investigational use: If devices are used in trials, you may need specialist cover.
A good broker will help align your contracts, product documentation, and insurance wording.
A batch of remote monitoring sensors reports inaccurate readings due to a calibration error. A healthcare provider alleges patient harm and sues for damages and legal costs.
Potential covers involved: product liability, PI (if design/specification is alleged), legal expenses.
A firmware update bricks devices in multiple clinics, causing appointment cancellations and operational disruption. The customer claims for losses and emergency replacement costs.
Potential covers involved: PI, cyber (if linked to a security incident), product recall/rectification (depending on trigger).
An electrical fault causes a fire, damaging stock and specialist machinery. Production stops for months.
Potential covers involved: property, equipment breakdown, business interruption.
Production systems are locked, and order processing halts. Sensitive supplier and customer data may be exposed.
Potential covers involved: cyber (incident response, BI from cyber, liability), possibly crime cover if social engineering is involved.
Underwriters typically want to understand:
What you manufacture and whether products are classed as medical devices
Where products are sold (UK/EU/worldwide)
Your quality management system (e.g., ISO 13485)
Testing, traceability, batch control, and documentation
Supplier vetting and incoming inspection
Software development lifecycle and vulnerability management
Incident response and recall plans
Contract terms, warranties, and indemnities
Turnover split (manufacturing vs services vs software)
Practical ways to strengthen your insurance submission
Document QA processes and keep audit trails
Maintain clear version control for firmware/software
Have a formal recall and customer notification plan
Use secure update mechanisms and penetration testing
Keep contracts consistent and avoid over-promising outcomes
There’s no one-size-fits-all, but consider:
Higher liability limits if your devices influence clinical decisions
Separate PI and cyber limits if you provide services and handle data
Recall cover aligned to the cost of retrieving and replacing units
BI indemnity period long enough to rebuild and re-certify production
A broker can model worst-case scenarios (recall volume, export exposure, key supplier failure) and recommend realistic limits.
In most cases, yes. If your equipment could cause injury or property damage, product liability is a core requirement and often contractually mandated.
If you truly only manufacture to a fixed design with no advice, design responsibility, or installation/service work, PI may be less critical. But many telemedicine manufacturers provide specifications, integration guidance, or updates—making PI a common requirement.
You should strongly consider cyber insurance and check whether your liability policies exclude software-related losses. You may also need PI that explicitly covers technology and connected device services.
Sometimes, but not always. If a vulnerability forces a recall or urgent patching programme, coverage depends on policy wording and triggers. This is a key point to discuss with your broker.
You’ll need to confirm territorial limits and jurisdiction. You may also need higher limits and evidence of compliance with relevant standards and regulations.
Telemedicine equipment manufacturing is a growth market, but it’s also a high-stakes environment where quality, compliance, and resilience matter.
The right insurance programme doesn’t just tick a box for contracts—it protects your balance sheet when a defect, disruption, or cyber incident hits.
If you want a fast, tailored quote, speak to a specialist commercial broker who understands medical devices, technology risk, and manufacturing—so your cover matches the reality of how you design, build, ship, and support your products.
Need advice or a quote? Call Insure24 on 0330 127 2333 or request a quote online at https://www.insure24.co.uk/
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