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Single-use devices & accessories · small volumes · built for EU MDR & FDA requirements

Single-use devices – from the very first lot.

Your team is creating innovative medical technology. We make sure the single-use accessory is ready when your device is – validated, documented and delivered in small lots, without you having to build a supply chain first.

Talk to usHow it works

From the first lot

Small volumes without minimum-order pain

Sterile or non-sterile

Whatever your accessory needs

Ready from day one

Expertise and infrastructure already in place

A familiar story

Your device is ready. Its accessory isn’t.

Your team is creating innovative medical technology – a surgical robot, a diagnostic platform, a new monitoring system. You have spent years on the technology, the software and the clinical workflow. The first clinical study is finally in sight – and then the question comes up: who actually makes the single-use accessory that goes with it?

The drape for the robot. The cartridge for the analyser. The electrode for the monitor. Suddenly your team is dealing with supplier qualification, packaging validation, biocompatibility, cleanroom production and batch records – and sometimes sterilisation, too. None of it is your innovation, but all of it stands between your device and its first user. Building that expertise in-house takes people, money and, above all, time.

That is the gap we close. 1stLot Medical takes over the single-use accessory with expertise and infrastructure that already exist – so your team can stay focused on what makes your technology unique.

What suddenly lands on your team’s desk

Packaging validation
Sterilisation, if needed
Biocompatibility
Cleanroom suppliers
Batch release & records
Technical documentation

With 1stLot, none of this has to be built in-house.

Speed

Time is the biggest lever

For a team creating new medical technology, every month without its accessory is a month without clinical data, without user feedback and without revenue. Doing it all in-house means acquiring expertise, qualifying suppliers, validating and setting up a QMS – one step after the other. With 1stLot, these steps run on infrastructure that already exists, and the first lot arrives much earlier.

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Fully in-house
Acquire expertiseQualify suppliersValidate processesSet up QMSFirst lot
With 1stLot
Interface & specValidation on platformFirst lotClinical studyUser feedbackMarket
Time gained

Time to clinical study

Validated, documented accessories ready for your clinical investigation – while your team is still refining the device.

Time to customer feedback

Small lots put real products in users’ hands early, so changes happen before scale-up, not after.

Time to market

The accessory workstream runs in parallel to the device, not after it. Your launch no longer waits for an accessory.

Our focus

Single-use accessories for innovative devices

From drapes and adapters for robotics to cartridges for diagnostics and electrodes for monitoring: if it is used once and belongs to a device, we can take it on – sterile or non-sterile.

Drapes

Probe covers

Instrument adapters

Instruments

Trocars & cannulas

Cartridges

Tubing sets

Filters

Electrodes

Applicators

Our model

Your team focuses on the innovation. We handle the accessory.

Two workstreams, running at the same time. Your engineers keep their attention on what makes your product unique. We bring the expertise for everything the single-use accessory needs – and a qualified partner network behind it, with redundancy for critical processes. For you it stays simple: one point of contact, one contract, one batch release.

Your team

on the innovation

Core technologySoftwareClinical evaluationMarket access

1stLot Medical

with expertise that already exists

Packaging validationSterilisation (if needed)BiocompatibilityCleanroom productionSupplier managementBatch release & records

Market launch

Three examples: A robotics team develops the arm and its software – we deliver the drape and the instrument adapter. A diagnostics team develops the analyser – we deliver the cartridge. A monitoring team develops the system – we deliver the electrodes. Each time validated, documented and ready for the clinical study, without accessory expertise built in-house.

The platform

Infrastructure that is already in place

You don’t build anything – you use what is already there. Your accessory is assembled at existing stations by trained staff, packed and sealed on validated equipment, stored with batch traceability and released with complete batch documentation.

Cleanroom assemblyPackaging & sealingWarehouseQuality & releaseLOTOK
A

Assembly stations & trained staff

Set-up stations, defined processes, qualified operators

B

Cleanroom capacity

Booked as needed – no cleanroom of your own

C

Validated processes

Assembly routines, standard packaging and – where needed – sterilisation families

D

Warehousing & logistics

Batch-tracked storage, picking and shipping

E

Quality management

Batch release with complete documentation, audit-ready from lot 1

F

Shared fixed costs

Validations and sterilisation runs shared across customers

System engineering

Clean interfaces between device and accessory

Your device and its accessory are different products – often in different risk classes. We define the interface between them precisely: how they fit, which tolerances must hold, how they work together, whether electrical requirements apply, and what biological safety – and, where needed, sterility – demand. Each product keeps its own technical file, linked by clear references. Changes on one side never surprise the other – and your device file stays lean.

Device

Technical file A

e.g. class IIb · owned by the device manufacturer

Interface definition

Mechanical fit
Robust tolerances
Function & performance
Electrical conformity
Biological safety
Packaging, sterile if needed

Accessory

Technical file B

e.g. class Is · lean and separate

Separate files
Clear references
Controlled changes
Transparency under NDA

Two ways to work with us: 1stLot Supply – you remain the legal manufacturer · 1stLot Manufacturer – we take on that role.

The process

From prototype to first lot – and beyond

1

Analysis

Define product, class and interfaces to the device

2

Network

Assign partners and platform processes

3

Validation

Validate processes, packaging and – if needed – sterilisation

4

Small series

Small lots with full batch records

5

Transfer

Handover to a series manufacturer when you grow

We build your supply chain so you can take it with you.

When your device moves into high-volume production, you receive a complete, transferable documentation package – and, if you wish, introductions to suitable series manufacturers.

For partners

Become part of the network

We bring you projects you could not serve economically on your own – bundled, clearly specified and with interfaces already defined. Device manufacturers are not our competitors but our referral partners.

We are looking for

Injection moulders and extruders with cleanrooms

Cleanroom assembly and packaging

Sterilisation providers (EtO, radiation)

Test laboratories

Device manufacturers for referral partnerships

Series manufacturers for later transfer

What you get

Pre-qualified projects with clear requirements

Bundled volume from many small customers

A pipeline of future series customers

Clean specifications and interfaces

One point of contact with medtech QM experience

Next step

Let’s talk.

Developing a device that needs single-use accessories? Or a manufacturing partner looking to join the network? Let’s find out in one conversation whether 1stLot fits your project.

Contact
info@1stlot.com

Web
1stlot.com