Medical Device Incubator Services
Cleanroom Access and Quality Infrastructure Without Building Your Own Facility
You have a device that works.
What you don’t have is a cleanroom, a validated manufacturing environment, or an established quality system — and your timeline does not allow you to build one from scratch.
LSO’s Medical Device Incubator Service provides facility access, ISO 13485 infrastructure, and regulatory guidance so you can move from development to production without capital-intensive buildout
Infrastructure Without Capital Expenditure
Building your own manufacturing facility requires:
Cleanroom construction
QMS implementation
FDA registration
Validation planning
Experienced manufacturing leadership
LSO provides:
Use of certified cleanrooms
Office space with a physical address
ISO 13485-certified manufacturing infrastructure
Quality management system development support
Rather than diverting capital to build cleanrooms and implement a quality system, you operate within an established ISO 13485-certified manufacturing environment.
Regulatory Alignment from Day One
Manufacturing decisions made early affect regulatory timelines later.
The incubator program supports:
FDA registration support
ISO and FDA audit readiness
Sterilization and package validation alignment
UDI implementation guidance
Quality infrastructure is not added after the fact. It is built into the production environment from the start.
Clinical, R&D, and Early Production Builds
Startups often need structured manufacturing support before full commercialization.
The incubator model supports:
Clinical and R&D builds
Early production runs
Packaging and validation support
Full traceability within an established
This creates a practical path from “working prototype” to “regulated production.”
A Proven Environment for Innovators
Startups generally do not have space or cleanrooms to perform medical device sample production. That’s where Life Science Outsourcing can help. We’re committed to helping medical device manufacturers find the answers and solutions they need to bring their innovations to life quickly and efficiently.
OEMs Seeking Surge Capacity
- Immediate cleanroom access: Class 7 (Class 5 pharma) cleanroom space available for short-term production needs.
- Scalable solutions: Manage seasonal demand or unexpected production surges with ease.
- Cost-efficient flexibility: Avoid delays and high capital investments with flexible rental options.
- Support for new launches: Perfect for accelerating new product introductions to the market.
- Expert resources: Advanced tools and engineering expertise ensure consistent product quality.
Startups
- Turnkey production space: Immediate access to Class 7 (Class 5 pharma) cleanrooms for prototypes or small-batch runs.
- Regulatory-ready environments: Build under FDA-compliant conditions without costly investments.
- Streamlined operations: Focus on innovation while we handle operational complexities.
- Scalable as you grow: Adaptable solutions for transitioning from pilot runs to full production.
- Guided expertise: Access to engineering staff to support your product development journey.
Research & Development Teams
- Controlled environments: Conduct critical testing and feasibility studies in ISO-certified cleanrooms.
- Short-term flexibility: Secure rental options tailored to R&D project timelines.
- No minimum build requirements: Ideal for small-scale runs or early-stage prototypes.
- Cost-effective experimentation: Avoid the need for long-term facility investments.
- Streamlined workflows: Leverage cleanroom setups to maintain efficiency during clinical builds.
- End-to-end support: Partner with experienced teams to ensure smooth project execution.
Cleanroom Access — Product Compatibility
LSO cleanroom access is designed to support medical device and regulated life science applications that require controlled environments, particulate control, and ISO-aligned quality systems. The following guidance helps determine whether your product is a good fit.
Products That Work Well in LSO Cleanrooms
| Suitable Applications | Notes |
|---|---|
| Medical devices (sterile & non-sterile) | Core use case |
| Single-use disposable medical devices | Assembly and packaging supported |
| Catheters, tubing, fluid paths | Medical-grade handling |
| Wound care products and dressings | Pre-sterilization workflows |
| Medical kits and procedure trays | Kitting and packaging supported |
| Sterile barrier packaging assembly | Sealing, inspection, and preparation |
| Diagnostic device components (non-reagent) | Hardware and consumables only |
| Medical device subassemblies | Particulate-controlled assembly |
Products Not Supported in LSO Cleanrooms
| Not Supported | Reason |
|---|---|
| Pharmaceutical / drug manufacturing | Requires pharmaceutical GMP infrastructure |
| Drug formulation or compounding | Outside LSO’s regulatory scope |
| Aseptic fill-finish operations | Not a CDMO |
| Cosmetics or personal care products | Different regulatory and cleanliness requirements |
| Food, beverage, or nutraceutical products | No regulatory or operational overlap |
| Biological or biohazardous materials | Requires BSL-rated facilities |
| Live cell, tissue, or microbial handling | Not compatible with cleanroom design |
Designed to Scale With You
LSO Incubator Support is not a short-term rental model.
It provides:
Facility utilization options
Access to experienced manufacturing professionals
Integration with assembly, packaging, sterilization, and testing services
As production demand increases, infrastructure remains aligned.
You do not outgrow the system you start in.
Frequently Asked Questions
No. Production occurs within LSO’s ISO 13485-certified environment.
Yes. FDA registration and audit support are part of the incubator framework
The incubator supports clinical builds, early production, and transition toward scale.
Yes. Certified cleanroom environments are available as part of the program.