How to Set Up a Lab: Expert Tips to Help Startups Get It Right the First Time

Setting up a lab is a major milestone for any biotech startup and one that demands careful planning. At Streamline BioOps, we provide laboratory consulting services and quality consulting to help life science startups build audit-ready, scalable labs that accelerate science, strengthen compliance, and inspire investor confidence.

Drawing on over 15 years of experience building, leading, and scaling laboratories and quality systems, I’ve developed a set of easy, practical steps to help founders get it right the first time.

Start with a Strategic Plan

Before purchasing a single pipette, define what your lab needs to accomplish in its first 12–18 months.

• What scientific or commercial milestones are you targeting?

• Which assays, instruments, and workflows are essential vs. “nice-to-have”?

• What certifications or compliance frameworks (like ISO 17025 or CLIA) will you eventually need?

A clear operational plan will help you design the right space, allocate budget wisely, and avoid costly retrofits later.

Streamline Tip: Begin with your end goals—validation, pre-clinical work, pilot production—and design backward from there.

Choose the Right Space

Your space determines your flexibility, compliance, and growth potential.

Consider:

• Infrastructure: Electrical load, emergency outlets, backup generators, HVAC, safety systems, and lab drainage.

• Flexibility: Modular layouts for scaling or pivoting assays.

• Shared vs. Private: Incubator labs (like Portal Innovations, Helix 51, or Polsky) reduce overhead for early teams; private space adds control but higher cost.

• Proximity: To partners, universities, or investors—location can impact collaboration and funding.

Build Smart, Lean, & Compliant

Instead of outfitting your lab all at once, focus on core capabilities that move you toward key milestones.

• Procure essential instruments first (centrifuge, biosafety cabinet, incubator, pipettes, freezer).

• Implement inventory systems early—barcode, track, and label reagents from day one.

• Document everything: Write SOPs as you go; don’t backfill later.

• Design quality into your workflow. Even if ISO certification isn’t required yet, build systems that meet those standards.

Develop a QMS Early

A Quality Management System (QMS) doesn’t need to be complex or expensive to make a big impact. In fact, creating a simple, right-sized QMS early can save you countless hours and dollars down the road.

Startups often wait until they’re preparing for audits or funding rounds to implement quality systems—but by then, you’re playing catch-up. Building an easy QMS now keeps you organized, compliant, and credible from day one.

Here’s how to start small:

• Document your core SOPs—equipment use, sample handling, and data recording.

• Create a training log for every employee or collaborator.

• Track instrument calibration and maintenance in a shared spreadsheet or lightweight digital system.

• Keep all controlled documents versioned, signed, and easily accessible.

These small steps build a foundation that scales. As your lab grows, you can expand your QMS into a full ISO or GLP-compliant framework without rewriting everything.

Streamline Tip: Think of your QMS as an insurance policy for your science. It protects your data integrity, reduces rework, and earns investor and reviewer confidence.

Plan Ahead for Data Storage and Integrity

Data is the lifeblood of any life-science startup — it’s what drives publications, funding, and investor confidence. Yet many early teams underestimate how quickly data management can spiral out of control without a plan.

Before you produce your first dataset, think through how your information will be stored, backed up, and accessed. A simple, consistent approach early on will protect your intellectual property and save enormous time later.

Here’s how to get started:

• Choose a secure storage platform: Use reputable, cloud-based tools (like Google Drive, OneDrive, or Dropbox for Business) with controlled access and automatic backups. Avoid saving critical data on personal drives or desktops.

• Create a clear folder structure: Organize by project, assay, and version — so you can find data quickly during audits or funding reviews.

• Define access permissions: Limit editing rights to core team members and maintain a record of who has access to what.

• Establish naming conventions: Consistent file naming (e.g., “ProjectName_Assay_Date”) saves hours of searching and supports reproducibility.

• Back up critical data: Maintain at least two copies of all raw and processed datasets — one local, one cloud-based.

• Plan for growth: As you begin producing large amounts of data or collaborating with CROs, outline when you’ll need to migrate to more advanced systems like LIMS, ELNs, or secure data lakes.

Streamline Tip: Treat your data like any other lab asset — it needs ownership, organization, and care. A clear storage plan early ensures your science remains defensible, reproducible, and ready for review at any stage.

Hire (or Outsource) Wisely

Early hires should be multi-functional scientists who thrive in startup environments. They’ll juggle research, safety, and sometimes even vendor management.

If headcount is limited, consider fractional operations support—a cost-effective way to access experts in lab setup, quality consulting, and process documentation.

Streamline Tip: Having a part-time lab operations consultant early can prevent compliance issues later and keep your startup investor-ready.

Procurement and Vendor Management: Build Partnerships, Not Just Purchase Orders

For startups, procurement isn’t just about buying equipment and reagents. It’s about building strategic vendor relationships that support flexibility, reliability, and growth. The right partners can save you money, time, and compliance headaches down the road.

Here’s how to approach vendor management like a pro from day one:

• Start with a critical needs list: Prioritize what you must have to reach your next milestone (e.g., pipettes, biosafety cabinet, centrifuge, incubator). Don’t overbuy early. Scale equipment as your workload and validation needs grow.

• Request multiple quotes: Vendors are often willing to negotiate, especially with startups. Ask about bundled pricing, academic discounts, or used/refurbished options.

• Evaluate vendors beyond cost: Consider lead times, service response, calibration options, and reputation for reliability.

• Document everything: Keep copies of quotes, service agreements, and warranties organized. These records can be critical during audits or when evaluating cost efficiency for investors.

Streamline Tip: Treat vendors as partners in your growth, not just suppliers. Strong relationships can unlock faster service, better pricing, and even introductions to other industry resources.

Set Up Simple Systems Early — Then Plan for Digital

Most startups can’t afford advanced digital systems right away — and that’s okay. You don’t need an expensive LIMS or full-scale automation platform to stay organized and compliant in your first year.

What matters is creating simple, structured systems early, and then developing a clear roadmap for when digital tools will become essential as you grow.

Here’s how to start:

• Use shared spreadsheets or cloud folders to track samples, reagents, and instrument maintenance.

• Keep a version-controlled SOP log in Google Drive or SharePoint with review dates and owner names.

• Create a training tracker to record who has been trained on what and when.

• Maintain a basic quality log for deviations, CAPAs, and audit notes.

Then, once you’re consistently generating data, managing multiple users, or preparing for audits or ISO accreditation, it’s time to evaluate lightweight digital.

Streamline Tip: Think of digital systems as a milestone, not a starting line. Build your foundation with simple, disciplined practices first — they’ll make your eventual digital transition faster, cleaner, and more cost-effective.

Align Operations with Funding Strategy

Your lab setup should support your funding milestones, not outpace them.

For early-stage teams, non-dilutive grants (SBIR/STTR, NSF, NIH) can offset infrastructure costs.
Keep your operations grant-ready by maintaining budgets, data integrity, and project documentation that align with reviewer expectations.

If grant writing isn’t your specialty, partner with experts who can frame your science and operational plan in a fundable story.

Plan for Audits Before They Happen

Audits don’t have to be fire drills. From day one:

• Keep equipment logs and calibration records.

• Maintain training files and SOP revision histories.

• Document risk assessments and CAPAs (Corrective and Preventive Actions).

By treating compliance as part of your daily rhythm—not a scramble before funding or inspections—you’ll save stress, time, and money.

Final Thoughts

Setting up a lab is more than assembling equipment—it’s about creating a foundation for growth, reproducibility, and credibility. With smart planning, scalable systems, and the right partners, your lab can drive your science forward and attract the funding you need.

At Streamline BioOps, we offer consulting services for startups, including laboratory consulting, quality consulting, and grant writing services that help you set up a lab built for success.

Let’s design your lab—and your roadmap—to work smarter, scale faster, and impress your next investor or reviewer.