We work with biomedical companies to optimize operations, ensure compliance, and boost performance from R&D to commercialization—unlocking their full potential through strategic consulting.

Our Services

Business Management

Optimizing your operations for efficiency and scalability.

  • Strategic Planning – Market assessment, competitive analysis, go-to-market strategy.

  • Growth Strategy – Product portfolio optimization, mergers & acquisitions due diligence, scaling strategies.

  • Change Management – Integrating new technology, post-merger integration, or restructuring.

  • Project Management Support – Management for complex product development or clinical validation timelines.

man in white dress shirt sitting beside woman in black long sleeve shirt
man in white dress shirt sitting beside woman in black long sleeve shirt

Financial clarity for biomedical innovators.

  • Cost Accounting & Margin Analysis – Accounting for device manufacturing and contract R&D services.

  • R&D Tax Credit Consulting – Optimizing tax incentives for research investments.

  • Grant & Non-Dilutive Funding Advisory – Paving the way for NIH, SBIR, and other funding sources.

  • Valuation Services – For startups raising capital, licensing technologies, or entering M&A.

  • Financial Modeling – Budgeting, cash flow forecasts, and burn rate tracking for biotech startups.

Aligning innovation with compliance and market needs.

  • Product Design and Prototyping – CAD modeling, biomechanics simulation, biocompatibility considerations.

  • Regulatory Consulting – FDA (510(k), PMA) and CE mark pathways, clinical trial design, documentation (Design History Files, Device Master Records).

  • Risk Management & Human Factors – FMEA, usability engineering, ISO 14971 compliance.

  • Clinical Validation & Testing – Preclinical study design, ISO 10993 testing strategy, data analysis.

  • Technology Evaluation – Feasibility studies for new devices or diagnostics.

woman in white and black polka dot shirt holding white headphones
woman in white and black polka dot shirt holding white headphones
man in blue dress shirt beside man in white dress shirt
man in blue dress shirt beside man in white dress shirt

Biomedical Engineering

Finance & Accounting

Data Infrastructure & Engineering

You might have the best product or service in the world, but if you can't effectively organize your data and other information technology infrastructures, you could be missing out on opportunities. Our data engineers help you understand and implement the right infrastructure solution for your brand and business, ensuring all teams have the knowledge to operate the right databases.

Data
Engineers

All of our data engineers are Boston University graduates.

4

23

Systems engineered

We've worked with clients from all walks of life, from tech to agriculture.

16

Ongoing projects

We keep in touch with our clients and offer ongoing support.

Streamlining operations to reduce costs, improve productivity, and ensure compliance.

  • Formulation and Process Development – For drug-device combinations, polymers, hydrogels, coatings.

  • Scale-Up Support – Transitioning from lab to pilot to full-scale manufacturing of reagents or biomaterials.

  • Sterilization and Contamination Control – Ethylene oxide, gamma, e-beam validation.

  • Material Compatibility & Testing – Chemical resistance, extractables/leachables, degradation studies.

  • Chemical Safety and Regulatory Compliance – REACH, CLP, SDS authoring.

Data Analytics

Effective data analysis helps businesses of all sizes to save money, see the bigger market trends and streamline internal processes. Our team helps you identify the data streams you should be tracking and following, and sets up processes and visualization tools to help you make sense of the data. From one-off consultation to ongoing partnerships, our data analysts are available on short notice to help you steer your business to the right direction.

Data
Analysts

Our in-house data analysts have a hands-on approach to data.

5

45

Companies analyzed

Last year, we were able to help nearly 50 companies.

130k

Dollars saved in a day

Our consultants were able to save our client $130k in a day.

Data Visualization

You've got the data, but struggle in visualizing the market changes and consumer behavior? We've got your back. Our in-house team of UI/UX designers ensure that all data, no matter how complex, can be displayed through visualization tools in ways that actually make sense to shareholders at a glance.

UI/UX designers

Our designers have an extensive background in data analysis.

3

1340

Visualizations made

From presentations to marketing materials and beyond.

23

Ongoing projects

Data changes, but our team stands by your side when you need us.

We’ve helped them

We've partnered with many household brand names to deliver insights and solutions to their problems with big data.

Happy clients

Don't just take our word for it – our clients frequently stay in touch with us and work with us on future projects that require big data insights.

John Bjerrand

I work in agricultural consulting, meaning that we often need to use big and complex datasets to justify expensive investments for our clients. Lilo's consultants helped us see the big picture with their visualization tools and expertise.

Anna Claudio

As the in-house supplier manager, it's sometimes had to understand which manufacturers work best for our needs. Lilo's data analysis helped us identify where we could save and which manufacturers worked the best for us in the long term.

Contact us

Whether you have a request, a query, or want to work with us, use the form below to get in touch with our team.