Baymar Solutions
- Company typePrivate
- Founded2006
- HeadquartersTampa, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Baymar Solutions does
Baymar Solutions, LLC is a privately held, founder-owned engineering services and contract manufacturing firm founded in 2006 by Andrew McCutchen and headquartered in Lutz (Tampa), Florida. The company provides end-to-end product development, regulatory, and manufacturing services for biomedical and commercial products, with primary customers in the in-vitro diagnostics (IVD) and medical device sectors and secondary exposure to aerospace/defense and pharmaceutical clients. Its service portfolio spans fractional engineering teams (electro-mechanical and assay development), agile/Scrum project management, FDA launch support (510K, PMA, IVDR), scientific and regulatory affairs (CDx/IVD assay development, reagent formulations, SOP drafting), and contract manufacturing at an FDA-registered, ISO 13485:2016 certified facility in Odessa, Florida that includes CNC machining, TIG welding, surface grinding, assembly, inspection, and a cleanroom (ISO 7/Class 10,000). Baymar Technical Staffing, launched in January 2022, extends the offering into contract-to-hire, direct hire, and long-term contract engineering and manufacturing talent solutions. Notable enterprise customers include Bio-Rad Laboratories, Roche Diagnostics, Visby Medical, HTG Molecular, Smith & Nephew, DRS Technologies, Securaplane (Meggitt), and Bravado Pharmaceuticals.
Baymar Solutions firmographics
Firmographics- Name
- Baymar Solutions
- Legal name
- Baymar Solutions, LLC
- Website
- https://baymarsolutions.com
- Company type
- Private
- Founded year
- 2006
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Ownership category
- akta.pro rank
Where Baymar Solutions is headquartered
LocationHeadquarters
- HQ city
- Tampa
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Baymar Solutions business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales
Revenue model
- Engineering Services: Fractional engineering team providing electro-mechanical and assay development services. Team supplements part of customer teams or serves as entire team with flexible engagements.
- Project Management: Configuration control, agile project management with scrum methodology, and vendor management and collaboration services.
- Contract Manufacturing: FDA registered facility with ISO 13485 certification manufacturing Class I and Class II medical devices. Supports low volume complex instrumentation, high volume consumable manufacturing, and cleanroom capabilities.
- Scientific & Regulatory Support: Assay development (CDx, IVD), reagent development and formulations, quality control requirements, clinical/technical literature drafting, and scientific SOP development.
- Technical Staffing: Baymar Technical Staffing division providing contract-to-hire, direct hire, and long term contract resources with nationwide on-site or remote support.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom quote-based engineering and manufacturing services |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
Baymar Solutions product offering
Product offeringCore offering
Baymar Solutions is a single source provider of full-scale engineering services for biomedical and commercial products. The company delivers fractional engineering teams, project management, scientific and regulatory support, U.S. FDA launch support, and contract manufacturing from an ISO 13485-certified, FDA-registered facility serving IVD and medical device companies across the entire product lifecycle.
Product overview
Baymar Solutions is a single source provider of full-scale engineering services for biomedical and commercial products, offering comprehensive product development, regulatory, and business support services. The company's portfolio consists of service offerings organized around fractional engineering (electromechanical and assay development), project management (agile/Scrum methodology), FDA launch support, scientific and regulatory services (assay development, reagent formulations), and contract manufacturing (fabrication, assembly, inspection, pilot plant). Supporting services include technical staffing through Baymar Technical Staffing division and IVD-specific talent solutions. The company operates an ISO 7 (Class 10,000) cleanroom facility and supports products across the entire lifecycle from planning through on-market support.
Differentiator
Problem solved
Functional benefit
Brands
- Baymar Technical Staffing: A business division providing contract-to-hire, direct hire, and long term contract resources for engineering and manufacturing career fields, with operations in Florida, Arizona, California, and Puerto Rico.
Products and services
- Fractional Engineering Team of engineers and scientists providing electro-mechanical and assay development services, allowing clients to supplement part of their team or use the entire Baymar team on a flexible engagement basis.
- Project Management Configuration control, agile project management using Scrum methodology, schedule building and maintenance, and vendor management and collaboration services.
- U.S. FDA Launch Support Comprehensive regulatory strategy, regulatory submission, testing and redesign, and contract manufacturing services to support medical device and IVD product launch in the U.S. market.
- Scientific & Regulatory Support Assay development for companion diagnostics (CDx) and in vitro diagnostics (IVD), reagent development and formulations, literature reviews, quality control requirements, clinical/technical literature drafting, and scientific SOP development.
- Contract Manufacturing FDA registered facility offering fabrication (CNC Machining, TIG Welding, Surface Grinding), assembly, inspection and test services, and pilot plant capabilities for Class I and Class II medical devices.
- Baymar Technical Staffing Nationwide on-site or remote staff augmentation with contract-to-hire, direct hire, and long term contract resources for engineering and manufacturing career fields.
Companies that use Baymar Solutions
Customer profileNamed customers9 records
Segments4 records
Ideal customer profiles3 records
Baymar Solutions technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Baymar Solutions partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core and regional.
- Bravado PharmaceuticalscoreStrategic collaboration for pharmaceutical development. Bravado utilizes Baymar's engineering capabilities to create unique pharmaceutical development dosage form equipment and delivery devices for tablets, capsules, semi-solids, nasals, ophthalmics. Baymar has previously designed unique tablet manufacturing and concept equipment for Bravado. The partnership aims to offer advanced packaging systems for comprehensive drug development from cradle to grave.
- Anteris MedicalregionalBaymar partners with Anteris Medical to provide localized support to clients in Germany and Switzerland, while collaborating to develop combination products for customers in the U.S. Anteris was founded in 2014 and supports pharmaceutical, biotech and medical device industries.
Scale indicators6 records
Recent moves9 records
Baymar Solutions competitors and assessment
Company assessmentBroad incumbents
- Flex Medical: Global EMS provider with a Health Solutions business covering medical device design, manufacturing, and regulatory services; competes for larger enterprise medical device programs where Baymar's smaller scale is a constraint.
- Jabil Healthcare: Global contract manufacturer with a dedicated Healthcare division offering medical device design, engineering, and manufacturing services; overlaps with Baymar on contract manufacturing but operates at far greater scale.
- Phillips-Medisize: Large-scale medical device design and manufacturing services provider owned by Molex; competes with Baymar on integrated design + manufacturing, but at significantly greater scale and with broader geographic reach.
Direct peers
- Sterling Medical Devices: New Jersey-based medical device design, development, and regulatory services firm specializing in Class II/III devices; competes head-to-head with Baymar for FDA 510K/PMA engineering and verification work.
- KMC Systems: Massachusetts medical device and IVD engineering services firm offering design, development, and contract manufacturing under ISO 13485 — competes for the same mid-market IVD and medtech design-transfer engagements.
- Invetech: San Diego/Australia engineering services firm specializing in IVD instrument and medical device product development with FDA and ISO 13485 capabilities — direct competitor for IVD-focused fractional engineering engagements.
- StarFish Medical: Canadian medical device design and productization firm offering fractional engineering, regulatory, and contract manufacturing services to IVD and medical device clients — directly comparable in service mix, customer type, and engagement model to Baymar.
- Sunrise Labs: Bedford, NH-based medical device engineering services firm providing design, development, verification/validation, and regulatory support to Class II/III device makers — closely matches Baymar's product development cycle service stack.
- Donatelle: Minnesota-based medical device contract manufacturer with in-house design, engineering, and FDA-registered Class II/III manufacturing — directly comparable on the contract manufacturing + design services combination.
Emerging players
- Greenlight Guru: Medical device quality management and eQMS software platform serving many of the same IVD/medical device customers Baymar serves; not a direct services competitor but an adjacent ecosystem player whose customers overlap significantly.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
Baymar Solutions social profiles
Digital presenceBaymar Solutions compliance and trust
Trust signalCompliance2 records
Baymar Solutions financial estimates
Financial estimateRevenue estimate
Valuation estimate
Baymar Solutions leadership team
Management profileNumber of profiles
Profiles8 records
Baymar Solutions subsidiaries and ownership
Company hierarchySubsidiaries1 record
Baymar Solutions funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Baymar Solutions M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Baymar Solutions
What does Baymar Solutions do?
Baymar Solutions is a single source provider of full-scale engineering services for biomedical and commercial products. The company delivers fractional engineering teams, project management, scientific and regulatory support, U.S. FDA launch support, and contract manufacturing from an ISO 13485-certified, FDA-registered facility serving IVD and medical device companies across the entire product lifecycle.
Is Baymar Solutions a public or private company?
Baymar Solutions is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Baymar Solutions founded?
Baymar Solutions was founded in 2006. It employs 11 to 50 people.
Where is Baymar Solutions based?
Baymar Solutions is headquartered in Tampa, United States, in the North America region.
How does Baymar Solutions make money?
Five revenue lines are on record. Engineering Services are the primary driver. The others are project Management, contract Manufacturing, scientific & Regulatory Support and technical Staffing.
Who are Baymar Solutions's main competitors?
Broad incumbents on record are Flex Medical, Jabil Healthcare and Phillips-Medisize. Direct peers are Sterling Medical Devices, KMC Systems, Invetech, StarFish Medical, Sunrise Labs and Donatelle. Greenlight Guru is listed as an emerging player.
Does Baymar Solutions have an API?
No public API is recorded for Baymar Solutions.