Occam Design

What Occam Design does

Occam Design is a Louisville, Kentucky-based medical device design, engineering, and contract-manufacturing firm operating as a division of CreoSalus, Inc. The firm provides end-to-end development services for medical devices, combination products, and consumer healthcare products, covering ideation, market analysis, design for manufacturing, prototyping, regulatory compliance (including 510(k) submissions and IEC 60601 conformity), short-run production, and go-to-market strategy. Its technical footprint spans two Louisville facilities housing five Class VII clean rooms and an in-house machine shop, plus four 3D printing modalities (FDM with and without temperature-controlled cabinet, LCD, and PolyJet Material Jetting). The company is ISO 13485:2016 certified (FM561687, valid through 2028) and FDA-registered, with experience across Class 1-3 medical devices and electro-mechanical systems including pulse oximetry, spinal TENS, EEG, EKG, ultrasound flow sensing, and oscillometric blood-pressure measurement.

The business model is project-based professional services sold B2B through direct engagement, primarily through a 'Free Project Analysis' top-of-funnel CTA. Customers are medical-device startups (Cerovations, Trio Medical, NOVi, Claustrum Design), enterprises (MagnaWave, a leading catheter company), and academic institutions (University of Kentucky). Beyond services, Occam Design is developing a proprietary Porous Brain Infusion Catheter (PBIC) for convection-enhanced delivery of therapeutics to the central nervous system, with a Device Master File being prepared for FDA and human trials planned at Duke University alongside chronic canine testing at University of Kentucky. The firm actively markets through blog content, white papers, webinars ('Medtech Momentum' series), and partnerships with Thuramed, Neuronetrix, Twin Star Medical, Ouchless Needle, Cobra, and Tetras, building an external-facing ecosystem around its development services and proprietary innovations.

Name

Occam Design

Legal name

Occam Design

Website

https://occamdesign.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

11–50 employees

Short description

Occam Design is an ISO 13485-certified, FDA-registered Louisville, Kentucky medical device development and manufacturing firm offering end-to-end design, prototyping, regulatory, and production services — and the proprietary Porous Brain Infusion Catheter — to medical device startups, enterprises, and academic researchers.

Ownership category

akta.pro rank

Product category

Medical Device Development Services

NAICS

Surgical and Medical Instrument Manufacturing (339112), Scientific Research and Development Services (5417), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Connected Therapeutics & Smart Drug Delivery Monitoring (HLACAFAL)

akta.pro secondary industry

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Medical device development
• Contract manufacturing
• Regulatory consulting
• FDA clearance services
• Product prototyping

Headquarters

HQ city

Louisville

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Medical Device Development Services: Full-service development firm providing comprehensive medical device development including market analysis, product development, regulatory consulting, and manufacturing. Revenue is generated through project-based professional services, contract manufacturing, and ongoing production services. The company offers services across all stages from ideation through FDA clearance to commercialization.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Occam Design provides full-service medical device development from ideation through FDA clearance, including market analysis, product design and engineering, prototyping, contract manufacturing in 5 Class VII clean rooms, regulatory consulting, and go-to-market strategy. The firm also develops proprietary devices such as the Porous Brain Infusion Catheter (PBIC) for targeted neurological drug delivery.

Product overview

Occam Design is a full-service medical device development firm offering comprehensive end-to-end services from prototype through FDA clearance. The company operates as a single integrated platform combining market analysis, product development (ideation, design, engineering), manufacturing (with 5 Class VII clean rooms across 2 facilities), quality and regulatory compliance, go-to-market strategies, and distribution support. Their portfolio includes specialized offerings such as wellness and wearables device development, 3D printing services, and a proprietary product—the Porous Brain Infusion Catheter (PBIC) designed for neurological drug delivery. With over 30 years of experience and ISO 13485:2016 certification, they serve clients across the U.S. and internationally, providing dedicated project management coupled with full engineering, manufacturing, and regulatory expertise.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Development Services Full-service medical device development offering ideation, industrial design, engineering, prototyping, contract manufacturing with 5 Class VII clean rooms, ISO 13485-compliant quality and regulatory consulting, and go-to-market strategy. Each client is matched with a dedicated project manager coordinating engineering, manufacturing, machine shop, clean room, and global vendor connections. Serves medical device startups, academic researchers, established device companies, and electromechanical/wellness product developers in the U.S. and overseas.
• Porous Brain Infusion Catheter (PBIC) A proprietary catheter for convection-enhanced delivery (CED) to the central nervous system, designed for more uniform and efficient distribution of infusates within brain tissue for targeted treatment of brain tumors and neurological conditions. Features a 2mm tip, 10mm porous length, 3mm width, with inner pore width of 14.97 μm and outer pore width of 37.21 μm. Developed as a standalone proprietary medical device product by Occam Design.
• Multi-Material 3D Printing Services Standalone 3D printing service using FDM with temperature-controlled cabinet, FDM without temperature control, LCD (Liquid Crystal Display), and Material Jetting (PolyJet) printers. Provides prototyping and short-run production parts, with material jetting parts approaching injection mold quality and ability to print multiple materials or colors simultaneously. Used by medical device developers and product engineers across prototyping and production runs.

Quantifiable outcome

• Over $3 billion in marketplace sales across developed devices
• +3 more outcomes

Named customers8 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Duke UniversitycoreStrategic or Co-development PartnerPartnership with Duke University for conducting human trials of the Porous Brain Infusion Catheter (PBIC). This collaboration represents a critical step toward FDA approval and market readiness for the innovative neurological drug delivery device.
• University of KentuckycoreStrategic or Co-development PartnerCollaboration with University of Kentucky for chronic canine model testing of the Porous Brain Infusion Catheter. Testing conducted over 90 days to prove safety and efficacy. Academic partner also referenced in testimonials providing regulatory guidance.
• ThuramedminorStrategic or Co-development PartnerSystem company partnership where both organizations create life-saving medical devices. Thuramed developed 3 Tetras Peptide Synthesizing devices with more in development. Represents collaborative ecosystem of medical device innovators.
• TetrasminorOthersPartner company logo displayed on website. Thuramed developed 3 Tetras Peptide Synthesizing devices.
• NeuronetrixminorOthersPartner company logo displayed on website as part of Our Partners section.
• Twin Star MedicalminorOthersPartner company logo displayed on website as part of Our Partners section.
• Ouchless NeedleminorOthersPartner company logo displayed on website as part of Our Partners section.
• CobraminorOthersPartner company logo displayed on website as part of Our Partners section.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Donatelle: Medical device contract manufacturer offering design support, molding, assembly, and packaging with regulatory expertise—comparable contract manufacturing and design-for-manufacturing capabilities.
• StarFish Medical: Canada-based full-service medical device design, development, and contract manufacturing firm serving startups and OEMs end-to-end—directly comparable to Occam's concept-to-FDA-clearance model with in-house ISO 13485 manufacturing.
• Tegra Medical: Contract manufacturer of finished medical devices with Class 7/8 clean rooms and ISO 13485 certification—directly comparable to Occam's manufacturing and clean room capabilities for Class 1-3 devices.
• Worrell: Medical device design and development consultancy providing industrial design, human factors, and engineering services—comparable to Occam's product development and design-for-manufacturing capabilities.
• Ximedica: US-based medical device design and development firm offering integrated engineering, regulatory, and manufacturing services to medtech innovators—closely aligned with Occam's one-stop-shop value proposition.
• MindFlow Design: Medical device product development and engineering services firm focused on electro-mechanical and connected health devices—overlaps with Occam's specialized expertise in pulse oximetry, EEG, EKG, and similar modalities.
• Bresslergroup: Medical device and consumer health product design firm with engineering and prototyping services—overlaps with Occam's electro-mechanical device development, wearables, and combination product work.
• Innovize: Medical device contract manufacturer with clean room assembly, die-cutting, and ISO 13485 certification—comparable CDMO-style manufacturing infrastructure for Class I-III devices.
• RND Group: Medical device engineering and development firm serving startups through commercialization—comparable in targeting early-stage innovators with full-lifecycle development support.

Broad incumbents

• Flex (Flextronics Health Solutions): Global-scale medical device contract manufacturer and design services provider—overlaps broadly with Occam's CDMO and design offering but at far larger scale, serving as a downstream competitor for late-stage/commercial-volume work.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/Occam-Design-208361145863592
• LinkedInlinkedin.com/company/occam-design

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Occam Design