SiMEDEx
SiMEDEx is a privately held ISO 13485:2016 certified contract manufacturer founded in 2017 that specializes in precision silicone extrusion for medical device OEMs. It produces micro, multi-lumen, reinforced, and standard tubing with sub-0.001" tolerances for implantable and drug-delivery applications.
- Company typePrivate
- Founded2017
- HeadquartersPaso Robles, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What SiMEDEx does
SiMEDEx, Inc. is a privately held contract manufacturer founded in 2017 and headquartered in Paso Robles, California. The company specializes exclusively in precision silicone extrusion for medical device applications, operating under ISO 13485:2016 certification and serving medical device OEMs across cardiac rhythm management, neurostimulation, vascular access, drug delivery, ophthalmology, urology, diagnostic equipment, audiology, and pharmaceutical fluid management. SiMEDEx reports 100+ customers across 21 countries, with direct sales coverage in North America, South America, and Europe supplemented by regional representative partnerships.
The company's product portfolio comprises four core extrusion lines: ID/OD extrusions for peristaltic pump and vascular access applications, micro extrusions with inner diameters as small as 0.002 inches for glaucoma stents and neonatal devices, multi-lumen extrusions for pacing leads and neuro-stim device insulation, and reinforced extrusions combining silicone with metallic or thermoplastic substrates for high-pressure and kink-resistant applications. Technical differentiators include tolerances below 0.001 inches verified through Keyence's automated Image Dimension Measuring System, antimicrobial additive layering, and a patent portfolio of 10 US patents held by founders covering extrusion equipment, processes, and raw materials. The CTO (34+ years in silicone), Director of Manufacturing (25+ years in medical silicone), and Director of Business Development (30+ years in medical OEM sales) provide deep domain expertise.
SiMEDEx generates revenue through custom, quote-based manufacturing with multi-year contract cadences and lead times of 2-8 weeks per job depending on materials availability. Pricing is not publicly disclosed and is determined per RFQ based on dimensions, tolerances, material specifications, quantity, and validation requirements. The company is founder-owned and managed with no external funding rounds, M&A, or parent company involvement disclosed. Customer acquisition relies on direct sales engagement, regional rep partnerships (MER Europe, Miller Med, Anderson Agency), LinkedIn presence, and participation in medical device industry events such as MPP West 2026.
SiMEDEx firmographics
Firmographics- Name
- SiMEDEx
- Legal name
- SiMEDEx, Inc.
- Website
- https://simedex.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- SiMEDEx is a privately held ISO 13485:2016 certified contract manufacturer founded in 2017 that specializes in precision silicone extrusion for medical device OEMs. It produces micro, multi-lumen, reinforced, and standard tubing with sub-0.001" tolerances for implantable and drug-delivery applications.
- Ownership category
- akta.pro rank
SiMEDEx industry classification
Industry- Product category
- Medical Device Components
- NAICS
- Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391)
- SIC
- Plastics Products, Nec (3089), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)
Keywords
Where SiMEDEx is headquartered
LocationHeadquarters
- HQ city
- Paso Robles
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
SiMEDEx business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Operations, Technology or R&D, Supply Chain, Marketing or Sales, Infrastructure
Revenue model
- Custom Silicone Tubing Manufacturing: SiMEDEx generates revenue through custom manufacturing of precision silicone tubing for medical device applications. Quotes are delivered within 48 hours and jobs typically completed within 2-8 weeks depending on materials availability and cooling lead times.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom Manufacturing Quote |
Go-to-market motion2 records
Distribution channels1 record
Marketing channels4 records
SiMEDEx product offering
Product offeringCore offering
SiMEDEx is a contract manufacturer of precision silicone extrusions for medical device applications, producing ID/OD extrusions, micro-tubing (inner diameters down to 0.002 inches), multi-lumen extrusions, and reinforced extrusions. The company serves medical device OEMs across cardiac rhythm, neurostimulation, vascular access, drug delivery, ophthalmology, urology, audiology, and diagnostic equipment markets, with ISO 13485:2016 certified quality systems and tolerances of 0.001 inches or less.
Product overview
SiMEDEx is a precision silicone tubing contract manufacturer offering four core extrusion product lines: ID/OD Extrusions for peristaltic pump and vascular access applications; Micro Extrusions with inner diameters as small as 0.002 inches for ophthalmology and neonatal applications; Multi-Lumen Extrusions for cardiac rhythm management and neuro-stimulation devices; and Reinforced Extrusions for high-pressure applications. The company operates under ISO 13485:2016 certification and serves the medical device market with both implantable and non-implantable silicone tubing solutions.
Differentiator
Problem solved
Functional benefit
Products and services
- ID/OD Extrusions High precision silicone tubing designed for peristaltic pump and vascular access applications, serving medical device OEMs requiring tight dimensional tolerances.
- Micro Extrusions Micro-scale silicone tubing with inner diameters as small as 0.002 inches, designed for treatment of glaucoma and premature babies in ophthalmology and neonatal care applications.
- Multi-Lumen Extrusions Multi-lumen silicone tubing used as primary insulation for pacing leads and neuro-stim devices, and as shafts for balloon catheters in cardiac rhythm, neurostimulation, and balloon catheter applications.
- Reinforced Extrusions Silicone tubing reinforced with metallic or thermoplastic substrates, designed for high-pressure and kink-resistant applications in medical devices such as urological implants and pharmaceutical fluid handling.
Quantifiable outcome
- Tolerances of 0.001" or less achievable with Keyence Image Dimension Measuring System
- +2 more outcomes
Companies that use SiMEDEx
Customer profileSegments7 records
Ideal customer profiles3 records
SiMEDEx technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
SiMEDEx partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and supporting.
- MER EuropecoreMER Europe serves as a regional sales representative for SiMEDEx covering European territories. They help customers in the region find the right silicone tubing solutions for their medical device manufacturing needs.
- Miller MedcoreMiller Med is a sales representative partner for SiMEDEx providing regional coverage and helping medical device manufacturers access SiMEDEx precision silicone tubing capabilities.
- Anderson AgencycoreAnderson Agency Inc. provides sales representation services for SiMEDEx, helping connect medical device companies with SiMEDEx's precision silicone extrusion capabilities.
- KeyencesupportingKeyence provides the Image Dimension Measuring System used by SiMEDEx for in-process and Final QA dimensional inspections. This technology enables automated edge detection for fast, accurate, and highly precise quality control.
Scale indicators4 records
Recent moves6 records
Expansion highlights5 records
SiMEDEx competitors and assessment
Company assessmentBroad incumbents
- Teleflex Medical OEM: Broad medical device and component manufacturer with deep custom extrusions, balloons, and catheter shaft capabilities serving many of the same OEM customers. Comparable as a larger incumbent in the medical tubing supply chain but with a much wider portfolio than SiMEDEx's silicone-only focus.
Direct peers
- Saint-Gobain Medical Components: Manufactures precision silicone and thermoplastic tubing, multi-lumen, and reinforced extrusions for medical OEMs, including pacing/neurostimulation insulation and catheter shafts — directly comparable in product line, tolerance regime, and ISO 13485 service model to SiMEDEx.
- Freudenberg Medical (Helix Medical): One of the largest medical silicone and thermoplastic extrusion manufacturers globally, serving implantable and combination-product device OEMs across cardiac, neuro, and drug delivery — directly overlapping SiMEDEx's core verticals and customer type. SiMEDEx's CTO previously led silicone extrusion operations at Helix Medical, underscoring the direct comparability.
- Fluortek Inc. Precision medical extruder specializing in multi-lumen tubing, PTFE, and fluoropolymer extrusions for catheter and minimally invasive device applications — a direct competitor in vascular and structural-heart catheter tubing, the same primary vertical SiMEDEx's BD leader previously ran sales for.
- Putnam Plastics (Avient): Medical tubing and extrusion specialist within Avient serving catheter, neurovascular, and drug-delivery OEMs with precision multi-lumen and micro-tubing — overlapping SiMEDEx's micro-tubing and multi-lumen capabilities for implantable and minimally invasive device applications.
- Spectrum Plastics Group: Specialty medical extruder (now part of Solesis) focused on catheter shafts, multilumen tubing, and balloon tubing for vascular access and structural heart applications — a direct competitor in the same customer segments SiMEDEx targets (vascular access, cardiac rhythm, neurostimulation).
- Specialty Silicone Fabricators: Pure-play medical and industrial silicone fabricator offering extrusions, sheeting, and dip-molded components; many of SiMEDEx's senior leaders (CTO, Director of Manufacturing) were long-tenured at SSF, making it a directly comparable peer in technology base, customer mix, and product portfolio.
- Trelleborg Healthcare & Medical: Global contract manufacturer of precision silicone and polymer extrusions for medical devices, including pacing leads, neurostimulation insulation, and drug-delivery tubing — directly comparable in product offering, regulatory positioning (ISO 13485), and customer base to SiMEDEx.
- Vesta (Lubrizol Life Science): Silicone and thermoplastic extruder for medical device OEMs, including micro-tubing, multi-lumen, and reinforced products for implants and drug delivery — directly overlapping SiMEDEx's product line, tolerance capability, and ISO 13485 service model.
- Qure Medical: Specialty medical silicone component manufacturer (silicone extrusions, molded parts) serving OEMs in pacing, neurostimulation, and drug delivery. SiMEDEx's Director of Manufacturing previously led western-region business development at Qure Medical, evidencing direct product and customer overlap.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks4 records
Key highlights5 records
Customer concentration
SiMEDEx social profiles
Digital presenceSiMEDEx compliance and trust
Trust signalCompliance2 records
SiMEDEx financial estimates
Financial estimateRevenue estimate
Valuation estimate
SiMEDEx leadership team
Management profileNumber of profiles
Profiles4 records
SiMEDEx funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SiMEDEx 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 SiMEDEx
What does SiMEDEx do?
SiMEDEx is a contract manufacturer of precision silicone extrusions for medical device applications, producing ID/OD extrusions, micro-tubing (inner diameters down to 0.002 inches), multi-lumen extrusions, and reinforced extrusions. The company serves medical device OEMs across cardiac rhythm, neurostimulation, vascular access, drug delivery, ophthalmology, urology, audiology, and diagnostic equipment markets, with ISO 13485:2016 certified quality systems and tolerances of 0.001 inches or less.
Is SiMEDEx a public or private company?
SiMEDEx is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was SiMEDEx founded?
SiMEDEx was founded in 2017. It employs 1 to 10 people.
Where is SiMEDEx based?
SiMEDEx is headquartered in Paso Robles, United States, in the North America region.
How does SiMEDEx make money?
One revenue line is on record: custom Silicone Tubing Manufacturing.
Who are SiMEDEx's main competitors?
Teleflex Medical OEM is listed as a broad incumbent. Direct peers are Saint-Gobain Medical Components, Freudenberg Medical (Helix Medical), Fluortek Inc., Putnam Plastics (Avient), Spectrum Plastics Group, Specialty Silicone Fabricators, Trelleborg Healthcare & Medical, Vesta (Lubrizol Life Science) and Qure Medical.
Does SiMEDEx have an API?
No public API is recorded for SiMEDEx.
What industry is SiMEDEx in?
SiMEDEx's product category is Medical Device Components. Its primary akta.pro industry code is HLAHAFAL, Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation). Its NAICS code is 339113 and its SIC code is 3089.