What Tensentric does

Tensentric is a privately held, ISO 13485:2016 certified engineering services firm founded in 2009 in Boulder, Colorado, focused on the design, development, and manufacturing of complex medical devices and in vitro diagnostic (IVD) systems. The company serves medical device OEMs, IVD developers, life sciences instrumentation companies, and cell and gene therapy process developers through four core service lines: Design and Development (concept through prototyping), Human Factors and Usability Engineering, Cybersecurity, and Manufacturing and Assembly (NPI and ramp-to-volume). Its core technical expertise centers on meso- and microfluidic cartridge architectures, with proprietary components spanning microfluidic vents and pressure reservoirs, pinch and check valves, multiple pump modalities, filtration systems, mixing technologies, electrochemical sensors, and reagent containment systems (blisters, thimbles).

The business model is B2B project-based professional services complemented by hardware sales through its 12,000 sq ft ISO clean-room manufacturing facility in Louisville, Colorado, opened in June 2019. Tensentric operates a sales-led, relationship-driven go-to-market, with Chief Commercial Officer Jeff Gentry managing direct enterprise client engagement and the company emphasizing repeat business and referrals. Pricing is custom per project (not publicly disclosed) and revenue is generated through design service fees plus volume manufacturing of designed products. Named customers and disclosed partners span Tier-1 medical technology firms: Medtronic, Stryker, Johnson & Johnson, BD, Philips Volcano, Vyaire, Quidel, Covidien, NuVasive, St. Jude Medical, Acclarent, Gambro, Carefusion, Hansen Medical, Inovio Pharmaceuticals, and Nestlé Health Science.

The company is founder-led (Wade Lukianow as co-founder and Chairman, Jeff Gentry as co-founder and Chief Commercial Officer) with a professional CEO (Cathy Falbo) and CFO who joined from Medtronic's Neurosurgery business. It received a growth investment from GenNx360 Capital Partners in February 2022. The team profile highlights unusually deep tenure, with most engineers carrying 20+ years of medical device experience, supporting the company's positioning as a turn-key concept-to-volume partner for regulated complex-system products rather than a commodity design consultancy.

Name

Tensentric

Legal name

Tensentric, LLC

Website

https://tensentric.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

1–10 employees

Short description

Tensentric is an ISO 13485:2016 certified engineering services firm that designs, human-factor-tests, and manufactures meso- and microfluidic medical devices, IVD systems, and life sciences instruments for enterprise OEMs in healthcare and pharmaceuticals.

Ownership category

akta.pro rank

Product category

Medical Device Engineering Services

NAICS

Surgical and Medical Instrument Manufacturing (339112), Other Scientific and Technical Consulting Services (541690), Other Specialized Design Services (54149)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Condition-specific Digital Therapeutics (DTx) (HLACANAA)

Keywords

• Medical device design
• In vitro diagnostics engineering
• Microfluidic system development
• Contract medical device manufacturing
• Human factors engineering services

Headquarters

HQ city

Boulder

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Design and Development Services: Engineering design and development services for medical devices and IVD systems from concept through detailed design and prototyping. Revenue generated through project-based professional service fees.
2. Manufacturing Services: Volume manufacturing of designed products including high-level assembly of complex systems during NPI and ramp-to-volume. Includes ISO certified clean room assembly area.
3. Human Factors and Usability Services: Human factors engineering services including usability optimization and compliance with US and OUS standards and guidance.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Tensentric provides turn-key system design, engineering, and manufacturing services for medical devices, in vitro diagnostics (IVD), life sciences, and cell & gene therapy products. Their offering spans early concept and ideation, detailed mechanical/electrical/software design, prototyping, human factors and cybersecurity engineering, and volume manufacturing including high-level assembly of complex microfluidic systems in an ISO 13485:2016-certified facility.

Product overview

Tensentric is a medical device design and manufacturing company offering turn-key system design services from initial concept through volume manufacturing. Their portfolio comprises four core service offerings: Design and Development Services (covering early concept, detailed design, prototyping, and custom instrument/consumable development), Human Factors Engineering Services (optimizing usability and regulatory compliance), Cybersecurity Services, and Manufacturing and Assembly Services (NPI and volume production in an ISO-certified facility). The company also offers specialized reagent blisters manufacturing as a sub-module. Tensentric serves Medical Devices, In Vitro Diagnostics, Life Sciences, and Cell & Gene Therapy industries, with technical expertise spanning microfluidics components including valves, vents, pumps, filters, mixing systems, sensing capabilities, electrodes, and temperature control systems.

Differentiator

Problem solved

Functional benefit

Products and services

• Design and Development Services Turn-key design and engineering service from initial concept through detailed design, prototyping, and development of custom engineered instruments and consumables for medical device and IVD clients.
• Human Factors Engineering Services Human factors engineering services that optimize usability and use-safety of products while maintaining compliance with US and OUS standards and guidance.
• Cybersecurity Services Cybersecurity services to ensure medical devices and IVD systems are secure and compliant with regulatory requirements.
• Manufacturing and Assembly Services Volume manufacturing of finished products in a dedicated ISO 13485:2016-certified facility, including high-level assembly of highly complex systems during NPI and ramp-to-volume production, with thermoforming, injection molding, laser welding, and large-scale cartridge assembly capabilities.

Quantifiable outcome

• Over 300 development projects completed for medical device and IVD clients since 2009

Named customers17 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Two partnerships are on record, tiered minor.

• Medical University of South Carolina (MUSC)minorStrategic or Co-development Partner · 1 January 2024Partnership with Dr. Adam Tanious and Dr. Ryan Gedney at MUSC to develop an alpha prototype for the Anchor Medical Bidirectional Vascular Access Sheath. Tensentric received SCTR STEP Grant funding of up to $10,000 to advance the vascular access medical device, which aims to simplify dialysis access procedures.
• University of Colorado BoulderminorStrategic or Co-development PartnerTensentric sponsors CU Boulder Chemical and Biological Engineering senior design projects. In 2022, sponsored a team for research and modeling of a recombinant protein production process for a diagnostic system.

Scale indicators2 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• StarFish Medical: Canadian medical device design, development, and contract manufacturing firm serving North American med-device startups and OEMs. Highly comparable to Tensentric in offering turn-key mechanical, electrical, software, and fluidics design plus volume manufacturing under ISO 13485.
• Gilero: US-based medical device and drug delivery design, development, and contract manufacturing firm with deep expertise in microfluidic cartridges and injection-molded disposables. Direct overlap with Tensentric's IVD cartridge and consumable engineering focus.
• Ximedica (Veranex): Medical device design, development, and manufacturing services firm (now part of Veranex) covering human factors, regulatory, and complex instrumentation. Comparable turn-key med-device service offering to Tensentric across diagnostics, surgical, and connected device programs.
• Insight Product Development: Medical and industrial product development consultancy offering mechanical, electrical, software, and human factors engineering for regulated devices. Comparable service mix and customer profile to Tensentric, particularly for complex instrumentation programs.
• Bresslergroup: US product development firm specializing in medical device, consumer health, and industrial product design through research, industrial design, mechanical, electrical, and software engineering. Comparable in offering human factors-led, multi-disciplinary med-device design services.
• HS Design: Medical device design and development firm specializing in human factors engineering, usability, and product development for Class I-III devices. Comparable niche overlap with Tensentric's human factors-led development workflow and med-device OEM client base.
• Donatelle: Medical device contract manufacturer and product development firm offering injection molding, assembly, and design support for Class II/III devices. Comparable in offering both design services and US-based medical device manufacturing under ISO 13485.
• Velentium: Medical device cybersecurity, embedded software, and product development firm with ISO 13485 and IEC 62443 expertise. Direct peer to Tensentric's cybersecurity service line and embedded systems work for connected med-device programs.

Broad incumbents

• Phillips-Medisize: Global medical device contract manufacturer (a Molex company) with integrated design services, drug delivery, and diagnostic device capabilities. Represents a much larger incumbent competing for the same OEM programs Tensentric serves.
• Cirtec Medical: Vertically integrated medical device contract design, development, and manufacturing firm specializing in minimally invasive, active implants, and drug delivery. A larger incumbent that competes with Tensentric for complex electromechanical med-device programs.

Market position

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

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 Tensentric