BlackHägen Design

What BlackHägen Design does

BlackHägen Design is a privately held medical device design and human factors engineering consultancy founded in 1995 by Sean Hägen and now led by CEO Philip Remedios. Operating from a 6,500 sq ft purpose-built facility in Dunedin, Florida, the firm provides five integrated service lines: User Research (contextual inquiry, simulated workflow studies), Industrial Design (3D-CAD modeling, prototyping), UX/UI Design (embedded GUI, mobile apps), Product Development (systems engineering, embedded microcontroller design), and Human Factors Engineering (usability testing, use-related risk analysis, FDA HFE reports). Its QMS is structured to conform to FDA 21 CFR Part 820, ISO 13485, and IEC 62366, enabling it to produce design controls documentation and HFE reports suitable for regulatory submission.

The firm serves medical device manufacturers ranging from startups and entrepreneurial entities to Fortune 100 multinationals, with documented engagements for Medtronic, Stryker, Olympus, Johnson & Johnson, Philips, Baxter, Bayer, BD, Edwards Lifesciences, GE HealthCare, ResMed, Smith & Nephew, and others. The integrated HFE-plus-industrial-design approach is positioned to minimize use errors, accelerate FDA submissions, and reduce design iteration cost; specific outcomes cited include an 80% per-case cost reduction on Smith & Nephew's Versajet handset, FDA submission readiness in 6 months for Perfint's Maxio robot, and 6 design awards for HeartHero's Elliot AED.

The business model is professional services consulting on project-based engagements. Pricing is not publicly disclosed; services range from specific offerings (e.g., usability testing) to turn-key solutions spanning product definition through pilot production and validation. Customer acquisition relies on direct enterprise field sales, thought-leadership content (LinkedIn, MDDI, DesignNews, MedTech Intelligence), conference presence (HFES, MD&M West, IDC), and free public audit tools (Industrial Design Audit, UX/UI Audit) used as lead-generation assets. Revenue is not publicly disclosed and no external funding rounds have been recorded.

Name

BlackHägen Design

Legal name

BlackHägen Design Inc.

Website

https://blackhagendesign.com

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

11–50 employees

Short description

BlackHägen Design is a privately held Florida-based consultancy providing integrated user research, industrial design, UX/UI, product development, and human factors engineering services to medical device manufacturers from startups to Fortune 100 firms, with FDA QSR and ISO 13485-compliant processes.

Ownership category

akta.pro rank

Product category

Medical Device Design and Human Factors Engineering Consulting

NAICS

Industrial Design Services (54142), Industrial Design Services (541420), Scientific Research and Development Services (5417)

SIC

Services-Engineering Services (8711)

akta.pro primary industry

Industrial/Product & Furniture Design (BPAHAKAM)

akta.pro secondary industry

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

Keywords

• Medical device design
• Human factors engineering
• Industrial design consulting
• Usability engineering services
• UX/UI design medical

Headquarters

HQ city

Dunedin

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Consulting Services: Professional consulting fees for design research, industrial design, UX/UI design, product development, and human factors engineering services. Services may be specific (Conceptual Design, Feasibility Engineering, Usability Testing) or turn-key from product definition through pilot production and validation.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

BlackHägen Design is a multidisciplinary design and human factors engineering consulting firm that delivers integrated R&D services for medical device manufacturers. Its offerings span user research, industrial design, UX/UI design, product development (mechanical, embedded, software), and human factors engineering, provided either as targeted deliverables (e.g., conceptual design, feasibility engineering, usability testing) or as turn-key solutions from product definition through pilot production and validation. Work is focused on Class I, II, and III medical devices and adjacent mission- and safety-critical products.

Product overview

BlackHägen Design is a multidisciplinary usability engineering and product design consulting firm established in 1995 in Dunedin, Florida. The company provides an integrated approach to research and development for medical devices, consumer products, and commercial equipment, spanning Class I, II, and III medical devices. Their core service offerings include User Research (contextual inquiry, simulated workflow, VR testing), Industrial Design (strategic branding, 3D-CAD modeling, prototyping), UX/UI Design (embedded GUI, mobile apps, wireframing), Product Development (systems engineering, embedded design, software validation), and Human Factors Engineering (usability testing, FDA submissions). Their internal Quality System conforms to FDA QSR and ISO 13485. The company has completed over 2,000 projects and holds 150+ patents. Their portfolio includes case studies such as the RIO Mechanical Tracking System for surgical robotics, HeartHero AED (6 design awards), Infusion Pump UI, Micromeritics AccuPyc, ON-Q* Infusion Device for Avanos, Versajet Handset for Smith & Nephew, Maxio Robot for Perfint, and Hip Orthosis for Orthomerica. They also offer free Industrial Design and UX/UI audit assessment tools.

Differentiator

Problem solved

Functional benefit

Quantifiable outcome

• 150+ patents generated for clients
• +5 more outcomes

Named customers33 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators7 records

Recent moves9 records

Expansion highlights4 records

Direct peers

• Starfish Medical: Canadian medical device design and manufacturing consultancy offering industrial design, human factors, and product development services to medical device OEMs. Closest functional analog to BlackHägen, although larger and with embedded manufacturing.
• Insight Product Development: Product design and development consultancy with a substantial medical device and HFE practice, serving both startups and large OEMs with user research, industrial design, and UX/UI services comparable to BlackHägen's offerings.
• MindFlow Design: Specialized medical device design and human factors consultancy providing user research, industrial design, and usability engineering for FDA-regulated devices; small firm operating in the same niche as BlackHägen.
• Farm Design: Boutique product design and engineering consultancy with a healthcare and medical device practice; provides industrial design, UX/UI, and product development comparable to BlackHägen's service mix, often serving startup and growth-stage medtech clients.
• HS Design: Human factors engineering and product design firm focused on medical devices, providing usability testing, task analysis, and design controls documentation; directly competes for HFE-specific engagements with BlackHägen's medical device clients.
• Worrell Design: Medical product design and development consultancy with deep industrial design and human factors practice serving medtech OEMs; now part of Accenture Industry X but historically a boutique peer operating in the same space as BlackHägen.
• Veranex (formerly Ximedica): US-based integrated medical device design, engineering, and regulatory services firm covering user research, industrial design, HFE, and product development for Class I-III devices; directly competes for the same OEM engagements as BlackHägen and is materially larger.

Broad incumbents

• IDEO: Global design and innovation consultancy with a healthcare practice offering design research, UX, and product design for medical and health clients; much larger and broader, but competes for medtech HFE/design mandates.
• Cambridge Consultants: Global product development and innovation consultancy with a strong medical device practice in HFE, industrial design, and embedded product development; broader scope and significantly larger scale than BlackHägen.
• Battelle Memorial Institute: Large nonprofit research and development organization operating medical device R&D, HFE, and human performance services to government and commercial clients; broader portfolio but overlapping regulated medtech service offerings.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/blackhagen-design
• Xx.com/blackhagendesgn
• Facebookfacebook.com/BlackHagenDesign

Compliance6 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 BlackHägen Design