Design Solutions
Design Solutions is a US-based medical device design and engineering services firm that delivers end-to-end electrical, software, mechanical, verification, and regulatory development to medical device startups, Fortune 500 OEMs, and government clients under an ISO 13485:2016-certified process.
- Company typePrivate
- Founded1998
- HeadquartersChanhassen, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Design Solutions does
Design Solutions, Inc. (DSI) is a US-based medical device design and product engineering services firm founded in 1998 and headquartered in Chanhassen, Minnesota, with a secondary office in Littleton, Colorado. The company operates an ISO 13485:2016-certified engineering process and delivers end-to-end development across electrical, software, firmware, mechanical, usability, verification, and regulatory compliance domains, with stated technical depth in ultrasound and energy-based systems, embedded processors, wireless communications (including PTCRB-certified cellular designs), signal and data processing, mechatronic systems, and single-use disposable design.
DSI serves a horizontal cross-section of the medical device industry, from early-stage startups requiring proof-of-concept and feasibility work through Fortune 500 OEMs needing full program execution, plus selected government and military medical device programs. Documented engagements span sleep apnea screening, contrast injection, wireless cardiac event recording, orbital atherectomy, peripheral artery disease measurement, intra-compartmental pressure monitoring, first-responder vital signs, impedance cardiography, and oximetry analysis software, with regulatory submissions including FDA 510(k), IEC 60601/61010, and international approvals covering US, EU, and Japan markets.
The firm operates as a private, bootstrapped professional services business generating revenue through project-based, custom-quoted engagements billed on multi-year contract cycles. Pricing is determined per project by scope, complexity, and timeline rather than published rate cards. Go-to-market relies on direct enterprise sales augmented by participation in industry trade shows (MD&M Minneapolis, MD&M West, MEDICA) and targeted digital content, with leadership positioned as senior embedded technical experts (collectively 90+ years of medical product experience) rather than a scaled consulting platform.
Design Solutions firmographics
Firmographics- Name
- Design Solutions
- Legal name
- Design Solutions, Inc.
- Website
- https://design-solutions.com
- Company type
- Private
- Founded year
- 1998
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Design Solutions is a US-based medical device design and engineering services firm that delivers end-to-end electrical, software, mechanical, verification, and regulatory development to medical device startups, Fortune 500 OEMs, and government clients under an ISO 13485:2016-certified process.
- Ownership category
- akta.pro rank
Design Solutions industry classification
Industry- Product category
- Medical Device Engineering Services
- NAICS
- Industrial Design Services (541420), Industrial Design Services (54142), Other Specialized Design Services (54149)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Industrial/Product & Furniture Design (BPAHAKAM)
Keywords
Where Design Solutions is headquartered
LocationHeadquarters
- HQ city
- Chanhassen
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Design Solutions business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales
Revenue model
- Medical Device Engineering Services: Design Solutions provides comprehensive medical device design and product engineering services on a project basis. They offer services including product design, software development, electrical design, mechanical design, design verification, and regulatory compliance. Revenue is generated through project-based engagements where they act as an extension of the client's engineering team or manage entire product development projects.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom project-based pricing |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels2 records
Design Solutions product offering
Product offeringCore offering
Design Solutions is a medical device design and product engineering services company that provides comprehensive end-to-end development from concept generation through manufacturing transfer. Their core offerings span medical device design and product engineering, software development, electrical design, mechanical design, design verification, and regulatory compliance for therapeutic, diagnostic, analytical, and biotechnology product companies.
Product overview
Design Solutions is a medical device design and product engineering services company offering comprehensive end-to-end development from concept through manufacturing. The company provides six core service offerings: Medical Device Design & Product Engineering, Software Development (including embedded real-time and Windows/Linux applications), Electrical Design (analog/digital circuits, microprocessors, wireless communications), Mechanical Design (instruments, enclosures, electro-mechanical assemblies), Design Verification (test planning and execution), and Regulatory Compliance (FDA submissions, IEC standards). These services have been applied across various customer case studies including sleep apnea screeners, contrast injector systems, wireless cardiac event recorders, orbital atherectomy systems, peripheral artery disease measurement devices, intra-compartmental pressure monitors, first responder vital signs monitors, ICG monitors, and oximetry analysis software systems. The company operates from ISO 13485:2016 certified processes.
Differentiator
Problem solved
Functional benefit
Products and services
- Medical Device Design & Product Engineering Comprehensive medical device design services spanning from concept generation to manufacturing transfer, including proof-of-concept development, product specifications, prototyping, and manufacturing documentation for therapeutic, diagnostic, analytical, and biotechnology product companies.
- Software Development Services Medical device software development from embedded real-time systems to user interface development, including IEC 62304 compliance, microprocessor-based embedded software, real-time operating systems, Windows- and Linux-based applications, signal processing and algorithm development, and mobile phone application interfaces.
- Electrical Design Services Medical electronic design services including analog and digital circuit design for medical sensors and patient monitoring, microprocessor/FPGA/DSP-based control and signal processing circuitry, motor control for fluid delivery devices, and telemetry and wireless communication system design.
- Mechanical Design Services Medical mechanical design services from instrument enclosures to complex electro-mechanical assemblies, including industrial design and product conceptualization, device enclosures and housings, electro-mechanical component integration, mechanical prototype fabrication, material selection and testing, and manufacturing drawings and documentation.
- Design Verification Services Design verification services including test plan creation, protocol execution, white box and black box testing, electrical, software and systems testing, and comprehensive reporting to ensure devices meet product requirements.
- Regulatory Compliance Services Regulatory compliance assessment and support including FDA 510(k) submissions, IEC 60601 and IEC 61010 pre-submission reviews, EMC and safety compliance, software gap analysis per IEC 62304, and international regulatory approvals.
Quantifiable outcome
- More than 25,000 wireless event recorder devices shipped to date
- +2 more outcomes
Companies that use Design Solutions
Customer profileNamed customers10 records
Segments2 records
Ideal customer profiles3 records
Design Solutions technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Design Solutions partnerships and signals
Strategic signalScale indicators4 records
Recent moves6 records
Expansion highlights5 records
Design Solutions competitors and assessment
Company assessmentDirect peers
- StarFish Medical: Canada-based medical device design and engineering services firm offering full-stack electrical, mechanical, software, and regulatory services to med device OEMs and startups. Highly comparable business model, service mix, and ISO 13485-backed delivery to Design Solutions, with a broader geographic footprint.
- Donatelle: Minnesota-based medical device contract design and manufacturer with ISO 13485-certified processes serving therapeutic and diagnostic OEMs. Highly comparable regional peer given geographic overlap and similar service offering.
- Medical Murray: US-based medical device design, engineering, and manufacturing services company serving OEMs and startups across Class II/III devices. Directly comparable full-service med device development model with similar size band.
- Ximedica: US medical device design, development, and contract manufacturing services firm serving Class II/III device OEMs. Directly comparable in service scope (electrical, mechanical, software, regulatory) and target customer profile.
- Gilero: Medical device design, development, and contract manufacturing firm offering concept, design, and production services. Comparable mid-market US med device services peer with overlapping therapeutic and diagnostic device focus.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Design Solutions social profiles
Digital presenceDesign Solutions compliance and trust
Trust signalCompliance1 record
Design Solutions financial estimates
Financial estimateRevenue estimate
Valuation estimate
Design Solutions leadership team
Management profileNumber of profiles
Profiles3 records
Design Solutions funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Design 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 Design Solutions
What does Design Solutions do?
Design Solutions is a medical device design and product engineering services company that provides comprehensive end-to-end development from concept generation through manufacturing transfer. Their core offerings span medical device design and product engineering, software development, electrical design, mechanical design, design verification, and regulatory compliance for therapeutic, diagnostic, analytical, and biotechnology product companies.
Is Design Solutions a public or private company?
Design Solutions is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Design Solutions founded?
Design Solutions was founded in 1998. It employs 11 to 50 people.
Where is Design Solutions based?
Design Solutions is headquartered in Chanhassen, United States, in the North America region.
How does Design Solutions make money?
One revenue line is on record: medical Device Engineering Services.
Who are Design Solutions's main competitors?
Direct peers on record are StarFish Medical, Donatelle, Medical Murray, Ximedica and Gilero.
Does Design Solutions have an API?
No public API is recorded for Design Solutions.
What industry is Design Solutions in?
Design Solutions's product category is Medical Device Engineering Services. Its primary akta.pro industry code is BPAHAKAM, Industrial/Product & Furniture Design. Its NAICS code is 541420 and its SIC code is 3841.