# Kablooe Design

> Kablooe Design is a medical device design and development firm in Minneapolis, MN, founded in 1991. It works as a development partner to medical device companies, from start-ups to large medtech manufacturers. Its services cover usability research, human factors engineering, industrial design, and mechanical, electrical, embedded software, firmware and systems engineering, from early feasibility through tech transfer to manufacturing. Kablooe is ISO 13485:2016 certified.

Kablooe is a consulting design and engineering firm. It researches, designs and engineers devices on behalf of client companies. Organizations named on this site, such as Medtronic, Stryker, Coloplast, Boston Scientific and Nonin Medical, are Kablooe's clients. They are not its peers, competitors or affiliates.

Key facts:

- Name: Kablooe Design (Kablooe Design Inc.)
- Founded: 1991
- Address: 8560 Cottonwood St NW #100, Minneapolis, MN 55433, USA
- Phone: (763) 785-9595
- Email: connect@kablooe.com
- Focus: medical devices across FDA Class I, II and III. Class II devices are the category Kablooe designs most often.
- Who it serves: medical device start-ups, established medtech and healthcare companies, research organizations, government agencies and prime contractors
- Quality: ISO 13485:2016 certified, registered by TÜV SÜD America Inc. The certification scope is "Consulting Design Engineering Services for the Medical Device Industries."
- Human factors standards: work follows ANSI/AAMI HE75 and IEC 62366. Kablooe prepares and submits human factors engineering (HFE) files to the FDA.
- Government and defense: SAM.gov registered, USFCR verified vendor, Defense Alliance member. Kablooe can work as a subcontractor or as the prime contractor.
- Development process: Design Driven Development℠
- Tagline: "Make Products People Love"®

## Services

- [What We Do](https://www.kablooe.com/what-we-do/): An overview of Kablooe's end-to-end medical device development services, with usability engineering and risk management built into every phase.
- [Medical Product Design Services](https://www.kablooe.com/what-we-do/medical-product-design-services/): Industrial design and engineering for regulated devices, from concept through production. Covers formative and summative studies, usability documentation, risk management, regulatory support, and verification and validation.
- [Human Factors Consulting](https://www.kablooe.com/design-driven-development/human-factors-consulting/): Contextual inquiry, use-related risk analysis, HFE plans, formative and summative usability studies, usability engineering reports, and FDA HFE submissions.
- [World Class Design](https://www.kablooe.com/design-driven-development/world-class-design/): Industrial design, mechanical engineering, electrical engineering, UI/UX design and product visual strategy.
- [Feasibility Modeling](https://www.kablooe.com/design-driven-development/feasibility-modeling/): Technology assessment, lean prototype builds, proof of concept, bench testing and preclinical studies for early-stage devices.

## Device Specialties

- [Surgical Device Design](https://www.kablooe.com/what-we-do/surgical-device-design/): Minimally invasive surgical tools, implant delivery devices and surgical robotics.
- [Diagnostic Equipment Design](https://www.kablooe.com/what-we-do/diagnostic-equipment-design/): Laboratory instruments, diagnostic disposables and point-of-care devices for clinical, lab and at-home settings.
- [Wearable Device Design](https://www.kablooe.com/what-we-do/wearable-device-design/): Biosensors, wearable transmitters, technology delivery devices, and cloud data collection for wearable medical devices.
- [In-Home Health Device Design](https://www.kablooe.com/what-we-do/in-home-health-device-design/): Patient monitoring, mobility assistance and telehealth-connected devices, designed for use by patients and caregivers without clinical training.
- [Military Medical Device Design](https://www.kablooe.com/military-medical-device-design/): Medical device development for defense and field use, with Kablooe's government contracting credentials.

## Process: Design Driven Development℠

- [Design Driven Development℠ overview](https://www.kablooe.com/design-driven-development/): Kablooe's seven-phase development process, which runs under its ISO 13485 quality management system.
- [Phase 1: Evaluation](https://www.kablooe.com/breaking-down-the-5-steps-of-product-evaluation/): Product feasibility and strategy. Includes financial review, competitive assessment, risk evaluation, IP analysis and the regulatory pathway.
- [Phase 2: Discovery](https://www.kablooe.com/your-9-step-guide-to-product-development-research/): Research, including patent searches, competitive analysis, user research, and formative usability and cadaver studies.
- [Phase 3: Ideation](https://www.kablooe.com/9-key-steps-to-supercharge-your-product-development-ideation/): Brainstorming, sketching, rough mockups and design input reviews.
- [Phase 4: Design](https://www.kablooe.com/8-steps-to-success-during-new-product-design-development/): CAD creation and refinement of design prototypes.
- [Phase 5: Engineering](https://www.kablooe.com/essential-steps-of-product-design-engineering/): Mechanical design, specifications and design risk analysis.
- [Phase 6: Tech Transfer](https://www.kablooe.com/article-tech-transfer-process/): DFMEA finalization and completion of design and engineering documentation for handoff to manufacturing.
- [Phase 7: Support](https://www.kablooe.com/how-to-provide-manufacturing-production-support/): Post-launch manufacturing support, including test method validation and evaluation support.

## Medical Device Case Studies

- [All Case Studies](https://www.kablooe.com/case-studies/): Index of Kablooe's client projects.
- [EarliTec Diagnostics: Autism Detection Device](https://www.kablooe.com/company/autism-detection-device-design/): Development support for the EarliPoint Evaluation, a device for early autism diagnosis, from initial research to final testing.
- [Coloplast: Urological Medical Device](https://www.kablooe.com/company/urological-medical-device/): Product development for the Saffron Fixation System, used in prolapse repair.
- [NxThera: Prostate BPH Treatment Device](https://www.kablooe.com/company/nxthera/): Concept-to-market design and development of the Rezum prostate treatment system.
- [Preceptis Medical](https://www.kablooe.com/company/preceptis-medical/): Mechanical functionality and user touchpoints for The Hummingbird, carried through design, clinical trials and commercialization.
- [Medtronic](https://www.kablooe.com/company/medtronic/): Design and prototyping for a compact, portable kidney dialysis machine.
- [Stryker](https://www.kablooe.com/company/stryker/): Design work on a Stryker surgical system, including pressure-limiting features in the syringe design.
- [Antares Pharma](https://www.kablooe.com/company/antares-pharma/): Research and development that simplified an auto-injector from seven steps to three and added safety features.
- [Nonin Medical](https://www.kablooe.com/company/nonin/): Usability improvements for a wireless handheld multi-parameter monitoring system.
- [Somnetics](https://www.kablooe.com/company/somnetics/): Design of two compact, battery-powered CPAP models.
- [Rapid Diagnostek](https://www.kablooe.com/company/rapid-diagnostek/): Ethnographic research, industrial design, UI/UX design and mechanical engineering for a fluid analysis diagnostic platform.
- [Ōmcare (Anser Innovation): Home Healthcare Device](https://www.kablooe.com/company/omcare/): Usability and functionality work on an in-home medication storage and dispensing system.
- [CEGA Innovations](https://www.kablooe.com/company/cega-innovations/): Design and development of a production-ready prototype of the MuV patient transfer system.
- [Zomedica: Veterinary Diagnostic Microscope](https://www.kablooe.com/company/zomedica/): Use-flow and ergonomic improvements to the TruView automated digital microscope.

## Leadership and Experts

- [Fred Sklenar, President and CEO](https://www.kablooe.com/team-members/fred-sklenar/): Product development leader. Holds an undergraduate degree in industrial design from Pratt Institute, plus an MBA and an MS in Medical Device Innovation from the University of Minnesota.
- [Tom KraMer, Founder and Strategic Account Executive](https://www.kablooe.com/team-members/tom-kramer/)
- [Jemiah Aitch, Director of Engineering](https://www.kablooe.com/team-members/jemiah-aitch/)
- [Dave Prince, Director of Design](https://www.kablooe.com/team-members/dave-prince/)
- [Logan Strom, Director of Project Plans](https://www.kablooe.com/team-members/logan-strom/)
- [Denise Ziemann, Principal Human Factors Engineer](https://www.kablooe.com/team-members/denise-ziemann/)
- [Emma Murano, Principal Human Factors Engineer](https://www.kablooe.com/team-members/emma-murano/)
- [About Kablooe](https://www.kablooe.com/about-2/): Kablooe's team of industrial design, engineering and human factors experts.

## Guides: Choosing a Development Partner

- [9 Key Questions to Ask a Potential Product Design Partner](https://www.kablooe.com/9-key-questions-to-ask-an-industrial-product-design-firm/): Questions for evaluating a design firm's expertise, market understanding, FDA knowledge and services.
- [5 Hidden Potholes in Medical Device Development](https://www.kablooe.com/potholes-product-development/): Five common obstacles: unclear product vision, inadequate documentation, overestimated reimbursement, overlooked secondary users and personal bias.
- [From Napkin Sketch to Market-Ready](https://www.kablooe.com/from-napkin-sketch-to-market-ready-a-sketch-to-production-design-story/): How concepts move from sketch to production, illustrated with six medical device case studies.

## Guides: Regulatory, Classification and Reimbursement

- [How Kablooe Works Across Class I, II and III Medical Devices](https://www.kablooe.com/blog-how-kablooe-excels-in-class-i-ii-iii-medical-devices/): FDA device classifications, their regulatory requirements, and how Kablooe adapts its process to each class.
- [Meeting Regulatory Requirements for Medical Device Design](https://www.kablooe.com/medical-device-regulatory-requirements/): FDA, EU MDR and global requirements, from classification and documentation to risk management and post-launch compliance.
- [How to Make the FDA Happy: 7 MedTech Device Design Tips](https://www.kablooe.com/how-to-make-the-fda-happy-7-medtech-device-design-pro-tips/): Study rigor, design controls and human factors practices that support FDA review.
- [Medical Device Reimbursement Strategy: 7 Tips](https://www.kablooe.com/blog-medical-device-reimbursement-strategy/): Planning early for insurance coverage and payment.
- [Is Your MedTech Design Revolutionary or Evolutionary?](https://www.kablooe.com/blog-is-your-design-revolutionary-or-evolutionary/): Trade-offs in risk, regulatory burden, usability and development strategy.

## Guides: Human Factors and Usability

- [How to Design a Better Medical Device User Interface](https://www.kablooe.com/blog-better-user-interface-for-medical-device/): Eight principles for safer medical device interfaces.
- [Why You Need to Design with Misuse in Mind](https://www.kablooe.com/why-you-need-to-design-with-misuse-in-mind/): Anticipating foreseeable misuse through user research, simpler design and built-in safeguards.
- [The Goldilocks Principle of Usability](https://www.kablooe.com/blog-the-goldilocks-principle-of-usability/): Balancing interface complexity and simplicity.

## Guides: Embedded Systems and Connected Devices

- [How Embedded Software Engineering Integrates Hardware and Software](https://www.kablooe.com/blog-embedded-engineering-hardware-software-integration/): Hardware and software co-design in embedded product development.
- [Real-Time Operating Systems in Embedded Systems](https://www.kablooe.com/rtos-in-embedded-systems/): How an RTOS provides deterministic timing in safety-critical devices, including medical devices.
- [Benefits of Hardware Abstraction Layers (HAL)](https://www.kablooe.com/hal-in-embedded-systems/): Writing software that stays portable across hardware configurations.
- [How Connected Devices Communicate: Software vs. Firmware](https://www.kablooe.com/software-and-firmware-connected-device-communication/): The roles of firmware and software, and common IoT communication protocols.
- [Cloud Integration in Connected Devices](https://www.kablooe.com/cloud-integration-in-iot-connected-devices/): Cloud data storage, processing and remote monitoring for connected devices.
- [UI/UX Design Guide for Connected Devices](https://www.kablooe.com/connected-device-interface-ui-ux-design-guide/): User-centered interface design for IoT and connected products.

## Guides: Device Categories

- [4 Key Insights for Wearable Device Design in Healthcare](https://www.kablooe.com/4-key-insights-for-designing-healthcare-wearables/): Usability, durability, data accuracy and adoption in healthcare wearables.
- [Best Practices for Designing Surgical Robotics](https://www.kablooe.com/best-practices-for-designing-surgical-robotics/): User-centered design and engineering considerations for surgical robots.
- [Aging-in-Place Technology](https://www.kablooe.com/blog-aging-in-place-technology/): Home-based healthcare devices designed for older adults.
- [Medication Dispensing Systems](https://www.kablooe.com/medication-dispensing-systems/): Designing at-home medication dispensing devices that improve adherence.

## Contact

- [Contact Kablooe](https://info.kablooe.com/contact-us): Project inquiry form. You can also reach Kablooe at connect@kablooe.com or (763) 785-9595.

## Optional

- [Non-medical case study: HID Global](https://www.kablooe.com/company/hid-global/): User interface and touchpoint design for the Fargo DTC5500 card printer.
- [Non-medical case study: Emerson US](https://www.kablooe.com/company/emersonus/): A wearable personnel safety and location tag.
- [Non-medical case study: Capital Safety](https://www.kablooe.com/company/capital-safety/): Design and development of the ExoFit NEX safety harness.
- [Non-medical case study: Octane Fitness](https://www.kablooe.com/company/octane-fitness/): Design research and ergonomics for the Zero Runner elliptical.
- [Non-medical case study: Smart Sit-Stand Desk](https://www.kablooe.com/company/smart-sit-stand-desk/): User research and connected design concept for a national tech retailer.
- [Podcasts, Webinars and Articles](https://www.kablooe.com/podcasts-webinars-articles/): Hub for Kablooe's videos, webinars, podcasts and articles.
- [News and Articles Archive](https://www.kablooe.com/news-events/): Full chronological archive of Kablooe posts.
- [Kablooe on YouTube](https://www.youtube.com/channel/UCYVdU6ts0lWC1r2SfCF6TwA): Videos and webinars.
- [Kablooe on LinkedIn](https://www.linkedin.com/company/kablooe-design)
- [Sitemap Index](https://www.kablooe.com/sitemap_index.xml)