The United States has quite a few companies dedicated to healthcare product development. These companies work on everything from new medical devices to software that helps with patient monitoring or treatment. Their role is important because the healthcare field has so many rules to follow before anything can be sold.
Top companies in this area usually have mixed teams of engineers, designers and regulatory experts. Some focus more on wearables or simple diagnostic tools. Others take on bigger projects like complex hospital systems. Altogether they form a solid group that supports the creation of new healthcare products across the country.
1. Itexus
Itexus develops custom healthcare software and supports healthcare product development from discovery through implementation, launch, and maintenance. Our work covers healthcare applications, system integration, healthcare analytics, and solutions designed around medical workflows and compliance needs.
We build healthcare products for patients, clinics, and healthcare organizations, with support for web and mobile applications, telehealth, medical data, and interoperability. The company also addresses healthcare product development needs in the USA through its presence there.
Key Highlights:
- Custom healthcare software development
- HIPAA-compliant healthcare solutions
- Healthcare application development
- System integration for healthcare systems and devices
Services:
- Healthcare product development
- Healthcare mobile app development
- Healthcare system integration
- Telehealth software development
- Healthcare analytics software
Contact Information:
- Website: itexus.com
- Email: [email protected]
- Address: 8, The Green, STE road, Dover, DE 19901, United States
- LinkedIn: www.linkedin.com/company/itexus
- Facebook: www.facebook.com/itexus
- Twitter: x.com/ItexusSoft
- Instagram: www.instagram.com/itexus.soft
2. Orthogonal
The company does medical device software remediation and testing automation. They offer eQMS for SaMD along with product analytics. The agency handles rapid concept sprints. Orthogonal includes SaMD product definition and sizing in the work.
Orthogonal develops medical device software and SaMD for healthcare. The company includes user experience design and human factors in its healthcare product development. They handle requirements definition and risk analysis for medical devices. The agency performs quality systems engineering and risk management. Orthogonal uses Agile software development for these products. Their verification and validation support the overall process.
Key Highlights:
- Medical device software and SaMD work
- Integration of user experience design
- Human factors inclusion
- Risk analysis performance
Services:
- Quality systems engineering
- Testing automation
- Product analytics
- Rapid concept sprints
Contact Information:
- Website: orthogonal.io
- Phone: 3128547317
- Email: [email protected]
- Address: 222 W Merchandise Mart Plaza, Suite 228, Chicago IL 60654
- LinkedIn: www.linkedin.com/company/orthogonal
- Facebook: www.facebook.com/OrthogonalSoftware
- Twitter: x.com/Orthogonal_io
3. Baytech Consulting
Baytech Consulting develops custom healthcare software for the sector. The company creates solutions aimed at hospitals and digital health. They build software to streamline operations and improve compliance. The agency enhances care with these products. Baytech Consulting includes security in the designs.
The company develops mobile patient apps and clinical portals. They handle process automation and workflow orchestration. The agency provides security and compliance support. Baytech Consulting does system integration and cloud enablement.
Key Highlights:
- Custom healthcare software development
- HIPAA-compliant platforms
- Mobile patient apps
- Clinical portals
- System integrations
Services:
- Process automation
- Security and compliance
- Cloud enablement
- Equipment integration
Contact Information:
- Website: www.baytechconsulting.com
- Phone: (877) 683-2592
- Email: [email protected]
- Address: 2102 Business Center Dr, suite 130, Irvine, CA 92612
- LinkedIn: www.linkedin.com/company/baytech-consulting
- Facebook: www.facebook.com/baytechconsulting
- Twitter: x.com/BaytechCorp
- Instagram: www.instagram.com/baytechco
4. BlueLabel
BlueLabel develops healthcare mobile apps along with websites and clinical care systems. The company specializes in building secure medical apps that patients and medical practitioners can use. They also create software for medical device control. The agency integrates the apps directly into EMR and EHR systems.
The company designs HIPAA compliant apps and supports cloud infrastructures. They have expertise in healthcare communication standards. The agency develops both mobile and web based healthcare tools. BlueLabel focuses on reliable and secure healthcare software. Their team handles the full development for such products.
Key Highlights:
- Healthcare mobile app development
- Medical device control software
- EMR and EHR integration
Services:
- Secure medical apps
- Clinical care systems
- HIPAA compliant design
- Cloud infrastructure for healthcare
- Healthcare communication standards work
- Mobile and web healthcare tools
Contact Information:
- Website: www.bluelabellabs.com
- Address: 18 West 18th St New York, NY, 10011
- LinkedIn: www.linkedin.com/company/blue-label-labs
5. Ensera
Ensera provides design and product development support for healthcare products. The company works with pharmaceutical and medical device concepts. They start from the earliest concept phase or update existing ones. The agency does prototyping, engineering and testing. Ensera includes human factors in the work.
The company works with a dedicated human factors team. They ask the right questions and carry out tests for performance. The agency partners to develop safer and easier-to-use products. Ensera supports from concept through to optimized designs.
Key Highlights:
- Healthcare product design
- Medical device development
- Pharmaceutical product work
- Concepting and prototyping
- Human factors integration
- Engineering and testing
Services:
- Ideation for new devices
- Optimization of existing designs
- User-centric product solutions
Contact Information:
- Website: www.ensera.com
- Address: 4255 S. Pipkin Road, Lakeland, Florida 33811
- LinkedIn: www.linkedin.com/company/ensera-group
6. Kapstone Medical
Kapstone Medical provides a single-source solution for new product development of medical devices. The company covers product engineering along with regulatory affairs. They include quality assurance in the offerings. The agency does industrial design including human factors.
The company handles manufacturing and takes an integrated approach to development. They perform validation and verification testing as needed. The agency works early on intellectual property strategy to protect designs. Kapstone Medical provides commercialization support. Their NPD teams flex to work in different systems.
Key Highlights:
- New product development for medical devices
- Product engineering
- Regulatory affairs
- Quality assurance
Services:
- Industrial design and human factors
- Manufacturing support
- Validation and verification testing
- Intellectual property work
- Commercialization support
Contact Information:
- Website: www.kapstonemedical.com
- Phone: +1-704-843-7852
- Address: 520 Elliot St, Charlotte, NC 28202
- LinkedIn: www.linkedin.com/company/kapstone-medical
7. Suntra MedTech Solutions
Suntra MedTech Solutions provides medical device development for healthcare products. The company turns client ideas into commercial medical devices. They assemble teams with systems engineers, software engineers, electrical engineers and mechanical engineers. The agency brings in regulatory advisors and project managers for the work.
The company applies human factors knowledge in the designs. They consider regulatory requirements early. The agency creates integrated designs and prototypes from requirements. Suntra MedTech Solutions performs verification and validation. Their team assists with design transfer and ongoing support.
Key Highlights:
- Medical device development
- Systems engineering
- Software and electrical engineering
- Mechanical engineering
- Regulatory advice
Services:
- Human factors work
- Prototyping
- Verification and validation
- Design transfer support
Contact Information:
- Website: suntramedtech.com
- Phone: 603-644-4500
- Email: [email protected]
- Address: 25 Constitution Drive, Bedford, NH 03110
- LinkedIn: www.linkedin.com/company/suntramedtech
8. HaA
HaA provides medical device development services. The company conducts market research to understand user needs in the field. They develop regulatory strategies for clearance paths. The agency works on human factors for user-friendly and compliant designs.
The company handles UI and UX design with a focus on user experience. They create well crafted industrial designs. The agency does prototyping for quick validation. HaA applies engineering. Their offerings include user feedback and testing along with quality assurance and regulatory compliance.
Key Highlights:
- Medical device development
- Human factors work
- Regulatory strategy
Services:
- Market research
- UI and UX design
- Industrial design
- Prototyping
- Engineering
Contact Information:
- Website: haapd.com
- Phone: (781) 606-4343
- Email: [email protected]
- Address: 333 North Ave, Wakefield, MA 01880
- LinkedIn: www.linkedin.com/company/haa-llc
9. Veranex
Veranex delivers medical device development from concept onward. The company provides biomedical engineering services for devices and diagnostics. They handle research, strategy and concept generation. The agency does concept development and design inputs.
The company performs detailed design engineering and development for medical products. They assure performance through testing and validation. The agency includes usability assessments and human factors. Veranex integrates manufacturing into development. Their work supports production and commercial aspects.
Key Highlights:
- Medical device development
- Biomedical engineering
- Product design
- Software engineering
- Testing and validation
- Human factors
Services:
- Research and strategy
- Design verification
- Manufacturing support
- Commercialization
Contact Information:
- Website: veranex.com
- Address: 5420 Wade Park Blvd., Suite 204, Raleigh, NC 27607
- LinkedIn: www.linkedin.com/company/veranex
10. StarFish Medical
StarFish Medical provides medical device design and development with in-house capabilities. The company transforms concepts into final products using multidisciplinary teams. They blend technical expertise, regulatory insight and user-centered design.
The company supports new product introduction with launch focus. They facilitate seamless tech transfers. The agency handles quality assurance. StarFish Medical does regulatory affairs. Their teams work on the full process. The agency includes various development stages.
Key Highlights:
- Medical device design
- In-house development capabilities
- User-centered design
- Regulatory insight
Services:
- New product introduction
- Quality assurance
- Regulatory affairs
Contact Information:
- Website: www.starfishmedical.com
- Phone: (949) 472-0275
- Email: [email protected]
- Address: 15560-D Rockfield Blvd., Irvine, CA 92618, United States
- LinkedIn: www.linkedin.com/company/starfish-medical
11. Delve
Delve provides human-centered medical product design. The company develops medical products including devices and equipment. They use cross-disciplinary project teams. The agency includes human factors and usability specialists.
The company handles user research. They do industrial design and interaction design. The agency covers mechanical engineering and electrical engineering. Delve includes software engineering. Their work spans product design and definition along with engineering development and verification. The company also does prototyping and testing.
Key Highlights:
- Human-centered medical product design
- User research
- Human factors and usability
- Industrial design
- Engineering development
Services:
- Product design and definition
- Interaction design
- Mechanical engineering
- Electrical engineering
- Software engineering
- Prototyping and testing
Contact Information:
- Website: www.delve.com
- LinkedIn: www.linkedin.com/company/delvedesign
- Address: 109 Kingston Street, 3rd Floor, Boston, MA 02111
- Instagram: www.instagram.com/delveinnovation
12. DeviceLab
DeviceLab provides medical device design and engineering. The company employs designers and engineers for full systems. They cover industrial design. The agency does mechanical engineering.
The company handles electronic and system engineering. They write software for devices. The agency develops user interfaces and experiences. DeviceLab does prototyping and pilot production. Their work includes other engineering specialties as needed.
Key Highlights:
- Medical device design
- Full system engineering
- Industrial design
Services:
- Mechanical engineering
- Electronic and system engineering
- Software engineering
- User interface and experience design
Contact Information:
- Website: www.devicelab.com
- Phone: (714) 598-0824
- Address: 3002 Dow Avenue Suite 218, Tustin, CA 92780
- LinkedIn: www.linkedin.com/company/devicelab-inc.
- Facebook: www.facebook.com/DeviceLab-Inc-162759901186839
- Twitter: x.com/devicelab
13. Resonetics
Resonetics provides product design and development for medical devices. The company supports initial design and prototyping. They handle validation and scale-up. The agency works on conceptual design and proof of concept.
The company does complex part design. They develop catheter delivery systems and handles. The agency includes implant design. Resonetics manages drawing packages and documentation. Their services cover design verification, validation and transfers to production.
Key Highlights:
- Medical device product development
- Conceptual design
- Prototyping
- Design verification and validation
Services:
- Catheter delivery systems
- Handle and mechanism design
- Implant development
- Design documentation
- Manufacturing transfers
Contact Information:
- Website: resonetics.com
- Address: 26 Whipple St, Nashua, NH 03060, USA
- LinkedIn: www.linkedin.com/company/resonetics
14. Root3 Labs
Root3 Labs provides medical device design. The company operates as a full-stack mechanical, electrical and embedded firmware engineering team. They maintain their own prototyping lab to support the work.
The company turns ideas into working prototypes or manufacturable products. They provide strategic advice and mentorship. The agency offers turnkey product development. Root3 Labs does custom project packages. Their team handles manufacturing support and design reviews. The company fabricates prototypes to ensure performance, functionality and manufacturability.
Key Highlights:
- Medical device design
- Mechanical engineering
- Electrical engineering
- Embedded firmware
- Prototyping
Services:
- Turnkey product development
- Manufacturing support
- Rapid design reviews
Contact Information:
- Website: www.root3labs.com
- Phone: 410-701-0164
- Address: 11408 Cronridge Dr Ste C, Owings Mills, MD 21117 USA
- LinkedIn: www.linkedin.com/company/root3labs
- Facebook: www.facebook.com/Root3Labs
- Instagram: www.instagram.com/root3labs
15. Cardinal Peak
Cardinal Peak provides healthcare product design and IoMT development. The company creates connected medical devices. They design wearables. The agency develops remote monitoring systems. Cardinal Peak works on digital therapeutics. Their services include virtual care platforms.
The company handles medical robotics integration. They focus on device connectivity. The agency includes cloud and mobile integration. Cardinal Peak supports from concept through prototyping. Their work covers secure and compliant product development.
Key Highlights:
- Healthcare product design
- IoMT development
- Connected medical devices
- Wearables design
- Remote monitoring
- Digital therapeutics
Services:
- Virtual care platform design
- Medical robotics design
- Cloud integration
- Prototyping
Contact Information:
- Website: www.cardinalpeak.com
- Phone: (303) 665-3962
- Email: [email protected]
- Address: 1380 Forest Park Circle, Suite 202, Lafayette, CO 80026
- LinkedIn: www.linkedin.com/company/cardinalpeak
- Facebook: www.facebook.com/CardinalPeak
- Twitter: x.com/CardinalPeak
16. A-listware
A-listware provides healthcare IT solutions and software development. The company creates medical device software. They do SaMD product development. The agency handles mobile app development for healthcare uses.
The company works on web design and development. They offer patient engagement software. The agency includes IT consulting. A-listware does modernization of systems. Their services cover data analytics. The company also handles support and cybersecurity for these products. They’ve included additional healthcare software options in the mix.
Key Highlights:
- Healthcare software development
- Medical device software
- SaMD development
- Mobile app development
Services:
- Web development
- Patient engagement software
- IT consulting
- Data analytics
Contact Information:
- Website: a-listware.com
- Phone: +1 (888) 337 93 73
- Email: [email protected]
- Address: North Bergen, NJ 07047, USA
- LinkedIn: www.linkedin.com/company/a-listware
- Facebook: www.facebook.com/alistware
Conclusion
The USA has a solid mix of companies focused on healthcare product development. They handle medical devices, software pieces, connected products and the work that sits between an idea and something ready for production.
It isn’t a simple match-up. Some put more emphasis on design and usability, others on the engineering or the compliance parts that come with regulated products. The right choice usually comes down to the type of product and how far along the development already is.
There’s noticeable variety in how they approach the work. Healthcare products carry extra requirements, and these companies deal with those details in different ways depending on their setup.