Medical Technology
HTD Health is your end-to-end partner for designing and developing connected medical devices, SaMD, and wearables. We expand device value, optimize disease management, and ensure seamless integration with care ecosystems.
Get in touchour focus
Engaging software for next-generation medical devices
In the ever-evolving landscape of healthcare technology, connected medical devices, wearables, SaMD, and IoMT have become integral components of a connected ecosystem, empowered by cutting-edge software solutions.
At HTD Health, we specialize in developing engaging software for next-generation medtech devices. Our mission is to revolutionize patient care by harnessing the potential of connected devices and advanced systems, enabling comprehensive care platforms adaptable to various clinical settings and home use.
With our expertise in health IT integrations and design for behavior change, we ensure the effectiveness and success of these systems. Our team possesses extensive experience in designing software applications catering to the needs of patients and healthcare professionals.
We are committed to overcoming the challenges of developing medtech solutions and delivering trustworthy, innovative, patient-centric care. Together, we can transform healthcare by pushing the boundaries of innovation.
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Agile Development for FDA-Regulated MedTech
At HTD Health, we specialize in Agile development tailored for the FDA-regulated MedTech industry. Our approach enables iterative, efficient software development while ensuring strict regulatory compliance. Embrace the advantages of agile methodologies with us, delivering high-quality medical device software with enhanced speed, adaptability, and adherence to FDA requirements.
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Business Strategy & Quality Advisory
Expert guidance in navigating medical device software development, will help you ensure regulatory compliance and industry best practices. With a strong emphasis on quality, & robust processes we assure safe and reliable software performance, benefiting patients and healthcare providers.
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Human Factors & Usability Engineering
Our profound expertise in human factors and usability engineering enables us to create medical devices that seamlessly integrate into users' workflows and deliver a superior user experience. By leveraging our knowledge in this field, we ensure that our clients' products are intuitive, efficient, and designed with the end-user in mind.
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Data Management & Software Integrations
With our deep expertise in data management and integrations, HTD Health enables seamless connectivity and interoperability across various healthcare systems and data sources. Our comprehensive solutions empower healthcare providers to harness the full potential of data, facilitating informed decision-making, personalized care, and improved patient outcomes within their MedTech ecosystems, including SaMD, wearables, and IoMT.
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Cybersecurity & Data Protection
Our teams implement robust measures to safeguard sensitive patient information and ensure the integrity and confidentiality of data. Our comprehensive security solutions mitigate cybersecurity risks, fostering trust among users and enabling the secure adoption and utilization of SaMD in healthcare environments.
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AI SaMD Development
We leverage sophisticated AI algorithms and rigorous testing strategies to deliver AI-driven MedTech solutions, including connected devices, SaMD or wearables. Our approach exceeds performance, safety, and functionality standards, ensuring robustness and market readiness while aligning with regulatory requirements. Partner with us to develop innovative, reliable, and compliant medtech products.
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Market Access and Reimbursement Strategy
HTD Health crafts streamlined market access and reimbursement strategies for MedTech solutions. We ensure market readiness and regulatory compliance while optimizing reimbursement pathways. Our strategic planning focuses on value demonstration and stakeholder engagement, facilitating smooth market entry and sustained success.
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User-Centered Design
At HTD Health, we focus on user-centered design to create intuitive and engaging MedTech solutions. Through in-depth user research, iterative prototyping, and usability testing, we ensure our products meet the needs of patients and healthcare professionals. This approach enhances functionality, accessibility, and user satisfaction, leading to better adoption and health outcomes.
What we do
FDA regulated software design and development
Any companion software serving a medical or device function is subject to FDA regulation. Like the hardware device components, software must also be rigorously documented throughout all phases of design and development. This helps ensure ease of FDA 510(k) application and De Novo classification request for class I and class II medical devices, and FDA approval for class III devices. Our internal Quality Management System (eQMS) Greenlight Guru helps the team manage the entire medical device software lifecycle.
Testimonials
The client perspective
HTD has met or exceeded all of our high expectations. They are excellent communicators who constantly find new ways to create value. In addition to delivering superb work on time and within budget, they've become trusted advisors on a range of critical issues. We could not be more pleased with our relationship and highly recommend HTD for any healthcare vendor or provider.
Brian Howe
Chief Executive Officer,
Format Health
client work
Next-generation devices
Wireless, Affordable, and All-Inclusive Ultrasound
Vave is a wireless, handheld ultrasound device. HTD designed and built the 510(k) approved companion mobile application.
We’ll contact you shortly
Email: info@htdhealth.com
A Biomedical Engineer by training, holds a Doctorate in Public Health focused on SaMD development and an MBA in IT Management – thanks to which she combines her engineering expertise with business acumen to tackle complex challenges in the medtech industry.