MEDICAL DEVICE DEVELOPMENT
Pioneering the future of healthcare
Struggling to integrate advanced technology into soft goods or wearable medical devices?
Developing products that maintain sensor connectivity and effectively deliver therapy can be complex and frustrating. Your patients rely on devices that provide seamless data monitoring and therapy delivery. We specialize in integrating these advanced features into soft goods, ensuring consistent performance and reliability.
Many developers overlook the challenges of combining comfort, functionality, and technology in medical devices. The result? Inconsistent data, poor user experience, and inefficient therapy.
We bring decades of experience developing innovative soft goods with integrated sensor connectivity, real-time data monitoring, and reliable therapy delivery. Our solutions ensure your products meet the highest standards for patient care and comfort.
Ready to revolutionize your medical devices with cutting-edge technology and soft goods expertise?
Limited on resources and seeking a partner who truly understands your needs? Look no further - we are ready to step in and support you.
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We recognize the challenges that come with resource constraints and the importance of finding a partner who comprehends your unique situation. As experts in our field, we understand the intricacies and demands of your industry, and we are well-equipped to provide the assistance you require.
With our extensive experience and proven track record, we have successfully partnered with numerous organizations facing similar resource limitations. We excel at optimizing available resources to deliver exceptional results, ensuring that your goals are achieved efficiently and effectively.
Our team is ready to roll up our sleeves and collaborate closely with you, offering our expertise, innovative solutions, and a fresh perspective. We take the time to truly understand your vision, challenges, and objectives, enabling us to tailor our services and strategies to your specific needs.
By choosing us as your partner, you gain access to a dedicated team that not only understands your unique situation but is also committed to your success. We will work tirelessly alongside you, offering support, guidance, and creative problem-solving to help you overcome obstacles and achieve your goals.
Don't let limited resources hold you back. Together, we can navigate challenges, unlock opportunities, and drive your business forward. Let us be the partner who truly "gets it" and helps you thrive. Get in touch with us today and let's embark on this exciting journey together.
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We understand that every project is unique, and that's why we offer flexible partnership options tailored to your specific needs. Whether you require end-to-end support or focused expertise in a particular area, we have the capabilities and experience to deliver exceptional results.
With our full-service development approach, we become an extension of your team, working closely with you from concept to completion. Our multidisciplinary experts collaborate seamlessly to bring your vision to life, providing comprehensive support and guidance at every stage of the process. From initial ideation and design to prototyping, testing, and final production, we ensure a smooth and successful journey.
Alternatively, if you require assistance in specific areas of your project, we're ready to jump in exactly where you need us. Our team of skilled professionals can seamlessly integrate with your existing team, filling the gaps and providing specialized expertise to drive your project forward. Whether it's design, engineering, prototyping, or any other aspect of product development, we offer targeted solutions that align with your goals and timeline.
By partnering with us, you gain access to a dedicated and experienced team that is passionate about delivering exceptional results. We bring a wealth of knowledge, technical expertise, and creative problem-solving to the table, ensuring that your project is executed with precision and excellence.
Whether you choose our full-service development or targeted assistance, we are committed to your success. Our collaborative approach, attention to detail, and commitment to exceeding expectations set us apart as a trusted partner in your journey.
Let's discuss your specific needs and explore how we can best support your project. Contact us today and discover the power of our tailored partnership approach.
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We offer end-to-end innovation, concept to commercialization services. Check out our areas of expertise:
Medical Device Human Factors and Usability
Medical Product Design
Medical Device User Experience Design
Medical Device Prototyping
Medical Product Engineering
MEDICAL DEVICE HUMAN FACTORS FEASIBILITY
Our research methods for medical devices offer invaluable insights throughout the entire human-centered product development cycle. With our expertise in human factors, we possess the distinctive skills to inform the design of new products by employing a combination of generative research methods and contextual inquiry. This approach allows us to define the optimal product experience, user personas, and task flows.
By delving into extensive research, we gain a profound understanding of your users and identify opportunities to address their specific needs. Our dedicated development team then takes these insights and transforms them into innovative solutions, which we rigorously evaluate in collaboration with the same users.
Through our comprehensive approach, we ensure that your medical device design is informed by user-centric principles and tailored to deliver a seamless and intuitive experience. By putting the needs and preferences of your users at the forefront, we create products that not only meet their expectations but exceed them.
Partner with us to leverage our medical device research expertise and unlock the potential to revolutionize healthcare solutions. Together, we can create innovative and impactful products that enhance patient care and improve overall well-being.
During the development process, our team of human factors experts provides crucial evaluative data through formative and summative usability testing, ensuring compliance with FDA standards. Our methodologies go beyond evaluating usability solely from a safety and risk standpoint; we also consider the overall user experience of the medical device.
Through formative usability testing, we gather insights early on to refine the design and address any usability issues. This iterative process allows us to optimize the device's usability, functionality, and user satisfaction. In the summative usability testing phase, we rigorously evaluate the device's performance in real-world scenarios, ensuring its effectiveness and identifying any potential areas for improvement.
By aligning our testing procedures with FDA expectations, we ensure that your medical device not only meets regulatory requirements but also delivers an exceptional user experience. Our human factors expertise allows us to uncover valuable insights that go beyond mere functionality, enabling us to create devices that are intuitive, efficient, and truly user-centered.
Partner with us to leverage our experience in human factors and usability testing, and together we can ensure that your medical device excels in both safety and user satisfaction. By combining regulatory compliance with a focus on the total user experience, we can help you create a medical device that stands out in the market and positively impacts patient outcomes.
MEDICAL DEVICE USER EXPERIENCE DESIGN
In the ever-evolving landscape of interfaces, where physical meets digital, our team of UX + UI experts collaborates closely with our human factors specialists to create interfaces that not only minimize the potential for user errors but also provide a delightful user experience.
Recognizing the unique challenges of medical device user experience design, we understand the critical importance of complying with usability standards to ensure the safety and efficacy of products for both patients and caregivers. We acknowledge that medical devices undergo rigorous scrutiny, surpassing that of many other interfaces.
To navigate these complex waters, we employ a comprehensive approach that includes risk assessments, formative and summative human factors evaluations, and close collaboration with our software engineers. Our multidisciplinary team can also work alongside your systems engineering team to define and document interfaces, streamlining the process of your 510k submission.
By incorporating human factors principles and adhering to usability standards, we create interfaces that not only meet regulatory requirements but also enhance the overall user experience. Our goal is to design medical devices that instill confidence in users while optimizing safety and effectiveness.
Partner with us to leverage our expertise in human-centered design, usability standards, and regulatory compliance. Together, we can develop innovative interfaces that not only meet the highest standards of the medical industry but also provide a seamless and intuitive experience for users and caregivers alike.
MEDICAL PRODUCT DESIGN
Our dedicated team of soft goods designers, apparel designers, and industrial designers are passionate about exploring new possibilities, envisioning impactful experiences, and evaluating concepts through both 2D and 3D design. With a focus on healthcare, we specialize in translating healthcare insights into innovative product solutions.
Using a human-centered design process, we place the needs and experiences of users at the forefront of our approach. By understanding the unique challenges and requirements of the healthcare industry, we ensure that our solutions not only meet safety and effectiveness standards but also deliver an exceptional user experience that aligns seamlessly with your brand.
Through our collaborative design process, we engage in extensive research, ideation, and prototyping to bring your healthcare products to life. Our team utilizes a combination of 2D sketches and 3D models and animations to visualize and refine concepts, ensuring that the final design is both functional and aesthetically pleasing.
We believe that successful healthcare design goes beyond mere functionality. It's about creating products that users can interact with intuitively, providing a seamless and satisfying experience. By focusing on the optimal user experience, we help you differentiate your brand and deliver products that resonate with your target audience.
Partner with us to leverage our expertise in industrial design and human-centered design principles. Together, we can transform healthcare insights into innovative and user-centric product solutions that not only meet industry standards but also leave a lasting impact on users and your brand.
MEDICAL PRODUCT ENGINEERING
Our engineering team adopts a disciplined and practical approach to device development. We comprehend the importance of engineering rigor, regulatory compliance, and clinical constraints, and make every effort to deliver optimal solutions that meet all requirements.
Collaborating closely with manufacturing vendors during the early stages of development, our engineers prioritize Design for Excellence (DFX) principles. By doing so, we ensure that our solutions are not only technically feasible but also manufacturable, meeting cost targets effectively. Utilizing both linear and nonlinear finite element analysis (FEA), hand calculations, tolerance stack-ups, and fundamental engineering principles, we strive to achieve robust and efficient designs.
Whether working independently or as an extension of your team, we are fully equipped to take your product from concept to production. Our engineers bring expertise, experience, and a meticulous attention to detail to ensure that the final design meets all necessary specifications and successfully transitions into manufacturing.
Partner with us to leverage our engineering capabilities and benefit from our pragmatic and results-driven approach. Together, we will navigate the complexities of device development, meet regulatory requirements, and deliver innovative solutions that meet the highest standards of quality, functionality, and manufacturability.
Our engineering team includes specialists within:
Technical Design
Engineering
Biomechanics
Engineering
Mechanical Engineering
Systems Engineering
Electrical Engineering
Software Engineering
MEDICAL DEVICE PROTOTYPING
Medical device prototypes are the bridge that transforms your design vision into a tangible reality, incorporating engineering, design, and human factors considerations. These prototypes not only serve as functional representations of your product but also provide invaluable insights to inform and refine your development activities.
With our dedicated team of in-house prototyping specialists and our sample room and suppliers, we possess the resources and expertise to deliver exceptional prototypes. Whether you require early proof-of-concept models or late-stage fully-functional prototypes, we are here to support you throughout the development process.
Our prototyping experts are ready to join your team at any stage, collaborating closely to meet your unique requirements. We understand the specific challenges associated with hard goods components for medical wearables, integration of hard goods with soft goods, and soft goods with multiple substrates.
Partner with us to unlock the full potential of your medical device design. Our comprehensive prototyping capabilities, combined with our collaborative approach, ensure that you have the tools and support needed to validate and enhance your product at every step. From concept validation to functional validation, we are committed to delivering prototypes that accelerate your development journey and bring you closer to successful production.
