Industry
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Medical Technology
Healthcare Product Development
Transforming Patient Care From Concept to Compliance
Minimizing Risk and Enhancing Patient Outcomes
Medical device product development is a complex process that involves many stages, from ideation to post-market surveillance. Along the way, there are risks that can arise, ranging from technical and regulatory risks to market and financial risks. To reduce the impact of risk on development, we prioritize risk mitigation early in the process which results in predictable execution. We help clients make innovative leaps by solving their most difficult challenges while maximizing product safety and quality.
Neuromodulation
Our work with Neuvotion on NeuStim highlights our commitment to advancing neuromodulation technology for therapeutic applications. NeuStim exemplifies our focus on precise engineering, user-centered design, and seamless integration of advanced technology. By enabling a direct connection between brain activity and muscle stimulation, IPS has helped offer personalized therapy and a pathway to renewed mobility and independence for individuals with movement impairments.
Medication Management
Controlling medication distribution and compliance is a problem that impacts millions of patients. Utilizing a number of integrated sensors and connectivity this device can tell when drugs are accessed and how many are left in the container. This data can be used for tracking compliance and refilling prescriptions. Our team leveraged our expertise in battery powered, wireless electronics and created a product that is easy to use improving the patient compliance experience.
Patient & Practitioner Experience
Practitioner experience operating medical devices significantly impacts patient outcomes. Our team studied user workflows and interaction points to redesign products that reduce errors and creates a premium experience for users. The result is noticeable in the ease of use and market adoption of the technology, and the improved outcomes for patients.
Solutions in Action
EON
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Non-invasive Fat Reducing Laser
The IPS team developed the product design language based on market and user research. Considerations for patient comfort and operator ease drove design decisions. The form and finishes were designed and selected to evoke a sense of premium luxury experience.
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AdhereTech
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Smart Pill Bottle
AdhereTech offers medication adherence solutions through connected devices, messaging services, smart phone applications, and intelligent data collection and analysis. The smart pill bottles offer SMS/Phone/Email reminders and non-adherence feedback.
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Purgo
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Medical Grade Air Purifier
The Pūrgo Medical Grade Air Purifier, a revolutionary solution developed by AeroClean to address the critical need for clean and sterilized air in medical environments. Pūrgo is a high-volume FDA certified air sterilizer, utilizing powerful UV light in a patented "Steriduct" to achieve a 4log kill of pathogens in a matter of minutes.
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Capabilities & Expertise
Design Research
We follow a user-centered design approach throughout the entire product development process. We have expertise in conducting thorough user research, surveys, and testing to inform iterative wireframing, visual design mock-ups and prototypes. The results are experiences that are not only functional, but also easy to use and accessible for all users.
MedTech Quality Management
We prepare our clients for FDA clearance, ensuring they have the documentation in place to pass their Premarket Approval or 510(k) submission. Our development methods align with ISO 13485, and we work within the Quality Management System of our clients to ensure the seamless transition from development to FDA submission.
Information Security
Patient safety and data security are of paramount importance to all stakeholders of a MedTech solution. Our design analysis capabilities and experience with designs and solutions subject to FDA approval have conditioned our engineers, developers, and designers to always keep patient safety as the top priority. Our on-staff HIPAA and cyber security experts help our clients cover all the bases to ensure critical data is always secure.
Patient Safety
We apply principles from various fields, including psychology, engineering, ergonomics, and safety science, to ensure that medical devices, technologies, and workflows are designed to meet the needs, abilities, and limitations of users, and to support safe, effective, and efficient delivery of care.
Design Validation
Development of products and solutions requiring FDA approval requires early planning of risk. Our approach is rooted in ISO 14971, Application of Risk Management to Medical Devices. The IPS team selects (or guides our client in the selection of) risk elements to be tracked during the development process, and then packages the assessment methods and acceptance criteria into a formal document. We’re well-versed in various risk assessment methods (FMEA, FMECA, hazard analysis, fault/event tree analyses, root cause analysis, etc.)
User Experience Design
Using the lessons learned from user research, we go beyond physical human factors and create emotional connections through elegant design solutions. We have the years of experience creating beautiful user interfaces that harmonize not only the physical, but the digital user experience as well. Designers work closely with both physical engineers and with cross-functional software teams to build comprehensive, cutting-edge solutions that delight the end-user.
