Reduce Risk & Improve Patient Outcomes
Medical product development is a complex process that involves various stages, from ideation to post-market surveillance. Along the way, there are many risks that can arise, ranging from technical and regulatory risks to market and financial risks. To reduce the risk of failure during medical product development, We follow strategies and best practices that help mitigate these risks. In such a regulated field, we help clients make innovative leaps by ensuring patient safety and documentation every step of the way.
Air Purification
Breathing clean air has never felt more important. Our team developed medical grade high airflow sterilization technology that can be used in a hospital operatory or office setting. Utilizing UV light and HEPA filters this sterilizer ensures efficacy quickly and efficiently.
Medication Management
Controlling medication distribution and compliance is a problem that impacts millions of patients. Utilizing a number of integrated sensors this technology can tell when drugs are accessed and how many are left in the container. This data can be used for tracking compliance and fill prescriptions. Our team overcame the challenge of low power draw 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 reduce error and create and premium medical products and solutions. The result is noticeable in the ease of use and market adoption of the technology.
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.
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.
Patient 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. Digitally, data security is currently as hot a topic as ever. Our on-staff HIPPA 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 14791, 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.
MedTech Quality Management
We prepare our clients for FDA clearance, ensuring they have the procedures and documentation in place to pass their Premarket Approval or 510(k) submission. Our processes adhere to ISO 13485 for Quality Management Systems empowering our clients with the tracking and documentation they need to comply with or exceed FDA standards.
