Users have a hard time describing the features they want, you have to extract it from them.” That’s what Insight brings to the deal—years of effective medical device user research. They combine that knowledge with product development methods that integrate compliance and FDA requirements; the perfect combination.”
Medical Design and Development
Experience matters
Insight has a medical background and set of experiences unrivaled in our industry. Since our founding in 1988, we have completed over 300 medical device programs and performed 30,000 hours of research for clients all over the world. Our work has provided significant market success for our clients and has helped to save countless patients and improve their quality of life.
Medical product development is complex and requires a unified and extensive collection of disciplines to ensure the success of a program. Insight’s multi-disciplinary team works together seamlessly while each member adds the unique perspective of their discipline.
Beyond the Basics
Understanding complexity in clinical workflows
Solutions for the healthcare industry must address a complex array of challenges in order to achieve market success.
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Demographic shifts are introducing significant changes in how health care is being delivered to patients. From an aging nurse population to a shortage of skilled caregivers to the invention of new roles (like hospitalists), an increasing number of tasks and responsibilities are being shared. |
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The clinical environments where medical solutions need to succeed are becoming increasingly diverse as health care and managed care continue to change. This places increased demands on the cost structures that solutions need to fit into. |
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Positioning medical devices and solutions for success in a global sense means understanding a range of complexities in order to define the right requirements. These complexities stem from variations in regulations, health care policies, attitudes toward sustainability, and cultural drivers. |
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Integrating new technology into healthcare solutions calls for establishing a thorough understanding of the workflow that it will integrate into and ultimately impact. Failure to do so introduces the risk that a solution may not be readily adopted or, worse, create new problems for caregivers. |
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In order for new solutions to be successful in the clinical space, they need to align with policies and procedures currently in place that regulate and define how clinics operate. Key to this is not only understanding what these protocols are, but also to understand how they are defined and activated, and how they might differ from place to place. |
Specialties and environments
Our work has touched nearly every specialty segment and environment within the medical industry. This experience provides us with an understanding unique to our field and makes us better at designing products that meet the demanding needs of the healthcare market.
Specialties we’ve experienced:
Anesthesiology, Bariatrics, Biomeds and Tech Support, Blood Collection, Cardiology, Electrophysiology, Emergency Medicine, Endocrinology and Diabetes, Internal Medicine, Neo-Natology, Nephrology, Neurology, OB-GYN, Oncology Ophthalmology, Orthodontics, Orthopedics, Otolaryngology, Pediatrics, Radiology, Respiratory Therapy, Urology
Places we’ve been:
Catheterization Lab, Central Supply, Diagnostics Lab Electrophysiology Suite, Emergency Department, Extended Care Facilities, Follow Up Clinics, Home Environment, Imaging/Radiology, Intensive and Critical Care, Labor, Delivery, Recovery, Neo-Natal Intensive Care, Nursing Stations, Operating Room, Outpatient Surgery, Pharmacy, Physical Therapy, Post Anesthesia Care, Sleep Lab, Step Down Floor, Unit Records Department
Frameworks and Systems:
Remote Diagnostics /Call Centers, DME Networks, Home Healthcare Clinicians Lab Services, Hospital Models: Socialized vs. Privatized, Hospital Models: Profit vs. Not-for-Profit, Hospital Models: University/Teaching, Hospital Models: Urban vs. Rural, 510(k), PMA, HIPAA JCAHO, Medicare, Reimbursement, ISO 13485, FDA QSR, BSI, UL, CSA, CE
Usability and human factors
From applying human factors and ergonomics standards to defining interaction strategies to performing human error risk analyses, Insight keeps the human element at the forefront throughout the development process. Our understanding of this regulatory concern is critical for guiding a process that mitigates risk and provides sound designs that are highly usable and intuitive.
Too often, what many consider as “human factors” is little more than quotes from Voice of the Customer research or preference testing. While both of these are important, neither are proof of risk mitigation; users cannot always tell you everything you need to know nor do they always select the most efficient or safest option when given a choice. A proper application of medical human factors is necessary to properly assess risk due to human error and complement other risk mitigation efforts common to development programs.
Below we list a few of the techniques that we use to provide FDA-worthy human factors inputs when designing for the medical industry:
- Heuristic Review
- Anthropometric & Ergonomic Analysis
- Competitive Benchmarking
- Workflow Analysis
- Cognitive Workload Analysis
- Performance Testing
- Control Mapping and Design
- HF and Ergonomics Analysis
- Standards Interpretation
- FDA Submissions Assistance
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