Expertise
Our starting point for a client encounter is always education and connection-making with a goal of understanding. When the rubber meets the road and its time to get things done, it matters what your team has under the hood. in2being team members bring deep expertise in areas including:
Technical Work
- Electronics Design
- Mechanical Design
- Software Design
- Embedded Systems Design
- Plastics Design
- Prototyping (all of the above)
- Design for Manufacturing
- IP Generation
- Conceptual Design
Regulatory/Management Work
- FDA Design Controls Management
- FDA Document Controls Management
- FDA Pre-Submissions (Q-Subs)
- FDA Breakthrough Device Pathway Submissions
- FDA 510(k) and Denovo Clearance Submissions
- FDA Quality Systems Development
- Regulatory Strategy/Planning
- Project Management
- Verification Test Management
- Manufacturer Management
Completed Work
Have a look at some Case Studies of completed work. We’ve done a lot, in a LOT of clinical domains:
- Cell Culture
- Cell Sorting (Fluidic and Acoustic)
- Urinary Catheters
- Urine Testing
- Respiratory Therapy
- Oxygen Monitoring
- Auto-Injectors
- Mouth Guards
- Hospital Alarm Systems
- Bone Drills
- Arterial Plaque Removal
- Venous Catheters
- Balloon Catheters
- Tissue Sample Handling
- Blood Alcohol Testing
- Wearables (Patch and/or Strap Fixed)
- Tinnitus Treatment
- Electrode Stimulus
- Bioresorbable Tissue Scaffolding
- Nerve Regrowth
- Surgical Catheters
- Aortic Dissection Relief
- RF Surgery
- Noninvasive Monitoring
- Hospital Hand Hygiene Monitoring
- Blood Fragility Testing
- Blood Adhesion Testing
- Injection Systems
- Peripheral IV Catheters
- Safety Needles
- Flow Cytometry (Cell Counting)
- Dental Absorption
- Cerebral-Spinal Fluid
- Extra Ventricular Drainage
- Automated Systems
- Vaginal Speculum
- Syringe Design
- Endotracheal Tube Design
- Pediatric Devices
- Surgical Pelvic Floor Support
- Surgical Guidewire Management
- Incompetent Cervix Treatment
- Catheter Based Mechanical Cutting
- RF Catheters
- Power Ultrasound
- Ultrasonic Surgery
- Ear Cartilage Shaping
- Patient Communications
- Pressure Sore Relief
- Inflatable Cushions
- Ambulatory Assistance
- Physical Therapy Devices
- Tonsil and Adenoid Removal
- Brachial Artery Ultrasound Techniques
- Blood Pressure Management
- Powered Exoskeleton
- AI/Machine-Learning
- Patient Warming
- Device Enclosures
- Portables/Batteries
- Dental Diagnostics
- Diagnostic AI
- DNA Diagnostic Integrated Systems
- CPAP/Sleeping Accessories
- Saliva Management
- Remote Sensing Ocular Pressure
- COVID Masks
- Eye Drop Delivery
- Ocular Impedance Wearables
- Ports/Caps for Catheters
- Micro-Assay Spotting
- Laboratory Fluid Control
- Reaction Measurement
- Auto-Transfusion Devices
- Blood Flow and Oxygenation
Don’t hesitate to reach out if we can be of any assistance in any areas of the above.
And below are some topic areas from the in2being team if you’re just browsing and would like even more reading material: