FIVAFlow: Evolving from MVP to Global Medical Product

FIVAMed is a Medtech company built around FIVA: a “Fluid Intravenous Alert” concept and device platform, founded by Canadian anesthesiologist, Dr. Orlando Hung.

The Halifax-based medical device company developed FIVAFlow, a compact, clip-on IV monitoring device that measures flow, detects empty bags, and alarms clinicians before problems arise. Designed to work with standard gravity sets, FIVAFlow serves resource-constrained health systems and supports partnerships for affordable, locally manufactured IV safety solutions, including initiatives in developing nations.

Dr Hung and the Enginuity Product Development team developed a solution, evolving multiple iterations from an MVP (minimum viable product) into a more robust, market-aligned device. Our team has worked through multiple product design iterations, and also provided end-to-end prototyping solution for this medical product.

First MVP:

A rugged, battery-powered device with one sensor that detected when the fluid level in the drip chamber dropped below a threshold, then pinched the IV line and sounded an alarm to prevent backflow or air. This version achieved the original safety goal but did not provide enough perceived value to justify setup and battery management effort for many users.

Second iteration:

The team added a second sensor and flow-counting capability, plus a display and user interface to show infusion rates. They redesigned the clamp mechanism to be more compliant and fit a much wider range of drip chambers sourced from multiple regions (North America, Europe, Mexico, China, etc.), achieving compatibility with roughly 95% of chambers in the field.

This required close collaboration between the mechanical, electronics, and firmware teams to refine sensor positioning, improve chamber fitment, calibrate flow detection logic, and ensure reliable performance across varying IV set designs.

Market repositioning:

Recognizing that North American and European hospitals were largely using infusion pumps, with their own economic and workflow dynamics, FIVEMed focused on markets where gravity-fed infusions remain prevalent and budgets for pumps are limited, particularly in Africa and parts of Southeast Asia. In these settings, Fiva filled the niche by providing reliable flow information and dry-bag alerts without the cost and complexity of full infusion pumps.

Throughout this evolution, Hung and Enginuity learned to broaden user input and systematically test in different clinical contexts and to treat firmware decisions as strategic commitments.

This case illustrates how a seemingly simple safety idea becomes complex the moment it enters the regulated, global reality of MedTech. FIVAmed’s journey from a very lean MVP to a globally compatible, software‑enabled device shows that regulatory drag and international variability are not edge issues; they are core design constraints.

FIVAFlow evolved from a lean MVP into a more robust, globally compatible medical device through multiple iterations spanning firmware development, PCB and electronics design, sensor integration, mechanical redesign, and manufacturability refinement.

The project also highlighted the importance of designing for international hardware variability, long-term regulatory considerations, and scalable production from the early stages of development.