Medical devices & diagnostics · Infusion safety
Shift Labs
A handheld monitor that counts the drops falling through an IV drip chamber and alarms when the rate drifts. Cleared by the FDA in 2015, sold into home infusion and military field medicine, and now very quiet.
Counting shadows
Most infusions given anywhere in the world run on gravity. A bag hangs above the patient, a roller clamp pinches the tubing, and a nurse stares at a clear plastic chamber, counts drops for fifteen seconds, multiplies, and converts to milliliters per hour.
It goes wrong a lot. A 2019 paper in Military Medicine cites a study in which paramedics calculated the correct drip rate 68.8 percent of the time, and another in which 21 percent of ward fluid bags infused correctly.
DripAssist is a plastic block a little larger than a phone. It clips over the drip chamber, shines infrared across it, and counts the shadows. A screen shows drops per minute, milliliters per hour and total volume. An alarm sounds when the rate wanders off a set point or stops.
It moves nothing. The FDA device listing is blunt: “The DripAssist is a passive device. It does not control the flow rate of fluids passing through a drip chamber.” One AA battery runs it for weeks. No proprietary tubing, no calibration.
The middle of the market
A hospital infusion pump costs thousands of dollars and needs power, service contracts and training. The alternative, in a home, an ambulance or a district clinic in Kenya, is a nurse and a wristwatch. Between those two options, in 2012, there was almost nothing.
That gap was the thesis. TechCrunch reported a suggested retail price of $225 in March 2015, a WHO sourced catalogue listed $395 by 2016, and a 2024 study put it at $400. The company sold to veterinary clinics first, because a distributor found the team during an early crowdfunding campaign and that path was shorter.
A professor who could not find a manufacturer
Beth Kolko is a professor of Human Centered Design and Engineering at the University of Washington who started out teaching rhetoric and literature. In the late 2000s she worked with students on a simplified ultrasound system for midwives in Uganda and Kenya, funded in part by the Bill and Melinda Gates Foundation. It worked. Nobody would make it.
An ultrasound executive told her cheaper technology would not support the cost of their sales force. “That was the day that I decided I was going to start a company, and eventually, that resulted in Shift Labs,” she told GeekWire in 2019.
She and mechanical engineer Koji Intlekofer interviewed clinicians about where care broke down, found five or six recurring pain points, and picked the one with the cheapest fix and the largest market. An Indiegogo campaign in 2012 raised $12,000. Y Combinator took them in the Winter 2015 batch.
Clearance, then customers
The FDA cleared DripAssist on October 13, 2015 under product code FLN, a class II monitor for gravity flow infusion systems. DripAssist Plus followed in May 2018.
Then came real distribution. USAID funded the device twice: $318,682 from 2015 to 2016 under an Ebola challenge, and $271,046 from 2018 to 2021 to evaluate it for oxytocin and magnesium sulfate delivery at Kenyatta National Hospital in Nairobi. Option Care Enterprises ran a 16 city pilot and launched DripAssist nationally for nurse monitored home infusion in July 2018. The Air Force awarded a Phase I SBIR contract worth $49,851 in March 2019.
In July 2020 Shift Labs handed the Americas away. Hometa took an exclusive license to manufacture and distribute DripAssist across the United States, Canada, Mexico, Central and South America except Brazil. In April 2021 Kolko moved to board chair and Dave Anderson became CEO.
Where the work went
In September 2022 the National Institute of Nursing Research awarded Shift Labs a Fast Track SBIR, R44NR019963, to build a closed loop version that would adjust the drip rather than only watch it. NIH records show $216,597 paid to Shift Labs, Inc., ending March 23, 2023.
Every later year of that grant is recorded to a different organization. Cove Technology Consulting LLC of Bainbridge Island, Washington received $34,595, then $868,295, then $716,570, with Chie Kawahara, formerly Shift Labs’ VP of product development, staying on as principal investigator. The company website has published no news since January 2022, and Kolko’s venture bio puts her ten years as founder and CEO in the past tense.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA 510(k) K150687 | Received Mar 17, 2015, cleared Oct 13, 2015. Traditional 510(k), product code FLN, class II, 21 CFR 880.2420. Listed as a supplementary monitoring system that does not control flow. | Public record |
| FDA 510(k) K172242 | DripAssist Plus, cleared May 25, 2018. No GUDID listing was found for this second model, while the original DripAssist is still listed as in commercial distribution. | Public record |
| Safety record | No MAUDE adverse event reports, recalls or enforcement actions in openFDA searches by brand name or manufacturer, Sep 23, 2026. | Public record |
| Independent pilot | Military Medicine, March 2019. IRB approved pilot with 28 emergency staff at Madigan Army Medical Center. Nurses and physician assistants were likelier than medics to see a benefit over pumps or gravity. | Independent |
| Independent comparison | Frontiers in Medicine, February 2024. Johns Hopkins, five infusion methods. DripAssist took longest to set up, a mean of 352 seconds against 71 for a $4 manual flow regulator, and the DripAssist stations were rated the most time consuming. Accuracy differences across all five methods were not significant at any goal rate. | Differs from marketing |
| Ease of use claim | The company promises “simplified and efficient workflows” and training in under five minutes. The 2024 study found DripAssist slowest to set up and among the hardest to operate. | Differs from study |
| Accuracy claim | Company materials state “99% accuracy in detecting infusion drop detection”. No independent accuracy validation against a reference standard was found in the peer reviewed literature. | Company-stated |
| Federal funding | $639,579 on USASpending across two USAID awards and an Air Force SBIR Phase I, plus $216,597 from NIH. Total on record, $856,176. | Public record |
| Air Force Phase II | Announced in September 2019, listed at $1,544,853 in an SBIR industry database. No Phase II obligation to Shift Labs appears in USASpending. | Not in the spending record |
| Deployment scale | Over 200 healthcare settings per a 2020 partner release, 1,000 to 10,000 units per a catalogue. No independent audit. | Company-stated |
| Patents | Five issued US patents assigned to Shift Labs, Inc., from 9,199,036 in 2015 to 11,464,905 in 2022. A 2020 application adds a weight sensor and flow restrictor, the closed loop idea NIH funded. | Public record |
Read plainly: the device is real, cleared, patented, bought by serious buyers, and carries a clean safety record over eleven years. What it never accumulated is outcome evidence. The two independent studies are a 28 person usability pilot and a bench comparison that found DripAssist slower to set up than a $4 plastic dial with no significant accuracy edge. The strongest claims, on accuracy and workflow savings, rest on internal work.
What to watch
- Whether the closed loop device, now developed under Cove Technology Consulting, reaches a 510(k) submission. Adding flow control changes the regulatory question.
- Whether Hometa, holder of the exclusive Americas license since 2020, is still manufacturing and selling.
- DripAssist Connect, the Bluetooth model announced in 2021. No clearance for it has appeared.
- Whether anyone publishes a real world outcome study rather than a bench test.
In their words
“There is no reason why we can’t make products for nurses and medical practitioners that they enjoy using. But no one is building products for the people who are going to be providing the care.”
Beth Kolko, co-founder and CEO, TechCrunch, 2015 · Independent
“If you look at infusion, either people are using pumps which cost thousands of dollars, or they are counting drops by hand. There’s this enormous, unaddressed middle space, and that’s where we come in.”
Beth Kolko, Medgadget interview, 2016 · Interview
“We ran the Indiegogo campaign back in 2012, it was actually one of the first, if not the first, medical device to be crowdfunded. The campaign raised $12,000 and was the first money into the company.”
Beth Kolko, Medgadget interview, 2016 · Interview
“If you are a medical device company, regulatory is really hard. If you are selling internationally, distribution is really hard.”
Beth Kolko, GeekWire, 2015 · Independent
“I continue to believe that non-expert innovation is crucial, especially for really wicked problems, because we have to learn how to see things differently if we’re going to solve things differently.”
Beth Kolko, GeekWire Health Tech Podcast, 2019 · Interview
“Hometa is an ideal partner to accelerate commercialization of DripAssist. They have a rapidly growing portfolio of products to address home-based infusion care, which DripAssist complements,”
Koji Intlekofer, CTO and co-founder, partnership release, July 2020 · Partner release
“I wanted to like the DripAssist, and it was more convenient than counting drops, but it is also time consuming trying to get the exact number.”
Study participant, Frontiers in Medicine, February 2024 · Peer reviewed
Related companies
Sources
- Public recordFDA 510(k) K150687 and GUDID listing, DripAssist
- Public recordFDA 510(k) K172242, DripAssist Plus
- Public recordopenFDA MAUDE, recall and enforcement searches, nil
- Public recordUSASpending awards AIDOAAF1500019, 7200AA18FA00014, FA875119PA054
- Public recordNIH RePORTER, R44NR019963, all fiscal years
- Public recordForm D and Form D/A, Shift Labs, Inc., CIK 0001639079
- Public recordUS patents 9,199,036 through 11,464,905
- IndependentIV DripAssist: An Innovative Way to Monitor Intravenous Infusions
- IndependentA comparative analysis of intravenous infusion methods
- IndependentShift Labs Launches Out Of Y Combinator
- IndependentStartup Shift Labs wants to change how medical devices are made
- IndependentRwanda trip report 2015 and Health Tech Podcast profile 2019
- InterviewApplying Human Centered Design to IV Infusions: Beth Kolko interview
- IndependentHow federal research funding fueled a startup with global reach
- IndependentDripAssist Infusion Rate Monitor product record
- CompanyShift Labs Partners with Option Care
- PartnerHometa and Shift Labs Partner on Alternate-Site Infusion Care
- CompanyShift Labs announces Dave Anderson as CEO
- CompanyShift Labs website, product and news pages
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
