How ACHB Helps World’s Leading Scale Manufacture Enter The Medical Market
OVERVIEW
ACHB has helped one of the world-leading manufacturers of food weighing and packaging machines enter the medical market with an industry-leading IoT integrated UMR System (Urine Measurement and Recording). According to the recent Deloitte report, the market for connected medical devices is predicted to grow from $14.9 billion in 2017 to $52.2 billion in 2022. To seize the rising opportunities in MedTech innovation, the customer uniquely leveraged ACHB’s extensive medical industry domain knowledge and engineering capability along with its existing technical IPs to facilitate exploring new business opportunities exceeding 2.2B JPY.
ACHB's Manufacturing department.
CHALLENGES
Planning & PoC
Market signals indicated that there was a strong demand for vital sign measurement automation, however, the customer had no previous experience in the medical field nor could turn it into a profitable solution. In the beginning the initial product specification was unfeasible, and the market positioning was unclear. And with a limited budget, the customer was simply not able to afford a lengthy PoC process.
EVT & DVT
The engineering limitations were exacerbated by the complex IoT integration required by the hospital systems for AKI(Acute Kidney Injury) and heart attack screening in data collection. Furthermore, an inefficient product development iteration process was due to the lack of design verification criteria and production-intent design selection dilemma. Hence, mass production yield verification was limited due to only having one production-worthy design.
Regulatory Compliance & PVT
Prior to the URM System, the customer’s IP portfolio covered only food and drug weightings. For the more advanced medical measurements such as urine, the company failed to meet strict industry requirements such as experiment methods, clinical trials, and application documents from PMDA (Pharmaceuticals and Medical Devices Agency) and FDA (Food and Drug Administration). And to meet mass production requirements, due to its unfamiliarity with the medical industry, the customer had a difficult time outsourcing to the right supplier for key device components, in-time production, and with high yield rate.
FACTS & FIGURES
- Cost-effective PoC development: PoC process shortened from 3 months to 1 month, and achieved cost reduction from 120,000 USD to 20,000 USD, a saving of 600% of the original cost.
- Accurate product strategy that aligns with corporate strategy: Proteinuria and hematuria measurement are proven to be the most in-demand functions for the market and the time-to-market was shortened to 2 years. Plus the 3D-printed J hook design is able to support any kind of urine bag. Therefore, the customer doesn't have to worry about the disposals, just focus on the data subscription as the better business model.
- Viable and scalable design engineering ability: The bulky battery size of the portable type was redesigned to increase mobility yet and still last for 3 days.
- Cloud storage support: Extensive big data analysis.
- Algorithm and system optimization.
SOLUTION
Planning & PoC
ACHB has helped one of the world-leading manufacturers of food weighing and packaging machines enter the medical market with an industry-leading IoT integrated UMR System (Urine Measurement and Recording). According to the recent Deloitte report, the market for connected medical devices is predicted to grow from $14.9 billion in 2017 to $52.2 billion in 2022. To seize the rising opportunities in MedTech innovation, the customer uniquely leveraged ACHB’s extensive medical industry domain knowledge and engineering capability along with its existing technical IPs to facilitate exploring new business opportunities exceeding 2.2B JPY.
EVT & DVT
ACHB was able to provide quick product proofing and engineering verification services that meet the needs of the medical industry along with customer’s IP to fulfill both customer expectations and hospital demands. This success was largely due to the accurate production- intent design selection from a build matrix of options. Instead of including all the functions into the design, ACHB provided a viable and scalable alternative based on its comprehensive market research and extensive engineering experience. In the end, the design included the two most in-demand functions, proteinuria and hematuria measurements, and drastically shorten the time-to-market from the originally estimated 5 years to only 2 years.
The UMR system ultimately achieved the customer’s goal of integrating the automation of conventional urine and hematuria measurement operations with the customer’s weighing sensor technology while automatically recording the measurement data. Furthermore, with extensive module and system design experience, ACHB was able to provide the add-on service while maintaining the design integrity. Given the urinary hemoglobin concentration, the conventional hematuria monitoring work becomes unnecessary, hence the risk of infection is drastically reduced because the chances of contact with the urine bag are minimized. In addition, the system eliminates the required use of specially designed urine bags along with the precision urine meter, thereby minimizing the overall costs.
Regulatory Compliance & PVT
To move on to the next phase validation, ACHB’s in- house regulatory analysts teamed up with its experienced engineering professionals to build a prototype UMR system for continuous user optimization. Further, ACHB was able to enhance the yield rate and swiftly adapt both mechanical and electrical designs in compliance with industry regulatory changes thanks to the early manufacturing design for DFM.
ACHB's QC inspector is checking quality inspection with Mitutoyo 3D CMM.
ACHB's engineers are confirming the prototype printed by the 3D printer.
ACHB's Class 10,000 cleanroom.
“The monitoring device makes the measurement of saline, urine, and blood easier, and the scanning device for blood trace is very helpful,” said Kelly, a surgical nurse at Mass General Hospital in Boston.
“With 15 beds in the ICU, the warning system of the monitoring device is very helpful at the nursing station if blood traces or discoloration show up. When a nurse needs to empty a bag into a measuring container, they must wear a cap, a gown, gloves, and goggles. All must be thrown away when finished. Using the precise monitoring device could save a lot and can avoid this whole process which happens 2 or 3 times a day per patient,” said Sarah, an ICU nurse at Steward Holy Family Hospital.
Diverse Industry Expertise
At ACHB, we don't just solve technical challenges—we partner with our clients to align our solutions with broader goals. By working closely with medical professionals and device manufacturers, we ensure that every system not only meets functional and regulatory requirements but also enhances the user experience, safety, and operational efficiency.