Introduction
This personalized medical device manufacturer seeks to disrupt the prosthetics space by rethinking how these Class I medical devices are made. They saw prosthetic arms currently on the market were inaccessible to patients due to high costs and cumbersome due to heavy weight (2.5-4 lbs). By leveraging the advantages of 3D printing to manufacture an ultra-lightweight (1-1.5 lbs), personalized, and extremely durable prosthetic limb, they will be able to provide prosthetics at 30-90% less than typical costs.
Because their product is custom-built for every patient, it also significantly increases the complexity of documentation to ensure traceability and compliance with regulations. To lower operational costs and simplify compliance, this medical device manufacturer chose Tulip for its flexibility as a multi-faceted solution to manage documentation with electronic device history records (eDHR), error-proof processes with digital work instructions, and increase data visibility throughout their operations.
Digitizing Assembly with Tulip Work Instructions
Their operations manager knew if they were to scale as a company, they needed to eliminate any unnecessary costs and ensure each prosthetic arm was built perfectly every time.
Her first priority was to error-proof the manufacturing process using Tulip's digital work instructions. Because each prosthetic arm is designed for an individual patient, assembly technicians have to accurately pick and assemble parts according to their unique customizations. Any error could result in the entire arm becoming a sunk cost.
Assembly technicians use digital work instructions to view order specifications, pull the correct inventory, and track progress through the assembly process. Interactive checklists and visual aids ensure every step of the workflow is completed accurately and efficiently. Before Tulip, it typically took 3-5 days to assemble one device. After digitizing the process, they cut that time to 1-2 days.
Automating Data Collection for eDHR
Managing device history records for each prosthetic arm is one of the greatest challenges for this scaling company. Before Tulip, it was a paper-based process that added up to 20 pages.
Now, they simply use Tulip apps in production to automate the data collection process and simplify documentation. The data follows ALCOA+ principles and helps ensure compliance by storing data in an electronic device history record (eDHR).
Bridging the Gap Between Multiple Systems using Tulip
After implementing digital work instructions, the team quickly realized that they could utilize the platform to optimize more than just the assembly process.
“Now looking at some of the tools we’ve created with Tulip, we’ve digitized the entire process, and that allows us to be scalable as a business,” said their CEO.
The operations manager has also been able to build Tulip apps that connect previously fragmented systems that created data silos and gaps in communication. She mentions struggling between their CRM, ERP, and Google Drive to manage their workflows and documentation, but Tulip has allowed this manufacturer to consolidate these systems into a single solution.
Because the final product undergoes multiple revision stages to create the perfect fit, the team needs to be capable of tracking exactly which parts are used at which revision level. The operations manager ditched their previous ERP system by using Tulip to create their own system with apps and Tables. Now they manage bills of materials (BOMs) and streamline inventory management in real time.
In addition to replacing their ERP system, the operations manager integrated Tulip with their CRM, FreshSales, using Connectors to create a bidirectional data transfer between systems. This connection enables this company to communicate the status of orders with their customers directly from a Tulip app, rather than switching back and forth to their CRM. This change improved their communication and transparency with their customers, leading to higher customer satisfaction.
Enabling Citizen Development
The operations manager previously had no technical background or coding experience, but with the no-code app editor, online training materials, and support from the Tulip team whenever she needed it, she has been able to build solutions that address the critical needs of the team.
The Tulip platform enables this company to continuously improve its processes in response to feedback from those closest to their operations and make decisions based on real-time data.
Tulip’s Composable Platform Creates Unlimited Possibilities
Being at the forefront of prosthetic technology, this manufacturer likes to “fail fast and move fast” to get their life-changing products to those who need them as quickly as possible while maintaining quality at an affordable price. they chose Tulip as a platform that is as agile as their operations as they continue to innovate and reach more patients.
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