ProteusValidated Combination Medical Device MES Solution involving Semiconductor, Medical Device, and Pharmaceutical Manufacturing

Use Case

01 Proteus

Utilized TrakSYSTM Features & Functions

Inventory Management

Messaging & Notification

Job/WIP Management

Regulatory Compliance

Electronic Forms

Workflow Management

Quality & SPC

Traceability & Geneaology

Electronic Log Book

Medical Device Industry

The medical device industry is often on the cutting edge of technology and innovation. Driven by explosive growth, the sector has become one of the largest in the world, with a market size of almost $150 billion1. To excel in this highly competitive industry, Proteus needed a software solution that could unify their production workflows and unique processes.

eDHR

02 Proteus

Adherence to prescriptions is a serious problem worldwide; approximately half of all patients don’t take medications as prescribed2. To meet this growing prescription problem, California-based company Proteus has created a physiological sensor incorporated into a medication pill.

The sensor contains tiny amounts of magnesium and copper that react together, sending a wireless signal to a battery-operated patch that’s worn on the patient’s abdomen. The patch, which lasts about a week, reports data such as vital signs, body position, and ingestion information to a tablet or smartphone via Bluetooth. This data is sent to up to the cloud. Once the data is in the cloud, it can be monitored by doctors and other caregivers.

The device, made by Proteus Digital Health, is an ingestible sensor about the size of a sand particle. With no battery, it is powered by the body itself. The chip contains small amounts of copper and magnesium. After being ingested, the chip will interact with

digestive fluids to produce a voltage that can be read from the surface of the skin through a detector patch, which then sends a signal via mobile phone to inform the doctor that the pill has been taken.

The uses for Proteus’ physiological sensors are seemingly endless, and can help patients with tuberculosis, mental health issues, hypertension, and diabetes, to name a few. Andrew Thompson, Chief Executive at Proteus would also like to digitize the drugs taken to treat neurological disorders. Disorders such as Parkinson’s Disease and Huntington’s Disease often require patients to receive drugs regularly – sometimes several times per day. Transplant patients, who often have to take immunosuppressive drugs for long periods following surgery, may also benefit from digitizing their medicine.

As Proteus continued to move forward with clinical testing for the technology, and volumes grew, their need for an MES solution became paramount.

Company Overview

03 Proteus

“Ease-of-customization with TrakSYS™ was a critical selection criteria for us as our manufacturing operations encompass very different activities within wafer processing, sensor production, and tablet compression. However, the ultimate deciding factor was Parsec’s professionalism and integrity. They integrated with us as an extension of our own team through design, development, training, documentation, and validation until we successfully cut over from paper-based processes to TrakSYS™”

- Craig Mynatt

MES Project Lead

Proteus’ Smart Pills, Wearable Patch, and Associated Software (Courtesy of Proteus Digital Health)

- Craig MynattMES Project Lead

04 Proteus

TrakSYSTM Solution Approach

Challenges:

• Creation of the Electronic Device History Record (eDHR) was a paper-based process consisting of 35 steps.

• Significant overhead in maintaining data. Mistakes were common in manual processes without verification systems in place.

• Compliance requirements with printed eDHRs.

• Hosted data system was not real-time and required manual entry of eDHRs.

• Solution had to address complex traceability issues as lots were grouped and then redefined for various processes.

Goals

• Eliminate the paper eDHR for all wafer production.

• Reduce errors and related Nonconforming Material Reports (NCMR).

• Provide automated quality and process data from instruments and vendor Certificate of Analysis (CofA).

• Provide SPC in real-time at critical processing steps.

• Enforce manufacturing workflows

• Ensure compliance with all FDA regulations

• Proteus’ IT team members participated in the initial MES rollout, and by the end of Phase 1, Proteus was able to take over the MES implementation using internal resources.

The manufacturing operations at Proteus are complex and involve many processes that take place over a relatively long period of time. As production volumes grew, the use of manual, paper-based Device History Records became more and more burdensome. Consequently, Proteus determined they had an immediate need for an MES software solution that would provide a wide range of benefits to the business.

The TrakSYS™ MES solution was configured to help users manage production routings and enforce workflows to achieve regulatory compliance, improve accuracy of data collection, and eliminate paper-based record keeping. Rather than stopping at “Paper-on-Glass” functionality, TrakSYS™ was leveraged to optimize operations management and create detailed electronic device history records (eDHR). The browser-based solution portal readily offers the users and managers the needed information to improve quality, performance, and conformance.

05 Proteus

TrakSYS™ Development Server

TrakSYS™ ProductionServer

Firewall

Ethernet I/O

Business Users

Lab Users

Shipping & Receiving

Cloud

2D Barcode Reader

2D Barcode Printing

Operator Workstations

Wafer Production

TrakSYS™Test Server

TrakSYSTM Solutions Architecture

With the help of Parsec’s implementation team, TrakSYS™ was integrated with Proteus’:

• Operator Workstations• Production Instruments• Barcode Scanners• Label Printers• Network Fileshares• SPC Data Warehouse

Integration with devices that included test systems, scales, barcode readers, environmental data instrumentation, and PLCs (Programmable Logic Controllers) allowed Proteus to benefit from comprehensive real-time visibility across the manufacturing processes.

Figure 1 - Proteus Architecture

06 Proteus

TrakSYSTM Solutions Results Expanded

• With real-time factory data readily available in charts and tables, Proteus operators were able to easily identify and investigate problems as they arose.

• Process metrics are now available to help Proteus create more accurate and complete cost models.

• Reduction of labor intensive work associated with paper-based DHRs, including: printing, storing, filing, archiving, and scanning.

• Decreased data entry mistakes, using process data, metrics, and automated test file imports. Freed operator time for value-added activities.

Figure 2 - Proteus eDHR Report

TM

Parsec is the developer of TrakSYS™, a proven operations management software application and solution platform designed to significantly improve manufacturing processes. Parsec is committed to providing best-in-class products and solutions to our worldwide community of clients to assist them in optimizing their manufacturing operations. There are thousands of TrakSYS™ licenses in use around the globe in a wide variety of Industries.

TrakSYS™ helps manufacturers to maximize asset utilization and efficiency, increase capacity with no new capital equipment, reduce production costs, decrease lead time, and improve profitability. For more information about Parsec and TrakSYS™ please visit the corporate website at www.parsec-corp.com.

About Parsec

Copyright Parsec Automation Corp. 2016 All trademarks are the property of their respective owners

1. Medical Technology Device spotlight. (n.d.). Retrieved June 14, 2016, https://www.selectusa.gov/medical-technology-industry-united-states

2. Proteus Digital Health. (n.d.). Retrieved July 06, 2016, from http://www.proteus.com/company/mission/

Sources