Case Studies Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

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	Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

Technology Category	Functional Applications - Computerized Maintenance Management Systems (CMMS) Functional Applications - Enterprise Resource Planning Systems (ERP) Functional Applications - Product Lifecycle Management Systems (PLM)
Applicable Industries	Healthcare & Hospitals Life Sciences
Applicable Functions	Quality Assurance Product Research & Development
Use Cases	Regulatory Compliance Monitoring Remote Collaboration
Services	System Integration Training
Challenge	At Photonicare, the team was always wearing different hats to maintain their agility, and implementing a paper-based quality system seemed like a retroactive solution. They believed such a solution would ultimately lead to more inefficiencies and time spent on manually documenting product and quality activities where quality could slip through the cracks. In order to avoid this, they began searching for a cloud-based, purpose-built solution that would contribute to improving their internal team efficiencies and maintaining their agility. As an early-stage company, the team at Photonicare is always looking for ways to improve their efficiencies while maintaining their agility. Ryan Nolan, Co-founder and VP of Clinical Operations, recalls their antiquated way of doing things in the beginning when it came to documenting things on paper. As a result of having to wear multiple hats and juggle competing priorities at a startup, they reached a point where their documents weren't as organized as they wanted them to be. Knowing this antiquated way was a time-consuming solution for managing documentation and quality processes, Ryan and the team at Photonicare began searching for a purpose-built solution that was as agile as their team. Read More
About Customer	Photonicare is an early-stage medical device company based in Champaign, IL, focused on providing physicians with better tools to make better treatment decisions and provide better care for children who suffer from ear infections. The company is led by Ryan Shelton, Ph.D., Co-Founder & CEO, Ryan Nolan, Co-Founder/ VP of Clinical Operations, and Heather Howard, Biomedical Engineer II. Their primary device, the TomiScope, uses ultrasound-related technology to visualize the middle ear for physicians to confidently diagnose middle ear infections. The company initially targeted the USA market and started from scratch with their quality management system. The team at Photonicare is known for wearing multiple hats throughout the production of their device, which requires documenting product development and quality activities. They sought a cloud-based, purpose-built solution to improve internal team efficiencies and maintain their agility. Read More
Solution	The team at Photonicare was looking for a medical device quality management system (MDQMS) that would be intuitive and nimble. During their search, Photonicare discovered the value of in-app controls and guidance from medical device industry experts that assured they would produce a high-quality FDA submission. After deciding to adopt Greenlight Guru, their team is now able to see all of their design controls in one place and can identify existing holes that need to be filled. Since they have been generating numerous documents and preparing their FDA submission, Heather finds value in being able to route documents electronically for necessary signatures so that she can focus on higher-value day-to-day activities. Ryan highlighted that having industry experts from the Greenlight Guru Customer Success team at their disposal helped them easily implement an MDQMS and jump-start their documentation efforts. Heather finds having a pre-existing Design History File (DHF) in Greenlight Guru is a “huge relief” that has eliminated the countless hours of manually preparing a DHF for their FDA submission. Their team believes that partnering with Greenlight Guru has been a competitive advantage for Photonicare – allowing them to get through different stages of development at a much faster pace than a paper-based system would have. Read More Log in to view content
Contents

Technology Category

Functional Applications - Computerized Maintenance Management Systems (CMMS)

Functional Applications - Enterprise Resource Planning Systems (ERP)

Functional Applications - Product Lifecycle Management Systems (PLM)

Applicable Industries

Healthcare & Hospitals

Life Sciences

Applicable Functions

Quality Assurance

Product Research & Development

Use Cases

Regulatory Compliance Monitoring

Remote Collaboration

Services

System Integration

Training

Challenge

At Photonicare, the team was always wearing different hats to maintain their agility, and implementing a paper-based quality system seemed like a retroactive solution. They believed such a solution would ultimately lead to more inefficiencies and time spent on manually documenting product and quality activities where quality could slip through the cracks. In order to avoid this, they began searching for a cloud-based, purpose-built solution that would contribute to improving their internal team efficiencies and maintaining their agility. As an early-stage company, the team at Photonicare is always looking for ways to improve their efficiencies while maintaining their agility. Ryan Nolan, Co-founder and VP of Clinical Operations, recalls their antiquated way of doing things in the beginning when it came to documenting things on paper. As a result of having to wear multiple hats and juggle competing priorities at a startup, they reached a point where their documents weren't as organized as they wanted them to be. Knowing this antiquated way was a time-consuming solution for managing documentation and quality processes, Ryan and the team at Photonicare began searching for a purpose-built solution that was as agile as their team.

About Customer

Photonicare is an early-stage medical device company based in Champaign, IL, focused on providing physicians with better tools to make better treatment decisions and provide better care for children who suffer from ear infections. The company is led by Ryan Shelton, Ph.D., Co-Founder & CEO, Ryan Nolan, Co-Founder/ VP of Clinical Operations, and Heather Howard, Biomedical Engineer II. Their primary device, the TomiScope, uses ultrasound-related technology to visualize the middle ear for physicians to confidently diagnose middle ear infections. The company initially targeted the USA market and started from scratch with their quality management system. The team at Photonicare is known for wearing multiple hats throughout the production of their device, which requires documenting product development and quality activities. They sought a cloud-based, purpose-built solution to improve internal team efficiencies and maintain their agility.

Solution

The team at Photonicare was looking for a medical device quality management system (MDQMS) that would be intuitive and nimble. During their search, Photonicare discovered the value of in-app controls and guidance from medical device industry experts that assured they would produce a high-quality FDA submission. After deciding to adopt Greenlight Guru, their team is now able to see all of their design controls in one place and can identify existing holes that need to be filled. Since they have been generating numerous documents and preparing their FDA submission, Heather finds value in being able to route documents electronically for necessary signatures so that she can focus on higher-value day-to-day activities. Ryan highlighted that having industry experts from the Greenlight Guru Customer Success team at their disposal helped them easily implement an MDQMS and jump-start their documentation efforts. Heather finds having a pre-existing Design History File (DHF) in Greenlight Guru is a “huge relief” that has eliminated the countless hours of manually preparing a DHF for their FDA submission. Their team believes that partnering with Greenlight Guru has been a competitive advantage for Photonicare – allowing them to get through different stages of development at a much faster pace than a paper-based system would have.

Impact #1	The team at Photonicare can now see all of their design controls in one place and identify existing holes that need to be filled.
Impact #2	Heather finds value in being able to route documents electronically for necessary signatures, allowing her to focus on higher-value day-to-day activities.
Impact #3	Having industry experts from the Greenlight Guru Customer Success team at their disposal helped them easily implement an MDQMS and jump-start their documentation efforts.

Impact #1

The team at Photonicare can now see all of their design controls in one place and identify existing holes that need to be filled.

Impact #2

Heather finds value in being able to route documents electronically for necessary signatures, allowing her to focus on higher-value day-to-day activities.

Impact #3

Having industry experts from the Greenlight Guru Customer Success team at their disposal helped them easily implement an MDQMS and jump-start their documentation efforts.

Benefit #1	Nearly 50% misdiagnosis rate using traditional otoscope devices.
Benefit #2	Greenlight Guru's MDQMS has streamlined the document approval process.
Benefit #3	Integrated risk management aligns with ISO 14971.

Benefit #1

Nearly 50% misdiagnosis rate using traditional otoscope devices.

Benefit #2

Greenlight Guru's MDQMS has streamlined the document approval process.

Benefit #3

Integrated risk management aligns with ISO 14971.

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Overview

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

Operational Impact

Quantitative Benefit