Download PDF
How Solius Replaced Paper with Eqms to Gain ISO 13485:2016 Certification in Weeks
Technology Category
- Functional Applications - Computerized Maintenance Management Systems (CMMS)
- Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries
- Healthcare & Hospitals
- Life Sciences
Applicable Functions
- Business Operation
- Quality Assurance
Use Cases
- Regulatory Compliance Monitoring
Services
- System Integration
- Training
The Challenge
The vision at SOLIUS was to bring the product to market as a medical device, meaning that their team was aware of the quality management regulations they would have to comply with. With four team members at the time, managing compliance and a QMS was an immediate hurdle they needed to overcome. They began to vet solutions that would help them manage the regulatory and quality requirements of their target markets, without them becoming overwhelmed with compliance efforts. They began searching for a solution that was cloud-based, secure, affordable, scalable, and came with advice from industry experts that could guide them along the way.
About The Customer
SOLIUS was founded by a duo seven years ago, but their product development efforts have ramped up in the past several years. Their device is a Class II phototherapy device that bridges a medical device and a wellness device that stimulates the body to produce Vitamin D–something the body is already meant to do. SOLIUS’ device is the first of its kind in terms of its labeling and conditions for use. This makes their pathway to market a bit more unique and may present some challenges. Their goal is to successfully bring their device to market with its current labeling with Health Canada, then meet with the FDA to assess how the device will be received.
The Solution
No one on the SOLIUS team had any expertise in medical device quality management at the time, leaving them thoroughly impressed by the talent and experience onboard at Greenlight Guru. These industry experts gave the team at SOLIUS the confidence in what they were doing with the software and industry knowledge. When it came down to making a decision, SOLIUS went with Greenlight Guru due to the stability of the company, impressive talent industry gurus onboard, and the stability of Greenlight Guru as a company. Linda Cox, Senior VP, QA/RA/Clinical Initiative at SOLIUS, assessed the cost of Greenlight Guru and decided that it was well worth it. Along with the software, they found immense value in the on-boarding process, knowledge base, and QMS templates. It was Greenlight Guru’s Customer Success Team that played a paramount role, providing guidance and mentorship during their earlier days. SOLIUS’ CTO worked with Greenlight Guru to get the software up and running, and found that the team was excellent in helping them get the system in place. It took them a few months to transfer all of their data into the system, due to initial hesitancy that they would make mistakes. Once they transferred over their data, they realized that there was really no way for them to mess it up. The team at SOLIUS worked with Greenlight Guru’s Customer Success Team on adopting the product and ensuring that their processes were sound. The guidance provided by Greenlight Guru reassured SOLIUS that they had made the right decision.
Operational Impact
Quantitative Benefit
Related Case Studies.
Case Study
Hospital Inventory Management
The hospital supply chain team is responsible for ensuring that the right medical supplies are readily available to clinicians when and where needed, and to do so in the most efficient manner possible. However, many of the systems and processes in use at the cancer center for supply chain management were not best suited to support these goals. Barcoding technology, a commonly used method for inventory management of medical supplies, is labor intensive, time consuming, does not provide real-time visibility into inventory levels and can be prone to error. Consequently, the lack of accurate and real-time visibility into inventory levels across multiple supply rooms in multiple hospital facilities creates additional inefficiency in the system causing over-ordering, hoarding, and wasted supplies. Other sources of waste and cost were also identified as candidates for improvement. Existing systems and processes did not provide adequate security for high-cost inventory within the hospital, which was another driver of cost. A lack of visibility into expiration dates for supplies resulted in supplies being wasted due to past expiry dates. Storage of supplies was also a key consideration given the location of the cancer center’s facilities in a dense urban setting, where space is always at a premium. In order to address the challenges outlined above, the hospital sought a solution that would provide real-time inventory information with high levels of accuracy, reduce the level of manual effort required and enable data driven decision making to ensure that the right supplies were readily available to clinicians in the right location at the right time.
Case Study
Gas Pipeline Monitoring System for Hospitals
This system integrator focuses on providing centralized gas pipeline monitoring systems for hospitals. The service they provide makes it possible for hospitals to reduce both maintenance and labor costs. Since hospitals may not have an existing network suitable for this type of system, GPRS communication provides an easy and ready-to-use solution for remote, distributed monitoring systems System Requirements - GPRS communication - Seamless connection with SCADA software - Simple, front-end control capability - Expandable I/O channels - Combine AI, DI, and DO channels
Case Study
Driving Digital Transformations for Vitro Diagnostic Medical Devices
Diagnostic devices play a vital role in helping to improve healthcare delivery. In fact, an estimated 60 percent of the world’s medical decisions are made with support from in vitrodiagnostics (IVD) solutions, such as those provided by Roche Diagnostics, an industry leader. As the demand for medical diagnostic services grows rapidly in hospitals and clinics across China, so does the market for IVD solutions. In addition, the typically high cost of these diagnostic devices means that comprehensive post-sales services are needed. Wanteed to improve three portions of thr IVD:1. Remotely monitor and manage IVD devices as fixed assets.2. Optimizing device availability with predictive maintenance.3. Recommending the best IVD solution for a customer’s needs.
Case Study
HaemoCloud Global Blood Management System
1) Deliver a connected digital product system to protect and increase the differentiated value of Haemonetics blood and plasma solutions. 2) Improve patient outcomes by increasing the efficiency of blood supply flows. 3) Navigate and satisfy a complex web of global regulatory compliance requirements. 4) Reduce costly and labor-intensive maintenance procedures.
Case Study
Harnessing real-time data to give a holistic picture of patient health
Every day, vast quantities of data are collected about patients as they pass through health service organizations—from operational data such as treatment history and medications to physiological data captured by medical devices. The insights hidden within this treasure trove of data can be used to support more personalized treatments, more accurate diagnosis and more advanced preparative care. But since the information is generated faster than most organizations can consume it, unlocking the power of this big data can be a struggle. This type of predictive approach not only improves patient care—it also helps to reduce costs, because in the healthcare industry, prevention is almost always more cost-effective than treatment. However, collecting, analyzing and presenting these data-streams in a way that clinicians can easily understand can pose a significant technical challenge.
