Harmonizing Processes Across the Medical Device Value Chain with a Next-Generation EQMS

Medical technology companies all over the world are dealing with several quality-related challenges, often caused by complexities in the supply chain. Many companies in this segment are realizing the limitations of on-premise legacy systems that are unable to facilitate harmonization and standardization of processes across sites, locations and suppliers.

Additionally, companies in the medical device industry also have to meet varying regulatory requirements in all geographies they operate in. In this context, it is also important for quality leaders to have a robust understanding of all key quality and compliance data – filtered by location and by product type. Remote monitoring and processing have become extremely critical.

At ComplianceQuest, we recently organized a webinar titled ‘ Next Wave of Innovation: Riding Digital Transformation throughout Medical Device Value Chain’. We invited a leader from Canon Medical Systems, Europe to share his journey of how digital transformation and automation added efficiency to the quality and compliance process, as the company was scaling rapidly.

If you are looking to digitally transform processes in your organization, listen to this Webinar to learn about how Canon Medical Systems, Europe implemented Salesforce and ComplianceQuest to automate and streamline all processes across customer engagement, quality management and regulatory compliance.

Find out more here: https://www.compliancequest.com/webinar/innovation-next-wave/

In this blog, we share a few key takeaways from the session.

Plan your Digital Transformation Roadmap for the Long-Term

Digital transformation is a process of many steps, but a next-generation CRM (Customer Relationship Management) software like Salesforce.com is a good place to start. It requires businesses to rethink their customer engagement processes and the goals they want to achieve. This is not just about managing customer contacts but about going beyond to understand customer needs, communicate with them on an ongoing basis, learn from their experiences and pass on the knowledge to internal manufacturing, quality and operations teams.

It requires the building of an ecosystem that brings different teams together — be it manufacturing, RA/QA, customer service or operations. And this needs to be integrated with the HCPs, patients and payers.

The next requirement is to build towards the future and not just solve current problems. The system needs to be scalable and flexible, so that along with addressing current challenges, it also enables continuous improvement in terms of productivity, efficiency and quality.

Thirdly, the businesses need to have a global lens. Not only should they plan for products for one specific market but think of other areas and geographies. Business leaders must think about scale both in terms of geographical expansion and product expansion. Your digital transformation program must be designed keeping in mind this ambition. It requires an integrated approach wherein the ERP, CRM, EQMS and other business systems are truly integrated and set up not for today but for the future.

The Digital Transformation Journey at Canon Medical Systems, Europe

Canon Medical Systems, Europe is a representative of Canon Medical Systems, Japan, managing their sales and distribution in various countries across the European Union (EU). It operates through a network of 10 subsidiaries that do business in 8 languages. The business covers sales and distribution in 39 countries (mostly in the EU but a few outside of Europe as well). However, there was a central team that was responsible for meeting all compliance and regulatory requirements in all 39 geographical regions.

In case of any issues, the central team had to deal with the local regulatory authorities and so had to be aware of country-specific regulations, in addition to location-specific quality aspects. The central regulatory team needed to have a finger on the pulse of all quality and regulatory information. There was a crying need for a next-generation EQMS, that had data at its core.

Canon felt a big need for a solution to manage all the diversity as well as felt urgency to take control of all those regulatory activities. It needed to:

• Gain control over regulatory activities such as incidents, post market surveillance, vigilance
• Harmonize and standardize processes across customer, supplier and internal dashboards
• Automate all processes including Audits, Complaints, CAPA, Risk Management
• Keep track of geography-specific regulatory needs

To achieve the above goals, it required the following:

• Control through Operational Dashboards
• Next-generation Reports and Charts to track all leading and lagging indicators
• AI-powered quality analytics to prevent problems ahead of time

Making the Shift from a System of Record to a System of Engagement

To realize the full value of a digital transformation effort, it is a good idea to embrace the following best practices:

1. Start with Metrics: Enterprises should begin by defining the key metrics that matter to them, and those metrics should be customer-facing. This helps with dissecting the goals and figuring out how to arrive at the operational metrics so that employees can be aligned towards a common end goal that drives customer engagement. Working backward from there to set quality metrics to track is a good practice.
2. Allow Global Harmonization: One of the biggest challenges businesses face is that they have several bespoke tools for different processes but they don’t talk to each other in real-time. As a result, a system of engagement is simply not possible. Harmonizing common processes across all geographies and functions enables employees across the board to speak the same terminology and language surrounding events and follow the same processes. This enables getting the metrics in a meaningful way from across regions. A globally harmonized process in a singular platform enables getting real-time metrics that help executives make decisions in real-time with live data.
3. Driving adoption across sites: The platform must enable the collection of site-level data and, more importantly, it must be used actively at all sites. It is imperative that operational leaders in a particular location encourage digital adoption. For a digital transformation effort to be truly meaningful, site-level adoption of the new platform is a must.

The combination of Salesforce for CRM and ComplianceQuest for EQMS was a solution that really worked for Canon. It was easy to use and the platform saw widespread adoption across all 39 regions. With ComplianceQuest EQMS, it was also really easy for quality leaders and the central regulatory team to have a finger on the pulse of all quality data and analytics.

Transformation for Scale

Canon had been running a system for 20+ years before going for a next-generation digital transformation effort.

The company’s quality leaders started by implementing 6 ComplianceQuest Solutions – Document, Audits, Complaints, CAPA, Change Control and Risk Management.

In addition to driving operational efficiency, the platform made it easy to capture trends and conduct analysis. It was easy to compare data from different countries and the solution leveraged cutting-edge AI technology to automate various processes related to risk management. For instance, the process of prioritizing various risks by urgency was automated using AI. Recommendations and predictions were features that were extremely useful for leaders at the company.

Additionally, the quality team also realized the benefits of moving to a cloud-based solution, wherein both IT infrastructure costs and maintenance challenges were removed.

If you are a quality leader in the medical device industry looking for a next-generation EQMS, look no further than ComplianceQuest. Request for a demo here:
https://www.compliancequest.com/online-demo