Medical Device Manufacturing Done Right in 2021 — And, the need for an integrated ERP, CRM & QHSE

Extended lockdowns to curtail the spread of the Covid-19 pandemic affected the global economy in general and the medical devices industry specifically. According to a report by Business Research Company, the demand for COVID-related medical equipment such as life support ventilators, medical grade PPEs and others, went up while demand for non-COVID medical equipment dropped.

In parallel, disruption of the supply of raw materials and components for manufacturing medical equipment also impacted the medical devices industry.

As a result, the medical devices market, which was estimated to be around $457 billion in 2019, declined to $442.5 billion in 2020 at a rate of -3.2%. While the market is expected to revive from 2021 and grow at a CAGR of 6.1% to reach $603.5 billion in 2023, the need to protect against such disruptions and adopt digital technologies has emerged as a key requirement for MedTech companies.

Leaders in the sector have also realized that embracing Industry 4.0 using automation, digital transformation and data-enabled decision making are critical to mitigate both macro and micro economic risks across the world.

Challenges Faced by the MedTech Industry Due to Covid-19

Though pandemics are not new, it has never disrupted the world as much as Coronavirus did. One of the primary differentiating factors of Covid-19 was the fast spread of the disease. This compelled businesses to introduce safety protocols such as reduced workforce on the shopfloor, social distancing, sanitization processes, and enabling remote work even as the lockdowns were eased over time.

From an operations perspective, this posed severe challenges for the medical device manufacturers who worked with legacy, on-premise systems.

Some of these challenges were:

• Legacy, on-premise software were cumbersome to use, especially when working remotely
• Difficult to get a single source of “trusted data” from across the operational lifecycle
• Inefficient automation of QMS processes
• Process of audits, inspections and regulatory submissions slowed down due to bottlenecks and delays
• Incident prevention with a data-driven approach was a challenge
• Automation of safety management processes ended up being a siloed effort
• It wasn’t easy to build a continuously improving process, primarily because of lack of data

This is typical for companies that have not walked the path of digital transformation and struggle with several bespoke systems that operate in silo. Integration in such cases can be expensive and the data may remain out of sync. As remote working becomes essential, it increases the vulnerability of the enterprise systems due to the access by multiple devices with questionable security protocols.

Digital Transformation to tide over Covid-19 Setbacks

To move to next-generation systems and platforms, businesses need a solution that can automate the existing processes end-to-end. They need a platform that protects their investments in legacy systems and at the same time leverages modern technology to facilitate a system of engagement.

This need has led to the acceleration of digital transformation by three to four years, according to a McKinsey Global Survey of executives, especially in the areas of customer and supply-chain interactions.

A cloud-based digital platform with an integrated ERP, CRM, EQMS and EHS has become a “must have”, especially in regulated industries like life sciences, medical devices, healthcare and manufacturing. The need for data-driven collaboration has clearly been established.

A case in point is SPR Therapeutics, a fast-growing company that manufactures Sprint PNS system, a minimally-invasive, 60-day implant specifically designed to deliver significant and sustained pain relief. The company’s siloed, antiquated system prevented the decision-makers from having a holistic view of their organizational data.

SPR chose to go with the Salesforce platform and selected Rootstock for ERP, ComplianceQuest for Enterprise-wide Quality Management System and Cloudloop for data analytics. This enabled the medical device manufacturing company to leverage customized solutions created in a consistent manner with a uniform experience and closely integrated to facilitate a system of engagement. This led to digital transformation in a quick and most affordable way. The scalability and reliability of the Salesforce platform were also major advantages.

Such an integrated platform provides a system of engagement, where business leaders can get data and information from all the stakeholders — the suppliers, the customers, and the employees — all working in unison in a collaborative fashion.

Here’s a virtual roundtable discussion about what separated the winners from the rest – our panel of MedTech experts discuss the pandemic’s impact on the industry, what’s working on the front lines and factory floors, and why your 2021 success depends on how well—and how fast—you can adapt.

Watch Virtual Discussion

Benefits of Digital Transformation

SPR had initiated its digital transformation before the Covid-19 pandemic hit the world. In early 2020, when the pandemic developed into a serious risk, they were able to use the data provided by its new systems. They were able to understand the impact of the pandemic and the consequent lockdowns for the company and create an appropriate response.

There were also able to put a dashboard together based on the information gathered from its sales team to track the territories with lockdowns, demand forecasts, and lockdown duration. This helped the leadership team make data-driven decisions around manufacturing schedule, inventory planning, supplier management etc. The process of keeping track of new regulations and meet compliance requirements was also streamlined.

Without Salesforce, Rootstock and ComplianceQuest systems, SPR would have had to deal with the uncertainties for a longer duration and the associated risks would have been greater. The integrated platform with the ERP, EQMS and analytics also helped them get rid of the remote desktop and VPN, and provide its remote workforce with a uniform experience.

The company was able to recover from the Covid-19 slowdown fast and did record sales month after month. But it was also able to see that its customer base was becoming a little unhealthy with extended credit. By catching this early due to the data insights they had access to, the management was able to establish a credit protection program that connected the accounting and financing teams directly with the sales teams while also establishing an appropriate training program that would be delivered remotely.

Complaint Handling with ComplianceQuest

The company was also able to bring down its complaint ratio significantly while improving sales. Many of their processes have multiple integration points between various processes connected through Rootstock, ComplianceQuest and Salesforce solutions, the complaint process has the largest number of integration points.

Real-time feedback from the field (from both patients and physicians) is captured in a systematic way and fed into an engineering and quality process that documents a complaint for further handling and investigation. This has enabled improvements in productivity and efficiency as well as quick resolution of complaints.

The company created flashboards that displayed the data in real-time and provided insights into areas that needed correction. Real-time solutions were implemented by the engineering teams for complaints that were trending in a way that was not healthy. By directly connecting the field to engineering, SPR was able to drastically increase sales and decrease complaints.

Digital Transformation for Accelerating Growth

With digital transformation initiatives, medical device manufacturers can improve timeliness and efficacy of response to customers and also ensure regulatory compliance. It facilitates connected discussions across the board, integrating customers, healthcare providers and patients, and also facilitates maintaining and managing records and documents.

Covid-19 has further increased the importance of digital transformation due to remote work and the need to meet customers virtually rather than in person. This requires leaders and executives to have data at their fingertips, accessible on mobile devices. A platform such as Salesforce with vendors like Rootstock, ComplianceQuest and Cloudloop offers a powerful combination and can assimilate data in real-time from different systems. With world-class dashboards, the time taken to go from data to insights is also reduced.

ComplianceQuest for MedTech Manufacturing

The ComplianceQuest EQMS solution is designed to enable medical device manufacturers to experience the benefits of digital transformation by providing end-to-end visibility into processes across the organization. It aligns with regulatory guidelines such as ISO and standards such as the FDA and MDR to automatically facilitate compliance and reporting.

By deploying the ComplianceQuest EQMS, medical device manufacturers can:

• Do a root cause analysis of a quality event with agility and initiate CAPA where required
• Improve complaints handling process from intake to resolution
• Prevent non-conformance through robust audit and inspection management processes
• Mitigate risks with CQ Risk Management solution
• Improve supplier quality management workflow
• Facilitate change management
• Proactively maintain equipment in optimal condition through preventive maintenance
• Ensure continuous improvement by incorporating feedback from the different systems

To know more about the ComplianceQuest solution, visit us here:https://www.compliancequest.com/

This blog is based on the webinar Medical Device Manufacturing: After Surviving 2020, Win in 2021.