Overcoming Product Data Management Challenges in the Life Sciences Industry

The life sciences industry is undergoing a paradigm shift with the increased emphasis on customer-centricity, the proliferation of IoT and Big Data technologies, and widespread global M&A activity. With most big pharmaceutical and medical device firms acquiring digitally disruptive companies and other competitors to drive innovation or increase market share, managing product data is becoming more complex and expensive. Global organizations spanning continents want to have to ability to design and manufacture products anywhere in the world. However, running such operations effectively requires a consistent production process and a single enterprise data repository containing bills of materials (BOMs), pharma recipes, and more to implement controls and enhance auditability. That becomes even more important if the company is looking to outsource its manufacturing operations. No longer can business tasks and workflows be coordinated on spreadsheets that are prone to human error and significant inefficiencies.

Data management is key

In the medical devices space, companies are increasingly facing regulatory compliance challenges while adhering to stringent regulations such as the EU Medical Device Regulation (EU MDR) and Unique Device Identification (UDI) in the United States. In principle, those regulations intend to drive companies to enable a holistic enterprise-level view into the product master data and develop robust capabilities to manage it effectively. That would allow companies to establish a unified view of descriptive and regulatory data relating to products for internal use, as well as make it easier for them to compile the product registration dossiers necessary to submit to global regulatory agencies for marketing and selling their therapeutic products in global markets.

For achieving faster compliance and reducing the cost of compliance, medical device companies can prepare geo-specific templates for submitting product information. Moreover, having all the master data in one place makes the process of resubmitting data, in the event of changes or modifications to products, more accurate, effective and efficient. Resubmission may also be required in some countries after a specific time has elapsed. Hence, managing time frames for submissions becomes a more complex, time taking and effort-intensive process. The complexities are accentuated when you consider rapid M&A activity in the medical devices space, which leads to data repositories being replicated and multiplied, and business-critical data residing in silos across multiple enterprise systems, Word documents and SharePoint folders.

Medical device manufacturers are feeling the need for establishing a reliable, electronic single source of truth that can serve as a centralized repository for all product-related data, including details such as ‘materials of concern’ information. Once implemented, the product data repository can be the single source of truth and control and feed all other systems, including ERP, CRM, labeling systems, global trade management (GTM), e-commerce websites for populating product description and features, and as-mentioned, global regulatory agency databases.

The advent of PLM cloud

Keeping in mind requirements associated with digitization of the product registration process and decentralization of product master data, pharmaceutical, and medical devices companies are slowly opening to the idea of cloud technology. That hesitation can be linked back to the regulatory validation process which in the past had been episodic – in most companies, at best, once in 18 to 24 months. Companies would wait for more than a year, sometimes two years, before updating their applications to avoid the arduous regulatory validation cycle.

However, with cloud adoption, that regulatory validation process would run continuously as software and infrastructure updates are pushed on a regular cadence (quarterly is common) by the software vendor. While that can seem like additional workload to a large life sciences company, its potential benefits cannot be ignored. With the proliferation of fourth industrial revolution (4IR) technologies and rapidly evolving market expectations, innovation should not take a back seat. Sitting in the catbird seat would require life sciences companies to accelerate the product development lifecycle, and the cloud is the right fit for such an initiative.

To take that a step further, we must talk about the implications of electronics and digitization built into medical devices these days. Apart from the hardware, companies also need to include software or firmware as a part of their product development and data management workflows. The data needs to be maintained and enriched for both the physical as well as software design, and that may compound challenges for life sciences organizations. However, that further exemplifies the role of cloud to deliver agility, scalability, and flexibility while managing the product lifecycle for multiple components of a solution. On-premise, legacy PLM solutions would not be able to adapt to the pace of innovation necessary to succeed in this age of the digitally savvy consumer.

Driving ROI with the Oracle PLM Cloud

At Birlasoft, we have been implementing PLM solutions for the life sciences industry for 15+ years with over six implementations at various stages on the Oracle PLM Cloud. Our global PLM practice consists of more than 300 consultants working with 145+ customers who have successfully delivered more than 300 PLM projects. In the life sciences space, we have been delivering exceptional value to our clients, leveraging the Oracle Cloud offering. For a global leader in medical technology, services, and solutions, we consolidated multiple legacy PLM instances into a new single global Oracle PLM instance. Our consultants have implemented common PLM processes to manage CAD, parts, BOMs, documents, work instructions, and changes to augment the company’s device master record (DMR), as well as design control records to support the design history file (DHF).

Birlasoft has developed proprietary turnkey solutions to help the highly regulated medical device industry boost the ROI of Oracle Cloud implementations. Our solution set includes a robust global product registration solution, a leading-edge UDI solution, EU MDR, and end-to-end FDA system validation services.

John Danese
John Danese
Industry Director, Life Sciences, Birlasoft
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