Data is the lifeblood for the Industry 4.0. As data flows through the value chain, it fuels digital transformation efforts, creating possibilities of leapfrogging operations from inefficient, slow, and manual to highly optimized and automated.    

When harnessed, manipulated and presented in the right forms, data allows improvements and even innovations to be manifested as the very core of ongoing operational activity. Operations across the value chain self-optimize, with the newly gained intelligence making the operation more intuitive, instilling the much desired agility and resilience into the entire value chain.

Data which creates actionable, intelligent and timely information is absolutely critical in dealing with the uncertainty and disruptions in a post-COVID world. As Google correctly points out, the ability to understand data, process it and extract value from it is imperative if companies are to leverage the true benefits of their digital transformation efforts.

Medical device manufacturers face a unique set of challenges where data and its management are concerned from an Industry 4.0 perspective. The industry is highly regulated, with mandatory requirements placed by bodies like the US FDA for strict oversight and validation on the products, processes and IT applications used.

Aside from strict oversight requirements comes the challenge of data existing in silos at an operational or enterprise level. There also may exist a dependence on multiple point solutions which have developed over the years in response to managing specific operational or supply chain problems.

Another and perhaps the most critical of all challenges is the ownership and responsibility when it comes to data extraction, storage, management and usage. IT and OT professionals within the organization may have conflicted opinions and may pass responsibility when it comes to owning the very data which is supposed to fuel the company’s digital transformation efforts.

Research from Tech-Clarity outlines the challenges pertaining to IT and OT convergence and the requisite overlap which must happen to enable the successful pursuit of digitalization. A majority of those surveyed believe that integration of equipment, plant and enterprise is essential for a successful Industry 4.0 campaign; however, the respondents believe that achieving this integration is a tall order.

It is clear that on the one hand IT and OT (business) need to collaborate and create conditions which are conducive to integration. On the other hand, achieving this much- needed convergence is a difficult task, and one which may require considerable deliberation, planning and effort.

Data is a Team Sport

When it comes to the efficient collection, manipulation and management of data within the medical device industry, the best approach is to create a well-defined and joint-responsibility based structure. Such a structure implies that the IT and OT professionals share the ownership of data. The goal is to ensure the data collected reaches the process execution application, like the MES, in a manner which leads to the most effective use of the collected data. Data should be a team sport and viewed as such from the very beginning of any digital transformation effort.

Modern MES Data Platforms are most suited as the foundation upon which a successful digitalization campaign can be built, but MES implementation itself goes beyond capturing and manipulating data to drive better business results. No MES implementation can succeed without a team which is driven to make it so. The human perspective is often lost in board rooms where tools like Automation, Robotics, Advanced Analytics, IoT and ML take precedence. In reality, digital transformation’s primary deliverable should not focus on the human aspect—not the elimination of the workforce, but the facilitation of the personnel. Automating repetitive jobs, while allowing process personnel to engage in more value-add activities, leverages their ‘tribal’ knowledge and best practices.

Human dynamics play a vital role in the eventual success of any massive transformation drive. In achieving the data readiness which enables said transformation, team members from both IT and OT have major roles to play. For medical device manufacturers, engaging process personnel who understand operational and oversight-related requirements is equally important as engaging IT personnel who understand the dynamics of data flow and structure within current point solutions and/or legacy MES application. Unless both business and IT comes together, no number of external experts or intuitive applications can deliver the desired results.  

A great way of engaging personnel and allowing them to collaborate is through a low code platform which enables users to configure processes as they see fit, while maintaining the overall integrity of the core functionality. With personnel more involved, the resultant IKEA Effect it might just lead to a more cohesive team-based approach to data collection, manipulation and management.

Is the Low Code platform a possible solution to the Team Spirit woes?    

A low code platform, as the name suggests, simplifies the way in which personnel use and enhance the functionality of an application. A modern modular MES data platform should allow users drag and drop type functionalities to create their own dashboards, processes and reports. A word of caution; if a ‘low code’ platform requires manual coding after even a rudimentary change being made, for example to facilitate the addition of a particular metric to an SPC chart or a parameter to maintenance report and the resultant analysis, the platform might not really be a low code platform.

A true low code platform should accommodate users with limited programming knowledge to create process flows and configure GUIs which reflect their needs. The platform would support core MES functionality to retain validated process flows, and enable scalability across multiple lines, facilities or manufacturing units.

In medical device manufacturing, a low code platform has great appeal to garner and foster the team spirit needed to make digitalization a success. Since the nature of the manufacturing process is designed towards validation at every level, the core framework of the MES, which accommodates all compliance requirements, can be the centerpiece of the team infrastructure. The MES can include all aspects pertaining to data collection, data standardization, data manipulation and data manifestation to support GMP.  

It is when additional customizations and localizations come into play that the low code platform shows its potential in creating a team- based approach towards data management. While an overarching MES application which covers all bases when it comes to compliance, validation and regulatory support is critical, there may be local nuances and location-based best practices which are dependent on the extent and ease with which a MES platform can be customized. For medical device manufacturers with numerous plants across the globe, personnel handling plant and process data may need to configure certain process aspects and reports to reflect those local needs.

With a low code platform, IT and OT personnel in a given location may configure additional functionality all on their own. It can accommodate an additional process step, like labelling to separate local from imported components through verifiable identification. Another example is configuring specific maintenance parameters for machinery modified and installed only in one location. Or, it could reflect unique quality control steps for a common product which is modified to meet specific export requirements to a particular company or geography.

A low code platform makes data gathering, analysis/review and reporting simpler, faster and more efficient. Adding low code to a modern MES allows IT and OT personnel to extend the use of MES beyond simple data visualization. The platform can be configured to deliver specific functionality for reporting and analytics to drive improvements and innovation based on the data now available to them, with minimal effort/coding. 

The right MES platform for medical device manufacturing allows users irrespective of their functional expertise and department to become co-creators and collaborators in shaping, defining and determining the functionality, workflow and the nuanced local processes on an ever-evolving and ever-improving data platform. A good low code platform allows customization of reports, dashboards, functionality and processes, but never compromises on the integrity of mission-critical process facets. This duality of standardization and customization is the hallmark of such a platform. Simply put, a low code platform used in medical device manufacturing encourages team participation and with participation comes ownership. It is ownership which when shared creates a winning team. This is only possible with the ‘right’ MES that entails the core functionality needed for medical device manufacturing, enriched with features such as low code to create a sustainable, adaptable platform for growth.