Manage and improve quality and performance across global regulated operations
The Life Sciences industry is facing transformational change. The convergence of technology, digitalization, additive manufacturing machine learning and 3D modeling is upon us. Indeed, the industry is poised to deliver breakthrough innovations at a rate, and cost, never thought possible.
And with this rapid change comes pressure from all sides – physicians, patients and payers alike – to deliver more of everything faster, to more niche markets. A more flexible, predictive approach to manufacturing is needed. And more patient-centric experiences at greater speed, but without impacting on consistent ‘as registered’ and ‘as designed’ quality.
For Medical Devices, ‘personalization’ (or the trending buzzword ‘individualization’) is on everybody lips. Devices must be more modular and more adaptable. The market is trending towards combination devices which attach to the individual and can administer drugs.
For Pharmaceutical and Biotech, the pressure is on to discover innovative, more economical means of production. For example, major global pharmaceutical companies like Leo Pharma and AstraZeneca are shifting their focus to the growth opportunities of biologic products which excel at targeting individual patient needs and can be more effective with few side effects. But, due to their more complex manufacturing processes, the costs of Biologic research and production are still seen as prohibitive to wholesale adoption.
Different problems, one solution
For all these segments of our industry, digitalization is the solution. And digital continuity is the thread that ties them together. The issues they face may be very different, but digitalization is the common means to their resolution. A therapeutic solution – whether a drug or a device – that has been developed and tested to the limit in the virtual world is going to be cheaper and faster to create than one that hasn’t received the digital treatment.
Connecting the people behind these products; breaking down the barriers between departments and partners – wherever they are, whatever their culture or language – with the latest, most relevant real-time data, will deliver quicker, better informed decisions. These, in turn, will help direct research, development and manufacturing – thereby fueling the accelerated innovation that is being demanded of them.
That’s why many manufacturers have been moving away from unidimensional cost-cutting strategies and towards comprehensive digital innovation strategies. The need to quickly incorporate technology innovations into their product lines is making management push for process improvements.
However, handling transformative product and process change isn’t possible with small process improvement patches. Strategic-level process improvements are required for organizations wanting to respond quickly to market and patient demands.
Adding a new dimension to manufacturing
Fortunately, by using the latest 3D computer-aided design technology, engineers can improve their models with, for example, more reusable components combined with more product and manufacturing data. This can be applied downstream for model-based manufacturing and to accelerate innovation in the production process. Technologically advanced tools are available for developing shop-floor work instructions and creating automated inspection procedures. Indeed, it’s a wonder why some shop floors still rely on 2D drawings, spreadsheets and ERP-generated paper production orders.
The shop floor at Trixell a leading manufacturer of digital radiology detectors which convert x-rays into digital images, definitely isn’t behind the times. Inspired by a large order that triggered a complete overhaul of its production processes and automation capabilities, production at Trixell has increased fiftyfold in just eight years.
“We had to increase production capacity, diversify the product range, reduce cycle times, improve productivity, whilst ensuring the final products comply to very strict medical standards.” Explained Benoit Duverlie, Industrial manager. Which is why Trixell turned to Dassault Systèmes’ Apriso software.
Production Unit Manager, Adeline Mallein, who monitors her unit via Apriso, is delighted that she can now “access real-time information… which enables me to control my unit precisely and much more reactively than before… In just a few clicks I can quickly access essential information relating to my activity.”
Meanwhile, on the shop floor itself, operators are guided at each stage of production according to routings set in the software. All it takes is a little training. “It has really simplified the operator’s tasks and helps us limit operating errors,” commented Patrick Bredy, Production Manager.
Furthermore, all the manufacturing parameters of a product are recorded and Trixell guarantees to its medical customers that it will keep the data for as long as required as proof of conformity – which can be 15 years in some markets.
“I have access to all the organized and referenced traceability data, simply and quickly, via databases which record every single entry by the production operators added Jeremy Gauthier, Product Technician.
What’s more, the centralized information can be analyzed to monitor progress initiatives, identifying areas where product and processes could be further improved.
Heading towards operational excellence
Research shows that less than 16% of pharmaceutical organizations analyze their production processes in real time, while only 25% of manufacturers use a software application for collaboration with contract manufacturers, or vice versa. But without the right software applications, companies are at a huge disadvantage. They have limited visibility of their quality and process data, therefore making it harder to develop robust processes, obtain good quality metrics, share responsibility with outsourced manufacturing, and reduce product variability to avoid recalls and patient risk.
In the white paper ‘Beyond Operational Excellence through Digital Continuity: Sustainable Health for Biopharmaceutical Manufacturing’ by Julie Fraser and Amy Rowell, the focus might be on pharmaceutical, but the lessons learnt can be applied throughout the whole Life Sciences industry. Especially the paper’s stance that, by better understanding the entire manufacturing process via deeper analysis, a manufacturer can transform its business.
“Companies are facing multiple challenges including increasing development costs, shifting outcomes-based economic models, and ever-evolving global compliance needs,” the paper argues. “To combat these challenges, companies are required to completely realign their offerings, processes, supply chains, and business structures to facilitate innovation, agility and sustainable high quality.”
The paper advocates what it calls ‘holistic knowledge management systems’ to better support innovation and deliver compliance: “This enables a company to leverage modeling, simulation and process monitoring tools within a common platform to facilitate performance and process improvements. Mechanisms for effective data collection, sharing, and analysis are the foundation of streamlining efforts required to meet development and manufacturing timelines, as well as regulatory obligations.”
This, in turn, promises positive results: streamlined process development and start-up; speedy submissions and approvals; higher quality and yield, with low process and product variability – all supported by a sustainable supply chain and an accessible, comprehensive knowledge base.
Optimizing production throughput
Pacira Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients.
Pacira’s manufacturing goal is simple but challenging: maximum product throughput with zero defects. To support this, the company launched a Continuous Improvement strategy leveraging Lean and Six Sigma methodologies.
Data gathering was recognized as a real issue. Pacira’s aggregated data sets represented only 15% of the total parameters and the model could only explain 59% of the results. That’s what drove the company to look for a solution that could accelerate data aggregation, modeling and prediction.
Dassault Systèmes’ BIOVIA Discoverant for Tech Transfer and early Commercialization was chosen to tackle this problem. BIOVIA Discoverant transforms data into useful information. It automatically aggregates and pre-formats content from disparate systems, acting as a central point of data access without duplicating the content.
The benefits have been very tangible, including $20K-500K savings in scrap avoidance, improved quality and yield, faster time-to-market through shorter cycle times and, therefore, the corporate Holy Grail of increased profitability. For the full story, read the case study here.
Answering the big question
To achieve development and manufacturing excellence, a company must find the answer to the following question: “How do we create more agile manufacturing and production operations to meet the market demands?”
Companies like Trixell and Pacira are proving that, by wholeheartedly embracing digitalization and digital continuity, they have taken the most effective route to affordable excellence, while accelerating speed to any market they choose. This is how to attain a robust and sustainable commercial production process, and obtain critical production operations performance monitoring, that gives the flexibility to continuously evolve development and move the manufacturing process forward. Because standing still is one thing the industry cannot afford to do.
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