Authors: Jens Shou Christensen, Sebastian Berninger-Lund
Citation: Schou Christensen J, Berninger-Lund S, “How Digitisation is Delivering Competitive Advantage in Device Assembly”. ONdrugDelivery, Issue 123 (Aug 2021), pp 15–18.
Jens Schou Christensen and Sebastian Berninger-Lund present the business case for the wider implementation of digitisation and the greater use of data to deliver assembly line improvements.
It is suggested that by as early as 2040, smart home products will be adopted almost universally across Europe. So far, the pace of uptake in new technologies has been meteoric – in 1998 just 9% of UK households had internet access, whereas today the figure is more than 90%.
This surge in demand for technology has transcended into the manufacture and assembly of drug delivery devices. Today, data and the digitisation of assembly equipment work hand in hand to deliver competitive advantage to pharma partners in terms of product quality, continuous improvement, de-risking maintenance and change management and, critically for the near future, the ability to deliver unique identities and traceability for every assembled device.
“While much of the industry focus has been on the development and market launch of connected devices, there has also been a quieter digital revolution in manufacturing and assembly, where the increase in complexity of pharma partners’ requirements (including more personalised medicines, the ever-evolving regulatory landscape and cost) has caused production facilities to look again at the use of smart manufacturing technologies.”
THE BUSINESS CASE FOR DIGITAL MANUFACTURING IS COMPELLING
Anyone working in drug delivery today will be very much aware of the advancements in connected devices and how the Internet of Things (IoT) is predicted to make a huge impact on patient adherence, as well as saving the whole healthcare industry billions of dollars as patients, healthcare professionals, payers and pharma partners take advantage of the data created to improve therapies and how they are delivered. While much of the industry focus has been on the development and market launch of connected devices, there has also been a quieter digital revolution in manufacturing and assembly, where the increase in complexity of pharma partners’ requirements (including more personalised medicines, the ever-evolving regulatory landscape and cost) has caused production facilities to look again at the use of smart manufacturing technologies.
A recent white paper from Bain & Company predicts some game-changing improvements following the implementation of digital manufacturing. Smart connected factories are estimated to produce savings of 20% or more, with a 14% increase in delivery reliability. There is also forecast to be a 17% reduction in costs related to poor quality and a saving of 15% in the cost of converting raw materials into drug products.²
For a few years now, some delivery device solutions providers have advocated the increased use of digitisation to deliver data-led enhancements, not just to monitor and improve product quality but also to drive overall equipment effectiveness (OEE), deliver predictive maintenance and use machine learning to continuously improve processes.
USING DATA TO DELIVER QUALITY AND COST IMPROVEMENTS
“Historically, actions such as root cause analysis would have taken many hours, a great deal of intellectual energy and costly iteration. Today, data, combined with expertise and experience, can effect big changes in performance in comparatively short timescales.”
The use of data to drive any kind of improvement is not a revolutionary idea, for example Six Sigma has been around since the mid-80s. However, in a recent survey conducted by Stevanato Group, 10% of respondents to an online study stated that no data was collected from their production operations, and an overwhelming 74% were only using data in a limited capacity to drive quality improvements, mainly in product quality, OEE and predictive maintenance. These respondents came from a range of functions within the pharma and life science industries.
Stevanato Group has been researching the positive impacts of a data-based quality checks, compared with visual or semi-automated checks. The company has noted the benefits both in terms of cost reduction and quality improvement. From a cost perspective, each machine is more productive due to fewer interventions during manufacture. While more or less the same number of validation systems are still required, manufacturing space has been optimised as fewer inspection stations are needed. Because the parameters for quality have been established, many problems can be addressed agilely in-line. In turn, the company is witnessing the need for a reduced overall manufacturing footprint and greater OEE.