The Revolution Rises

The fourth industrial revolution, Industry 4.0, is generating significant discussion in the biopharma industry, with a number of people believing that it is all hype. For me, however, Industry 4.0 is real and represents a period where we can integrate automation and information in a completely different way through kinetic systems. This could fundamentally change the production environment and redefine how factories work.

There are many technologies that fall into the category of Industry 4.0, but there are two that I am particularly excited about: predictive analytics and augmented reality.  Predictive analytics are promising because our industry is flush with data that it does not take advantage of. Using predictive analytics, it will be possible to integrate data to teach machines to make predictions about the future, such as the future state of the product or the future flow of material, which can be used to steer the production environment. Imagine being able to use existing data to predict failure or delay at release. There is a huge opportunity for the industry to be more proactive in the production environment.

Augmented reality could potentially change compliance on the shop floor because it opens up the possibility of providing guidance via smart glasses or projections onto the actual work surface. Performing a line changeover with smart glasses would mean that operators have instant access to key information and should reduce the potential for errors while boosting operation efficiency. It would also transform training and reduce the documentation burden.

But change for biopharma brings with it many challenges. Firstly, there is applying new technologies in a useful way. Right now, there is a lot of experimentation driven by technology. For example, a company may have a team experimenting with 3D printing or virtual reality, but in most cases such a team will be looking to apply that technology irrespective of where the biggest value potential lies or where the biggest problems are in the workflow. This can produce a technology application that ultimately isn’t very helpful because it is not geared towards solving a problem, and can contribute to the sense that new technology is just hype.

Another challenge on the technology side stems from closed architecture promoted by vendors. Many technology players offering digital solutions to the biopharma industry are trying to create closed ecosystems rather than open architectures. Essentially, one could say they are trying to emulate Apple’s long-standing strategy of locking customers into proprietary systems that makes it very difficult for customers to change vendors in the future or work across different systems – and inevitable a large pharma company will have many different systems. Without more open source, inter-operable solutions, the industry won’t be able to obtain true value from Industry 4.0.

There are also human-related challenges that accompany new innovations in technologies. Change is unnerving for employees. Those on the shopfloor may see new technologies as a threat to their jobs – although I would argue that isn’t the case – and may be reluctant to adopt or aid successful implementation. Even if the reluctance can be overcome, Industry 4.0 technologies will also fundamentally change the workflow and necessitate a massive change management effort because people will need to change many of the routines they follow every day to align with the new processes.

Finally, there is the question of regulators. Anything that we want to roll out in pharma manufacturing – no matter how innovative and promising – will need to meet the requirements of regulators. To achieve that, we need to generate an industry-wide dialogue about Industry 4.0, such as where new technologies would be most beneficial and what type of alignment and standards are required to get everyone – manufacturers, vendors and regulators – on the same page.

I’m pleased to see that the industry is pushing hard. In the past few months, we’ve had many conversations with NIBRT (Ireland’s National Institute of Bioprocessing Research and Training) and brought together a digital alliance of half a dozen pharma companies called Biopharma 4.0, which aims to drive forward a dialogue on how to apply and standardize some of the Industry 4.0 approaches. Many have woken up to the potential of Industry 4.0 and are now pursuing it aggressively, and I look forward to the day these technologies translate to cheaper and more available, higher quality medicines for patients.