Pharma Manufacturing? There’s an App for That

Mobile technology and apps have become a staple of the pharma industry in terms of disseminating information to patients. Much less is known about their impact on manufacturing, but thanks to developments in cloud computing, the sky’s the limit.

I’ve always specialized in – and been fascinated by – information technology. I actually started out writing software code for the types of backend systems run by large manufacturers, such as their enterprise resource planning (ERP), manufacturing and execution platforms. It was complicated stuff – and I liked it! Eventually though, I became curious about how my code was being used in the field, which was a real eye-opener.

Companies understand that they need IT systems, but they don’t always understand how to fully exploit them – and perhaps with good reason; traditional IT infrastructure is based on purchased hardware and software, which means it can take time to implement and adjust to in a large company. Around eight years ago, some colleagues and I came up with a theory: looking at the way that companies procure, and considering their IT infrastructure and technology, it was clear that change happens very slowly. However, human beings want more flexible ways to interact with their work – and mobile technology has changed the way we interact very rapidly. We saw a real need for a new kind of flexible IT technology.

Companies understand that they need IT systems, but they don’t always understand how to fully exploit them.

Into the cloud

Around the same time that we were considering how to act upon our theory, we saw the growing rise and acceptance of the “cloud.” In cloud computing, applications, data and services are hosted over the Internet and can be accessed on demand. At first, there was apprehension about this way of working. On the one hand, cloud computing signifies cost savings because you are using cheaper resources that are being managed by somebody else, but on the other hand it signifies a loss of control – for the exact same reason. Today, however, you’ll find cloud computing being happily used by many companies. I think we can all say that the cloud is a pleasant way of working. No longer do we have to be at our office desks to get work done – we can work from any location and can even access the same data using phones or tablets. But this is only the tip of the iceberg. Since cloud computing has become more mainstream, a number of vendors have popped up to take advantage of the technology by developing specialized platforms and apps.

Pharma companies are certainly aware of the potential of apps, but only in certain areas so far.. For instance, most pharma companies have invested in apps that help disseminate information to physicians and consumers, and sales reps have also been armed with mini marketing tools. In this area, pharma’s use of mobile technology is very mature – and there has also been a lot of discussion around the potential of mobile health – or mHealth (see 'Apps Around the Industry' box below). If we delve deeper into the operations and inner workings of a pharma company, it’s a different story. Mobile technology can be used to help boost business efficiency by increasing employee productivity or better controlling inventory, for example. But right now, uptake is not even close to that seen with mHealth. Frankly, there is a very good reason for this. As pharma is heavily regulated, companies spend a lot of time and resources in implementing validated systems to run their business and manufacturing operations. There hasn’t really been the opportunity (or the time) for them to innovate in this area. As I mentioned at the start, when it comes to IT infrastructure, things tend to change very slowly.

Nevertheless, appreciation of the problems faced by pharma companies continues to grow. Advances in mobile technology mean that, instead of completely overhauling existing infrastructure, it’s possible to put a more modern interface over the top that allows the whole system to be used in a more modern and intuitive way.

These are Blend Sheets, used to make sure that ingredients, formulation, packaging and quality are to spec. The instructions may be in different places or in different forms, so combining them into a single app is powerful.

Mobile Rise In 2017, the number of mobile phone users worldwide is expected to reach 4.77 billion (1). To put that into context, the world’s population is expected to rise to 7.5 billion by 2017.

Smart mobile phones are capable of carrying out many of the tasks we’d typically use a laptop for. In 2015, Wired magazine made a prediction that smartphones could completely replace computers within a few years, adding that the global PC industry has been on a downward trend for some time (2).

Almost any task can be performed on a phone using an ‘app’ and indeed there seems to be an app for everything, from booking restaurants, to finding maps, to making lists, to telling you (in a pirate accent) where you parked your car.

In pharma, mobile health (mHealth) is a buzzword and there is huge potential for the pharma industry. According to industry estimates, by 2018, 50 percent of 3.4 billion plus smartphone and tablet users will have downloaded mobile health applications (3).

References Statista, “Number of mobile phone users worldwide from 2013 to 2019 (in billions)”, (2016). Available at: bit.ly/1SoS1Fj. Accessed June 10, 2016. Wired, “In Less Than Two Years, A Smartphone Could Be Your Only Computer”, (2015). Available at: bit.ly/1DBbw9p. Accessed June 10, 2016. FDA, “Mobile Medical Applications”, (2015). Available at: 1.usa.gov/1ZLxWy8. Accessed June 10, 2016.

Bringing clarity to manufacturing

There are a growing number of apps that can be rolled out in pharma manufacturing. Historically, manufacturing managers would plan in the morning, and then review what happened the day before the following morning. They’d create a new plan accordingly, for example, increasing or decreasing throughput. Over time, each square foot of the facility is used more efficiently, and the experience allows more agile decision making in the future. Apps can accelerate this process because they can be designed to interpret data from multiple systems within a manufacturing environment, giving a clear picture of what is happening in real time on the plant floor – and they can alert someone if something is out of specification. Such real-time information can be used to more efficiently deploy the workforce where it is needed throughout the day.

Another potential area for apps to make a mark is in maintenance. When something goes wrong, there is inevitably a considerable amount of wasted energy as the engineers investigate the problem, search for a solution, consult with specialists, locate repair manuals and finally order new parts. Apps can provide a toolkit for engineers that includes manuals, repair videos, warranty information and details about parts – all in one place. And it can be accessed on the plant floor via a tablet or smartphone.

There are perhaps hundreds of ways in which mobile technology can better improve employees’ daily lives.

How to Make a Good App Identify the value. It’s no use making an app for the sake of it – it must have a purpose.

Identify who will use the app and then design it around their needs – consider how the technology will integrate with the user’s job function.

Keep it simple. It may seem like a good idea to stuff your app with as many features and capabilities as possible – but end users want to get their job done and nothing else.

Allow the end user to have input into the design of the app – an app is useless unless it’s used.

Keep the focus on the functional aspects of the app. Deciding on whether something is ‘good’ can often depend on a variety of factors, such as performance and aesthetics. But for an app, it’s the users who decide if your app is good or not. And the most important criteria is to make the app useable and functional.

These two examples are very broad and can apply to any manufacturing organization. Neither of them reinvent the wheel but they are examples of how apps can help support leaner operations. And the beauty of apps is that they are pretty easy to create. If you have an idea, then an app provider can probably make it happen. As an example, I worked with a company to develop an audit management tool. During FDA inspections, the company found that people had to be taken out of their jobs to be ‘available’ because everyone had different pieces of information. Audits are necessary, of course, but there can be a loss of productivity while they occur. The new app we created virtualized the audit; a live stream indicates what is needed for the audit and alerts are sent out to the right people. Instead of everyone involved sitting idle in a conference room, staff can continue working at their desks until they receive a notification telling them they are needed – and what piece of documentation is required. Moreover, the person coordinating the audit can view the status of the message, such as when it was received and when the person had confirmed they were on their way. It also better served the FDA auditors, because they received the information in a timelier manner. Although this isn’t an ‘off-the shelf’ app (there are very few specific to the pharma industry), it does demonstrate what can be achieved with some creative thinking.

Apps Around the Industry Sanofi developed its GoMeals app to help patients, particularly diabetics, make healthy decisions about their meal choices. The app provides facts about food, such as calories, tracks the number of calories burned and helps patients monitor glucose levels. It also has a restaurant locator that allows you to browse menus to find healthy meal options.

GlaxoSmithKline has developed several patient-focused apps, including an app to support patients with asthma (which includes advice and monitoring tools) and an app to help people quit smoking. The company has also developed apps for children, such as one that encourages children to brush their teeth by using superhero characters.

Bayer has developed a pollen forecast app that allows users to see local pollen forecasts, track the severity of their symptoms, and read advice.

The US Centers for Disease Control and Prevention has released dozens of apps. Examples include a guide to help physicians decide on the correct antibiotic regime for a sexually transmitted disease, and an app that examines influenza-like activity across the US.

The World Health Organization has created several apps, including a pediatric app designed to help doctors, nurses and healthcare workers care for children in developing countries.

In the UK, the Medicines & Healthcare products Regulatory Agency has released an app that allows users to report side effects to medicines.

The FDA hasn’t released any apps of its own – but to offer guidance in the area, it released the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff in 2013. The FDA only deals with apps that present a risk to patients if they don’t work as intended, as well as apps that may impact on the performance of traditional medical devices.

The pharma industry isn’t the only one looking to engage patients with mobile technology. There are countless apps available that target health – and more are released on a daily basis. In particular, technology companies, such as Google, Apple and Samsung, have all released health-related apps in addition to smart devices to track exercise and heart rate.

Reaching for the sky

Cloud computing is a great platform – and the sky’s the limit as to what we can potentially do with it. But it’s not up to vendors as to what gets created – the main creative thinking needs to come from the pharma manufacturers themselves. There are perhaps hundreds of ways in which mobile technology can better improve employees’ daily lives. And as people become more used to the tech and what it can do, they’ll have more ideas of how they can use it. People are generally quite comfortable with apps now in their everyday lives, but there can be a concern when it comes to using them within a business. Remember though, deploying an app is not the same as deploying a whole new IT infrastructure (apps are much more flexible). How long it takes actually depends on a company’s own internal process for implanting innovation. If a company is innovative, agile and selects the right tools, then a simple but significant app can be implemented in less than a month.

The way we do commerce today is likely to completely change in the future because of the ongoing innovation in mobile technology. At the moment, mobile is where the Internet was in 1994. In 1994, it was difficult to explain to people how important the Internet would be and why they needed to get on board – but today, it’s ludicrous to think of an office without the Internet. In the future, it will be equally absurd to consider working life without apps. In some industries, the future has already arrived.

This article was written based on a conversation with George Mashini, CEO of Catavolt, USA.