By Ken Parmelee
Relative to the exciting world of smartphones, iPads, and mobile applications, the topic of ‘Paperless Pharma’ might certainly seem to be a rather retro and uninspiring topic. But let’s stay the course on this – the discussion over what it really means will literally reshape the Pharma business in coming years. Underlying the obvious, there are some ideas that will pop up here that are significant to Pharma’s future.
Going paperless, in and of itself, offers the usual tactical productivity gains: cost reductions, better auditing and the like. But it is hardly transformational when looked at in this tactical way. This is merely making a paper process digital. What we need to do is look beyond the tactical, and discover what becomes strategic in making the move to a paperless Pharma world.
To discover what is groundbreaking and strategic requires us to take a deeper look at the areas of process improvement and automation. As referenced in my last blog post on this topic, Mobile Creates Bigger – Much Bigger – Borders for Pharma and Life Sciences, smart pills like those being developed by Novartis and others are changing the way we can detect and monitor drug ingestion, interaction, and reaction, among other things.
The key driver behind these technologies is that we now live in a world of more and more connected devices. The smart pills data, for example, is read by a near field device such as a watch, a phone, or an electronic bandage. That data, in turn, can then be sent automatically back to monitoring systems via a mobile phone, WiFi, or through syncing with other connected devices.
Wouldn’t it be fantastic for a doctor to be able to remotely scope out the vital signs on a patient and tell that patient exactly how they are doing? In a sense, it brings the idea of the old ‘doctor’s home visit’ (yes, doctors did do this once) back, and allows physicians to raise their level of personal interaction with patients without the need for non-existent or undesirable travel time by either.
Some people are skeptical – many are concerned about personal rights infringement, which centers on such questions as: ‘How do I know that chip isn’t monitoring and checking things I’m not aware of?’ and ‘Who has access to or who else may be accessing my data?’ As with all monitored things, there is always the potential to misuse the data, but the odds are very small that this will prove to be the case in the vast majority of cases. In situations where such data might be more sensitive (perhaps if the patient were, say, the CEO of a Fortune 500 company) security can certainly always be stepped up to meet the requirements of any given situation.
On the other side the argument, the medical advances that clearly should and will be made with all of the additional data and analysis that becomes possible, will change medicine as we know it; and it will, without a doubt, lead to much better patient care.
Minor risks are worth taking. Some of us strongly believe that the benefits far outweigh most concerns. Where many of us are in agreement is that by embracing today’s technologies, the drug and medical industries can be fundamentally improved. There is definitely interest is such improvements from consumers, as well as for the overall life sciences industry itself.
Aside from consumer concern over allowing data to be collected, there is the issue of having access to the data. Data in and of itself is valuable for any single doctor, but that data will only become extremely potent if the data can be shared and accessed easily. Systems for this purpose – which are able to share the data while fully protecting patient privacy, are springing up, driven by the accurate perception that the need for digital patient records is now reaching a critical juncture.
Numerous Medical Possibilities
If you were you to look up ‘Diabetes’ on the App store, for example, you would see many mobile applications that do various things such as tracking carbs, insulin use, and so on. These are all simple standalone applications. At a deeper level, consider these: As a consumer wouldn’t it be great to automatically get timely refills of needed medications? If a person medicine-dependent, wouldn’t it be powerful to see the result of not staying compliant? What if you could receive alerts on your phone if you were low on Vitamin C, or close to dehydration, or any number of other day to day items that are not life threatening, but add to quality of life.
From the medical practitioner’s perspective, a doctor armed with data reflecting such information as how the body of patients react to all kinds of stimuli and medications over time, will be far better able to manage the care of those patients. Such monitoring will also provide key leading indicators of potential health issues and possible disease far earlier in time (long before a patient is likely to display overt symptoms), and will allow doctors to proactively inform patients of such problems and issues, and to begin early discussions of treatments or other ways to resolve those problems and issues.
Doctors today typically don’t have an hour by hour view of how much of a given medication is taken. Taken to the next level, having this information then also provides the information on how a patient’s body reacts when the medication is taken, an hour later, or when at rest vs. while active, and so on – many combinations become possible to monitor.
Unless a person is under constant monitoring this data would not otherwise be knowable. For pharmaceutical and medical device companies, a doctor will be able to verify efficacy, discover interaction issues, and provide valuable information to allow for the fine tuning of medication dosages to actual use. This alone will allow life sciences companies to make significant new improvements and will drive entirely new developments and improvements in both medical devices and drugs.
It all Sounds Great, but can This be a Reality?
From a pure technology perspective, gathering the data is simple. The power of what we have discussed previously requires software and hardware systems, interaction between them and the automation of analysis. Add to this the powerful ability to automate ‘process.’ Capturing the necessary processes for how data flows and is analyzed is the key to creating great value. It would be the failure to capture these processes that would render a mobile solution less valuable if not a failure.
The impact on patient care and the possibility of truly individualized medicine are in reach given enough data. For an individual one of the important points is that this has minimal impact on a patient’s life. While quality and reliable medical care would be at the forefront of consumer concerns, drug innovation, drug trials and investment will all benefit from smart monitoring technologies.
The investment to bring to market the next blockbuster drug is one of the largest expenses that Pharma companies shoulder. With all the research and development cost upfront, a company’s ability to weather failure is minimal. When coupled with pressure to drive down costs of medications, patent expiration and regulatory compliance, Pharma companies need better field data faster – much faster – to ensure their products perform as expected while not creating other issues. That is a very tall order.
Which, finally, brings us to how could all of this really work? The software, hardware, institutional knowledge – this is admittedly still a fragmented undertaking. Most research efforts here tend to be focused on resolving specific issues and providing a solution for that specific piece. Interoperability and ‘process’ are beginning to come together, but there is a great deal yet required to make the real value of paperless Pharma pay off.
But these efforts have begun, and mobility has been – and will continue to be – the key driving force to making it happen.
Ken Parmelee is the former director of product management for Antenna, and currently a notable analyst at Gartner, Inc.