The Food and Drug Administration in the US has a lot of responsibility to protect and advocate for consumers. And one department in the FDA, the Center for Drug Evaluation and Research (CDER), regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
Over the past few months I have been spending time with a range of Australian companies, getting to better understand their business models and approaches to innovation. While there is plenty of good news for Australian businesses and their innovation practices (see my previous article), there is a justified sense of concern around maintaining sustained, robust growth in the face of digital and exponential disruption.
What the Australian Economy Gets Right About Innovation; and Lessons for Other Countries (Part 1 in series)
Over the past few months I have been spending time with a range of Australian companies, getting to better understand their business models and approaches to innovation. After working with US / European organizations for many years, it’s been refreshing to see the actions and impact of innovation in this market.
We often talk about the role of innovation in an age of constant, radical disruption, as defined by the 4th industrial revolution. Within this new environment, innovation leaders should play an essential role in helping the organization thrive and drive growth.
As part of today’s changing technological landscape, it is vital to create a workplace culture that adapts to those changes. Doing so starts with having a comfortable workplace culture to begin with. Making your employees feel at ease in their current working conditions is the basis of creating a workplace that can adapt to changes.
In the context of business management and economics, innovation has mainly been considered as a source of profit and growth. But innovation can also have a transformative role and recently more and more innovators and entrepreneurs are not only considering the financial returns of their projects, but also the societal impacts that they might bring with them.
Everyone seems to agree that innovation is a risky business: it involves a lot of experimentation, which often ends up in failure. High tolerance for failure therefore can be considered as a major prerequisite for any successful innovation program.
The number one issue for aging consumers is the lack of privacy related to sensitive medical information and other data that wearables like Fitbits and heart monitors bring without proper oversight. This is part of the reason for the FDA’s Digital Health Innovation Action Plan (DHIAP), which is meant to speed up the evaluation process for digital health technologies and allow the FDA to better focus on high-risk products.
Taking an innovation, product or other service global has many advantages, but also throws up many challenges. Overcome the challenges and what you are likely to see is a more robust and profitable concern - but get it wrong and you are likely to incur some losses and potentially damage your business.
That the new Apple iPhone X uses facial-recognition software (FRS) to unlock the device rather than a pin or fingerprint, underlines the importance of this burgeoning technology. We will likely see a massive spread in the use of FRS which will bring many benefits but some serious risks which we need to start addressing now.
The aim of the precautionary principle seems laudable: lacking scientific consensus, the burden of proof for an action or policy not being harmful to the public or to the environment lies on those taking that action. In practice, however, this principle has proven a deterrent for innovation - particularly within the EU. How can the innovation principle - that is, examining new policies or plans for a negative impact they have on innovation - help to supplement and balance out the precautionary principle?
The revolution in self-driving vehicles has advanced faster than insurance companies can react to it. These cars introduce unique factors that must be integrated into the models that are used to set insurance premiums. At this time, coverage for self-driving cars is set using the same formulas as for traditional cars. Not long ago, there was a fatality involving the Tesla Model S. This occurred while the vehicle's Autopilot mode was active. The case brought new attention to the risks of using self-driving cars on the road, and insurance companies noticed.
Innovation at best is like watering a nice healthy plant, making it grow and blossom; however, watering without the plant is just getting the dirt wet. Nothing happens. Currently, all over the world and with more than 100 major innovation themed events yearly, complete with great photo opportunities for local and national leadership, most nations have little to show for these super expensive efforts. It seems that we talk a lot about innovation and find ourselves stuck in the suffocation of great ideas. And, suddenly the Trump nation erupts on a high note!
Many product organizations have some type of Project Management Office (PMO), even if they refer to it by a different name. The PMO is a critical component to a successful product delivery, yet it often carries a reputation for being heavy-handed policy enforcers. When focused on the right things, the PMO plays a pivotal role in driving innovation process excellence and ensuring profitability.
There has been a continued debate around finding and adopting a set of standards for innovation. I blow a little hot and cold on this - not dependent on the time of day but the very “force” that is pushing the agenda along. Far, far too many who push for standards often have very narrow agendas, where this fits their commercial purpose and you get the feeling that they are not as aligned to the broader innovation communities as they should be.