Design Innovation vs. The ‘What If?’
There are many obstacles to a successful product design getting into the marketplace (in the medical device space, some would argue that the FDA needlessly creates even more, however, that’s for another day’s discussion). Therefore, designers need not allow themselves to become derailed by a “What if?” scenario regarding an innovative idea they have for a new product design. By that, I’m referring to situations that may or may not reflect a realistic concern for a real world environment.
There are many variables that do need to be considered prior to the start of the development of a medical device: Does the market want the product? Will there be reimbursement for it? Can it be designed affordably? Designers need to be aware of many more factors as well (check out the Perspectives responses for more insight into this topic, just a few page turns from here). There are also design aspects that need to be reviewed to help enable the best possible product. This is where the realm of the “What if?” scenario to which I am referring in this column exists.
Recently, there was news of an implantable birth control device that is being developed. It would function for a significantly longer period of time than any other product on the market – a true innovation for the space. The technology would be a substantial improvement upon current options as the device offers the woman the ability to turn on and off the unit should she, during the 16 years of service life, decide that having a child is of interest.
One counter I’ve heard to the development of this technology is, “What if the device is hacked and turned off without the woman’s knowledge?” Given the news that Barnaby Jack sparked when he demonstrated the ability to nefariously hack a pacemaker and insulin pump, is this the type of question that will be asked of any medical device that can be accessed or controlled remotely? Should the ability to hack a medical device become a reason for not introducing innovation in a particular space?
Medicine is moving into a fantastic age where it can be made available to virtually anyone anywhere in the world. Telehealth, mHealth, Internet of Things, and the miniaturization of electronics are all contributing to the development of medical devices that offer a premium level of healthcare. As a result of these advances, new challenges emerge for the design engineers creating new, spectacular products. This includes the security of data and the device itself. If a device relies on the ability to transfer data wirelessly, the designers need to be aware that this could lead to flaws that enable remote access of the device by people who should not have such influence on the unit. This goes for technologies from a fitness tracker to an implantable pacemaker. Developing methods with which to address device safety and security must be paramount for developers of these new technologies.
Engineers can no longer overlook threats from malware or direct attacks by “hackers” on medical devices. Even if the chance of a successful attack is extremely unlikely (some have claimed that Jack’s demonstrations were performed under ideal conditions that wouldn’t exist in the real world), it is obvious that the threat is there. Should that one in a hundred, thousand, or million chance come to pass (I honestly couldn’t say what the real odds of a successful hack are), the damage done by the media event over it would be enough to sink not only the company responsible for the hacked device, but perhaps even that sector of device technology or implantable devices entirely (that offer remote access). I’m not sure the full damage done by such an event can even be confidently predicted, but without question, it would be devastating.
The “What if?” scenario, therefore, cannot hinder the release of disruptive medical device technology. It should, however, serve as a cautionary tale for designers. If someone on the development team (or even another person in the company) offers a “What if?” scenario during the development of a device, the designers, should take pause and consider it. They should either ensure that the situation is an impossible scenario or one that’s already been safeguarded against. Because determining that a scenario is simply “unlikely” is not good enough. No company or development team wants to be first on the market with the device that is hacked and kills a patient as a result.
Fortunately, I have yet to hear of a development project that has been scrapped due to the challenge made by a “What if?” scenario. Then again, it’s highly unlikely that I would ever hear of such a decision being made. Therefore, I have to appeal to you as a reader and member of the medical device development community to ensure that you never allow a project to be derailed due to one of these “What if?” scenarios and instead, make every effort to address the situation as best you can.