Archive for the ‘fda’ Category
Med Tech spends a lot of time and interest on getting brand right. Precision graphic restrictions paired with copy that strikes a positive, knowledgeable tone are the expected norm. But sometimes the prescribed boxes and creative areas and subheads always in the same order become too familiar. And then the many pages of the branding guidelines present a calcified artery (or a narrowed alley, if you prefer) that can feel stuck.
Almost inhuman. Lifeless. Especially when most med tech firms offer much the same fare.
This is exactly why agencies are invited to pitch: someone recognized their communication had become more wooden, less engaging and sort of like yet another chain restaurant in yet another strip mall.
So the person with clout (or vision or both) says, “Hey, what if we started from a blank page.” Or perhaps you’ve been in conversation with someone and raised the question: “Surely even a med tech firm can seem almost human and engaging?”
That’s where the opportunity begins. Because it’s hard to start over when you live inside an organization. On the inside you’ve already drunk the brand Kool-Aid. And the regulatory restrictions and legal waffle-words troll through you conversations even when talking with your five-year old (“Jimmy, randomized studies correlate earlier bedtimes with general health and well-being. Many physicians would likely suggest you go to bed right now. OK?”)
The point is not to get rid of their brand. Not at all. The processes and procedure the brand encapsulates are a solid investment (that is, until they aren’t anymore). The point is to be yourself and offer a new way of thinking that floats away from the expected norm. Know there will be resistance. Brand managers will fight. But you’re just trying to bring a bit of life to the brand.
I spent the early years of my working life being formed by the medical device industry. I was energized by the mission of seeing people restored and hearing joyful patient stories. I enjoyed the banter with physicians and learning about the junction of technology and living systems. And I was charmed by the folks I worked with: some of the smartest people around, with a bent toward helping others. Not everybody, mind you, but enough lively, mission-fed people that the workday was full of surprise.
Things change. Corporations mature—for better and worse. Lately it seems the balance sheet and the quarterly earnings call too easily drown out mission. Smart people who enjoy a challenge still work there, and it is an industry with more and more specific boundaries. So if your agency is pitching medical device work, please be aware of these three influences that shape the perspective of the people you will be talking to:
- Legal pinioning
- Regulatory straight jacket
- Branding dead ends
These perspective-shapers sounds like a bummer, but smart agencies with a knack for operating in tight quarters can help make a difference. The first two perspective-shapers are fairly obvious. Naturally, the best medical device companies hold the patients who receive their therapies in the highest regard. And you would not want to work with a company that didn’t. But in our litigious age, there’s lots of money to be made from suing manufactures for all sorts of things. Naturally, medical device companies ramp up their risk-averting processes. Lawyers review nearly every outward facing piece of communication and regulatory reviewers—the picky cousins of lawyers—delight in ferreting out each word of potential deviation from the FDA-approved copy. And the work of lawyers and regulators is invaluable.
Branding dead ends are not so obvious and few will admit to them out loud. These take a bit more explanation, so I’ll reserve it for another post.
But in your initial approach to conversations with med tech employees, know that most of their conversations are like walking a tightrope: marketing is always a balance between what you’d like to say and what you can say given the published studies. Agencies with more consumer experience can find this deadening. But resisting the pinioning and the straight-jacket—in your own way—is one of the ways your team can add value. It’s just got to be believable. And it becomes more believable when you ask for and expect the list of approved claims before starting work on your pitch. Since every claim must have a valid reference, basing your creative on the right foundation can make the difference between making the final cut and being dismissed as not up to snuff.
Image Credit: Engadget
A sluggish FDA is partly a response to our demand that they arbitrate safety
[Full disclosure: I consult for the medical device industry.]
Tomorrow’s hearing with the House Oversight and Government Reform Subcommittee on Health Care is all about looking for a better way to get medical devices approved. MassDevice reports Minnesota Rep. Erik Paulsen will be there to push for an “ ‘innovation pathway’ for pioneering medical devices.” Paulsen is also there to try to block a proposed $20 billion tax on the medical device industry.
Lives ride on the safety of medical devices. The companies I work for take this very seriously and institute redundant processes to check, double- and triple-check that all the right things were done. They take a great deal of pride in their record and FDA oversight is likely a boon to Minnesota’s culture of medical device safety.
That the FDA is slow to approve medical devices and is often seen as a bottleneck for innovation does not surprise me. How could it be otherwise, given that Americans want iron-clad guarantees that everything with the FDA seal is perfectly safe? We want and expect the FDA to play a God-like role in assuring us nothing harmful every escapes their jurisdiction. And sharp-toothed lawyers constantly circle and swim in at the first hint of blood, so it is also a big-money game.
Do we expect too much from the FDA? Is anything ever truly safe and entirely understood? Though the FDA would likely argue that they are simply applying “reasonable standards for safety,” the public doesn’t see it that way. FDA “approval” means something far more to most of us: that nothing should ever go wrong. That’s too big a role for a person or an agency. Even God doesn’t issue a decree like that: He only says that it all works out in the end for those in relationship with Him. By the way: my experience is that the FDA never “approves” anything. They just clear it for market release. Subtle difference, right?
We all need to be reminded again of what constitutes a reasonable standard for safety.
Image credit: Kay-too