Interviewing Steve Ubl, the new president of the Advanced Medical Technology Association (AdvaMed; Washington), a rather interesting picture comes to mind.

It is the image of a man sitting on a large bed of very sharp nails – and smiling.

The sharp nails, of course, are the challenges faced by the medical device/med-tech industry and, therefore, the association. And Ubl readily acknowledges the breadth and depth of these challenges – from recent press reports of problems with implantable devices to an FDA again without official permanent leadership.

And he lays them out in some detail, as background to the initiatives he plans to head up for the organization.

But as he gears up for the effort, he says: “I’m excited. I’m excited to be involved in this industry, and its great interacting with the AdvaMed staff again. We’re going to make a big impact on the issues. I’m bullish, despite the environment.

“I wake up every day excited about coming to work.”

Ubl is, of course, no stranger to this particular landscape, having been AdvaMed’s executive vice president for government relations from 1998 to 2004, leaving to head up his own consulting firm for healthcare. He then got strong backing from a variety of member companies and government policy people in support of his selection, Art Collins, the association’s chairman and CEO of Medtronic (Minneapolis), told Diagnostics & Imaging Week in announcing the appointment in mid-July.

Ubl fills the post vacated by Pamela Bailey, who somewhat abruptly left AdvaMed in March to head the Cosmetic, Toiletry and Fragrance Association (Washington), whose members clearly have fewer regulatory windmills at which to tilt.

Ubl is generally considered one of the key people in carrying out AdvaMed’s push for the launch of regulatory user fee payments in the medical device sector, and he was a key organization player in pursuing targeted FDA and Medicare policy reforms.

Charting the future path for ongoing policy-guiding efforts obviously will be one of Ubl’s overriding goals as the association confronts the barriers, barriers its members see as blocking access to both global and domestic healthcare markets.

But the association will pursue greater emphasis on an outreach to the public, he said, so as to boost the view that new and oncoming medical technologies add to the economy and create human value.

A recently released report from RAND Health (Santa Monica, California) focused on the way in which both new and yet-to-be-realized medical technologies could greatly increase the costs of U.S. healthcare and threaten the Medi-care payment system. But Ubl said that the study employs overly broad hypotheticals.

“With all due respect to RAND,” he said, “basically any of these models have potential flaws. The flaw is that you can’t look in a crystal ball and say which [technologies] may be substituting for ‘transformational’ technologies as hypotheticals.”

Incremental improvements in med-tech will produce “transformational change,” he said, citing the still relatively new precedents such as angioplasty procedures and coronary stents. And he expressed “bullish optimism that technology, over time, will reduce costs in the shape of minimally invasive procedures, reduction in overall disability.”

As an initial blueprint for how the organization will proceed, Ubl laid out three priorities.

The first, he said, will be to fill “several key openings” in the organization and “bring the best and brightest individuals to complement an already strong team.” This will include recruiting of a “house” general counsel, a new chief administrative officer to focus “on the operation side of the house” and a lead person in public affairs, perhaps with a vice president title.

Secondly, he said that he would seek to place more emphasis on research activities to bolster med-tech’s value proposition in the eyes of the public and governmental officials. “Modern healthcare advocacy is changing,” he said. “It’s a lot less about who you know than what you know – about what you can prove in quantifiable data.”

The association previously launched a separate organization to conduct research in this area, and Ubl called that “one piece of the puzzle.” But he said that bolstering the association’s research budget would produce “more of a quantitative underpinning for all of our advocacy work.”

Thirdly, Ubl promised to pursue “more aggressive goals for the organization.”

He credited previous productive activities by the association, but said: “We need to take it to the next level” and pursue “some big hairy audacious goals, BHAGs – think bigger and longer-term, in a proactive posture. The best defense is a strong offense.”

Among these BHAGs, he said, will be a push for a minimum 180-day review for “breakthrough” products by the FDA; other “achievable” performance goals by the agency in the upcoming round of negotiations concerning user fee regulations; and a focus on changing the reimbursement regulations in Japan, where use of UK, France and German pricing information holds sway.

For the latter, he said, “The goal we’re talking about is completely redesigning the [Japanese] reimbursement system,” now in a round of every-other-year assessment, set to wind up by the end of the current year.

Additionally – and perhaps counter-balancing the perception that AdvaMed most often offers a big-company emphasis in its policymaking emphasis – Ubl promised “more focus on small companies.”

As to AdvaMed’s efforts to communicate the benefits of med-tech, Ubl said the goal will be to tout medical technologies by putting them “in the hands of policymakers” and “expand that concept in a formalized way.”

Such efforts will include taking members of Congress to hospitals and having them “scrub in and witness advanced technology procedures in a first-hand way. We’re excited about that initiative – showing is much more effective than telling.”

As to how this broader appreciation of med-tech will be carried to the press – and here he acknowledged the media’s “messenger” role in the public perception that medical technologies are too often too expensive – he said: “Stay tuned.”

Overall, he said that the association’s goal would be a better understanding that “the ecosystem of innovation is a pretty broad and complex thing” and that AdvaMed needs to “engage in all of these issues.”

“I hope to bring AdvaMed into some of these broader debates, the coverage for the uninsured, the adequacy of funding for hospitals, [to] broaden the issues that we engage in,” he said.

Reminded of a goal set for him by Collins when his appointment was unveiled in July – that he was not to conduct “business as usual” but rather to shake up the status quo – Ubl said: “That’s what I’m here for.”