A Diagnosis in Flux
Like other sectors, the in-vitro diagnostics space is being impacted by rapid
introduction of new technologies and a host of other factors.
Jim Stommen • Contributing Writer
Some have held the perception that diagnostics is a some- what sleepy segment of healthcare that hasn’t been buffeted by the kind of change that often-amazing developments in
medical technology have brought to many other disciplines.
Well … no. Let’s call that a misperception.
The fact is that diagnostics in general—and certainly in-vitro
diagnostics (IVD) in particular—is awash in change, sparked by
an abundance of new technologies, some of which are just starting to reach commercialization stage after years of existing as tan-talizing“potentials.”Still other developments are nascent, nearing
the reality end of the development scale.
To get an idea of where the IVD sector stands today and what’s
on the horizon for that segment, Medical Product Outsourcing
talked with officials from various companies and organizations involved with the space, from contract manufacturers of high-throughput analytical systems to providers of some very basic
disposable components. Particularly valuable was the input from
a diagnostics sector consultant whose work with some of the
largest players also brings her in contact with the contract manufacturers and other suppliers whose roles are expanding exponentially as the segment undergoes rapid change.
Needs Change, as do Requirements
Kristin Pothier, a partner at Weston, Mass.-based Health
Advances LLC, leads the consulting firm’s Diagnostics and Life
Sciences Practice. She said she views the big company/contract
suppliers relationship from a perspective of what her client
companies need from those suppliers as their customer needs
change over time.
“When they use an contract manufacturer,” she said,“they are
looking for a partner who understands what their customer needs
are today, what the platform needs to look like to meet the customer needs of tomorrow, and how that will change over time.”
Pothier said the traditional view, going back 20 years, was
“big box, basic core lab,” However, the industry has changed.
“Over the past 10 years the emergence of molecular and
other newer technologies have changed the platform complex-
ity and we will be seeing even more of that in the future,” she
said. “This means contract suppliers have had to pick up the
pace in terms of offering a combination of the highest quality,
the needed complexity, and the lowest cost associated with
building these components for IVD.”
As for the impetus of change, she said new technology is