January 14, 2013 12:57 pm by Amy Siegel | 0 Comments
It should come as no surprise that the movement toward more
rigorous post-market surveillance of medical devices has gone global.
While US med-tech titans like Medtronic and J&J have made headlines for
selling bad
defibrillator leads and faulty hip
joints, America certainly doesn’t have the monopoly on device
recalls; it was a French
company that marketed substandard
breast implants used in some half million women worldwide,
landing the CEO in jail after a media-stirring manhunt.
Fueled by this highly visible run of
device recalls, post-market data demands are increasing for the more risky (Class III and
some Class II) new medical technologies in the U.S. as well as in
Europe. While Europe may still provide a faster route to regulatory approval
for such devices, post-market requirements are creeping in like an expensive
final cheese course served by European regulators and health systems just when
companies are feeling most broke and tired. So regulatory approvals may come,
but actual, meaningful revenues? Not so fast.
To dig deeper on the changing med-tech
launch conditions in Europe, S2N talked to Terry McCarthy, Co-Founder and
Managing Director of FirstClinTech,
a Holland-based company providing a range of services (business development,
clinical support, logistics and technical service) aimed at ’easing’ medical
device companies into the EU markets. FirstClinTech came to life filling a
service void left by a failed ventricular assist device company, so Terry knows
a thing or two about the market challenges for novel medical technologies in
Europe.
On paper, European-wide
efforts to strengthen and harmonize regulation of innovative medical devices
are progressing at a leisurely pace, with a target adoption of
yet-to-be-clarified regulations by 2019. ’Don’t let that timeline lull you into
complacency, though,’ warns Terry, who is already seeing some Notified Bodies
stepping up their post-market data requirements ahead of any new regulations
being in force. This escalation in post-market requirements has real,
quantifiable implications for emerging med-tech companies.
Delayed Commercial Revenues
Terry cites recent examples where Notified Bodies have made CE
approval of implantable devices conditional upon satisfactory surveillance data
captured for a defined period of time or number of implants. ’We often
confront the unrealistic assumption that as soon as you have CE mark you can
start selling and generate revenue,’ says Terry. While companies generally
understand that significant revenue will be gated by reimbursement, which is in
turn gated by efficacy data, heightened post-market regulatory requirements
could translate into longer dwell times in ’limited launch’ (a.k.a. paltry
revenue) mode than expected. For
some product types, companies are often end up giving away lots of devices
during this phase, further reducing early market revenues.
Increased Post-Market Expenses
The most obvious cost associated with
post-market surveillance is study management; this expense can vary widely
depending on the surveillance study size and device complexity. ’You want to do
enough science to back up what you said in your dossier,’ advises Terry, ’and
also see that the patients enrolled in the post-market study resemble those in
the pre-market study.’ For example, a physician might be tempted to try a newly approved device in a ’train
wreck’ patient for whom there are no other options, even if this is an
off-label application with much lower efficacy prospects. ’Ensuring that
appropriate patients are included in the post-market surveillance studies means
that companies need to have people on the ground interacting with centers,’
says Terry.
Tougher Sales Channel Decisions
This need for tighter control in the
early commercialization phase can also impact the decision of whether and when
to go with direct sales representatives or sell through a distributor in
Europe. ’A distributor
will naturally want to sell as many devices as possible, whereas company management and the
Notified Body all want the first tranche of patients to be done in a fairly
controlled way,’ cautions Terry. Other post-market obligations, such as
device traceability (another recall-inspired global initiative), must also be
carefully considered in distributor relationships and contractual arrangements.
Despite heavier post-market burdens,
regulatory consistency across Europe will likely benefit emerging med tech
companies in the end. ’The current situation is confused,’ says Terry. ’Harmonization should improve
transparency and establish a more level playing field for medical device
companies.’ A major
bridging of regulatory frameworks across the Atlantic, however, is likely a
long way off. Terry and others agree that Europe will continue to take a
more risk-based, safety-focused approach to device approvals for the
foreseeable future. Getting insurance payment for new devices in Europe, or the
US, is another matter entirely.
For more predictions and insights about
the changing landscape for med tech in Europe, read this
excellent article from FirstClinTech.
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