3 Tips to a Successful
Outsourced Device Launch
By Tom Nadal, Director of Business
Development, CleanCut Technologies
Whether you’re a seasoned medical device professional or a recent grad stepping into
your first full-time position at a medtech
OEM, chances are you’ll be a contributing
member of a new product launch team.
The team’s success, as well as your own,
will depend largely on ensuring critical
project deliverables are completed on-time
and within projected budgets. For the project leader, there is the added responsibility
of managing the overall efforts of the team
members and answering to upper management. Every project is going to have
unexpected challenges. The project team
needs to analyze the situation and respond
quickly to keep the project on-track. Experience is key. If working with seasoned
medical device professionals who have
been in the trenches, are well-connected in
the industry, and appreciate the “
speed-to-market” mindset, the team will be better
equipped to make the changes needed to
hit the project milestones for success.
Following are three key tips for an
on-time, under-budget medical device
product launch — without having to pop
four aspirin a day.
1. There Is No Substitute for Experience
One wouldn’t take a new $75,000 luxury
automobile to the generic “coupon” auto
shop for major service. An investment like
that is valued and as such, a shop with
experienced technicians who have the
tools, equipment, and specialized training
needed to get the job done right, the
first time, would be identified for the job.
Launching a medical device is similar in
that experience is key to getting the job
done right, the first time.
The recent MD&M event listed
over 400 companies offering contract
manufacturing services. How does a
team leader select the right partner for
the specific needs of the project? Due
diligence is required — understanding a
contract manufacturer’s (CM) expertise,
the services it provides, its reputation in
the industry, how many customers it has,
what tools and processes are used for
managing projects, and the backgrounds
of the team members working on the
project. The ideal partner will not only
score high marks but also be able to offer
suggestions, based on the employees’
years of experience, as to what’s required
to optimize success. Also, the ideal part-
ner will have the ability to react to unex-
pected challenges and make the changes
necessary to keep the project on track.
The CM’s connections in the industry
may also improve material and servicing
deliverables with third party suppliers.
Inexperienced medical device companies
may focus on cost over quality, only to be
burned when late in the project, the team
discovers that its definition of quality is not
the same as its low cost supplier.
Bottom Line: Work with an experienced, reputable CM that will provide the
confidence that it will go the extra mile to
ensure a project’s success.
2. Think of Packaging Earlier in Process
Development stage companies pitching
new, innovative products to investors
rarely highlight the product’s packag-
ing configuration. It’s common for these
companies to focus their resources on
product development, but not dedicate
enough resources on packaging design,
which could actually be a large factor
in a product’s acceptance. Device shelf
packaging that does not fit properly on
the hospital’s storage racks, or a device
that’s difficult to remove from its sterile
packaging, or even excessive packaging
waste are all reasons a new device might
not be fully accepted in the market.
Working with a CM with packaging design expertise will ensure these important
factors are not overlooked.
Ideally, the CM should be able to produce packaging samples quickly to obtain
critical marketing feedback. This can
be achieved by having CAM-produced
packaging components as opposed to
having tooling fabricated for production
equipment. Another benefit of CAM is the
ability to make changes quickly and without any tooling costs. R&D or marketing
feedback on device packaging will be faster
and less expensive with CAM.
An important early project decision is
determining whether the packaging for a
device is a pouch or tray. A full service CM will offer the benefits of both
packaging methods, but to reduce initial
costs and get more immediate feedback,
a pouch with a backer card for additional stability of the device inside a pouch
may be the optimal choice. Changes to
tray design require tooling changes to
fabricate the tray, and may also necessitate additional tooling costs to seal the
tray in production. Pouches don’t have
the same tooling requirements and some
design changes may not require any additional tooling.
Bottom Line: Work with a CM with
packaging design expertise for faster, less
Figure 1: The ideal CM should have a Class
VII and/or Class VIII cleanroom; CleanCut
Technologies has both. Pictured here is its
dedicated Class VIII cleanroom.