The future of manufacturing for biotech
products is looking increasingly digital.
Automated factories that rely on networked
robotics will lead to flexible operations
and even real-time responses to potential
issues. Biotech products will be monitored
throughout their lifecycle, beginning with
clinical development through manufacturing
to patient consumption, in what is
termed the “digital thread.”
But how will the industry get there? And
how can biotech manufacturers take advantage
of the Internet of Things? It’s easy to be
wowed by the promise of new technology,
but the challenge lies in implementing it successfully
within a heavily regulated industry.
Ryan Smith, Vice President of Engineering
and Product with SightMachine, a company
that markets software platforms for a
variety of manufacturing firms, believes that
companies who achieve success in digital
transformation do so through a strong
investment in planning and relying on the
right people for the role of the project.
He will go into more detail about the
nature of digital transformation for the
biotech industry in his talk, “Driving
Digital Transformation: Best Practices for
Realizing Value from New Technology
Within your Organization,” at the 2nd PDA Europe Annual Meeting (9 a.m., June
14, Track A: “Connectivity, Smart Devices
“We’ve done enough engagement with big
companies now that we have a sense of how
things are going to work,” Smith explained.
In his experience, those companies that
treat a new technology as if it were a
smartphone, i.e., unwrap, install, and
sit back, do not see as much success as
those companies that strategically plan
out the implementation and identify the
right individuals for the project. And it’s
the latter approach that Smith believes is
critical for a company to achieve digital
“There needs to be the right people in
place at the site,” he said, admitting that
this can be a challenge if the technology
is totally new. It may not be immediately
clear who should be involved. This may
require recruiting for individuals with
specialized skills. Anyone leading a digital
transformation project should ask “who
are the experts that need to be involved in this project to make it a success, and how do we get them in order and in place prior to starting?
“Otherwise, you’re a bit behind and you have to try and scramble and round up people,” Smith added.
“Envision what the end goal of the project is and what success would look like if you looked back. So, who are the people to get that
through...those are the types of backgrounds that are good to recruit for early in the process.”
And a company’s senior leadership must support and encourage the transformation in order for it to be realized.
“In order to actually initiate change, that
has to come from within. And that’s a
culture shift for a lot of these companies.
There has to be top level commitment by
senior leadership, who say, ‘we are going to
move to adopt digital technology.’ And that
can be especially tricky in regulated industries.
So, you really have to have that buyin
in order to get that going,” Smith said.
Once the right people are in place, the
next step is figuring out the long-term
goals of the project. Naturally, this will differ
for each individual company, depending
on the type of project.
“At the beginning of the project, you’re adding
infrastructure and foundation to what a
digital landscape will look like for your organization
in five years, but we also make sure
we have the concrete nets or business gains
we want to initiate with this first run.”
Interestingly, while many biotech companies
are concerned about how regulators will
respond to their implementing new digital
manufacturing technologies, in his experience,
the regulators are generally accepting
of new technologies provided companies
ensure that product remains in compliance.
Smith believes that by 2027, almost all
biotech companies will have been “digitally
“In ten years, I think it will seem very
strange we did things like we do right
now,” he said.