The Medical Device Industry of a Country Founded on Precious Metals
Dawn A. Lissy • President & Founder, Empirical
It was a lot to take in running on about five hours of sleep following an inter- national flight complete with a lost
luggage cliché. Representatives from multiple agencies—governmental, regulatory,
medical device companies, hospital purchasers, materials experts, testing laboratories, and more—were coming together
in Lima, Peru, for a workshop on medical
device regulation and standards.
The goal: to learn more about developing infrastructure, processes, and systems
to support a successful medical device industry in Peru—an emerging third-world
country where roughly half the economy
is related to precious metals and ores.
Further, it was all in Spanish, a language
in which I can find a bathroom if I gesture
wildly enough and—perhaps more importantly—order a Pisco sour (on a good day).
This was an exciting day despite lost
luggage and lack of sleep; I was there on
behalf of the U.S. Food and Drug Administration (FDA) to explain ASTM material test methods of orthopedic devices. I
donned my translation headset and did
my best to follow the conversation.
As I worked to reconcile the moving lips
of the speaker on stage with the accented
chatter in my ear, I realized it was an apt
metaphor for Peru’s efforts to develop a
domestic medical device industry. Similar
to the conference, there appear to be multiple, simultaneous conversations about the
same topics with the same goal. However,
pieces are getting lost in the cross-talk.
To explain, I was part of a panel of industry experts invited to the Peruvian capital to share knowledge on a range of topics geared toward bolstering the emerging
medical device industry in Latin America’s
seventh largest economy.
This is new territory for Peru. Since the
Spanish conquest, gold and silver have
been defining forces in Peruvian culture
and history. Thanks in part to the country’s
democratic stabilization this century and
strong prices for those precious metals in
recent years, a country that has tradition-
ally imported medical devices is working
to build a domestic industry to support
medical device development.
To do that, Peruvian officials are turning
to agencies from countries (like the United
States) with gold-standard, well-established
markets for guidance. For this conference, I
was joined by colleagues Terry Woods, solid
mechanics laboratory leader with FDA;
Spiro J. Megremis, director of the Research
and Laboratories Science Institute, Ameri-
can Dental Association; Brian Berg, senior
research fellow, Boston Scientific Corp; Ste-
phen Spiegelberg, president, Cambridge
Polymer Group; and Jessica Roop, interna-
tional policy manager, American National
Standards Institute (ANSI).
Roop told me this particular workshop is
part of ongoing support from ANSI through
the Standards Alliance, a public-private
partnership between ANSI and USAID
initiated in 2003. Trade between the two
countries increased from $9 billion in 2009
to $14 billion in 2015. The medical device
industry is just one sector showing signifi-
cant growth under what Roop described as
“an important bilateral relationship.”
“Standards Alliance activities since the
beginning of the project have led to major
progress in standards capacity for the Pe-
ruvian national standards body, Instituto
Nacional de Calidad (INACAL),” she said.
“Not only does Peru’s progress reveal an
increased technical expertise in standards-
related issues, technical trainings in sec-
tors like medical devices present a prom-
ising shift toward higher-value products.”
Rocío Barrera Santos of Peru’s Ministry
of Foreign Trade and Tourism, explained the
efforts to establish a national quality system
and standards to lay a foundation for an in-
dustry that could be competitive and pro-
tect consumer health. The ministry is one of
at least five governmental agencies working
to establish systems and standards.
Because this is an emerging industry
for the country, a dearth of experts in Peru
is affecting how quickly these standards
are coming together, Barrera explained.
A lack of a quality systems culture in Peru
means there’s no current infrastructure to
roll out processes for certifications, stan-
dards, and other layers of oversight and
guidance the country requires to support
a successful industry.
“It can be a challenge to bring these
groups all to the table, and to reach the
appropriate audience in a country like
Peru,” Roop said. “ANSI relies on our
strong network of members in the U.S. to
The ancient Peruvian city of Macchu Picchu.