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Publication Date: November 25, 2022
DOI:10.14738/abr.1011.13329. Roberto, V. L., & Sánchez, P. C. A. (2022). Case of the Development of a Biomedical Device Innovation Project of a Mexican Public
University to Face COVID-19. Archives of Business Research, 10(11). 28-43.
Services for Science and Education – United Kingdom
Case of the Development of a Biomedical Device Innovation
Project of a Mexican Public University to Face COVID-19
Vega-González Luis Roberto
Secretaría de Vinculación y Gestión Tecnológica
Instituto de Ciencias Aplicadas y Tecnología
Universidad Nacional Autónoma de México, Circuito Exterior S/N
Ciudad Universitaria, A.P. 70-186, Alcaldía Coyoacán, CP 04510
Ciudad de México, México
Sánchez Pérez Celia A.
Grupo de Dispositivos Biomédicos
Instituto de Ciencias Aplicadas y Tecnología
Universidad Nacional Autónoma de México, Circuito Exterior S/N
Ciudad Universitaria, A.P. 70-186, Alcaldía Coyoacán, CP 04510
Ciudad de México, México. Tel. 56228602, ext. 1141, 1134
ABSTRACT
Through the case study method, in this article, the activities of an innovation project
carried out by the Biomedical Devices group of the Institute of Applied Sciences and
Technology of the National Autonomous University of México (UNAM) to face Covid- 19 pandemic are presented. A notable result is that the drastic reduction of
university development times required to deliver results to the health sector in the
form of technological products to face the disaster situation is observed. However,
it is also noted that some government authorities in the field of intellectual property
and health permits act as barriers that make it difficult to reach the innovation
frontier because the time required to obtain governmental authorizations. This
situation made it difficult to reach the moment of launching the technological
product to society. It is concluded that the joint reaction time of the different
innovation actors is one of the main variables or dimensions that must be reduced
through emergency policies and actions that must be planned, based on the
organizational and individual learning that occurs in contingent situations.
Keywords: technology development, dynamic organization systems, pandemic
INTRODUCTION: THE COVID-19 PANDEMIC A WORLDWIDE DISASTER
With the first cases of COVID 19 sickness produced by Sars-Cov-2, announced in Wuhan, China
in December 2018 and its rapid world dissemination, the world has lived an unprecedented
experience, which has mobilized all governments, health, and social structures. While the global
challenges of poverty, inequality, climate change, environmental degradation, the need to
ensure peace and justice are far from being satisfactorily addressed, new challenges such as the
Covid-19 pandemic have emerged, necessitating countries take emergency measures to deal
with them. (Mulgundmath, 2021).
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Roberto, V. L., & Sánchez, P. C. A. (2022). Case of the Development of a Biomedical Device Innovation Project of a Mexican Public University to Face
COVID-19. Archives of Business Research, 10(11). 28-43.
URL: http://dx.doi.org/10.14738/abr.1011.13329
It is interesting to note that close antecedents of SARS-CoV 2, (severe acute respiratory
syndrome coronavirus 2), which causes the disease COVID 19, were the SARS-CoV that
appeared practically with a difference of approximately ten years during this century. The SARS
CoV 2 viruses appeared during the years 2002 to 2003 and the MERS-CoV (Middle East
respiratory syndrome coronavirus) that appeared in 2012 at the province of Guangdong, China.
The latest of these, named SARSCoV-2 was detected in late December 2019 in Wuhan, China.
All of them are zoonotic viruses that have been transmitted from animals to humans (Perlman,
2020).
The MERS-CoV virus was transmitted from camels to humans, while the SARS-CoV and SARS- CoV2 viruses are believed to have been transmitted from bats to humans. (Guerrero, S., 2020).
The first reported case of COVID-19 was detected in Mexico on February 27, 2020. On April 30,
64 days after this first diagnosis, the number of patients increased exponentially, reaching a
total of 19,224 confirmed cases and 1,859 (9.67%) died. Most of the COVID-19 cases were in
Mexico City. The average age of the patients was 46 years. Of the 12,656 confirmed cases, the
highest number of infected occurs in the age range between 30 and 59 years (65.85%), and
there was a higher incidence in men (58.18%) than in women (41.82%).
The deceased patients had one or multiple comorbidities, mainly hypertension (45.53%),
diabetes (39.39%) and obesity (30.4%). (Suárez et al. 2020)
In every country fair public policy should be the right of society to have access to primary
medical and mental health care, to have social support programs, to carry out intersectoral
efforts to improve public health and the use of information technologies to disseminate
communications and notices, this does not always happen in Mexico nor in Latin American
countries. Therefore, pandemics affected intensively most of Latin-American countries.
Within that critical panorama, in mid-October 2021, the government of Mexico reported that
the epidemic has involved an estimated 3,973,789 people who have tested positive, of which
there were 39,244 cases of estimated active people and 297,656 deaths. (Government of
Mexico, 2021)
Looking for some explanation for this tremendous problem, probably in México, the numbers
of infections and deaths obey to the social inequalities and inequities pointed out by Menéndez
(2005), existing in the country because of the Mexican Neoliberal Health Sector Politics
occurring between 1980 to 2004 where decentralization, reduction of health spending,
selective primary care, health commercialism, and privatization of health services were the
main processes. Crisis probably began in 1980 when the economic politic process was
characterized by the low economic growth, the persistence and deepening of socioeconomic
inequalities, the increasing concentration of wealth in a small sector of society, and the
expansion of the situation of poverty and extreme poverty that led to talk about two lost
decades. Inequalities express themselves through of a whole series of variables, among which
stand out economic / occupational levels, if people belong to the rural or urban environment,
the condition indigenous / non-indigenous, the situation of marginality and / or poverty,
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belonging or not to the official social security, the possibility to have or not a major medical
insurance and the situation of genre.
According to the situation described, we can affirm that the main structural factors that explain
the situation of health system in México are fragmented society, struggling economies,
permanent socio-political crises, precarious living conditions, inadequate health infrastructure
and vast socioeconomic inequalities.
Beyond the health aspect, Covid 19 has greatly impacted the Mexican economy. The snowball
effect of Covid-19 has spread from health problems to economic problems. Chiatchoua, et al.,
(2020) point out that during the emergency the Mexican government implemented measures
such as the resources gathering to support the health infrastructure, joint work with the armed
forces, their health infrastructure, and the increase in the budget to strengthen the shielding of
social programs. According to the Mexican Institute of Competitiveness IMCO, (2020), during
the pandemic, between January 2022 to May 2021, more than 2 million jobs were lost.
In the country, there also appeared and increased mental health society member’s problems.
To make things worse, the World Health Organization suggested social isolation, limitation of
mobility or quarantine of the population, as the most effective strategy in containing and
mitigating the speed of spread of the infection and avoiding the collapse of state health systems.
However, social distancing generates adaptive and maladaptive reactions. (Taylor, 2019; Rubin
and Wessely, 2020)
Asmundson and Taylor (2020) mention that social isolation functions as a stressor that
increases the possibility of presenting mental problems for the first time or the exacerbation or
recurrence of pre-existing mental disorders. Among mental illnesses experienced by different
members of society there are fear, distress, anxiety, depressive, sleep and acute stress
disorders, suicidal ideation, or suicide.
The pandemic also generated several additional problems such as boredom in society due to
isolation, difficulties or financial losses generated by the situation and concern about stigma- discrimination, in case of being positive for the infection or, paradoxically, being a worker in
the health sector in charge of care direct to convalescent patients. Health personnel in the first
line of care for seriously ill patients due to COVID-19 infection, have been equally vulnerable to
mental health problems, due to the death of patients, excessive hours and work pressures and
the distancing of family members, in some cases.
On the other hand, Carlsten et al., (2021) point out that epidemic and pandemic infections have
historically brought devastation to the general population but have had a disproportionate
impact on worker’s morbidity and mortality that is often overlooked.
A contingent situation is always critical and transforms societies. Notably, in the Covid-19
context, some sectors of the regional economies and societies have been benefited. For example,
the demand for agricultural and livestock products increased and the pharmaceutical sector
had unusual growth and momentum, emerging groups were formed for the development of
drugs, vaccines, medicines, medical devices and diagnostic instruments. The profession of
medical doctors and nurses was revalued and the need to modernize and expand hospitals and
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Roberto, V. L., & Sánchez, P. C. A. (2022). Case of the Development of a Biomedical Device Innovation Project of a Mexican Public University to Face
COVID-19. Archives of Business Research, 10(11). 28-43.
URL: http://dx.doi.org/10.14738/abr.1011.13329
distribution systems for drugs, food and goods in general appeared. The demand for
agricultural and livestock products and food in general increased.
Within this context, the objective of this article is to identify the organizational aspects and the
key variables related to the innovation project development of a medical device realized by the
academic group of biomedical devices of the Institute of Applied Sciences and Technology
(ICAT) of the National Autonomous University of Mexico (UNAM). This was one of the
contributions of the UNAM to face the COVID 19 pandemic.
THEORETICAL FRAMEWORK
Competitiveness, the classic focus of innovation
Crespo (2019) considers that the contemporary academic study of innovation takes place with
an evolutionary perspective addressing the linking among different institutions and agents to
develop entrepreneurial competitiveness strategies to drive social welfare and economic
development. The globalization process positioned the knowledge as the fundamental resource
of the modern economy and innovation as its practical application process. (Kirshner, 2009)
According to Lundvall and Johnson (1994), acknowledging that knowledge is the most
fundamental research output in our contemporary economy and learning is therefore the most
important process, the precursor of innovation has been the globalization process that has
intensified the interdependence of states by relying on international products
commercialization. Nevertheless, the constant increase in travels all over the world for
recreation and to carry out international trade has had its effects on the rapid spread of new
viruses and diseases.
After disaster: health the new focus of innovation
Schuster (2014) describes what natural disasters means. Amid environmental distress, disaster
means the collapse of biodiversity, global warming, melting glaciers, peak extraction of natural
resources, structural poverty, intense pollution, high impact industries, large zones of
monocropping and pandemics. All those situations anticipate the scenario of a planet becoming
orphaned of life.
The Covid-19 pandemic outbreak may be a ubiquitous sign of how much the human species
threatens its habitat, to face this situation minimizing losses. Mattietto (2021) proposes the
need to develop scientific knowledge of catastrophes towards preparing appropriate responses
to these unfortunate events that repeatedly happen in human history.
The world motivations drastically changed after the Covid-19 pandemics; life never be the same
in any of its aspects. Mironko (2021) states that one of the many lessons that the COVID-19
pandemics provides is that no business can think of returning to the old ways. Every business
large and small needs to develop better habits to survive downturns and succeed in pursuing
the vision towards the future.
The lives of millions of people have been affected during the coronavirus pandemic that spread
throughout the world in 2020. Pandemics turned into a global disaster; therefore, society is
changing establishing new norms for healthcare education, social life, and business.
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Confinement measures have focused on the reduction of the spread of the epidemic and the
minimization of the load of morbidity and mortality so that healthcare systems remain
functional.
During the severe acute respiratory syndrome (SARS) (2002–2004) epidemic, social
disengagement, mental stress, and anxiety were associated with increased suicide rates in the
elderly population. Parents and children who were quarantined or isolated during pandemic
diseases met the clinical criteria for post-traumatic stress disorder. Data from previous
economic depressions and recessions suggest profound increases in substance use disorder,
depression, and suicide. In the current COVID-19 pandemic, there have been great impacts on
mental health, frontline healthcare workers face the possibility of anxiety and burnout and
moral injury, alongside fears of becoming ill. (Inkster, et al., 2021)
Healthcare measures have focused on treatment, case isolation and contact tracing. In that
regard, many digital tools have been developed to assist with contact tracing and case
identification. Kouroubali et.al (2021) propose that after COVID-19 era, digital health will
provide the integrated care needed. Moreover, Faragli et al., (2020) emphasize that aging in
western countries has led to an increase in the number of patients with multiple comorbidities.
As it is well known, since the very first beginning of medicine and then throughout modern
times, healthcare systems have been structured on a face-to face patient–physician interaction.
With COVID-19, Chronic Heart Failure (HF) patients are facing an increased challenge regarding
the management of body fluids since to avoid contagion, they cannot approach hospital
attention. For these reasons, telemedicine has turned from being a “nice to have” approach to
an essential requirement.
All over the world, there was a disruption in the medical supply chain caused by the slowdown
of conventional manufacturing, supply, and distribution channels during the COVID-19
pandemic. The combined effect caused widespread shortages in personal protective equipment
and test kits including swabs for sampling. These shortages catalyzed local efforts to use
nontraditional, rapid manufacturing to meet urgent healthcare needs and other medical
supplies. (CDC, 2020., Decker, et al, 2020., Gallup, 2020., Ranney et al., 2020., Antonini et al.,
2021)
Innovation in healthcare products: the swabs
While the COVID-19 pandemic has placed unparalleled demands on modern healthcare
systems, the industry response has vividly demonstrated its resilience and ability to bring
innovations to market quickly. According to McKinsey, healthcare company leaders can learn
from the rapid response to the COVID-19 crisis when innovating in future. Nevertheless, cost
pressures in healthcare systems will likely increase in the coming years due to growing health
demands and macroeconomic challenges.
To meet both the humanitarian challenge and the obligation to stakeholders, leaders of
healthcare organizations need to meet the innovation imperative. If under normal
circumstances, healthcare innovation is costly and time-consuming, the difficulties and costs
that health organizations encounter when seeking innovation in times of crisis increase
strongly but will have their benefits in the medium term. History tells us that organizations that
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For Meyer (2001) a case study consists of detailed investigation of one or more organizations,
or groups within organizations, with a view to providing an analysis of the context and
processes involved in the phenomenon under study. For Gummesson (1988:76, cited by Meyer,
2001) an important advantage of case study research is the opportunity for a holistic view of
the process: “The detailed observations entailed in the case study method enable us to study
many different aspects, examine them in relation to each other, view the process within its total
environment.”
Tellis (1997) considers that a case study can be seen to satisfy the three tenets of the qualitative
method: describing, understanding, and explaining. Meanwhile, Ebneyamini & Reza (2018),
indicate that a case study is an empirical inquiry that investigates a contemporary phenomenon
within its real-life context, especially when the boundaries between the object of study and
context are not clear. Yin (2003). It is one of the most powerful methods used by researchers to
realize both practical and theoretical aims. Researchers in technology and innovation
management need to use more field-based research methods.
THE CASE: DEVELOPMENT OF BIOMEDICAL DEVICES AT ICAT-UNAM
It all started after the declaration of a global and national pandemic of COVID 19 in December
2018. At the beginning of 2019, the Federal Government and the Government of Mexico City
convened the research and development institutions of the Universities and the Public and
private institutions to urgently develop R&D projects to obtain prototypes, medical supplies,
and own technologies to face the health crisis in Mexico.
On March 30, 2020, the UNAM's Program to Support Research and Technological Innovation
Projects (PAPIIT) launched the extraordinary call "Development of medical supplies and
instrumentation to face the new COVID-19 pandemic in Mexico", for various university
institutions to present projects to face the health crisis.
Under the call of the Coordination of Scientific Research, various institutions of the UNAM
presented development projects through joint proposal number IV100320, "Development of
supplies and instrumentation in attention to the health emergency caused by COVID-19".
The development of 3D printed swabs
Responding to this call, the Group of Biomedical Devices of the Institute of Applied Sciences and
Technology (ICAT), presented the project: “development of swabs by means of 3D printing for
taking samples of infectious diseases”, receiving funding of around $178,000.00 MX, (~
$8,900.00 USD). Although the resources were available until March 2020, the project started
immediately in January 2021.
The project was successful in a timely manner. The first results gave rise to a swab design
manufactured by means of 3D printing. Immediately, on May 13, 2020, the ICAT, through the
General Directorate of Legal Affairs (DGAJ) of the UNAM, requested the protection of this
technology to the IMPI with the file MX/u/2020/000166. At the time of this writing the formal
examination has already been passed and the substantive examination is in process.
The ICAT’s main researcher carried out various approaches to different public institutions
seeking support to test the technology. Likewise, she made the link with the Secretariat of
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agreements to avoid the double payment of royalties in those batches of production,
distribution, and sale of swabs, in which both companies participate. Instead of being
competitors, it is expected that they work in harmony; in other words, in demanding high- production projects, ADES 3D will produce and deliver the polymer swabs to TROKAR, who will
sterilize, pack the batches, and distribute them in the market. Nevertheless, as discussed below,
a few problems appeared along the project development, and they had to be solved.
Throughout the tests, it was observed that the first swabs shown in Figure 2, made of a single
piece and in a single material generated some discomfort in the people from whom the sample
was taken due to their lack of flexibility. The results reported in the clinics and hospitals where
the tests were performed were adequate in terms of the number of cells obtained in the sample
collection by rotating the swab, according to the authorized sample collection procedure.
To solve the problem, the design was improved, facilitating manufacturing and also decreasing
its impact on the environment, because the new model that came out in early 2021 is
manufactured in two parts, the first is a holding handle made of the biodegradable and
biocompatible polymer polylactic acid (PLA), consisting of a comfortable holding area and an
extension with dimensions that allow the operator to take a sample safely, since the design
respects the necessary distance to facilitate the taking of the sample; in addition, it has a notch
to facilitate the safe and fast cutting of the swab for the operator. The second part is the
extension or tip for the collection, which should preferably be manufactured with flexible
materials such as thermoplastic (TPE), which gives the set the necessary flexibility so that it can
be easily manipulated, while being flexible enough for patient comfort.
Figure 2. First generation of polymeric swabs developed at ICAT-UNAM
Source: Group of Biomedical Devices ICAT-UNAM
The new design shown in Figure 2 made the swab more flexible and sustainable since the
thermoplastic used in the tip is biodegradable and therefore environmentally friendly. This new
production technology allowed the manufacture of a model for use in children.
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Roberto, V. L., & Sánchez, P. C. A. (2022). Case of the Development of a Biomedical Device Innovation Project of a Mexican Public University to Face
COVID-19. Archives of Business Research, 10(11). 28-43.
URL: http://dx.doi.org/10.14738/abr.1011.13329
Figure 3. Second generation of polymeric swabs developed at ICAT-UNAM Complete polymeric
device assembly with flexible side tip for infectious sampling
Source: Group of Biomedical Devices ICAT-UNAM
The first concern on intellectual property, was to define the most appropriate strategy to
protect the swabs for taking samples since the situation imposed some restrictions. The first
requirement was the necessity to obtain the certificates and protection titles as soon as possible
to be able to deal with the contingency. On the other hand, it was clear that the time required
to obtain patents would cancel the commercial opportunity of the project. Another aspect to
consider was to protect the technology within the maturity period of its life cycle. The most
appropriate solution was the request for a first utility model to protect the technological
characteristics of the product and processes of the first swab model obtained in 2020. The
copyright of manuals and industrial designs were also protected.
Later, at the beginning of 2021, when the technology of manufacturing the swab base was
improved, enhancing its performance and sustainability, a second utility model was
immediately filed to protect the new technological characteristics including the protection of
the manufacture of a pediatric model.
However, the main problem in terms of intellectual property was the response times of both
the university legal offices and the Mexican Institute of Industrial Property (IMPI), which is the
Mexican authority on the matter. Faced with the impossibility of carrying out personal
procedures to submit the applications, the IMPI developed an online platform to obtain the
required documentation and formats, make the payments of the corresponding fees and submit
the validated documentation signed by the institutional proxies. The average time required to
draft and submit a utility model application under normal conditions; that is, without a
pandemic, is about three to four months of writing and a couple of months of administrative
procedures. Given the contingency, those times were reduced by half.
It is remarkable that an excellent relationship and communication was always maintained with
the directors of the companies ADES 3D and TROKAR, with which licensing agreements were
signed, this facilitated the negotiation of their contractual terms, such as scope, exclusivity,
royalties’ percentage, and front payment, among others. However, one of the main problems in
negotiating and signing the licensing agreements with the companies was to demonstrate and
convince those responsible for the General Directorate of University Assets (DGPU, from
Spanish) about the value of the technology. The time that was required to develop the
agreements and the negotiations took an average of two months, while the authorization and
legal certification of the DGPU took more than four months.
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Once the licensing problem had been solved, the next phase of the project was the
accompaniment of the companies for the establishment of the swab production line,
distribution logistics, packaging, and sterilization of swabs. At this point, the main problem has
been obtaining the health permit from the Federal Commission for Protection against Health
Risks (COFEPRIS). TROKAR manager submitted a first application for sanitary registration to
COFEPRIS in January 2021 and a second one dated July 2021. By July, 2022 there have been no
results, although it is assumed that COFEPRIS must respond within 90 days at the latest.
This is one of the aspects in which SECTEI, as a government entity, could assist the project team
by taking steps with COFEPRIS in order to release the required sanitary registration. Once this
problem is overcome, the launch and sale strategy will come.
It is estimated that by first quarter 2023, two modifying agreements will be signed with the
companies ADES 3D and TROKAR to extend the scope of the original licensing and include the
new swab models.
RESULTS
At the beginning of october 2022, the situation of the polymeric swab project developed by
ICAT-UNAM is as follows:
3D polymeric swabs
• Technology
Technology developed for two models: (a) basic model manufactured in one piece with special
reticular tip design to obtain enough infectious sample without producing disturbing or
damage to patient during the patient’s sampling process; (b) improved model manufactured in
two pieces, giving more flexibility and sustainability.
• Performance Tests
Swabs were approved for their use at the Hospital General de México “Eduardo Liceaga” and
the UNAM’s Faculty of Medicine Covid Coordination Group
• Intellectual property
Two utility models have been filed at the Instituto Mexicano de la Propiedad Intelectual (IMPI).
Due to the health crisis, the documentation was submitted digitally, and the authority handled
the matter through a digital file. The formal and substantive examinations have followed the
normal process times and a more expeditious procedure has not been handled to grant the
certificates or titles that allow the project to be expedited. By the first week of April 2022 the
IMPI sent to UNAM as second requirement for the examination of the utility models.
• Technology transfer
Two technology transfer agreements signed with two enterprises, one on the field of 3D
Printing and the other in the manufacturing and sale of expendable medical devices
• Manufacturing
Printing, sterilization, and packaging implemented and tested at the technology transferred
company using good manufacturing procedures complying with a quality system approved for
medical devices.
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Roberto, V. L., & Sánchez, P. C. A. (2022). Case of the Development of a Biomedical Device Innovation Project of a Mexican Public University to Face
COVID-19. Archives of Business Research, 10(11). 28-43.
URL: http://dx.doi.org/10.14738/abr.1011.13329
• Government Liaisons
Permanent and continuous work with the Secretaría de Educación, Ciencia Tecnología e
Innovación (SECTEI) of the Mexico City Government entity that have pursue relations with
other federal government levels, hospitals, regulation entities, potential users, enterprises and
so on. With the SECTEI’s promotion there has been promotion to sign a Triple Helix Agreement
including of course government, licensed companies, and the university through the ICAT to
define the best procedures to follow so that the swabs reach the market and have a positive
impact on society by contributing to the attack on the health crisis.
• Health Regulation Permits
Tests, device samples and paperwork submitted and filled by TROKAR, the licensee and
manufacturing company at the Federal Commission for the Protection against Sanitary Risks
(COFEPRIS, for Spanish). More than a year after, company didn’t receive the certificate that
allowed to put the swabs on the market and sale them. This situation is clearly the main project
bottleneck.
DISCUSSION
To understand the phenomena that occurred in this project, let's review what was the role of
the participating actors. After reviewing the requirements of the health sector, the ICAT ́s team
realized that there were no swabs on the market for taking infectious samples, since they are
normally imported and were not manufactured in Mexico. In a couple of months from the
moment the pandemic was declared, the swab inventories ran out in the country and in the
shortage, they could not be purchased even imported.
Therefore, the objective of the ICAT ́s group of biomedical devices for participating in the call,
was to develop biomedical devices to face the health crisis, intending to reach society and
contribute in some extent to fight the pandemic through the development of swabs for taking
infectious samples. All this in accordance with ICAT's mission, which is to apply a multi and
interdisciplinary approach to integrate research and technological development activities
seeking to apply the knowledge generated to the solution of relevant problems in country ́s
environment.
The SECTEI acted in the project as a Mexico City government development institution which
objective was to foster, align and tune the efforts of companies, public university ́s R&D
institutions and the health sector institutions as Covid ́s hospitals and health Research
Institutes. Figure 3 shows the chronology of the events occurred in the project.
In addition, Figure 4 shows a different representation of the development of the innovation
project presented. The initial driving force was the declaration of the pandemic. The dynamic
project response was driven by the external society needs and market “forces” that interacted
in the development of the 3D polymer swabs project life span.
Figure 4 also allows us to view other aspects to discuss the phenomena. By the end of 2021 it
became clear that there were some barriers impeding innovation. The first one came from the
IMPI which is the intellectual Property authority in México delaying the granting of intellectual
property titles to UNAM although they were biomedical devices to help facing the enormous
demand of sampling and diagnosis devices in the pandemics.
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In addition, when everything was ready to launch the product to market by the licensed
companies, and once they integrated the sterilization, packaging, and overcome the quality
control system problems, the market launch of the polymeric 3D swabs stopped until obtaining
the sanitary register and permission from COFEPRIS.
In April 2022, the Ministry of Health of the Mexican Government publicly announced that the
pandemic had resigned, in consequence, in a term of weeks there were available at market
imported swabs. This situation naturally offered a big obstacle to sell the ICAT’s technology
product. Nevertheless, according with the Secretary General of the United Nations (2019),
COVID-19 will not be the last pandemic that the world must face, then it is necessary to continue
working on preparing for new infectious outbreaks. Furthermore, the PAHO Director asked to
invest in the prevention, preparation, and response to events with epidemic and pandemic
potential, because, she said, the question is not if there will be a new pandemic, but when. (OPS,
2022). Therefore, the project presented in this work must continue.
CONCLUSION
A work team made up of two small companies and researchers from a public university
research institute joined forces to carry out the adventure of an innovation project. They did
everything in their power and everything necessary to achieve an innovation that could help
face the COVID-19 health crisis in the country and may be beyond. The work team understood
that COVID-19 became a trigger not just for business and SME ́s but for health innovation;
nevertheless, after two and a have years (March 2020- October 2022) they did not be able to go
to the market for the reasons beyond their control, explained above.
Historically, great crises generate great reactions, to face similar future situations, it is
necessary to transform and create a new health system with a social vision in Mexico. It is also
necessary to form government emergency reaction groups capable of processing and issuing
fast track permits allowing project teams not to abandon the matter because the epidemic
seems to subside.
The UNAM is doing its job, however the formation of triple helix groups to carry out the projects
seems to be insufficient. To overcome all barriers, it is required a lot of persistence, thrust, and
not get demoralized. The working group needs to maintain its innovative spirit, they learned a
lot with the project and fortunately the crisis subsided. As stated in the theoretical framework
of this article, for a successful project, it is imperative to ensure a harmonious balance of all key
entities that are responsible for the innovation system. That means that every institution that
takes part in the innovation process must do their job properly.
Even that the dynamic response of the project presented in this case had obstacles, actors will
continue doing their best efforts to reach the innovation objective and contributing with the
fighting to the actual or the pandemics to come. In the upper right corner of Figure 4, it is
suggested that once the required sanitary permits are obtained, the project will be reactivated
and probably the collaboration agreements and the intellectual property strategy will surely
have to be updated. At that time, market conditions will have changed, and new obstacles must
be overcome. However, the project team will continue to work to be prepared and in time to
deal with any future epidemics related to respiratory tract diseases.
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Roberto, V. L., & Sánchez, P. C. A. (2022). Case of the Development of a Biomedical Device Innovation Project of a Mexican Public University to Face
COVID-19. Archives of Business Research, 10(11). 28-43.
URL: http://dx.doi.org/10.14738/abr.1011.13329
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Roberto, V. L., & Sánchez, P. C. A. (2022). Case of the Development of a Biomedical Device Innovation Project of a Mexican Public University to Face
COVID-19. Archives of Business Research, 10(11). 28-43.
URL: http://dx.doi.org/10.14738/abr.1011.13329
Figure 3 Events chronology for pandemic ICAT ́s biomedical devices projects
Figure 4. Innovation project response to Covid-19 impulse