Smart Investment Allocation Through Regulatory ExpertiseBy Miriam Bello | Thu, 09/24/2020 - 13:18
Q: What makes Insumos para la Salud (IPS) the choice consulting company for the medical devices sector?
A: We are a consulting firm specialized in regulatory affairs for medical devices. Our primary focus is obtaining COFEPRIS approval for our clients’ products. We provide solutions that help them enter the Mexican market quickly and successfully by determining a regulatory strategy that’s well suited for them. At IPS, we have a broad understanding of the medical devices sector and have experience working with all device classes and categories. In addition to our regulatory consulting services, we offer market intelligence strategies so companies can enter the country with a clear panorama regarding return on investment, buyers and sellers. We have allied with Pragmatec to create informative projects for our clients; we deliver market studies supported by qualitative and quantitative research data to develop a tailored strategy.
Moreover, IPS works as a hosting company. Foreign manufacturers with no local presence in Mexico can grant us ownership of their sanitary registration to serve as their in-country representatives. At the same time, they remain in total control of their products and focus on their sales and marketing strategies. This saves the client on costs, such as having an office in Mexico that would mean more investment due to the different logistics requirements. IPS is always interested in building strategic relationships between the medical devices manufacturer and the distributor to deliver the best results possible. We also work with local companies that need regulatory assistance or market analysis.
Q: What did COVID-19 change within the company?
A: Due to the regulatory context, we have adapted our review, quality and communication processes. Even before the pandemic, we would work with the cloud and other digital tools that supported our internal communication and project management, as projects can take up to a year.
As a result of the pandemic, we have diversified our portfolio. We are now working with COVID tests and other key supplies for the pandemic, such as masks or hand sanitizer. We are always up to date with COFEPRIS and the global context to offer the best solutions possible and save time. We maintain constant communication with our clients because they all have different realities: the crisis has favored some while others have not. IPS has not neglected any device or product just because of the pandemic. Due to the uncertainty around COFEPRIS, we advise the client that the smartest solution is to gain time when the pandemic has passed by delivering their paperwork to COFEPRIS. We are also contributing to investment continuity. We are working to obtain market approval of COVID-19 tests, which are connected to other entities. PCR tests are cleared by INDRE and serology tests go through an INCMNSZ validation process.
Q: What are the major opportunities that will emerge for Mexico’s medical devices sector after COVID-19?
A: Many opportunities have surfaced as a result of COVID-19. We have a strong medical device manufacturing power at the border. However, initiatives such as the INCMNSZ ventilator developed through a public-private alliance open a new door to medical devices development, not just production. This effort puts a spotlight on our technology development potential, which is very positive. But we are still missing resources and support for educational and talent activities, which is a big barrier for the country to accelerate and boost its abilities.
Q: How have COFEPRIS’ regulatory changes impacted your work and the medical devices sector?
A: In 2018, after the change in administration, we started to see a somewhat introverted COFEPRIS. In the past, Commissioner Sánchez y Tepoz was very active in meetings or forums and he was very open to dialogue and to approach the healthcare industry. The current COFEPRIS took around one year to resume the work it had inherited from the past administration and start assigning positions within the commission. Through our submissions from that time, it was evident that COFEPRIS was stressed with the transition and it was taking long periods to get approvals out. We also noted its internal struggles to fill certain positions because we would see different approval signatures on our sanitary registrations, to the point of having registers signed by Novelo Baeza, the current Commissioner. We went from having three-month approval periods, which was advantageous as the average time for the standard review process is 12 months, to working with complete uncertainty. This slow process drove us to start working more with third parties. However, the commission established a “first in, first out” model that rendered third parties almost irrelevant because there was no prioritization for submissions under that route. Moreover, COFEPRIS was not establishing a dialogue with the third parties, either. In February of this year, the commission released guidance that set new presentation and organization rules for submissions. These new rules increased times and costs for companies, and yet, things have not changed.
COVID-19 changed this scenario and we have seen a more open COFEPRIS that has been actively releasing guidelines and updates on its processes and approvals list. It also seemed to be more open to talks with the industry, so this could be a good indicator of a further opening. The commission has been prioritizing all documents that arrive during this period. However, it has a backlog of older procedures still on the waiting list and will apparently stay there a while longer.
COFEPRIS was also working on its digitalization right before López Obrador’s administration, which would be incredibly beneficial and would speed up times substantially. It had a digital platform that advertising third party reviewers could use to submit their advertising permit application. However, the current administration backtracked this effort.
These changes have been a barrier to our work, but they are out of our hands. Due to COVID-19 isolation measures, COFEPRIS is receiving dossiers by mail, but this is still risky for us, the senders, because we have to meet or go to the office to assemble the dossier as it cannot be submitted digitally.
Another change that impacted the industry was ProMéxico’s termination. This body delivered impact information about the industry and its status, strengths and areas of opportunity. As market strategists, ProMéxico’s information meant proof of Mexico's living potential in the sector and how much it could grow with investment. There is a great deal of uncertainty within the sector as the government is making changes in regulation, tenders, distribution, among others. These are not good signs to attract foreign investment.
Q: What are IPS’ short-term goals?
A: We are opening an office in the US to target the Midwest and help companies from there achieve a soft landing in Mexico. Moreover, we are looking forward to approaching and supporting Mexican startups because we know that a project in healthcare requires a great deal of advisory due to the sector’s strict requirements.
Lastly, we are very interested in sharing content about the industry with our clients because since ProMéxico’s closing, it has been hard to find trustworthy material in English to contextualize the country to our clients. In fact, the Mexico Business News platform has been very useful for us due to its content and the quality of the material.
Insumos para la Salud (IPS) is a consultancy that specializes in medical devices and provides a wide range of services, from market intelligence and COFEPRIS approvals to the post-market phase.