The value of innovation in a sector where any change can affect the registration of a medicine
The pharmaceutical industry needa to innovate in a continuous way to optimize its processes, increase efficiency, reduce development times and respond to scientific and technological challenges of a increasingly demanding market. However, it has to do it in a high regulated environment, in which pacient security is a essential requirement.
At this industry, the client is, in las instance, the pacient. This reality means that any innovation has consequences that go far beyond mere technical feasibility. Un like other industrial sector, introducing a new technology it is not just demonstrating that it works; it also has to be guarantee that it´s implementation doesn´t commits quality, security and neither the efficiency of the medicine.
Module
Main content
1
Administrative and legal information
2
Quality, security and effectiveness sum ups
3
Medicine quality
4
Non-clinical studies
5
Clinical studies
This requirement it´s articulated through the Good Manufacturing Practices (GMP), the joint of rules that regulate the manufacturing of medicines to assure that they are produced in a cohesive way and with the quality levels required from the health authorities.
However, the scope of the GMP goes further that the main manufacture process. It also affect to areas and facilities, services such as water, air, vapour, manufacture and conditioning equipments, IT equipments, analytical methodes and, in general, to any element that can influence on product quality and safety.
All this information is part of the Quality module, known as CMC (Chemistry, Manufacturing and Controls), integrated on the dossier or registration file of the medicine. It documents how the product is manufactured, with what equipment, under which conditions and throughout which quality controls. The approval of this file from health authorities is which allows the commercialization of the medicine.
In consequence, a modification that, at first, could seem unrelated to the medicine (such as implementing a new software, installing a collaborative robot, implementing a artificial vision system or modifying a productive operation) could affect to processes previously validated that are part of the documentation presented to regulatory bodies.
These type of changes requires the development of risks analysis, qualification and validation activities previous its implementation, the updating of documents and, also, the processing of regulatory modifications.
In other words, at the pharmaceutical industry is not enough with introducing a technological improvement. It is necessary to demonstrate with documents that the change is justified, evaluated, validated and control, so that the medicine compliant can be maintaines during its life cycle.
For that reason, any change implies a significant investment of time, resources and costs for the pharmaceutical companies. The greater is the potential impact on a process or a registered product, higher would be the effort required to implement that innovation with all the guarantees.
The need of innovation spaces pre-GMP
The GMP environments are design to guarantee the most robustness, traceability and control of the productive processes. Precisely for that reason, not always constitute the most adequate scenario to experiment with emerging technologies or develop concep test in its initial phases.
Innovation requires of creativity, capacity to explire different approaches, flexibility to experiment and margin to iterate about different technological alternatives before reaching a sufficiently mature solution for its industrial implementation.
It is precisely on that point where technology centres contributes a differential value.
Pre-GMP enviroments allows to evaluate new technologies, validate concepts, quantify benefits and reduce technical uncertainities before facing the demanding pahes of validation and implementation on a regulated environment. In this way, comapnies can take decisions with a more solid technical base and minimize risks associated to the incorporation of new solutions.
CARTIF´s contribution to the pharmaceutical innovation
CARTIF can contribute to the pharmaceutical innovation in three strategic ambits:
Innovation in processes and products
The optimization of chemical and biotechnological processes, the industrial scale and the improvement of productive operations continue to be priority fields for the pharmaceutical industry.
Operations such as extraction, spray drying, fermentation or chemistry synthesis continue offering a wide margin for innovation. At the same time, these more classical technologies live with other challenges associated to development and manufacture of advances therapies, such as genetic, cellular and tissular therapies, that plan new tehcnological and productive needs to which from CARTIF we have to look.
Industry 4.0 for smarter production
New technologies offer important opportunities to improve the efficiency of processes without the need of step in directly over productive systems already validated or work on not accessible environments for product or operator protection
Technologies such as digital twin, artificial intelligence, artificial vision, advance analytic, collaborative robotic or augmented reality allows optimize the decision-making, reinforce the support for the operation and improve the efficiency in those environments where the accesse to the process is limited or where any direct intervention involves a high degree of complexity, as is the case in the aseptic manufacture of sterile products or high-potency products such as hormonal or cytotoxic agents.
Sustainability and energy efficiency
Optimising resource use, improving energy efficiency and developing circular economy strategies represent an opportunity to simultaneously enhance both the environmental sustainability and competitiveness of pharmaceutical companies.
The implementation of solutions that reduce the energy consume, minimize the residues generation and promote a more efficient use of the resources allows advance through more sustainable productive models without resign to high quality standars that requires the sector.
CARTIF: innovate in non GMP environment, but thinking on GMP
The activity we develop at CARTIF is focused mainly in the stages leading up to industrial implementation and regulatory validation processes. However, working on pre-GMP environment doesn´t mean working aside from the requirements that will condition the future development or implementation of the technology.
Our role is help pharmaceutical and biotechnological companies to explore new solutions, validate emerging technologies and reduce the technical uncertainty before facing the complex stages of implementation on a regulated environment.
Because, although we work before GMP, we innovate thinking on an environment where our knowledge of the sector and its practices are essential so that any innovation could reach the market.
From CARTIF we not only act such as applied knowledge generators, but also as catalysts for innovation ecosystems that boost the development, validation and adoption of new technologies by the pharamceutical industry.
A technological ally for pharmaceutical innovation
From CARTIF we understand the innovation such a process focused on generate useful, applied and transferable knowledge. Pharmaceutical industry needs spaces to experiment with the flexibility needed to transform new ideas on viable industrial solutions, without losing sight of the regulatory requirements that will condition their future implementation.
Because, in a sector where operational excellence is inextricably linked to regulatory compliance, innovation requires a combination of creativity, scientific knowledge and industrial vision. Having environments in which to develop and refine new technologies before their implementation under GMP conditions constitutes a strategic advantage for reducing risks, accelerating technological development and facilitating the bringing of innovation to market.
In a context where any changecould can have impact on the registration of a medicine, innovating prior to GMP doesn´t mean innovating aside from GMP, but rather doing so with GMP in mind from the outset.
👉 If your company is exploring new technologies to optimise pharmaceutical processes, carry out R&D projects or prepare for future GMP implementations, at CARTIF we can help you validate solutions and mitigate technological risks.
Innovation in business: decision-making, budgeting and key factors for creating value
There are days when I leave a meeting and am left with a strange feeling. I’ve heard various organisations talk about innovation with the same conviction as if reciting a mantra: it’s important, it’s part of the strategy, we must innovate. And yet, when you try to bring the talk down to earth — to day-to-day operations, to the practicalities, to the decisions — there’s silence: almost no one has decided what innovating means in their context… or what they’re willing to change to make it happen.
That’s why I still believe thatinnovation shouldn’t be a matter of flip-flopping. It’s not a case of ‘yes today, no tomorrow’. It’s not something we do ‘when we have time’. It’s not a leap of faith. Innovation demands sustained commitment. It demands a methodical approach. It demands sacrifices. It demandsroutines. And it demands something even more uncomfortable: that the entire organisation takes a hard look at itself.
All too often, I see organisations taking pride in their R&D, their technological capabilities and their brilliant teams. And that’s fine by me. But I also see how those results end up sidelined, waiting their turn, stuck in a never-ending pilot phase or a proof of concept that never makes it into the business.
I want to be very clear about this:
‘Investing in R&D means generating results.’
‘Investing in innovation means successfully utilising and capitalising on those results.’
If there’s no adoption, if there’s no use, if there’s no real impact… there’s no innovation. There’s wasted potential. There are brilliant teams feeling frustrated. There’s technology waiting for someone to finally make a decision.
‘Innovation isn’t about having more ideas. It’s about making decisions’
Decisions that affect the entire organisation, not just senior management or the head of innovation or AI (which, these days, seem to be one and the same). Decisions in which quality, production, finance, marketing and sales are all aligned around a simple idea: if innovation is important, it shows in how we work… not in how we talk about it.
Decisions that require us to define the kind of innovation we want to drive forward. To choose which business or market challenges are worth tackling. To decide which projects to continue and which to halt. And even to accept that some day-to-day practices are no longer fit for the future we say we want to build.
And decisions that inevitably lead us to the elephant in the room: the budget.
Because innovation needs its own budget. Not ‘whatever’s left over’. Not a vague allocation that’s negotiated each year. Not ‘if a public call for proposals comes up, and if not, then next year’. An explicit budget for exploring, for experimenting, for embracing uncertainty.
I have written on previous occasions that innovation cannot be a stand-alone project or a silo. When we talk about capitalising on innovative outcomes, we are talking about people working towards a common goal, coordinated departments, and companies that operate within an ecosystem that embraces this philosophy.
That is why it is so crucial to involve, right from the start, those who will benefit from the investment in R&D: those who will use the technology, those who will implement the new process, or those who will sell the new service. Innovation is not simply ‘delivered’ at the end: it is built together with them from the very beginning.
Because those who make decisions about innovation are shaping their future. Making decisions about innovation means deciding today what you will protect tomorrow… and what you are prepared to leave behind. It means accepting that the present cannot be the only criterion. It means understanding that challenging the status quo is not a threat: it is essential to staying relevant.
And, by the way, not making a decision is also a decision. Not setting aside a budget is deciding to put the future on hold. Not involving those who will use the results is deciding that they probably won’t be used. Not defining what innovation means in your organisation is deciding that everyone can interpret it however they like… and that, in the end, nothing of significance will happen.
The question isn’t whether your organisation talks about innovation.
The question is whether the management team is really deciding their future.
Is your company ready to innovate?
Before we talk about innovation, it is worth asking ourselves a few uncomfortable questions. Not to assess the rhetoric, but the reality:
Is there a specific, fixed budget for innovation, or does it depend on whatever funds are ‘left over’ or on one-off calls for proposals?
Is the entire organisation, from senior management down to operations, aligned with clear innovation objectives?
Are R&D results being turned into practical solutions, or do they remain at the pilot stage and never make it to market?
Are those who will use, integrate or sell the solution involved from the outset, or are they only brought in at the end?
Is the actual impact of innovation measured, beyond the number of projects or ideas generated?
If several of these answers leave you feeling unsure, the problem is probably not a lack of ideas… but a lack of decision-making
👉 If your organisation wants to move from talk to real innovation, get in touch with our team and let’s work together on solutions that make a difference
Isaac Newton, working from an eminently mathematical foundation, made it clear more than 300 years ago that the most solid way to understand the world is to formulate hypotheses and gsubject them to experimentation and observation, in order to empirically conclude wether they hold up or not. Thanks to this method, we have achieved unthinkable milestones: preventing and curing diseases that once devastated us, reaching the moon, and even allowing you to read this from anywhere on the planet.
For 21st century engineers, this story may sounds repetitive. However, today it´s more necessary than ever not only to hear it, but to listen to it and reflect on it. Our profession consists of designing and developing products and services- in the broadest sense- that solve real problems for people. Clearly, we try, but with some perspective, too many cases emerge in which we invest our most valuable resources (time, money and energy) in perhaps brilliant solutions…that no one wanted.
“The most solid way to understand the world is to formulate hypotheses and subject them to experimentation and observation”
The result is often waste, demotivation and, at best, learning. Very expensive learning. Isn´t there a cheaper way to achieve the same lesson? Yes: the Build-Measure-Learn cycle. This approach, popularized by Eric Ries in his book The Lean Startup, is equally applicable to engineering, where early hypothesis validation can save huge amounts of resources. The dynamic is simple: we start with a hyptohesis (that point of convergence between the creator´s vision and what the client could accept) and design an empirical and frugal way to obtain tangible observations that validate or refuse that hypothesis.
Infography Build-Measure-Learn.
The sequence is: Idea; Build (product); Measure; Data; Learn; New idea. The objective isn´t to “guet it right the first time”, but to minimize the resources neede to achieve useful learning. The tool that best optimizes this cycle is the MVP (Minimum Viable Product): a product simple enough to generate measurable results as quickly as possible, convert them into data, extract clear learning from them, and thereby validate or reject the initial hypothesis.
For it to work, it takes more than just method. It takes intellectual humility. Sometimes the “brilliant idea” was nothing more than a fantasy and it´s time to pivot. Just as empiricism helped us abandon geocentrism, spontaneous generation, humoral theory or witchcraft, perhaps its time to return to that same apporach to test the hypothesis on which we build not only our profession, but also our society.
In short, less faith in our assumptions and more respect for the evidence. Let´s build small, measure earliy, learn fast. And, if necessary, change course before continuing to invest in something no one is expecting.
🤝 Looking for a technology partner to develop your idea? Contact our team.
If innovation is return, impacto, income… why don´t we innovate more?
During the time I´ve been working on innovation and, in my case, boosting the use of technologies by entities through the transfer process, I´ve been able to speak and see examples of why do we find difficult to innovate.
We find it difficult because we struggle to dedicate time, resources and energy to planning what to innovate in, because we find it hard to accept that competition is growing because it has made innovation its main strategy.
Because we find it hard to propose new ways of doing things, new projects, new ideas to our superiors, because it’s easier to stick with what we’ve always done and not get involved in “other issues.”
Because it´s hard for us to leave that comfort zone, of that acquired routine that, although it no longer challenges us, offers us security in achieving results.
We struggle because innovation means venturing into uncertainty, and that scares us. We fear error, the possibility of failure, the idea that the resources we put in may not yield the expected results.
We struggle because the unknown is frightening, and even more so when achieving it requires overcoming certain barriers and facing risks that, although sometimes known, we don’t always understand how to manage.
It´s also difficult for us because innovation requires a change in mindset. It’s not just about investing in new technologies or products; it’s about transforming our way of thinking, questioning what we take for granted.
We struggle because we often prefer what we know, even if it means remaining stagnant.
And yet, the truth is that the real risk isn’t in innovating, but in not doing so. The real danger lies in looking to the future and realizing that we’ve been surpassed by those who dared to change.
For all these reasons, the key to innovation is understanding and, above all, accepting that risk is part of the process. This way, you can identify how risk affects you and establish the conditions to mitigate it.
“The key to innovation is understanding and, above all, accepting that risk is part of the process.”
How to manage risk in innovation
A risk management system inherent to the innovation process is the first step toward unlocking this fear of innovation. This isn’t just a theoretical process, but rather a matter of implementing certain concrete actions that create an ideal environment to stimulate innovation.
In my experience, the factors that are crucial for creating a good risk mitigation system are:
Create your own innovation ecosystem and surround yourself with strategic partners: technology centers, universities, startups, client or supplier companies to promote the transfer of know-how from these entities and accelerate collective learning, thus reducing the time to impact.
Planning innovation budgets: allocating specific resources to innovative projects within a specific timeframe, avoiding innovation depending on improvisation or success associated with competitive competition. Resources should not be allocated that jeopardize the organization’s core business, but sufficient resources should act as a driving force. One percent of a year’s budget is already a lot. It’s important because just as what isn’t on the agenda isn’t a priority, what isn’t budgeted doesn’t exist.
Leadership drive: Firm commitment from the top is the engine that gives legitimacy and continuity to innovation and allows the ecosystem you’ve chosen to endure over time and achieve results. This commitment is reflected in actions, not only budgetary but also through participation in meetings on new initiatives or in ecosystem analysis and selection.
Implement innovative routines: Incorporate practices that make innovation a constant. Innovation isn’t a one-time or improvised effort. It’s about encouraging trial and error and fostering ideation, the generation of new proposals for change, and an entrepreneurial spirit among teams. It’s about creating an innovative culture that permeates the organization horizontally.
Adapted profitability indicators: Designing specific metrics that realistically measure innovation, considering technological and market maturity and its potential impact and scalability. This means moving away from traditional economic indicators, which are adequately designed for investment projects or continuous improvement projects in general, but are ill-equipped to measure the results or profitability of risky projects that require much broader and more flexible ranges and that require accepting the need to abandon a project at a certain point.
All of this pursues a very clear objective: to build CONFIDENCE in the process, because if risk is a constant in innovation, trust is the constant that balances it.
Trust is like the lifeblood of innovation processes because it’s what we don’t see, but it connects all the elements that make innovation possible and, above all, helps mitigate risk. Trust connects people’s courage to propose ideas, management’s vision to drive them forward, and relationships with your ecosystem. It helps you acknowledge and accept that mistakes are part of learning and the innovation process.
Ultimately, the key is that innovation doesn’t progress solely through technology or resources; it progresses through the people who drive it and, above all, through the shared trust between them. This trust is what turns risk into opportunity and allows us to bring the future into the present.
Innovate for you, innovate for me, innovate for us.
Innovation isn´t just about having a good idea. It´s about fighting for it when nobody does. It´s about shaping it when it´s still intangible, about falling a hundred times until, suddenly, something starts to shine.
We tend to think when we talk about innovation, that thanks to the emergence of a brilliant idea we´ve solved that small goal or problem or, on other occasions, a huge problem that can transform the world. The truth is that no brilliant idea goes very far unless it´s achieved by people who, with great effort and perserverance, manage to “materialse” that brilliant idea.
Innovations can emerge from any corner of an organization. Often, management levels find it easier to turn an intuition into a line of work, but it´s also common for a good idea to emerge from the technical team, production, quality, or even administration. The real challenge is ensuring that the idea survives all the obstacles involved in becoming a reality. And there are many obstacles, fromclose colleagues, managers who don´t support the idea because is more comfortable to remain in their comfort zone, to obtaining internal or external financing. In other words, the challenge of innovation often lies in surviving the effort of going from an idea to a clear reality.
“The challenge of innovation often lies in surviving the effort of going from an idea to a clear reality”.
History is full of brilliant ideas that died for lack of perseverance. But it´s also full of projects that were born, not beacuse they were obvious or perfect, but because someone insisted beyond reason. Rarely do these ideas and the people behind them change the worl as we know it (disruptive innovations1).
To illustrate with real-life examples how brilliant ideas change the world, let´s talk about one of the most shocking stories of innovation: the 2014 Nobel Prize in Physics awarded to Isamu Akasaki, Hiroshi Amano and Shuji Nakamura for the invention of the BLUE LED. That small invention allows us to have thin LED screens today, and thanks to which you can read this from your laptop, mobile phone or tablet (there are several more applications thanks to this invention)
Source: La Vanguardia. https://www.lavanguardia.com/ciencia/20141007/54416831597/nobel-fisica-2014-akasaki-amano-nakamura.html
BLUE LED History
For decades, red, green and yellow LEDs were achieved. But not blue. And without blue, efficient white light, LED displays, and low-consumption projectors couldn´t be created. The world´s leading companies and research centres tried and failed. It was simply too difficult.
The challenge lay in the base material. Gallium nitride (GaN) was the best option, but it was very complex to synthesize and dope. The crystals were defective. The light emission was unstable. Many tried and all gave up.
All except three people: Isamu Akasaki, Hiroshi Amano y Shuji Nakamura.
Akasaki and Amano, from Nagoya University, began experimenting in the 80´s.
Nakamura, an engineer at a small Japanese company called Nichia Corporation, continued his research almost self-taught, against the advice of those around him.
For years, they worked with limited resources, without visibility, suffering constant failures and rejection from the scientific community. But they persisted.
In 1993, Nakamura finally succeeded in developing the first highly efficient, commercially available blue LED. That blue light not only changed lighting, but also paved the way for new sustainable and more efficient technologies. In 2014, the three received the Nobel Prize in Physics for an innovation that took 30 years to see the light of day… literally.
I would encourage you to reread the story of this invention in more detail, because it truly is a great example of how perseverance and effort can literally change the world for the better. Furthermore, we can learn valuable lessons from this story:
Most companies abandon an idea if there are no results within six months. The blue LED took more than a decade to work, and decades to be recognized.
Understand innovation as a marathon, not a sprint.
True innovation requires more effort than genius.
Innovation must be sustained, even when there are no results.
“In organizations, we should value those who persist with rigor and conviction. Not all ideas are going to change the world, but many that would never do so because no one fights hard enough for them. Like the blue LED, perhaps your company’s next great innovation isn’t in the most visible idea, but in that person who keeps believing in it, even when everything else fails.”
Because in the end, innovation isn’t just about being right, it’s about having the determination to prove it when no one else sees it.
1. Disruptive Innovations
A process by which products, services, or business models are introduced that radically transform an existing market, creating new ways of satisfying needs or even creating entirely new markets
Talking about Dubai means revisiting the Innovating R&D posts on the CARTIF blog. It means discussing the characteristics of ecosystems that foster resilience and help avoid “lotus flower” scenarios. It means reflecting on the essence and purpose that keep us in constant motion and make us feel fulfilled. It’s about engaging in continuous, repetitive routines of trial and error to achieve breakthroughs through innovation. It means encouraging a demand for innovation that prevents undervaluing its true worth. Ultimately, it means giving the attention it deserves to our beloved “i” of Innovation.
The lotus flower, capable of blooming in the mud, has long symbolized perseverance, transformation, and beauty that emerges from adversity. Dubai has flourished in a naturally adverse environment, positioning itself as one of the most powerful innovation ecosystems in the world. Dubai shares that spirit: in the heart of the desert, it has built not just a city, but a vision of the future. A vision not limited to the present, but one that boldly embraces innovation as the driving force of its strategic development.
Dubai is not a product of chance. It is the result of an ambitious roadmap, built on political and economic decisions that have placed innovation at the core of its identity. Initiatives like Vision 2040, the Blockchain Strategy, Smart Cities, and incentives for startups in fields such as AI, fintech, sustainability, or health are not isolated gestures — they are essential components of a model designed to anticipate the challenges of tomorrow.
Free zones, tech hubs, acceleration programs, and urban experimentation spaces reflect Dubai’s commitment to being a living lab for disruptive solutions. Dubai understands that building the future is not about waiting for it to arrive, but about designing it in the present — with a mindset open to collaboration, adaptable, dynamic, and deeply strategic.
“Building the future is designing it in the present”
Experiencing Dubai from the inside reveals much more than the shine of its skyscrapers. Its multiculturalism, obsession with efficiency, and rapid execution capabilities make it fertile ground for those looking to turn ideas into real-world impact. Amid cultural contrasts and social challenges, a spirit of perseverance stands out: every step, every investment, every reform is aligned with a long-term, shared goal.
Like the lotus flower that rises above murky waters, Dubai blossoms on arid land thanks to its roots: vision, strategy, and innovation. It is precisely that connection between resilience and future that makes it a global benchmark for those who believe that innovation ecosystems are not improvised, they are built.
In just a few decades, the city has evolved from a small trading port to a futuristic metropolis, driven by a visionary development model rooted in economic diversification, free zones with unique incentives, and a strong commitment to technological innovation. This transformation is not only the result of strategic decisions, but of a mindset open to change and entrepreneurship, which enables the attraction of talent, investment, and global opportunities.
Dubai blends ambitious megaprojects and cutting-edge infrastructure with a multiculturalism felt in every corner: over 200 nationalities coexist in an environment where adaptability is key. Initiatives such as Vision 2040 or the Blockchain Strategy reflect the emirate’s long-term approach, with a strong focus on technology and continuous improvement of the business landscape.
From a personal perspective, living and experiencing Dubai means confronting its contrasts: luxury and austerity, tradition and modernity, the local and the global. This duality doesn’t weaken its model — it enriches it. Despite ongoing cultural or social tensions, what truly stands out is its capacity for constant reinvention, creating an ecosystem where startups, major corporations, and innovation coexist and thrive.
Dubai represents the power of rising boldly from complex conditions. Its apparent perfection may seem artificial, but it is precisely that relentless drive for improvement that fuels its ongoing progress. Along that path, it becomes not only a business benchmark, but also a symbol of what strategic vision, global openness, and resilience can achieve.
Innovate for you, innovate for me, innovate for us.
