Does interdisciplinary science truly exist?

This is a rhetorical question; the answer is, of course, “yes” because there are researchers who stray out of the confines of their specific scientific domain and wander out toward another scientific domain, ending in that no man’s land so dear to Michel Foucault. 

The In Silico World consortium has recently released in open access a report entitled “Regulatory barriers to the adoption of in silico trials”, which summarises years of work on this specific topic.  In chapter 4 of this report, entitled “A reflection on interdisciplinary decision-making”, we debate with a very narrow focus the complex issue of recognising justified true belief in an interdisciplinary domain”. But from it, we drew a more general reflection that we propose here.

Suppose we accept Thomas Kuhn's idea that in each scientific domain, periods of cumulative progress are periodically interrupted by periods of revolutionary science when the whole domain jumps from one paradigm to another. In that case, we see how interdisciplinary scientists are heralds of a particular class of paradigm change, modifying the confines of that scientific domain (or creating a new one). 

But these researchers travel in dangerous, unexplored lands. The biggest risk is the lack of well-tested pragmatic epistemology. There are many reasons why science fractions knowledge space into scientific domains.  A particularly important one is the need for a pragmatic, operational interpretation of the process through which a group of peers agree on a particular belief.  The best way to collectively decide when a belief is a Justified True Belief varies considerably over the knowledge space.  The ways physical and social sciences decide what a Justified True Belief is are very different and form what we call the pragmatic epistemology of each subdomain of science.

The scientific method is unforgiving; in particular, if the peers of a scientific domain choose an ineffective pragmatic epistemology, the result will be that they will tend to assume as true (and build upon it) tentative knowledge that is then falsified at a later stage. Everything produced using that tentative knowledge must be trashed when this happens, and the overall cost can be very high.  So eventually, the peers of each scientific domain develop a set of operational rules tempered at the fire of experience to decide how, in that specific knowledge territory, a Justified True Belief is considered as such.

If you are conducting interdisciplinary research, you are wandering out of the comfort zone of your domain of origin.  For example, say you are a physicist who has started exploring particular aspects of living organisms, a topic traditionally within the remit of biology.  The pragmatic epistemologies of biology and physics are profoundly different, and rightfully so. Our physicist is faced with two choices: either continue to be coherent with his/her domain of origin and use the pragmatic epistemology of physics or adopt that of the host domain, biology.  The first option is usually healthier: not having been trained as a biologist, the choice to adopt the pragmatic epistemology of biology can be challenging for a physicist (and vice versa, of course).  But in both cases, the choice is always poor.  That is because that researcher is not investigating physics or biology but a new knowledge domain (let us call it biophysics) for which a well-tested pragmatic epistemology is not yet available. 

Interdisciplinary research is precious because it expands the scientific enquiry to previously untouched portions of the knowledge space. However, we must accept that it operates in difficult conditions from an epistemological point of view, and the quality of the knowledge produced might not be as high as that provided by other, more established domains. It also requires a very special mindset, which is less rigid and more accepting. However, the biggest challenge is the need for epistemological attention. Most scientists are uninterested in how knowledge is produced from a philosophical point of view; like cops, they apply the existing laws with little interest in how the legislative process works.  Interdisciplinary scientists do not have this luxury; they need to understand the philosophical basis of their work and spend time debating how to decide what is true.

“Does interdisciplinary science truly exist?” ©2024 by Marco Viceconti is licensed under Creative Commons Attribution-NoDerivatives 4.0 International (CC BY-ND 4.0).

This opinion piece was published in my personal blog, and as an Open Access document on Zenodo.

European Union: from the land of rights to the land of rules

As usual, this blog post is inspired by a series of events, conversations, news, and opinions I collected in the last few weeks, which condensated the need to share an opinion piece through this channel publicly. As always, for everything posted in this blog, these are my personal opinions, which do not necessarily represent the official views of my employer or any of the organisations I am affiliated with in various roles.

The topic is complex and politically sensitive. It is also very general, dealing with how the European Union produces its policies. My narrow perspective refers to the specific domain of in silico medicine technologies. I am not qualified to generalise, but I suspect the problem I am describing below is not specific to a particular area of innovation.

I always have been a champion of the European Union. Compared to the USA, the European Union has been, for many years, the land of rights. Coherent with the values of the majority of its citizens, we created a society where healthcare and education are rights, citizens' privacy is protected, and so on. I am very proud of this. But I am afraid the last few years transformed the EU into the land of rules and bureaucracy. This is crippling our ability to innovate and compete, I believe.

The introduction of in silico medicine is revolutionising healthcare. The ability of computer models, built with advanced techniques such as Artificial Intelligence, to predict changes in the health state of individual subjects opens amazing opportunities but also, as is always the case with disruptive technologies, a whole new set of potential risks for individuals and society. The differences in recent policy-making between the USA and the EU are creating dramatic disparities between researchers and companies working in this field.

When the General Data Protection Regulation (GDPR) was introduced in 2016, many, including myself, praised the European Commission. Eight years ago, it was already evident that information technology companies were abusing the personal data they collected, health information being very sensitive, which was already having a major impact on my research domain.  However, as the GDPR was enforced, biomedical researchers in some member states faced huge difficulties.  The idea of demanding the member states define the rules under which exceptions to the GDPR could be made for scientific research, while it was probably a smart political move to achieve complex legislation within a reasonable timeframe, created a nightmare in which every member state has different rules and multicentric studies across member states are very difficult.  I am sure the legislators had no intention to prevent ethically robust biomedical research, but de facto, this is what has happened. 

This story is well known to all operators in the field and shows, in my opinion, a pattern.  The European Parliament decides to legislate on a socially relevant topic, which has significant implications for complex innovations, usually technological.  Technical advisors are mobilised to support the legislative process, and the legislation tries its best to capture all possible implications of such innovation and how the legislation will impact the socioeconomic processes that involve such innovation. The results are large, complex legislations aimed to “cover all bases”.

However, for disruptive innovation, no group of experts, no matter how good, can foresee all the special cases and all the implications that such extensive policies can have. And the more complex the legislation is, the higher the chance it will produce unforeseen and undesired effects.  In many cases, the issues are related to the correct interpretation of the law and its application into procedures that streamline whatever legal process economic operators need to do to comply with.  The problem is that no one is in a position to handle this post-legislative process.  The European Parliament cannot manage the application of its laws, and the European Commission does not always have the in-house technical expertise necessary to do this.

I suggest that for such complex pieces of legislation, a federal agency should be appointed to oversee the application of such legislation, providing guidelines addressing concrete cases as they emerge, offering support and training, and uniforming the procedures across the union.

In silico medicine, particularly In Silico Trials, has been one of these disruptive innovations.  In the USA, where such federal authority exists (Food and Drug Administration, FDA), the first guideline on using computer modelling and simulation in the certification of medical devices was published in 2016.  The Medical Device Regulation (EU 2017/745) acknowledges the growing role of software artefacts in medical products. However, in 2024, we still do not have a guideline that assists notified bodies in deciding when evidence obtained in silico can be accepted.  The only technical standard for in silico methodologies is the ASME VV40:2018, whose production was driven by the FDA, which recognised the need.  Only this year, the IEC-ISO started a workgroup on the topic that will produce an EU-harmonised standard in some years, but this is only because the community of practice has lobbied for it.  When a new in silico methodology for all types of medical products is developed, one can ask the FDA for qualification advice to explore if such methodology suits regulatory purposes. In Europe, the European Medicine Agency (EMA) provides this only for drug development tools; nothing is available for medical device development tools.

Such a condition is reversing the flow: historically, medical companies would certify their products first in the EU and then in the USA. Today, for in silico solutions, many companies choose the opposite strategy and start with the USA regulator, ensuring clear, reliable regulatory pathways for such products.

In front of us, we have the application of the Artificial Intelligence Act in the next three years and the completion of the legislative process for the European Health Data Space regulation.  Both pieces of legislation could have a tremendous impact on health technology innovation. Without central authorities with the technical skills to provide guidelines on these new legislations, the EU will face the same shortcomings as the MDR and GDPR.  

Originally published online in the Blog “The Secret Life of Marco Viceconti”, https://secret-viceconti.blogspot.com/  

“European Union: from the land of rights to the land of rules” © 2024 by Marco Viceconti is licensed under Creative Commons Attribution-NoDerivatives 4.0 International.

How to gently retire

It has been two years since I have posted on this blog.

The reason is simple: 2023 and 2024 have been crazy, so busy that I could never find the time to let my mind go free and produce stories that, in my humble opinion, are worth to be shared.

I hope things will improve in 2025, primarily because I am starting to implement my "Gentle Retirement" plan.  I decided to write about such a plan for two reasons: the first is that one element of this plan will drastically reduce my attendance at conferences and other similar events, so I want to inform my many friends and colleagues who will not see me anymore about my future.  The second and most important is that all my closest work friends are in their sixties, or close to that,  so I am sure they are all wondering the best way to retire.  I am not sure mine is the best, but it might be worth sharing how and why I plan to approach this final passage of my professional career.

First, I will give a brief history of myself to contextualise this.  After a short but fundamental period in the USA working with Prof Alì Seireg (see this article on one of his many achievements), I returned to Bologna (IT) and, in late 1989, started the Medical Technology Lab at the Rizzoli Orthopaedic Institute. I worked there until 2011. When I left, the lab hosted 45 between PhD students, post-docs and researchers. I moved to the University of Sheffield, where in 2012, we started the Insigneo Institute for In Silico Medicine. I directed Insigneo for seven years, driving it to become the largest research institute on this topic in Europe.  In 2018, I returned to Bologna as a full professor of industrial bioengineering at the Alma Mater Studiorum - University of Bologna. I also had a joint appointment as director of my old lab at Rizzoli. For the third time, I had to restart from scratch, and despite my promises to take it easy after the crazy years with Insigneo, at the end of 2023, my group counted around 40 researchers.

Comes in 2024, and life is getting complicated.  Working in Italy has never been easy, but the considerable funding of the COVID-19 recovery plan combined with our proverbial administrative ineptitude makes our daily work a nightmare.  The right-wing government is underfunding public healthcare, and working in a research hospital like Rizzoli is becoming more and more difficult. On top of this, I experienced some serious health problems.  And suddenly, I realise that for the first time in my career, the pain is more than the gain.  Time to retire.  But how can I retire while preserving as much of my legacy as possible? 

The first thing I have already cut is the time spent travelling to conferences and similar events.  All the travel budget is now spent to support the travelling of my coworkers; they slowly have to become the faces of our team, replacing me in the perception of our community. 

I still have substantial funding until 2026.  However, I will not apply for any further funding; on the contrary, I will support my coworkers who are in the position to have their own research funding to pursue opportunities.

From Sept 1st, 2024, I will resign as Director of the Medical Technology Lab at the Rizzoli Institute.  The lab has three senior researchers who already run it without me for the seven years while I was in Sheffield; in addition, two of my younger coworkers have a tenure-track position, so I am optimistic the lab will survive my departure. 

At the end of the year, we will close my largest EU grant as coordinator, the In Silico World project.  This four-year endeavour has been a fantastic journey; On Sept 3rd, 2024, we will present the results to the research community in Stuttgart in conjunction with the VPH conference. 

After that, I will be left with primarily national funding that will finish in 2025, except for one project.  As these projects close, I will support the post-doctoral staff in finding a new position elsewhere.  I also hope there will be a tenure-track position in my university department to continue my academic legacy. 

By the end of 2025, I will be left only with the coordinating role in the DARE project, in which my responsibility as a spoke leader is primarily managerial.  Any research activity will be continued by those coworkers who managed to retain a tenure-track position in Bologna.

I will close all my professional social network accounts as my research career fades. I might open one to stay in touch with friends, but only to discuss non-professional topics. I will continue to post occasionally on this blog, but only about culture, society, and philosophy. 

In April 2027, I will be 66 years old.  Depending on my health, I could retire then or wait a few more years, during which I will focus on teaching and tutoring. The mandatory retirement age for full professors in Italy is 70, so I could keep teaching until 2031.

I do not have much more to offer regarding scientific discovery.   In math, the Field Medal can be won only by those 40 or younger. I always thought that was an exaggeration, but I must admit that my creativity has constantly decreased in the last years.  What I can still do is share the significant experience I accumulated in these many years with the researchers in training through teaching and tutoring.

Those who know me tend to describe me as a workaholic. So how will I manage with all that free time?  My wife and I would love to spend time in other places worldwide, so if you need a visiting teacher, talk to me.  Then, I need to go back and brush up on my musical skills, which I did not cultivate in the last 40 years. I would also like to volunteer; it seems a moral imperative in this growingly egoistic society. So, do not worry about me; I will manage even without working 14 hours per day, seven days per week. 

As I fade from the public eye, being part of this international research community has been an honour.  thanks to all of you who worked, debated, revised, laughed, and argued with me during this long career. 

Farewell.

Marco