Three questions – three answers: Frieder Hänisch, Limbach Gruppe

The 2b AHEAD expert network in dialogue. Health experts regularly raise relevant questions on the future of health. Other experts from our network comment on this – and in turn ask new questions that will go to new experts. In this way, an inspiring dialogue grows and we will continue to expand it.

Focus today: Frieder Hänisch from the Limbach Gruppe

The expert questions today go to Frieder Hänisch, Project Manager Business Development at the Limbach Gruppe based in Heidelberg.  The Limbach Gruppe was founded as an association of independent laboratories and is the largest owner-managed laboratory group in Germany.

Asymmetry of knowledge

Peter Ohnemus, DacadooPeter Ohnemus, founder and CEO of Dacadoo: DNA testing is becoming more powerful and cheaper. How will we manage this asymmetry between customers and health insurers in the future? The customer can know everything about his clinical picture and the health insurance companies simply have to pay “blindly”?

Frieder Hänisch, LimbachgruppeFrieder Hänisch, Business Development, Limbach Gruppe: There are two scenarios in which genome sequencing is used in a way that can be experienced by the individual: Diagnostic sequencing based on a case of illness or sequencing on behalf of a customer for self-payers.

In the case of a disease, genome sequencing is indicated in a selection of disease patterns for therapy decisions. In Companion Diagnostic, the most effective drug is selected on the basis of the individual genome. Prominent examples are oncological diseases such as breast cancer. Here, medicine has learned that the drugs originally developed are ineffective in some patients because the mechanism of action of the drug cannot interact with the cell receptors. In 2017, however, there were only 14 disease entities for which such a procedure can be used meaningfully.

In my view, there is no asymmetry in this scenario. Both the patient and the health insurance company have a high degree of interest in the fast, target-oriented and thus also most cost-effective therapy.

In the case of a healthy payer, the knowledge of the genome information has to be considered from both sides: A) the information is available to the health insurance company but not to the contributor, and in the opposite case B) the genomic information is available to the contributor but not to the health insurance company.

A) The health insurance company corresponds to an insurance company in its business model. It therefore always has an interest in knowing individual disease risks and their probabilities of occurrence in order to control the business model via the contribution rates. In extreme cases, this means measuring premiums on the basis of the individual genome. As long as society does not block it by ethical norms and legislation, the procedure described is likely to be followed in the future.

It should be mentioned restrictively that the genome only permits statements about the probability of occurrence for a selection of diseases. In my view, knowledge about the Internet browser history of a health insurance fund member is much more meaningful for the formation of risk models than genetic information.

B) The current commercial offers for genome sequencing such as “23andMe” (genome sequencing service for 99 USD, as of November 2018) or MyHeritage present themselves more as lifestyle products for enthusiasts and genealogists. In essence, there is another question at the forefront: Does a psychological factor come into play when private genome analysis provides a probability of illness for serious illnesses that can only occur in the middle phase of life? Huntington’s disease, for example, does not break out until around the age of 40. Knowing a predisposition can lead to an enormous increase in psychological stress. The right of knowledge contrasts with the right to conscious ignorance.

I would not speak of a “blind payment” by the health insurance companies. A payment is made in case of illness, not in case of the probability of a future illness. Furthermore, on average 80% of the individual health costs are incurred at the end of life due to intensive medical care (about the last two years of life). From this fact out I consider the information advantage of an individual by knowledge of its hereditary information negligible for the health system.

Personalization vs. data protection

Arkadiusz Miernik, Universität FreiburgArkadius Miernik, Professor at the University of Freiburg: How will the further development of data-based, personalised treatment approaches be possible if data protection requirements become increasingly strict?

 

Frieder Hänisch, LimbachgruppeFrieder Hänisch, Business Development, Limbach Group: Thank you very much for this very up-to-date and important question. It is also a complex question.

Even today, without personalized treatment approaches, pharmaceutical research faces the great challenge of identifying the ideal patient population and including it in the later phases of clinical trials. Since the statistical effect strength of the new treatment approach must exceed that of the treatment previously used, the choice of study group per se is becoming increasingly difficult. The fundamental hurdle is therefore the study design and only much later data protection.

Data protection becomes relevant if the largest possible data pools are to be created over a longer period of time and then evaluated. In other words, all studies that use a big data approach. On the scientific side, I’m a little sceptical about the use of Big Data. More data does not necessarily mean better data. For me, the most important question here is the minimum data set that is required to answer the question.

I see the use of new technologies such as blockchain technology as a promising solution. It offers the possibility of a validated and complete documentation of the used data (smart contracts). This technology makes it possible, for example, to link the personal data of study participants with a token. Each use of the data in the sense of an analysis should generate a traceable transaction. The data owner thus has the option of controlling the use of his data and retaining decision-making authority similar to copyright. A little further thought can also result in new payment models for the use of personal health data. The study participant deposits the data anonymously and, in the event of a request for use from a study, can release the transaction, if necessary even for a usage fee.

Unfortunately, as far as I know there is no implementation of this technology yet, so this thought experiment has yet to prove itself in reality.

Interaction of the physical and the mental

Florina Speth, 2b AHEADFlorina Speth, Senior Researcher, 2b AHEAD ThinkTank: The interplay of our mental and physical state is often still ignored in the Western medical world. How will this develop in the future?

 

Frieder Hänisch, LimbachgruppeFrieder Hänisch, Business Development, Limbach Gruppe: In contrast to physical diseases, which are described and understood very well in molecular terms, mental diseases are predominantly phenotypically characterized. Similar symptoms are interpreted as similar diseases. Since the symptoms and intervals of the disease phases are very broad in the area of mental diseases, this basic assumption may lead to a misleading classification of disease patterns. It would be better to classify according to the molecular profile. As an analogy, the reclassification of bacteria based on findings from genome analysis should be mentioned here.

Furthermore, the diagnosis of mental diseases is essentially dependent on standardized questionnaires, in which the patients’ self-awareness contributes to the diagnosis and is also based on the psychologist’s subjective experience. Although biomarkers for diagnosis are in research, they have not yet gained market acceptance.

However, the further development of this field of science is clearly recognizable and the standard work on the classification of mental diseases “Diagnostic and Statistical Guide to Mental Disorders” (DSM-V) increasingly refers to the basic molecular events.

Neurodegenerative diseases – such as Alzheimer’s dementia – are diseases of old age. Life expectancy worldwide rose from 50 years in 1960 to over 65 years in 2010. This increase by 15 years has unmasked these clinical pictures. They have always been there, but their symptoms were hardly relevant because other diseases had already led to death.

These orthodox medical examples show a developing understanding for the mental impairments also in the western world. With reference to your initial question, I cannot name any good reasons in Western medicine for this strong physical focus. In Asia this connection of body and soul is, in my opinion, also based on the religious world view. In Japan every object is attributed a soul, which is a completely different basic understanding than our western division into organic/animated and inorganic substances.

 

The immature patient has had his day

The roles of doctor and patient in the future: What was the immature patient yesterday has long since changed. The one who just had to wait patiently and yield to the judgement of the only competent expert in white is no longer satisfied with this role. Or at least should not do it anymore. See below for counter-examples.

Steven Joffe from the University of Pennsylvania has just described in a pleasingly differentiated and clear article how the three factors of patient rights, available knowledge and direct-to-consumer tests have lastingly changed the doctor-patient relationship. He outlines how the immature patient comes to eye level. Joffe’s article deserves an urgent reading recommendation. It is hereby pronounced.

Three factors
  • Factor 1: Patient rights. For the first time ever, their formulation has led to the claim of patients to have their own opinion, their own decision and the corresponding information provided by the physician.
  • Factor 2: The Internet as a constantly growing source of medical knowledge.
  • Factor 3: The increasing availability of medical tests with scientific requirements directly for patients. We have already discussed this new role for laboratories with the associated business models on various occasions here and here. Joffe clearly emphasizes the impact of this development on the entire healthcare system.

For the sake of precision, we are talking here exclusively about the doctor-patient relationship between practicing physicians. The immature patient of the hospital is a similar but more complex subject. I will take up this point at a later date.

A contemporary role of the doctor

Joffe shows how, on the one hand, our traditional image of roles in health care is still very much alive. Here is the expert whose judgement is to be followed. There the receiving patient. On the other hand, Joffe demonstrates how these roles already lose their justification.

The contemporary and forward-looking role of doctors is therefore threefold:

  • The doctor as the patient’s advisor and health coach,
  • the gatekeeper for advanced medical knowledge and special testing, and
  • Finally, access to optimal follow-up services. That is, the medically necessary, although perhaps not directly required of the patient. Here, the doctor is the one who has an overview of the consequences of an illness and treatment. Who, on his own initiative, is committed to what is medically necessary – and in this way creates added value.

So much for the present.

Second opinion at Yahoo?

However, this present also includes this picture from a doctor’s office, which has been circulating on Twitter these days and has received thousands of approvals within a very short time:

 

The immature patient - Dr. Google must stay outside
The sign reads: “Patients who have already received their diagnosis via google are asked to obtain a second opinion not from us, but from yahoo.”

 

The reaction: several thousand likes, hundreds of comments along a line “Patients can be so annoying if they don’t trust the doctor’s diagnosis”. Yes, they are, at least for perceived half- and three-quarter gods in white. Is a doctor afraid of patients who want to take responsibility for themselves? In any case, he has difficulties with setting commas in the4 German language. But there is always something.

Those who hang up such signs in their practice deny their patients much more than just the ability to search the Internet for specific health information. With the reference to Yahoo, the poster looks like it did in the year 2000. The mentality behind it is much older; it goes back deep to the last century.

Counter-question: Who seriously wanted to recommend to a patient to rely exclusively on the knowledge that a single expert reproduces from his memory within a few minutes? With an effort of research, limited by the time that the health care system is currently paying.

A future-oriented role for the physician

Even more important from the point of view of futurology is the question of how to continue the series of trends and drivers:

Patient rights, available high-quality knowledge and B2C test procedures are followed at least by

  • Artificial intelligence in everyday use by doctor and patient,
  • an exponentially growing database in type and quantity,
  • large international players who are entering the healthcare market and claim a competent role here,
  • more and more: an interpretation of biology and medicine as information technology.

On this basis we then negotiate the roles between health seeker (ex-patient) and competent companion, supporter and initiator (ex-physician). The immature patient has had his day.

 

Healthcare of the Future (2/2)

In the summer of 2018, I gave the keynote speech at the Roche Days “Diagnostics in Dialogue”. I then noted a few very basic thoughts on the healthcare of the future. They have just been published by Roche. The first part is here; this is the second part of the slightly shortened text.

From patients to healthcare customers

Data-based knowledge of people’s sensitivities will also blur the boundaries between illness and health. The fact that people are not either 100 percent healthy or ill is not a new idea for the healthcare of the future. However, the broad data basis makes it possible not only to discover existing diseases. In the future, healthy people will also know a lot about the risks of potential diseases. This in turn raises the question of where the line between healthy and sick lies. The WHO defines health as a state of physical, emotional, mental and social well-being that goes far beyond the absence of illness or complaints. A forward-looking understanding.

Today’s patients depend on the data collection, evaluation and interpretation of their attending physician. In their perception, they are dependent on him. Patients of the future have the largest amount of data on their own health status and have access to their evaluation and interpretation. While classical patients look towards illness, symptoms and deficits, future customers focus on health. Patients become health customers.

Customers look for suitable service providers

Health customers are changing the health market with their attitude. They choose the right health service provider to optimize their state of health. Its attractiveness will depend on the added value it can deliver. It will be crucial for the successful service providers of the healthcare of the future to know exactly what the needs of potential customers are. They will analyse how each of their healthcare customers “ticks”, what their needs and expectations are and how best to communicate.

In the sense of “optimized” health, technologies could also be used in the world of tomorrow to expand or fully maintain bodily functions: The contact lens displays necessary information when needed. New organs are created in the 3D printer from the patient’s stem cells. Perhaps it will also be completely normal to order organ replacement from the doctor long before the first organ resigns.

Healthcare of the Future Michael Carl

Human – Machine Organisms

In the future, personal interaction will lose its central role today. People will increasingly experience that a machine simply understands them better. Communication with machines can be superior precisely because it follows clear structures and takes into account a multitude of data and parameters. If we continue to consistently think ahead, computers could become personal assistance systems that make calls on behalf of their owners, obtain information and offers at a frequency and perseverance that people would not be able to. Service providers in the healthcare of the future will have to adapt to this.

As a result, the way work is done will change completely. Where today we are talking about interfaces between man and machine, in the future we will look at man-machine organisms. In learning systems, algorithms will emancipate themselves as human tools. They will become de facto fully-fledged team members and will even take on management tasks.

New way of thinking

All these changes require a fundamentally new way of thinking and thus a change in corporate culture. In order to do justice to the possibilities and progress of digitalisation in the healthcare of the future, we must fundamentally rethink our ideas of values, quality and dealing with mistakes. Our way of thinking so far does not allow us to keep pace with the exponential pace of change. We must not just wait and see. We must act, even if we exceed our competencies and avoid good intentions. In the world of tomorrow, the maxim applies: Better to apologize afterwards than to ask for permission beforehand.

The Future of Healthcare (1/2)

In the summer, I gave a keynote speech at the Roche Days “Diagnostics in Dialogue”. Afterwards, I wrote down some very basic considerations about the future of healthcare. They just appeared in a Roche publication. This is the first part of the slightly shortened text.

The feeling that the world is turning faster and faster is not deceptive. The familiar linear and controlled pace of development is increasingly becoming a thing of the past. Our environment is changing exponentially – one could actually say that our world will never again develop as slowly as it does today. This development will be driven by the large amount of data available – also in the future of healthcare.

Internet of Everything

Today’s idea of data composition and data quality is generally too narrow. Technology experts confirm: By 2020 at the latest, thoughts and sensations will also be part of everyday data. Even today, electrodes can read brain waves used by paraplegic people to steer their wheelchairs. In a few years’ time, electrodes will no longer be attached directly to the patient’s head, but sensors will read our thoughts from a meter away.

Every object of everyday use will potentially be connected to the Internet and networked – the chair on which we sit, our refrigerator or our car. In the so-called Internet of Everything, not only computers, laptops, tablets and smartphones are connected to each other, but also intelligent machines that generate additional data. For tomorrow’s children, the phrase “I’m going online” is incomprehensible, since it would mean that they were offline before.

Networking large amounts of data leads to highly adaptive products that can adapt to the individual, changing needs of people. This especially applies to the future of healthcare: Recorded data from smartphone apps, sensors from smart homes and wearables open up new possibilities for individually adapting health services to each patient.

Personal health networks

This form of personalized medicine is therefore data-centered medicine. Data about a patient is already numerous today, and continues to increase exponentially. Where yesterday perhaps a laboratory value and an X-ray image were the basis of a medical decision, in the future a multiparametric overall picture will be created for the medical recommendation of action. This will also change structures and processes in the context of patient management. Patient data assume the leading role in the entire treatment chain. The data-based knowledge of a patient’s condition and the potential diagnoses, therapies or preventive measures derived from it are also driving the increasing specialization of professions in the future of healthcare.

New health providers

Dynamic healthcare networks will emerge around the individual, whose nodes will be both the traditional players in the healthcare industry and new providers: companies in the food industry, sports and fitness, medical technology or the IT sector. The pace of decision-making for preventive measures or therapies is increasing, as is that of new developments for products and health services. In addition, this form of personalized medicine offers the opportunity to find new places for health and to place health topics flexibly, for example at home, in the car, in a restaurant or at work.

Future of Healthcare Michael Carl

Data Interpretation and Data Sovereignty in the Future of Healthcare

When patients have more and more information, this does not mean more knowledge or understanding at the same time. This is why the explanation and interpretation of data and the communication of risks, for example, are becoming increasingly important. Patients need experts to advise them. However, this role will no longer automatically fall to the family doctor in the future. On the contrary, different players in the healthcare industry are competing for this function, which is usually limited in time. These can be contact persons for certain clinical pictures – for the cancer patient the oncologist, for the woman who wishes to have children the gynaecologist – or contact persons who are important in a certain phase of life, e.g. a caregiver for an elderly person. There will be competition for the control function. Because whoever plays this role will have a decisive influence on the other players in the network and their care tasks.

Blockchain as key

Of course, all these predictions only occur when people release their personal data for medical analysis. Data protection of the future must therefore mean that the patient has sovereignty over his or her data. He determines how they are dealt with. They must be able to rely on the fact that their data is available at all times. At the same time, he must be protected against access by unauthorized third parties.

Blockchain technology plays a decisive role in this context. The best-known and oldest blockchain application is the digital currency Bitcoin. In the blockchain, information is not stored on a single server, but rather decentrally on different computers in a network. In order to falsify information, it is no longer sufficient to hack a single server, but every single computer in the blockchain. This makes the technology particularly secure. It is thus also suitable for the exchange of sensitive health or disease data in the future of healthcare.

Read in part two of the text how data-centric medicine leads to a new picture of disease and health. Digital communication is fundamentally changing the future of healthcare.

Digital diagnostics: Disruption does not start in harmlessness

Today, two tweets have rushing through my timeline. Both touch on the subject of digital diagnostics and they show an idiosyncratic, seemingly contradictory picture. Does digital diagnosis lead to better results – or a diagnosis by a human doctor? And from whom do we want to receive such a diagnosis?

Digital diagnosis as a life saver?

The Intelligent Health AI from Basel is bringing positive news, enthusiastic about the feasibility.

Digital diagnosis: AI can do

One could object: Where is the news? The fact that the diagnostic capability of halfway modern systems of artificial intelligence is superior to human expert knowledge should come as no surprise. This imbalance is well documented. Every oncologist, radiologist and probably almost every laboratory doctor will confirm this. Even if the ideas of the consequences probably differ considerably: The fact is indisputable.

Analog students at MIT?

Futurist Andrew McAfee paints a different but remarkable picture of his practice at the university:

Digital Diagnostics

Contrary to all reason, it seems that the next digital elite – nothing else is being trained here at MIT – is actually putting up with disadvantages. They opt for human diagnostics and not for digital diagnostics. He does not comment on the motives. Even if he did, this would hardly lead to a statistically reliable picture.

Three models of interpretation

Let us place the two impressions next to each other and interpret them together. Three patterns of interpretation seem plausible:

Interpretation 1: In case of doubt, technological fascination is always the solution for the others. Autonomous driving is as inspiring as it perfectly makes sense, if only one’s own steering wheel does remain. I call this the deficit model of technological disruption. The guiding principle is the fear of losing familiar solutions, services and features, despite all the technological fascination.

Interpretation 2: The time lag shows an apparent contradiction. This is the model of harmonization over time. Today, students reject what they will get used to over the coming years. At first glance, this is an obvious idea. At second glance deceptive: Those who allow themselves to be guided by this interpretation are in danger of covering up the disruptive character of innovation with harmony sauce.

Interpretation 3: In this juxtaposition we clearly see how one of the most important innovations in health care will take place. The model of the creation of meaning through innovation. A conventional diagnosis that does not involve life and death will – with good reason – be made and communicated by a human doctor in the foreseeable future. Even if an AI would actually be better, there is no real risk. However, when it comes to the threat of fatal diseases, AI offers a leap in quality; those who want to overcome this threat are less choosy when it comes to choosing the means. The main thing is: something works, even if it´s digital diagnostics.

Disruption does not begin with harmlessness

If this third approach prevails, we will see AI in use very soon. The triumph of digital diagnostics, however, will not begin in the harmless and risk-free, but – on the contrary – where it really counts: In the fight against life-threatening diseases. Ebola, malaria, rapid cancer will bring AI into the everyday life of healthcare before it also devotes itself to the fight against colds and lice infestation. Sometime later.

I tend, you will suspect, to the third interpretation. The most important innovation of healthcare of the future will begin with questions of life and death. But please, judge for yourself.

3D Printing of Organs: State of the Art and Prognosis (2)

The future technology 3D printing of organs. The first part focused on Dr. Anthony Atala and his work at the Wake Forest Institute for Regenerative Medicine in Winston-Salem, North Carolina. He will probably be the first to receive formal approval for 3D printed implants. Dr. Gabor Forgacs has a different focus. While Dr. Atala strives to replace organs 1:1 with printed implants, Dr. Forgacs sees greater potential in the field of pharmacology. He is interested in printing individual biomaterials on which doctors can test the effectiveness and mode of action of pharmaceuticals. A test on the individual body, but before prescribing the drugs to the individual patient. The advantages are obvious: risks are reduced, intolerances become apparent in advance, and dosages can be tested. As a result, patients can be treated more efficiently: cheaper, gentler, more effective.

With Organovo, Dr. Forgacs can claim to have founded the first commercial company in the field of 3D printing of organs. He was already a guest at the 2b AHEAD ThinkTank in 2012. With his focus on samples for toxicological tests, he also avoids most hurdles to approval. In addition, he expects an application of 3D printing, especially in the area of prostheses, which has long since become reality in many areas. Hearing aids have long been in use in the double-digit millions. However, the actual potential of Forgacs’ approach seems to lie in the area of pharmaceutical development anyway. Every day that technology can shorten the enormous development cycles of new drugs is enormously valuable in monetary terms alone.

3D printing of organs Gabor Forgacs

Use cases as drivers for 3D printing of organs

It’s worth taking a look at TeVido BioDevices, a company based in Austin, Texas. In contrast to Atala and Forgacs, founder Laura Bosworth does not start on the technology side, but from a relevant problem. In this case: the reconstruction of the breast after cancer. More precisely: The medically correct, but often visually unsatisfactory reconstruction. TeVido manufactures artificial nipples using 3D printing technology with natural optics thanks to natural substances.

3D printing of organs is therefore a safe candidate for a promising future: technology with experience and potential for scaling, decentralized know-how, relevant use cases.

3D Printing of Organs: State of the Art and Prognosis (1)

3D printing of organs is a regular guest on almost every list of technologies  influencing the healthcare of the future. At the same time, this technology seems almost old again, we have been talking about it for so long. Would we still call it a future technology? Without compromise, yes. 3D printing of organs has the potential to fundamentally change healthcare. The image of our body is changing. yesterday, medicine was working on restoring an original state given by God or nature, tomorrow the improvement and expansion of physical functionalities will become the central task. Here is a brief overview of the main players and their roadmap.

Probably the most important actor is Anthony Atala, surgeon, urologist and director of the Wake Forest Institute for Regenerative Medicine in Winston-Salem, North Carolina. During my most recent visit in spring 2018 I could not only hold a printed kidney in my hand, I could observe machines printing blood vessels, bones, livers, heart cells. His initiative to industrialize the processes for the production of any organs is even more promising. Only half of his total of 500 employees in the laboratory are physicians. At the same time, mechanical engineers, among other things, are working on reliably standardizing the processes in order to be able to offer them at many locations in this way.

The principle “3D printing of organs” is always the same and simple in logic: Whoever is able to grow organs from human stem cells can a) produce organs whenever he needs them and b) will prevent the organ from being rejected by the body. Risks are reduced and lifelong therapies are eliminated. The acute shortage of donor kidneys in particular is eliminated; the transport of transplants is no longer necessary. So far the consensus.

100% or more?

Among the researchers developing this technology, opinions differ at c): Will we also be able to improve the organs? Will my printed heart, my kidney, my liver be more efficient than the original one? And will my organs receive additional functions that were not yet provided for in the original configuration of my body? We see how the image of our body changes in the face of this possibility alone: The functional scope of the institutions, the coordination among each other – all this becomes a configuration. The body becomes a configurable machine. The only difference is whether the ideal is to restore the initial 100% as accurately as possible – or an individual and targeted deviation.

Dr Atala is the most important representative of those who rely on the 100% model. At the same time, he is the one whose laboratory is closest to formal approval by the FDA. His perspective: At the beginning of the 2020s, the first procedures for 3D printing of organs will be approved. First for rather simple structures, later step by step also more complex ones. Until the mid-2040s, it will be normal in many parts of the world to talk to your physician of trust about an exchange of almost any organ as a matter of course. In this way, he expects to be able to increase normal life expectancy to around 120 years.

3D Printing of Organs
Dr. Atala showing a printed kidney

Read about the work of 3D printing pioneer Gabor Forgacs in part 2.