Stratipath har flera år tagit plats på listan över Sveriges bästa teknikstartups. På bara fyra år har deras forskningsbaserade AI-produkt antagits av svenska sjukvårdsregioner. Allt började när MedTechLabs-forskarna Mattias Rantalainen och Johan Hartman kopplades samman med entreprenören Fredrik Wetterhall av KI Innovation.

Hej Fredrik! För den som inte känner till Stratipath, vilka är ni?

– Stratipath utvecklar AI-baserad precisionsdiagnostik som hjälper läkarna inom sjukvården när de ska välja vilken behandling en cancerpatient ska få. Det finns ju många utmaningar inom sjukvården, vi jobbar inom cancerområdet och där det finns många bra screeningprogram, till exempel för bröstcancer. Men många patienter hamnar i sjukdomsgrupper där man inte kan bedöma hur aggressiv cancern är. De analyser som kan svara på den frågan är både dyra och tidskrävande så långt ifrån alla patienter får tillgång till dem. Det leder till en ojämlik sjukvård, din behandling och diagnos kan variera beroende på var du bor eller vilken vårdgivare du träffar. Så i situationer där det står klart att du har cancer men man kan inte bedöma hur aggressiv den är, där kommer vi in med en diagnostisk lösning som bygger på avancerad artificiell intelligens och djupinlärning. Vår metod är enkel, kostnadseffektiv och snabb. I jämförelse med dagens metoder, som kan ta upp emot flera veckor, så tar vår analys under 30 minuter. Just nu har vi en kund som ska starta upp med vår lösning och deras nuvarande analys tar i genomsnitt 20 dagar. Som patient går du under tiden och väntar på din dom. Den här tiden är extremt stressande för patienterna. Och för de anhöriga, kan tilläggas. Det påverkar även arbetet inom sjukvården, där man är angelägen om att komma igång med behandlingen, att behöva boka om patienter och plocka upp ärendet igen, där det krävs att man läser in sig på patientens sjukdom ännu en gång, skapar mycket merarbete.

Förstår de ni träffar vad ni gör?

– När vi träffar våra kunder inom hälso- och sjukvården så upplever jag att de förstår direkt vad vi gör och vad värdet är med våra lösningar. Andra kan ha litet svårare att förstå då det diagnostiska och onkologiska arbetsflödet är komplext och inget som man ser om man inte arbetar i det. Det som många kommer i kontakt med och som man kanske främst förknippar cancerdiagnostik med är screening/mammografi som syftar till att upptäcka misstänkt cancer. Det är det första och endast ett av många steg innan diagnos och behandling. Vi kommer in när cancern är upptäckt och den grundläggande diagnostiken är gjord och man står inför det viktiga beslutet vilken behandling patienten ska få.

Fredrik Wetterhall, VD and medgrundare av Stratipath.

Var står ni nu och vad har tagit er dit?

– Vi är just nu i situationen att tre svenska regioner använder vår lösning i sin diagnostik och vi får med all sannolikhet in ytterligare vårdgivare under våren. Sen tittar vi på att starta upp försäljning i andra delar av Europa, främst norra Europa. Vi startade 2019 och vi kom in i klinisk drift i april förra året, så vi har funnits i fyra och ett halvt år. Vi var tre som startade bolaget och den första anställde kom in 2020. Nu är vi 16 personer som jobbar här på Nanna Svartz väg i Solna. Under dessa år har vi lärt oss mer om vår produkt används, gjort uppdateringar, valideringsstudier och börjat utveckla fler tillämpningar även utanför bröstcancerområdet. Den stora utmaningen vi står inför nu är att rulla ut internationellt.

Det låter som att det gått ganska snabbt för att vara ett life science-bolag?

– Det krävs ju alltid att man har en regulatoriskt godkänd lösning, det var och är ett stort och omfattande arbete att kunna kvalitetssäkra en produkt. Vi hade förmånen att när vi startade bolaget så var redan mycket på plats. Det gick till så att jag, Johan Hartman, patolog på KS och professor på KI och Mattias Rantalainen, docent på KI möttes via KI innovation. Johan och Mattias och deras forskargrupper hade samarbetat under många år redan så vid den tidpunkten hade de redan lovande resultat, så vi startade inte med ett tomt vitt papper och det är därför som vi kunde få ut en produkt förhållandevis fort.

Var befinner sig Stratipath om fem år?

– Då är vi ett väletablerat bolag och finns på huvudmarknaderna, i Europa och Nordamerika. Men vi får redan nu förfrågningar även utanför dessa regioner så vi har säkert etablerat oss på andra marknader också. Om fem år har vi en breddad produktportfölj, både inom bröst, men även inom andra stora solida cancerdiagnoser så som prostata, colorektal med flera. Vi fokuserar på de stora cancerdiagnoserna då vår teknologi förutsätter tillgång till stora datamängder, dva vår teknologi passar inte lika bra för mer sällsynta cancerformer. Vid den tidpunkten erbjuder vi både prognostiska men också behandlingsprediktiva lösningar. En viktig del i vår utrullning är samarbeten med större företag, som Sectra och amerikanska Prosia och Paige. Det finns även fler företagssamarbeten som är på gång men som jag inte kan nämna nu. Det här är en viktig del för att vi ska kunna få genomslag globalt, dessa samarbeten ger oss möjlighet att nå fler patienter. Vi kommer om fem år att vara över 100 personer och behöver öka teamet både inom R&D och den kommersiella sidan. Idag ligger större delen av kostnadsmassan på R&D. Vi kommer inte heller rymmas i dessa lokaler. Vår ambition är att finnas kvar i Hagastaden, men vi kommer nog också att ha sajter utanför Sverige. Så att vi finns nära våra kunder och för att nå kompetens på andra håll i världen. För det går inte att rekrytera bara här i Sverige om vi ska ha den vassaste kompetensen.

Vad betyder Stratipath i ett större perspektiv för svensk medtech?

– Jag kan nog mest utgå från sjukvårdens sida. Vi kan bidra till en mer jämlik och hållbar sjukvård. För den är ojämlik idag. Det finns olika behandlingar och det finns många under utveckling, många bra. Men alla behandlingar kan inte ges till alla patienter, det finns kostnader och biverkningar som hindrar det. Vi kan bidra till en mer kostnadseffektiv sjukvård och vi kan bidra till att sjukvården kan ge sina patienter rätt behandlingar snabbare. Förhoppningsvis kan vår resa skapa intresse för andra forskare och kliniker att ta sin forskning hela vägen till patient, inspirera dem att kommersialisera sina resultat. Sen är det utan tvivel så att vi har byggt en fin kompetens här i Stratipaths team som jag tror kommer gynna andra medtechbolag.

Delar av Stratipaths teamet på kontoret i Hagastaden.

Vad behövs för att ni och liknande bolag ska kunna utvecklas snabbare än idag?

– Tillgång till kapital. Investeringsklimatet i USA och även i Europa är så annorlunda mot här. Där reser företagen fem till tio gånger mer kapital än vad vi kan göra i Sverige, vilket innebär att de kan utvecklas snabbare. Detta har blivit en ännu större utmaning pga krig och oro i världen som gjort att riskaptiten hos investerare gått ned ännu mer, och många investerare är också rädda för hälsovårdssektorn då det vet att det är svårt och tar tid att införa ny teknik. Sen behöver vi kompetens. Inom just vårt område ser vi att det finns bra kompetens in Sverige, men det finns andra länder som satsar ännu mer. Så vi konkurrerar om talangerna med Asien, Europa och USA. Om vi som land vill att vi ska fortsätta vara världsledande inom tex vår sektor behöver vi säkerställa att vi har världsledande forskningen och utbildning, och att det är attraktivt för talanger att stanna i, eller flytta till, Sverige. En sak som vi i näringslivet behöver ta ansvar för är att vi på riktigt förstår sjukvården och vilka problem och utmaningar som finns och verkligen behöver lösas. Här tycker jag att det finns förbättringspotential och jag tror att nyckel är att bolag ska startas kring problemet de vill lösa och inte runt en teknik de vill hitta användning till. Sen tror jag att Sverige måste se till att sjukvården får bättre möjligheter att anamma ny teknologi. Men detta är knepigt för deras främsta fokus ska ju vara att ta hand om patienterna och jag tror att många inom vården är trötta på olika IT-projekt som aldrig tar sig förbi pilotstadiet. För oss är det viktigt att våra lösningar testas och utvärderas i skarp miljö och inte i någon sidoverksamhet, det är först då vi kan få riktig feedback. Här har vi varit lyckosamma men jag vet många som inte varit det. Nästa utmaning är att skala upp användningen och då krävs det oftast ändring i riktlinjer och ersättningssystem. Förändringar av dessa är ofta ganska långa processer som tar många år, som kräver resurser och en uthållighet som inte många mindre bolag har. Det gör att många vårdgivare sitter fast i gammal teknik när det finns både bättre och billigare alternativ. Det är varken bra för sjukvården, patienter eller företag. Här skulle det vara önskvärt att det gick att göra snabbare förändringar, det skulle alla vinna på. Sedan ska man så klart inte tumma på patientsäkerheten eller att ställa krav på klinisk evidens, men jag tror att alla i samhället skulle vinna på snabbare införande av ny teknik i sjukvården. I Tyskland har man infört DiGA för att snabba på införandet av vissa typer av nya digitala lösningar. Det löser långt ifrån alla problem men kanske kan det vara något för Sverige att ta efter?

Vilken är din bakgrund och vad har gjort att du valt att satsa på Stratipath?

– Jag började en gång på Siemens Elema, med utveckling av intensivvårdsventilatorer. Det som fick mig att stanna inom hälso- och sjukvårdssektorn var att jag behöver ett tydligt och bra syfte med det jag gör. Det har jag haft svårt att hitta inom något annat område än hälsosektorn. Jag började med mjukvaruutveckling på 90-talet och har sedan 25 år tillbaka sysslat med kommersialisering och implementering i sjukvården, både på leverantörs- och vårdgivarsidan. Jag upplever det som väldigt stimulerande att utveckla nya produkter inom sjukvården och se hur det skapar radikal förbättring för både enskilda patienter och sjukvården i stort. Under min karriär har jag startat flera företag baserade på forskning från KI. Det var Mats Ferm på KI innovation som matchade mig med Johan och Mattias, och vi började tillsammans fundera på hur vi kunde hitta en modell så att resultaten från deras forskning kan skapa värde för sjukvården och patienterna. Först tänkte vi oss att det skulle kunna ske genom ett större etablerat bolag, men vi kom fram till att vi skulle kunna nå större impact genom att starta ett eget företag. Vi fattade tycke för varandra, där vi såg att vi hade en bra kompetens tillsammans, kommersiellt, kliniskt och tekniskt, och på den vägen är det. Jag är imponerad av Johan och Mattias som kliniker och forskare som vågar satsa på företagande på detta sätt. För det här är en ny värld för dem, att ta steget från forskning och sjukvård och lägga tid och energi på att bygga upp ett företag, för det ska erkännas att det inte alltid är så lätt. Deras drivkraft är att deras forskning ska komma patienterna till godo.

Vad ser du mest fram emot under 2024?

– Att komma ut bredare och nå fler patienter med våra lösningar. Lära oss mer om hur vår produkt används i sjukvården, i Sverige och internationellt. Se den impact som produkten kan göra. Det är det som är mest belönande för en själv, att få se att den används och gör nytta. Det finns så många bolag, projekt och produkter som inte slår. Sen är det väldigt stimulerande att jobba inom det här området, med den snabba utveckling som pågår. När det kommer till teamet är det en ynnest att få umgås med drivna, högkompetenta människor. Jag är extra stolt att vi har en jämn könsfördelning, många nationaliteter, åldrar och bakgrunder. Alla som jobbar hos oss tror jag gör det för ett högre syfte, det förenklar rekryteringen, och det gör det lättare att kliva ur sängen med ett leende och åka in till kontoret även när det är mörkt och snöstorm ute. Passionen är central och viktig för att alla ska orka. Det är inget kort race vi kör, vi vet att vi kommer att behöva kämpa på under många år.

Fakta om bolaget:
Stratipath är ett svenskt bolag som utvecklar AI-baserad precisionsdiagnostik med målet att radikalt förbättra cancerdiagnostiken, och förutsättningarna för alla som drabbas av cancer. Stratipaths AI-lösningar analyserar vävnadsprover från tumörer och möjliggör mer precisa behandlingsbeslut genom förbättrad och snabbare patientstratifiering inom sjukvård, kliniska prövningar och läkemedelsutveckling. Det gör att fler patienter kan få tillgång till precisionsdiagnostik vilket bidrar till en mer jämlik och hållbar cancersjukvård. Stratipath grundades 2019 och bygger på världsledande akademisk forskning vid Karolinska Institutet. www.stratipath.com

In Sweden, more than 18,000 people suffer an acute ischaemic stroke every year. With correct and rapid treatment of stroke, both lives are saved, and the affected person can avoid lifelong disability, something that both provides increased quality of life for the patient and saves big money for society. The new treatment options that have emerged over the past decade require more knowledge in healthcare, which is one reason for the new course offered through MedTechLabs.

The course “Acute stroke, diagnostics and treatment” organised by MedTechLabs started in October 2023. The course is aimed at residents and specialists who want to train in this area to better follow the national recommendations and guidelines for examination and treatment of stroke and TIA. The new course was offered to doctors in Region Stockholm as well as in other parts of the country and was quickly oversubscribed.

We spoke with Håkan Almqvist, senior physician and neuroradiologist at Capio St Göran, who is responsible for the course. Håkan has worked almost all his professional life with stroke, first at SÖS and later as a neuroradiologist at Karolinska and has followed the modern development of how to find and eliminate thrombi/embolisms since the late 90s.

Hi Håkan, can you tell us a bit about the course and why it is given?

“The course aims to provide knowledge about the benefits of acute reperfusion therapy within 24 hours in several patient groups, including those with relatively large established infarcts. The management and assessment of TIA is also included in the course. “The biggest problem with stroke care is still that patients come in too late, so it’s important that everyone in the community knows that help is available and picks up the phone if they have symptoms. But we in the healthcare chain also need to be on our toes and know what is needed for the patients. We must dare to be rational and inclusive, even if there is a low probability of stroke. Because it can be difficult to know whether your judgement is correct. Doctors need to see many cases to become skilled in their judgement and that takes time, especially in a smaller hospital.”

How do you deliver the course?

“In the first round, we offer it free of charge to 40 participants who receive around 30 video lectures and case study material with commentary, which we distribute using Collective Minds Radiology and their radiological imaging system. It is up to the student how much time they spend on that part, but I would say it is about two and a half days, at their own pace. In addition to this, we have a mandatory physical meeting in the form of a seminar in Stockholm where case studies are discussed. The knowledge check takes place at this seminar and active participation is required to obtain the course certificate.”

Who came up with the idea for this course?

“Many of us realised early on that there was a lack of continuing education for the new forms of examination and treatment that have emerged in the field. When MedTechLabs started, it was realised that there was a need for training in the region. Professor Staffan Holmin, together with KTH professor Mats Danielsson, saw an opportunity for the centre to contribute to and provide training. “As early as 2018, we started recording parts of the material that is now used in the course, along with new material in 2023. The pandemic and questions about which platform to use have meant that it has taken some time.”

What do you think has made the course so popular?

“The course only corresponds to a few days where you choose when for about 1 month. That certainly has an impact. But it is up to the student how much time they spend. I think long courses are becoming more difficult to attract. That we have a hybrid approach with self-study with lectures and being able to browse cases combined with a physical seminar with the teachers. A course must also be able to provide both a course certificate and an ST certificate. This is probably exactly what many doctors are looking for in terms of continuing education.”

When will you hold the course next time?

“This is the first time we have held it, and we will of course further develop it based on the feedback we receive from the course participants. Then we will see how many times a year is reasonable. It is also a question for Region Stockholm, which this time allowed doctors from other regions to attend free of charge. But hopefully we will also organise the course in 2024.”

MedTechLabs has granted SEK 35 million for two new medical technology research programmes. The first will develop a new method for monitoring fetal oxygenation during labour. The second programme will develop a new method for early diagnosis of brain diseases using MR elastography.

This year’s call from MedTechLabs was launched in the spring and the decision to adopt two new research programmes was taken by the centre’s steering committee in early October. Johan Schuber, Executive Director of MedTechLabs, says that the approved programmes strengthen the centre’s focus on conducting clinically relevant research.

Current fetal monitoring methods have weaknesses and the researchers in this new programme aim to improve them to reduce the risk of organ failure in the baby during delivery. This is an important area of research that affects many patients and maternity services, not only in Sweden but also worldwide.  

The programme ‘Continuous lactate measurement and prevention of fetal hypoxia during delivery’ is led by Malin Holzmann, Karolinska Institutet (KI), and Saul Rodriguez Duenas, Royal Institute of Technology (KTH). Malin Holzmmann is a senior physician at the Unit for Pregnancy and Childbirth at Karolinska University Hospital in Solna, Sweden, and an associate professor at KI. Saul Rodriguez Duenas is a senior lecturer at the Division of Electronics and Embedded Systems at KTH. The goal is to achieve continuous lactate measurement during labour, which would represent a completely new technology in healthcare with the potential to fundamentally change fetal monitoring.

The second research programme focuses on understanding how brain tissue changes when exposed to diseases such as Alzheimer’s, Parkinson’s, MS, or brain tumours. With the increasing availability of drugs to treat these diseases, early detection of the diseases in time is becoming more important to slow down disease progression as effectively as possible.

The programme “Clinical application of next-generation brain magnetic resonance elastography for neurodegenerative diseases and brain tumours” is led by Rodrigo Moreno, KTH and Tobias Granberg, KI. Rodrigo Moreno is Associate Professor and Senior Lecturer at the Department of Biomedical Engineering and Health Systems at KTH. Tobias Granberg is Senior Lecturer at the Division of Clinical Neuroscience at Karolinska Institutet. MR-Elastography (MRE) is already used today to diagnose liver diseases, but its complexity has so far hindered its clinical use for the diagnosis of brain diseases. The main objective of this multidisciplinary programme is to enable MRE to be performed also for the brain and to evaluate its clinical utility in neurodegenerative diseases and brain tumours. The project covers MRE technology from image acquisition and analysis to its use and evaluation in clinical trials. The goal is to enable clinical implementation in Region Stockholm within five years, thus contributing to better treatment for patients.

Research in both programmes is expected to start in January 2024.

MedTechLabs is an interdisciplinary centre for patient-oriented research that will contribute to breakthroughs in the development of medical technology with significance for the important challenges of healthcare and our major public diseases. In all programmes, researchers and clinicians with both technical and medical expertise collaborate. The centre is run jointly by KTH, Karolinska Institutet and Region Stockholm.

For more information, contact:

Johan Schuber
Executive Director of MedTechLabs

Phone: 08-790 67 64
E-mail: jschuber@kth.se

Website: www.medtechlabs.se

LinkedIn: https://www.linkedin.com/company/medtechlabsstockholm

SVT – the Swedish national broadcasting company – highlights the impact of research on AI for breast cancer detection in mammography, conducted by MedTechlabs researchers Kevin Smith and Fredrik Strand. Also, Lancet published a scientific article on the study conducted at Capio Sankt Göran Hospital in Stockholm.

What differences in cancer detection and unnecessary recalls are the results of various combinations of AI and radiologists? Lancet Digital Health has published the results of a prospective clinical trial conducted in Stockholm.

MedTechLabs researcher Fredrik Strand is surprised at how accurate the AI was and says that the potential for AI to handle most of the screen-reading is huge.

Karin Dembrower is chief physician and medical director of the Mammography Department at Capio S:t Göran’s Hospital where the clinical study was conducted. She is very satisfied with the results.

– We found slightly more cancer and recalled fewer women who turned out to be healthy, so we made fewer women worried. And we freed up time for the radiologists to do other diagnostics than looking at mostly healthy women’s images. We have managed to cut the queues considerably so we are a queue-free breast centre now, she says in the feature.

The AI-assisted breast cancer detection system has been operational since summer 2023 at St Göran’s Hospital in Stockholm.

– We have shown that our AI technology works on St Göran and their equipment. But that doesn’t mean that any AI will work on all equipment, so it’s something you need to check before introducing it, says Fredrik Strand in the same feature.

Watch the tv-feature here (in Swedish)

Read the Article in Lancet Digital Health here (full text)

On the 24th of August MedTechLabs were proud to be among the medical research facilities in Stockholm and Uppsala to host a visit by GE Healthcare Top Management. Their team was happy to see the progress of the world’s first clinical evaluation of the Deep Silicon CT detector technology for photon counting CT here at BioClinicum in Hagastaden.

Peter J Arduini, President and CEO at GE Healthcare later stated:

“I spent time in my early GE HealthCare career working in CT. This week, it was thrilling to be at the epicenter of this exciting innovation, and I look forward to the potential transformation it will create for CT and the benefit for patients worldwide. Photon counting has the promise to further improve the capabilities of traditional CT and increase imaging performance for oncology, cardiology, neurology, and many other clinical CT applications.”

 

On 19 April 2023, MedTechLabs organised a seminar focusing on strategies for researchers to better identify and protect their digital innovations. Also on the agenda were tactics and practical tips on patenting or other ways to extract business opportunities from science linked to digital applications.

Niclas Roxhed, director of MedTechLabs, began by giving a background to MedTechLabs and its focus on interdisciplinary, translative research in later phases, proximity to clinical trials and clinical implementation, and industrial collaboration. He then gave the floor to Måns Marklund, IP strategist and founder of Cascelotte.

Måns then explained how he and his company have analysed results from researchers linked to MedTechLabs, examined the volume of patents and also made an in-depth study of their quality, potential economic value and technical standard. Compared to some of the world’s best research centres, these patents were found to be of a very high standard, especially those linked to Mats Danielsson and his research teams.

– Other research at MedTechLabs turned out to be more linked to digital applications and artificial intelligence, which may be one reason why this kind of research does not lead to as many patents. After discussions with Johan Schuber, Executive Director of MedTechLabs, we therefore decided to investigate this phenomenon more closely, said Mats.

How good is Sweden in international comparison?

Mats explained the importance of looking at the differences between different kinds of technologies. Normally, Sweden ranks 12th in the world in terms of all technology patents. However, many come from Ericsson, which inflates the volume. In life science alone, Sweden is ranked 15th, which is still very high, and an indication of how good Sweden is even without Ericsson.

– In AI, Sweden is ranked 20th in terms of patents, also very high considering we are a small country. But perhaps there is room for more patents, with increased knowledge of how this works and why patents should be granted in this area as well. We also know that if there are patents in an area, there are many other intangible assets there. It could be trademarks, knowledge of data and data use, design and so on. So, the patents indicate a country’s ability to transform innovation into economic value, Mats explained.

He went on to add that AI is also one of the most patented assets now, so it is not true that AI cannot be patented, even if it is slightly different from other technologies. This also applies to the life science area in general, compared to other patent areas.

– It is important to understand which strategies, tactics and practical approaches are good to know when it comes to both AI and life science. Therefore, we chose to invite Michael Kitzler and Malin Keijser Bergöö, who both work as lawyers specialised in European patent issues at Rouse, said Mats and handed over to these speakers.

Positions of control and the commercialisation of innovation

– In a commercial context there are some fundamental questions you need to ask yourself, like what you’re selling – sometimes it seems like you’re offering one thing when it’s actually something else. In the context we are talking about now, many of you are probably in an early phase of commercialisation, maybe you have created a company and you have something to sell to someone, Michael began.

He then described how Rouse usually starts by identifying the intellectual assets that the research team or company has built up over time and then translates these into different “control positions”, which he explained as the aspect of control that creates ownership and/or control over an innovation over time. Some of these can be patented, some may need to be kept secret until later, some can be contracted with other actors, and some are based on a unique combination of capabilities that are difficult for others to acquire.

He explained that different companies/teams need different mixes of control over assets and gave the example of a company that had 55 per cent of its assets covered by patents, 25 per cent by external agreements of some kind and 10 per cent by secrecy-based control. Software and IT companies tend to have fewer patents and are more likely to use other methods, while high-tech companies put a lot of effort into getting patents. Michael argues that medtech companies are somewhere between high-tech companies and software companies in terms of control positions.

– Looking at the trends in medtech, the statistics show that there are more patent applications in this industry than in others. So, is it worth the money to make these applications? Probably, said Michael. 

The largest patent owners in medtech include companies like Siemens Healthcare, Philips, Fujufilm, Canon Medical Systems and Merative. Then there is a “long tail” of companies that may not have as many patents, but these can be very important. Michael gave the example of Elekta, with only 12 patents in the field of AI, but which are very significant. Even further down the list, there are companies with maybe four patents, which can be very relevant portfolios despite their small number. To summarise, it doesn’t take many patents to make a difference and achieve commercial success, it’s all about the content of those patents, Michael explained.

Michael then listed the commercial values that patent control positions create for medtech companies, from limiting business risks to contributing to the company’s participation in key ecosystems (see image below).

Patenting medtech and AI in practice

– Your field is one of the toughest to patent. Partly because it has to do with things you do with the help of computers, which the patent authorities are very careful about before approving, which makes it complicated and requires more work and the right strategies, Malin began.

She explained that in some countries there is a ban on patenting treatments, which can affect companies, and that you are then allowed to patent the devices you use, not the methods. This differs depending on where you are in the world; in China, for example, it is easier to patent treatments. In Europe, on the other hand, it is often impossible to patent treatment methods. In the US it is more unpredictable, where a single court decision can change the situation so that it suddenly becomes possible to patent something that was previously impossible, and vice versa. Malin emphasised that having said that, it is still often possible to patent – in some way. You may have to go through the equipment instead of the method, or do it in other ways, but it is always possible to patent something.

– One thing we saw when we looked at medtechlabs was projects in bioelectronic medicine where inflammation is reduced by electrical stimulation via an implant. If you want to patent at an early stage here, the concept constitutes a treatment method, which means that you might choose to patent the implant instead. But competing companies may then choose to use a different implant. So very broad concepts can be difficult to patent with commercial success, Malin explained.

She then gave an example of pacemakers. A pacemaker stimulates the heart and is therefore considered a treatment, which cannot be patented in Europe. But the actual method of identifying which signals the pacemaker should use to stimulate the individual patient’s heart in the right way can be patented – if you state that you store this data somewhere and do not use it directly to stimulate the heart. Then, of course, you can also use this stored data to stimulate the heart. An example of how you can adapt the design of patents to the legislation and get an effective patent that provides indirect protection for the treatment method anyway.

Malin also gave the example of a company that has patented a detailed description of how they trained their medical image recognition algorithm, thereby gaining intellectual property protection for their innovation. This protection has been granted worldwide, including in Europe. Another example involved wristbands used to alert an elderly person to a fall. The company used AI and machine learning to correctly interpret the signal from the bracelet. The solution to obtain patent protection here was to focus on specific parameters that were used when the algorithm analysed the signal to distinguish between an accident and the wearer just lying down. Such parameters could be, for example, which room the wearer was in, whether the wearer had moved, slept recently, run, etc. The combination of parameters provided a basis for the way the algorithm works, and this was the basis of the patent application.

– One challenge when you want to patent AI solutions is that you can’t always describe why the solution gives the answers it does, because they are based on an algorithm that has trained itself to find the answers on huge amounts of data, but in patent applications you have to be able to describe this, said Malin.

Michael summarised the need to contextualise AI and gave some key takeaways: patenting can be a powerful tool to control the value-creating phenomena that arise in digital medical technology. However, a systematic approach is required by those who want to create control through patents and other control measures. Finally, patenting in digital medtech is more complex than in most other fields and therefore requires well thought-out strategies. To achieve powerful patents in medtech, you must do the right thing, which often requires a more systemic approach. You also need to understand the full range of assets you have and how they can be used and controlled, concluded Michael.

Questions from the audience

Niclas then moderated questions from the audience, to which the participants provided answers. 

Question: What is required to be able to patent an AI model for radiological images?

Answer: The way to build and train the model, e.g. based on specific parameters, if these are very different from other models, then it is easier to patent it, provided it is new. Just using a general model trained on many images is more difficult.

Question: What happens if a researcher has published an academic paper describing such a method?

Answer: It depends on how long ago it was published. In the US, you have one year to apply for a patent after publication without blocking yourself from patenting. In Europe, you must apply before publication. It should be added that academic papers do not always disclose the whole innovation, they can be more general and do not necessarily describe details that make patenting impossible, in Europe.

Q: What happens if you have patented and published something and then want to patent something that is slightly different from what was first patented?

Answer: It always gets complicated if you change things in a follow-up patent application. It is better to have everything worked out and right from the start. But the reality and needs of publishing an innovation may take priority and you should generally file an early patent application; it is better than not claiming your innovation at all.

Q: What does protection mean in practice if a large company infringes?

Answer: Unfortunately, those with the most money win. But if you have a patent, you can enlist the help of another big company to help you win against the infringer. The patent can also act as a deterrent to large companies who don’t want to get into trouble. Large companies may also appreciate that a smaller player talking to them has a patent for their innovation, so that it is clear what it is about.

Question: You can’t patent data, but can you patent the way you curate data when training an AI?

Answer: It depends on whether the approach is very different from how the same thing has been done before. If it is done in a different way, it can work, compare with the example of the bracelet that would warn of falls, where the choice of parameters was part of the curation. Then there is the actual database protection, that you own this data. And when you process the data, a new data set is created, much like the translation of a literary work from Swedish to English. In some cases, it can be difficult to prove who originally owned the data. The EU also requires that certain health data must be made available to other users, known as data sharing.

Q: Does a patent application need to have proof that the innovation works?

Answer: No, normally not. A classic example is the patent protection of perpetual motion machines.

Question: Can recommendations for treatment be patented?

Answer: Yes, the example of the pacemaker is such a case, where the signal to be used for the treatment was first stored and then used.

Question: Is it common for sufficient preparatory work to be done on IP at the pre-commercial stage? Answer: Yes, I would say so (Michael). But you should always make a business case before applying for a patent, because it can cost around one million to do all the IP work, and then you need to know that you will earn at least that amount to make it worthwhile (Malin).

KTH Innovation: we can help in these phases too, for the researchers who need it.

Nicklas: And KI Innovation can also contribute in a similar way.

Niclas: and to present a credible business case, you need to try in the IP area beforehand. This is at least my experience from this area.

Michael: And we’ve said here today that all patents can ultimately be broken by big players, but if you don’t have a patent right from the start, you have no control over what you’ve come up with and no negotiating position.

Niclas: What belongs to the field of medtech is also the long lead times, not least when the innovation is to be tested clinically and then implemented, generating the need for a lot of additions to the patent application.

Question: What are the three most important things to consider for a research group that has developed an innovation and wants to commercialise it in the future?

Niclas: To patent at all. I always suggest it to my postdocs – for every paper, the legal requirement that it is an innovation is there. There should be potential there. For every paper we publish, we submit a patent application, in principle. You also have to consider whether you can get your money back on such an investment. If you don’t see that possibility within a year, you might drop the application. 

Question: We talked earlier about how you can’t protect a biomarker, but you can protect technical equipment. Nor can you patent a single molecule, but is it possible to patent a combination of molecules?

Malin: It depends on the country. In the US, you used to be able to patent treatments using a combination of biomarkers, but that is no longer possible. Nowadays this is considered a natural phenomenon that cannot be protected.

Question: how to protect AI innovation in early collaborations between researchers and companies. How do you protect the agreements you make there, when you may not even have published anything?

Michael: This is an important phase where you need to define the origin of the innovation through agreements. Even if it is too early to apply for the patent, the agreement is valid in court. Unfortunately, research teams often settle for agreements that are too general and do not go into the details of who owns what and how this will be handled at a later stage. Again, researchers need to get proper help from lawyers who know this area, because creating these agreements is complicated. I have seen so many cases where it has gone wrong.

Question: How broad can patents for diagnosis based on AI be?

Answer: It depends on whether you put in things like what parameters you used. Just using general descriptions that you used AI is not enough. Then your patent may only cover, say, 17% of the solution you developed. But then you still have protection for that part of the window. Many patents are quite narrow, but if you have the smartest solution, the market will probably not settle for an inferior solution just because it is not protected. And then you have something to sell.

Do we have the right organisation for highly specialised care in Sweden, with seven university hospitals competing for highly specialised assignments?

That question was debated at the Almedalen seminar where Staffan Holmin and Mats Danielsson participated: “From frontline to routine care. How to create the cutting-edge healthcare of the future?”. The panel also included Acko Ankarberg Johansson, Minister of Health, Björn Zoëga, Hospital Director, Karolinska University Hospital, and Annika Östman Wernerson, President of Karolinska Institutet, Olivia Wigzell, Director General, National Board of Health and Welfare.

Portrait picture of Mats Danielsson and Staffan Holmin

The seminar was organised by the Karolinska University Hospital and Dagens Medicin Sverige. Nina Hedlund was the moderator. Here is a web link to the seminar (which was held in Swedish): https://lnkd.in/gih5QWay

In episode no 121 of Karolinska Institutet’s podcast Medicinvetarna, Magnus Boman gives his views on potential applications and ethical challenges in the use of AI in medicine and research. 

On behalf of the MedTechLabs steering committee, Magnus Boman is mapping healthcare needs in terms of AI, and possible synergies between research centres and suggests training courses in the area that MedTechLabs should be responsible for.

You can find the episode here (in Swedish).

Picture of Magnus Boman

Associate Professor Peder Olofsson, Department of Medicine, Solna, Karolinska Institutet, and MedTechLabs research leader, receives the Heart-Lung Foundation’s major research grant of SEK 15 million in 2023. He receives the grant for his research on the stimulation of the nervous system for the treatment of atherosclerosis.

Cardiovascular disease, of which atherosclerosis is an important cause, is the most common cause of death in Sweden and worldwide. Peder Olofsson will use the grant to investigate whether it is possible to reduce atherosclerosis by stimulating the body’s own nerve reflexes.

“Our goal is to develop new treatments for cardiovascular disease that utilise the body’s own nerve reflexes. It is important to better understand how the nervous system regulates atherosclerosis and vascular inflammation – key causes of heart attack and stroke. This can open up completely new approaches and specific treatment of hitherto unknown disease mechanisms,” says Peder Olofsson, in a press release from the Swedish Heart-Lung Foundation.

A new centre that brings together current and future expertise and technology in medical imaging. Expectations for the Centre of Imaging Research (CIR) and what it can achieve in terms of research, industry collaboration and clinical application are sky-high. In this article, Daniel Lundqvist, who heads the centre, talks about how the CIR will make its mark in Sweden and internationally.
Daniel Lundqvist formally became director of CIR - Centre for Image Research - in October 2022. The importance of the new centre was marked by the participation of both Karolinska Institutet's President Ole Petter Ottesen and Karolinska University Hospital's CEO Björn Zoëga in the inauguration. Most of the centre is in Karolinska University Hospital's BioClinicum research building, which is also well integrated with KI. MedTechLab's CT lab is now part of the CIR infrastructure. One block away is the Scilifelab, which also conducts research in the field of imaging.

Daniel Lundqvist is a brain researcher at KI and has a passion for medical infrastructure. He explains that the first thoughts of a single imaging centre came more than 20 years ago, and that brain researcher Martin Ingvar, former head of the MR Centre, and Staffan Holmin, physician and research leader at MedTechLabs, were among those who started working on realising the ideas early on. 

The CIR will bring together the best instruments, platforms, and technologies available in medical imaging, and Daniel has started building the centre's structure and initial operations. 

– In addition to the co-location, we have upgraded with the latest in medical imaging technology. But I want to emphasise that as important as it is to have all this great technology in one place, it is equally important to bring together all the experts in the field of imaging so that they can collaborate and learn from each other, Daniel explains. 

By bringing these people together, level four of the BioClinicum also forms a professional community that is unparalleled in the world. The CIR is likely to be attractive to researchers internationally, which will benefit recruitment to research projects linked to the centre. 

One goal of the CIR is to create benefits for users in research, healthcare and industry. The centre makes it possible to devote resources to their common needs, such as a new platform for storing and sharing image data, which would have been difficult for the various users to create on their own.

The activities at CIR will contribute to the translation of research results into clinical activities, known as translational research. This is facilitated by the proximity to Karolinska University Hospital, which is just a stone's throw away with its doctors and patients.

CIR is partly based on imaging facilities that have already existed for a long time at Karolinska Institutet and Solna University Hospital. What is new is that these are being brought together physically. An important reason for establishing the centre was the realisation of how important it is to be able to perform multimodal imaging, i.e., to combine different types of imaging. Today, this is a logistical challenge when facilities are scattered in different locations, and it also puts a strain on patients or research subjects when they must be moved around. Surprisingly rarely, for example, MRI, MEG, PET and CT are combined on the same individual, even though it is often important to obtain a detailed and multifaceted overall picture. The CIR will therefore enable a wide range of imaging of the structure, function, and metabolism of living organs, using the various modalities of technology available and constantly evolving. The diagnosis and study of cancer, cardiovascular diseases and brain imaging are the focus. For example, NatMEG, a national infrastructure for magnetic encephalography that is one of the most advanced in the world, will be part of the centre. 

One of the CIR's strengths is that we have the very latest or even tomorrow's methods that we are evaluating and trying to utilise. Such as the new photon counting CT technology with silicon detectors that is now being validated in MedTechLabs and a new MRI with ultra-high field strength, called 7-tesla, which is available in Huddinge. - We are currently upgrading NatMEG with an improved system for measuring brain activity with a 128-channel system for on-scalp MEG. This is the latest and greatest in the world," says Daniel.

The centre's ability to provide researchers and clinicians with more information about the appearance, function and metabolism of organs can be of great importance for individual patients with severe diseases. Daniel takes epilepsy as an example: 

- In the brain, epileptic seizure activity can begin as an intense activation of a very small cortical region, which then expands over time to involve progressively larger and larger cortical areas. If a patient needs surgery to remove the part of the brain where seizure activity starts, one will naturally want to identify the exact starting point as accurately as possible. With the technology available at CIR and NatMEG, we believe that it will be possible to find the seizure activity’s starting point more accurately and thus the method can also guide the neurosurgeon with greater certainty, says Daniel.

Another exciting area where CIR could play an important role is theranostics, which combines therapy and diagnostics. Theranostics uses a targeted radiopharmaceutical that can identify and diagnose the extent of a cancer, and then treat the cancer either with a therapeutic radiopharmaceutical (or with targeted oncological treatment).  This method successfully improves the effectiveness of cancer treatment while maintaining quality of life. The field is relatively new and rapidly developing. Sweden has an internationally prominent position in the field, and is among the most active countries in Europe, both in the preclinical development of theranostic drugs to translating and participating in clinical theranostic studies and in initiating them. 

Nationally, there are many links to CIR and Daniel is already involved in several Swedish coordination projects where the focus is on sharing and making data available. Internationally, the centre will also be an important Swedish node for various research collaborations, such as the European e-infrastructure for brain research, EBRAINS. Synchronising CIR with EBRAINS will make it easier for CIR's imaging platforms and users to share and use data in European collaborations between researchers, clinicians, and industry. 

- It has taken a while to realise what a great job I have been given and I am both proud and humbled by this assignment. Since I have worked with imaging issues and imaging infrastructure for a long time, I know that it can be challenging and involves a lot of responsibility. But it is so exciting to be involved in creating something that offers new and unique opportunities that will ultimately benefit healthcare and patients. I share this feeling with many others who will work here at CIR, concludes Daniel.