Intervju: Cosylab - Kako bo covid - 19 spremenil zdravstvo in zdravljenje

Pandemija bolezni covid-19, ki jo povzroča zahrbtni koronavirus, se v večini držav še ne umirja, navkljub požrtvovalnim naporom zdravstvenega in podpornega osebja. Javno življenje je v številnih državah po svetu ohromljeno, njihovo gospodarstvo pa deluje zgolj s polovico moči. Medtem, ko se zdravniki in sestre borijo za življenja množice umirajočih bolnikov na respiratorjih, se podjetja poskušajo prilagoditi spremenjenim razmeram dela in gospodarjenja, hkrati pa uveljaviti nove rešitve.

Med njimi so tudi proizvajalci medicinskih pripomočkov, ki se že pripravljajo na nove izzive v zdravstvu po koncu pandemije. Pri današnji zdravstveni krizi gre namreč za mnogo več kot samo za »maske, respiratorje in cepivo«. Agilna manjša podjetja in startupi že danes ponujajo trgu prelomne medicinske rešitve in pripomočke, ki napovedujejo prihodnost zdravstva. Med mnogimi lahko navedemo, denimo, Smart Blood Analytics z AI-podprto analizo krvnih preiskav za diagnostiko koronovirusa, MESI Medical s kompaktnimi EKG »tablicami« ali UVentions s pametnimi UV-sterilizacijskimi sistemi za široko uporabo tako v bolnišnicah kot v domovih.

Inženirska hiša Materialise, specializirana za 3 - D tiskanje, je razvila napravo, ki lahko delno nadomešča respirator, saj zagotavlja nadtlak za dihanje kar prek kisikovega voda. FDA je dovolila rabo domačega dializnega aparata »na kolesih« podjetja Outset Medical, ki za delovanje potrebuje zgolj dovod navadne vode in električni priključek. Podjetje Dynocardia je razvilo nosljivo napravico ViTrack za zvezno merjenje krvnega tlaka z optomehanskim senzorjem.

Največji izziv, ki čaka startupe, je kako zadostiti regulatornim zahtevam za medicinske pripomočke. Zagonska podjetja namreč nimajo vpeljanih sistemov in znanja, kako voditi celotni razvojni proces v okviru regulatornih okvirov. Značilni čas za uvrstitev medicinske naprave na trg je 3 do 5 let, za bioinovacije ali nova zdravila pa je lahko še daljši.

Kako izziv premagati? Obstajajo inženirske hiše, ki že obvladajo celotni proces razvoja medicinskih pripomočkov, od planiranja in razvoja do končne certifikacije ustreznosti in umestitve izdelkov na trg. Te lahko pomagajo zagonskih podjetjem uresničiti načrte, saj imajo izvedence za vsa potrebna področja in tudi vpeljane procese.

Ena od takih grup je ArrowFast Medical Device Engineering, ki je nastala v okrilju družbe Cosylab d.d. s sedežem v Ljubljani, svetovnega integratorja krmilnih sistemov za protonsko terapijo in velike fizikalne naprave. Njen vodja, Igor Rogelj, poudarja: »Družba se pod pritiskom pandemije začenja zavedati, da se moramo precej bolje pripraviti, če želimo zavarovati družbo in gospodarstvo v primeru novih epidemij. Pričakujemo korenite spremembe v delovanju zdravstvenih sistemov, ki bodo nastale zaradi ukrepov držav in mednarodne organizacije WHO od zgoraj, hkrati pa bodo plod tudi inovativnega delovanja podjetij in posameznikov, ki bodo spremembe gnali 'od spodaj'.«

Glede smeri zdravstvenega razvoja Rogelj dodaja: »V ArrowFastu izrecno vidimo inovacijo v avtomatiziranih in varnih sistemih za diagnostiko bioloških vzorcev brez stika z zdravstvenim osebjem - najsi bodo to drive-in točke, diagnostični »strežni avtomati« ali celo daljinske naprave za domačo merjenje življenjsko pomembnih funkcij. Le malo pozneje bodo v prihodnosti prišle na vrsto množične nosljive in mobilne napravice za pametni nadzor funkcij in zgodnje diagnosticiranje bolezni. Samo vprašanje časa je, kdaj se bo razmahnila raba telemedicine in videokonferenčnih konzultacij pacientov z zdravnikom. Naprave za daljinsko nadziranje in upravljanje zdravja bodo postale naša stalnica.«

»Ne gre zato«, konča Rogelj, »da smo v naši grupi bili sposobnejši od drugih inženirjev za medicinske pripomočke. Gre kratko malo za to, da imamo že vrsto let izkušenj ter znanje in vzpostavljene procese za razvoj in certifikacijo medicinskih naprav. Take izkušnje pa so odločilnega pomena za uspeh startupa, in sicer za uspešno certifikacijo naprave in plasiranje novega proizvoda na trg.«

 Kako bo covid-19 preoblikoval zdravstveno industrijo in spodbudil inovacije

Igor Rogelj je vodja iniciative ArrowFast, ki je nastala znotraj visokotehnološkega podjetja Cosylab d.d. z namenom, da zagonskim podjetjem s področja medicinskih naprav omogoči čimhitrejši preboj na trg v času pandemije in posledic, ki jih bo le ta prinesla. Igor zadnjih 25 let deluje na področju visokotehnoloških startupov, ki se ukvarjajo z nišnimi rišitvami in produkti na področju medicinskih naprav.

Igor, mi lahko poveš nekaj o svojem ozadju; kaj te je pritegnilo k medicinski tehnologiji in zdravstveni industriji?

Izjemno me privlači nivo inovacij in visoke tehnologije, ki smo ji priča v zdravstveni industriji. Poleg tega pa vidim resnične, merljive, koristi dela, ki ga opravljam. Veliko sem tudi delal s startupi, kjer si vedno lahko priča novim tehnologijam in izzivom. Najprej sem delal za podjetje Plasmait iz Gradca, kjer smo razvijali posebne naprave za proizvodnjo medicinskih delov, kot so stenti, vodilne žičke, namenske medicinske niti in igle za diabetike. Zdaj sem v Cosylabu, kjer se ukvarjamo s programsko in strojno opremo za medicinske naprave.

Kako meniš, da bo pandemija koronavirusa spremenila zdravstvo?

Pandemija je bila velik šok, ob enem pa prebujenje za zdravstvo po vsem svetu, pa tudi za celotno družbo. Dojeli smo, da se s takšnimi pandemijami ne znamo učinkovito spopadati, kar pa nas bo prisililo v zelo konkretne spremembe v prihajajočih letih. Spremembe se morajo zgoditi od zgoraj navzdol, torej od Svetovne Zdravstvene Organizacije in vlad, menim pa, da bodo glavno gonilo sprememb inovacije. Te bodo zdravstvu omogočile, da se reorganizira in na novo opremi, hkrati pa postane mnogo učinkovitejše v boju z epidemijami in pandemijami, kot je covid-19.

Vlade in zdravstvene organizacije bodo morale temeljito razmisliti o tem, kako se bodo spopadale s pandemijami, in sicer z vidika pravočasnega in fokusiranega odziva ter hitrega vpoklica delavcev v nujni pomoči, še predvsem pa v učinkovitem diagnosticiranju in zdravljenju pri močno nalezljivih boleznih. Menim, da bomo videli inovacije na področju avtomatizirane in varne diagnostike z minimalno vpletenostjo medicinskega osebja. Tak primer so laboratoriji za odvzem bioloških vzorcev, kamor se zapeljemo z avtom, avtomati za diagnosticiranje, pa tudi naprave za diagnozo na domu. Še dlje v prihodnosti pa lahko pričakujemo, da bodo mobilne in druge naprave, ki jih lahko nosimo, igrale veliko vlogo pri preventivnem nadzoru in zgodnjem odkrivanju. Telemedicina in virtualni posveti med pacienti in zdravniki bodo v prihodnosti postali norma. Če bomo želeli zaščititi družbo in ekonomijo, se bomo morali na prihodnje epidemične izbruhe veliko bolje pripraviti. Zato pričakujem, da bo v zdravstvu prišlo do tektonskih premikov.

Kakšne inovacije lahko pričakujemo v zdravstvu in medicinskih napravah v času recesije, ki se videti neizbežna, oziroma je že tu?

Poleg smrtnih žrtev, ki smo jim že priča, bomo zagotovo občutili tudi gospodarske posledice pandemije. Po drugi strani pa krize vedno prinesejo tudi inovacije. Vodje novih programov in pobud že zbirajo sredstva, pa tudi podporo glede regulative, da bi okrepili inovacije v zdravstvu. Že zdaj se kaže, da bo tvegani kapital veliko vlagal v startupe za medicinske naprave in v nove poslovne modele, ki bodo omogočali učinkovito spopadanje z globalnimi okužbami vsemi spremljajočimi tveganji za javno zdravstvo.

Rekel si, da bodo spremembe prišle od zgoraj navzdol, pa tudi od spodaj navzgor. Kdo bo gonilo inovacij, ki bodo privrela od spodaj?

Glavno gonilo sprememb so vedno inovatorji in startupi. Ti so najpomembnejši! Velika podjetja so preveč strukturirana in prepočasna, da bi se lahko dovolj hitro odzivala na spremembe - in jih hkrati omogočala. Po drugi strani pa so majhna, agilna, podjetja izjemno hitra, saj se lahko osredotočijo na obstoječi problem. Ko svojo rešitev pripeljejo na trg, pa zagotovo postanejo tudi zanimiva tarča za prevzem.

Kakšna podjetja, produkte in rešitve nam bo prinesla pandemija?

Vidimo, kako dejavno so se podjetja odzvala na pomanjkanje respiratorjev. Imamo številne in raznovrstne iniciative, med njimi tudi slovensko. Podobna je tudi pobuda cambriških podjetij, ki prav tako razvijajo respirator »z nule«. V bitko so se vključila tudi velika podjetja, kot so Airbus s svojim respiratorskim izzivom. Nemški startup Uventions, denimo, razvija rešitev, ki omogoča razkuževanje prostorov prav medtem, ko zdravstvena ustanova deluje, ne da bi škodovala ljudem.

Omenil sem že možnosti diganosticiranja s strežnimi avtomati, brez navzočnosti zdravstvenega osebja. Verjetno bo diagnostika postala cenejša in dostopnejša tudi bolnikom samim. Morda se bo tako razširila, da jo bomo lahko uporabljali kot preventivo in bo postala del našega vsakdana. Tudi na tem področju že opažamo številne iniciative, ki poskušajo razviti najhitrejše, najvarnejše in najcenejše diagnostične naprave za koronavirus. Tako,  denimo, švicarsko podjetje s slovenskimi koreninami, Smart Blood Analytics, razvija AI model, ki paciente diagnosticira na temelju rutinskih krvnih preiskav. Na področju umetne inteligence (AI) je že mnogo podjetij, ki trdijo, da lahko predvidijo ali celo diagnosticirajo okužbe in omogičjo omejevanje izbruhov samo z analizo velike količine podatkov ali odvzetih krvnih vzorcev.

Kaj pa bodo največje prepreke, s katerimi se bodo podjetja srečevala, ko bodo svoje rešitve želela pripeljati na trg?

Vsako zagonsko podjetje želi prodreti na trg v najkrajšem mogočem času. Vendar pa v zdravstvu in za medicinske naprave obstajo zelo stroge regulative - z razlogom - saj morajo biti naprave varne in pravilno razvite. Seveda pa je inovacija znotraj tako rigoroznih okvirov izjemno zahtevna, sploh za startupe, ki pogosto nimajo vsega zahtevanega znanja, procesov in ljudi. Pomanjkanje znanja jim tako lahko izjemno oteži in podaljša pot od razvoja in rešitve pa do trga.

Kako želiš ti pripomoči k temu, da bi inovacije hitreje dosegle svoje uporabnike?

Ker je Cosylab že dolgo navzoč pri rešitvah za zdravstvo, imamo veliko izkušenj in znanja, predvsem glede regulative. V prvi vrsti lahko pomagamo, da bi inovacije prišle na trg v čim krajšem mogočem času in da bi bile čim varnejše. Prav zato smo znotraj Cosylaba oblikovali ozko fokusirano razvojno skupino Arrowfast, ki bo z znanjem in izkušnjami podpirala startupe pri njihovem razvoju inovacij in pri čim hitrejšem prodoru na trg. Kot vodja te pobude sem zelo vesel, da smo se v podjetju tako hitro odzvali.

Kako pa sam preživljaš te karantenske čase?

Haha, precej podobno kot vsi ostali! Opravljam svojo dolžnost in ostajam doma. Imam pa to srečo, da lahko v Cosylabu, kot visoko tehnološkem podjetju, in tudi v ArrowFastu, nemoteno nadaljujemo z delom – če, seveda, odmislim dinamiko domačega dela z otroci v sosednji sobi 😊.

Interview: Cosylab - How will Covid - 19 change healthcare and medical technology

The pandemic of the COVID-19 disease which is caused by the Coronavirus is not yet subsiding in most countries, despite the sacrificial efforts of medical and support staff. Public life is crippled around the world, with economies operating at significantly lower outputs. As doctors and nurses fight for the lives of a multitude of dying respiratory patients, companies are trying to adapt to the changing work and management environment while seeking new solutions.

Manufacturers of medical devices are already preparing for the new challenges in healthcare after the end of the pandemic. Today's health crisis is much more than just a problem of "masks, respirators and vaccines." Agile smaller companies and startups are already offering groundbreaking medical solutions and gadgets to the market that are giving a sense of the future of healthcare.

Among these solution providers, for example, is Smart Blood Analytics with AI-supported blood-sample analysis for Coronavirus diagnostics, MESI Medical with showing off compact ECG tablets or UVentions with smart UV sterilisation systems for widespread use in hospitals and homes. The Materialise engineering firm specialising in 3-D printing has, on the other hand, developed a device that can partially replace a respirator by providing overpressure for breathing via the oxygen supply. The FDA has approved the use of Outset Medical's home-based dialysis machine, which requires only plain water and an electrical connection to operate. Dynocardia has developed the holy grail of continuous blood-pressure measurement - a wearable ViTrack device with an optomechanical sensor.

But the biggest challenge awaiting startups is how to meet the regulatory requirements for medical devices. Startup companies generally do not possess the systems and knowledge to manage the entire development process within regulatory frameworks. Typical time-to-market for a medical device is 3 to 5 years, while it can be even longer for bio innovations or new drugs.

How can a small new company overcome the challenge? There are engineering companies that already master the entire process of developing medical devices, from planning and development to final certification of suitability and placement of products on the market. These can help startups realise their plans, as they have the expertise for all the areas they need and the processes in place.

One such group is ArrowFast Medical Device Engineering, created under the auspices of Cosylab d.d., which is a global integrator of proton therapy control systems and big-physics devices, headquartered in Slovenia. The group's leader, Igor Rogelj, points out: "Under the pressure of the pandemic, society is beginning to realise that we need to prepare much better to protect society and the economy in the event of new epidemics. We expect radical changes in the functioning of health systems, which will result from the top-to-bottom actions of countries and the WHO international organisation while being at the same time influenced by the grass-roots activity and innovative work of companies and individuals."

What direction will the development of medical devices take? Rogelj explains, "At ArrowFast, we explicitly see innovation in automated and secure systems for diagnosing biological samples without contact with healthcare personnel - be it drive-points, diagnostic 'vending machines' or even remote home measuring devices vital functions. In the future, mass-produced wearable and mobile devices for smart vital-functions monitoring and early disease diagnosis will become common. It is only a matter of time before the use of telemedicine and videoconferencing doctor-patient consultations will be an everyday occurrence. Remote monitoring and health management devices will become a mainstay in healthcare systems."

"It is not," Rogelj concludes, "that we in our group are smarter than other medical device engineers. The primary differentiating factor is that we possess years of experience and knowledge and have processes in place to develop and certify medical devices. Such experience is crucial to a startup's success - for the successful certification of its medical device and the launch of the device as a viable new product on the healthcare market."

How will COVID19 shape Medical industry and drive innovation

Igor Rogelj is the Head of ArrowFast Medical Device Engineering, a Swiss-based group formed within Cosylab d.d. Over his 25-year long career, he has built his business development and B2B marketing profile in high-tech startups that went to market with specialized niche products, especially in the MedTech industry. Igor is also one of the owners and directors in Plasmait Group – a machine builder for medical and other industries.

Igor, can you tell us a bit about your background, and what attracted you to MedTech and Medical Industry?

From the very start of entering the Medical Industry, the level of its innovation and high-tech appealed to me. And besides that, I see a real, measurable benefit to the patients and the clinical profession through the work that we do. I’ve also worked with startups a lot because you can always look forward to new technologies and new challenges with them. I started with a company Plasmait in Graz. We developed and built special machinery for the production of medical components such a stents, guide wires, special medical ropes and diabetes syringes, and fine tubes. These days, I have switched to software and hardware engineering, developing medical devices at Cosylab.

How do you see the healthcare changing in light of the COVID19 pandemic? 

The corona pandemic has been a shock and awakening for the healthcare industry worldwide, and the society in general. We have learned and recognized that we cannot deal with this level of pandemic effectively. And that prompts us to make some real changes in the years ahead. Those changes have to come from the top-down, which means from the WHO and the governments, but I envisage that the biggest driver of change will be innovation. The latter will allow the healthcare systems to re-equip themselves, reorganize themselves, and make themselves a lot more efficient, especially in situations such as epidemic or pandemic outbreaks, like COVID19. 

The governments and health organizations will have to rethink pandemic response strategies in terms of timely and focused response, rapid deployment of emergency resources, but also efficiency in diagnosis and delivery of care in case of highly contagious diseases. We will see innovation in the areas of automated and safe diagnostic sample collection with minimal involvement of medical staff, such as drive-in facilities, vending machine diagnostics points, or even remote, home-based, diagnostics devices. Looking further into the future, one can envisage wearables and mobile devices to play a significant role in preventative monitoring and early diagnosis. Telemedicine and doctor-patient consultations via video conferencing and remote monitoring devices will eventually become a norm. We will have to prepare a lot better for future epidemic outbreaks if we want to protect our society and economy. We anticipate profound changes in the healthcare system.

At this moment, it seems that recession is inevitable, if not already happening. Yet, every recession or crisis leads to innovation. What kind of innovation can we expect to see in the Medical and MedTech industry?

Besides the tragic death toll and suffering that we are already witnessing, we are likely to experience the aftermath of the economic downturn that is about to follow the pandemic. On the positive side, crisis always leads to innovation, and we can already see incentives from leaders to provide a sufficient amount of regulatory and financial support to facilitate the growth of innovation in the medical industry. There is some indication that VC funds will be eagerly perusing startups within medical devices in new business models that can make a real contribution in stemming epidemic outbreaks, and mitigating the risks to public health that accompany these catastrophes. 

You said that the change would come both from the top-down and bottom-up. Who will be the driver of the innovation from the bottom down?

The driver of the grassroots will and have been the startups and the innovators. They are, by far, the most significant driving force. Large companies have been very inefficient at driving innovation as they are too structured, and slow-moving to follow the pace of change. On the other hand, small, agile companies can move quickly; they can focus on the problem at hand and are therefore much more efficient. Once they bring their product to market, they are undoubtedly prime targets of the large corporations to take them over. 

What kind of companies, products, and solutions can we expect to see spring out from the pandemic?

Companies are already developing and deploying respirators en mass. We have seen various respirator initiatives like the one at Cambridge that are building the product from the ground up. There are also many other, ranging from those of big companies such as Airbus Ventilator Challenge to national incentives like the one we have here in Slovenia. There are also startups such as the German Uventions, which is developing solutions that enable disinfection during regular operation, taking care not to harm humans. 

I’ve already mentioned some of it like drive-in diagnostic facilities, and sample collections without any involvement of clinicians and automatic diagnosis through a vending machine-like apparatus. Ideally, we would have diagnostics as low cost, that the patients themselves can deploy. These monitoring and diagnostic devices can be used by the patient during the quarantine, or even, if low cost enough, as a preventative measure – and become a part of our everyday life. There are already many initiatives trying to find the quickest, safest, and cheapest diagnostic tools for coronavirus. Our colleagues over at Smart Blood Analytics have developed an (AI) diagnostic model which diagnoses the corona virus-infected patient based solely on a series of routine blood tests. And other AI companies are saying they can predict or even diagnose coronavirus infections or localize the outbreaks by analyzing enormous amounts of data or blood samples.

What do you think will be the most significant roadblocks companies and startups can expect when they try to bring their new solutions to the market?

Besides the fact that every startup wants to come to the market as quickly as possible, for many years we’ve seen one of the major obstacles for the startups have been rigorous regulatory frameworks. Regulatory frameworks are necessary tools to ensure that the medical devices that come to the market are safe and designed appropriately. However, pursuing innovation through such regulatory frameworks is a considerable task. Especially for startups who don’t have specific skills, processes, and know-how in place to make the most efficient route from the start of development to launch to the market. Lack of regulatory expertise hinders them from moving through the certification process and development as fast as possible.

How do you hope to contribute helping innovation in MedTech?

As Cosylab is a medical company with an extensive set of software and hardware skills with strong regulatory practices and experiences, so we should be at the forefront in providing the right support for innovation reaching the market as efficiently and safely as possible. The management of Cosylab has, therefore, decided it’s appropriate to form a very focused group that will be able to facilitate startups as they develop their innovative devices and bring them to the market. We call this initiative ArrowFast, and as its leader I am thrilled to be a part of it. 

What are you doing these days in isolation?

Ha, ha, pretty much the same as everyone else around the world. I am doing my duty, staying at home. I am lucky however, that in a team like ArrowFast, which is part of such an advanced tech company as Cosylab, we can continue to work with minimal interruption — not counting the usual work-from-home dynamics with kids in the room next door.