Intervju z Blažem Triglavom, Mediately

“Rezultat certifikacije je tudi večje zadovoljstvo zaposlenih”

26. maja letos v veljavo stopa leta 2017 sprejeta uredba o medicinskih pripomočkih, ki med drugim prinaša spremembe za proizvajalce programske opreme in aplikacij. 19. člen uredbe namreč veli, da “programska oprema sama, kadar jo proizvajalec posebej nameni za uporabo za enega ali več medicinskih namenov iz opredelitve medicinskega pripomočka, šteje za medicinski pripomoček.” Slovensko podjetje Mediately, ki zdravnikom omogoča enostavno iskanje informacij o zdravilih, ponuja različna orodja za predpisovanje in diagnosticiranje, ter se spušča tudi na področje izobraževanja v medicini. Na uredbo so v podjetju dobro pripravljeni.

 Z direktorjem Blažem Triglavom smo se pogovarjali o tem, kako se podjetje loteva novih trgov in kako so se lotili certifikacije aplikacije Register zdravil, preden v veljavo stopi uredba o medicinskih pripomočkih.

Podjetje Mediately je danes staro sedem let. Za začetek: kakšna je vaša refleksija o razvoju podjetja?

Register zdravil Mediately, prej znan pod imenom Modra jagoda, je nastal zaradi med zdravniki zaznane potrebe po hitrejšem iskanju informacij o zdravilih. Hitro smo ugotovili, da se s problemom ne srečujejo le zdravniki v Sloveniji. Na Zahodu so tehnološke rešitve sicer že obstajale, v vzhodni in osrednji Evropi pa ne. To so postali prvi trgi za naš prvi produkt - aplikacijo o informacijah o zdravilih za zdravnike. S širitvijo in rastjo podjetja smo začeli razmišljati, kako lahko celoviteje pomagamo zdravnikom pri kliničnem delu, saj so zdravila le majhen del klinične zgodbe. Ugotovili smo, da zdravniki potrebujejo podporo tudi pri diagnosticiranju in določanju aktivnosti bolezni. Aplikacijo smo tako razširili še z kliničnimi orodji, ki pridejo prav v vsakodnevni praksi. Izdelali smo tudi orodja za odmerjanje nekaterih zdravil. Zdravnik namesto, da prebira dolgo in pusto navodilo za uporabo zdravila, v izdelan kalkulator znotraj naše aplikacije vnese potrebne parametre in dobi odgovor.

Koliko orodij trenutno ponujate?

Trenutno ponujamo več kot 70 orodij, od splošno uporabnih za vse zdravnike, do specializiranih in sicer na področjih multiple skleroze, kronične vnetne črevesne bolezni, rakavih obolenj, atrijske fibrilacije in še precej drugih. Nabor orodij vztrajno širimo.

Kje so v tej zgodbi izobraževanja? Zakaj se lotevate še tega, glede na to, da jih organizirajo tudi druge organizacije in podjetja?

Pri pripravi orodij smo bili prepričani, da so zdravniki s temi klasifikacijami, enačbami,  novimi smernicami in drugimi novostmi seznanjeni in jih že uporabljajo. Izkazalo se je, da ni vedno tako, in da je tudi na tem področju podpora v obliki izobraževanja zelo dobrodošla.

Naša misija je vedno bila zdravniku ponuditi najboljšo možno informacijo o zdravljenju. Izobraževanja o smernicah, orodjih in zdravljenju tako podpirajo našo usmeritev. Pravzaprav je naš razvoj je šel v obratni smeri: najprej smo se osredotočili na zdravila, ki so na koncu poti odločanja, potem smo razmišljali o diagnosticiranju in sedaj o osnovi - izobraževanju. Koncept učenje-diagnoza-zdravljenje sedaj v celoti pokrivamo, in tako lahko pomagamo pospešiti izboljšave v klinični praksi.

Koliko uporabnikov imate trenutno?

Prisotni smo v osmih državah - Sloveniji, na Hrvaškem, v Srbiji, na Češkem, Slovaškem, v Romuniji, Bolgariji in od lani tudi v Italiji. Vsakodnevno nas uporablja več kot 100.000 zdravnikov, v povprečju več kot enkrat dnevno. Zanimivo je, da je naš zadnji trg, Italija, sedaj naš največji trg, čeprav smo na trgu šele nekaj mesecev, in je prisotnih kar nekaj konkurentov. Za primerjavo: v Italiji je skupno 240.000 zdravnikov, na vseh ostalih naših trgih skupaj pa okoli 170.000, tako da je izziv za razred težji kot prej.

Kakjo ste se lotili vstopa na italjanski trgi in tam prisotne konkurence?

Po temeljiti analizi konkurence smo ugotovili, da je na trgu več manjših igralcev. Z nekaterimi smo stopili v stik z interesom o prevzemu. Eden izmed ponudnikov, ki je imel okoli 10.000 uporabnikov, je našo ponudbo sprejel. Na ta način smo lažje kot s klasičnim marketingom prišli do prvih uporabnikov. Danes nas v Italiji uporablja 20.000 zdravnikov, približno polovica med njimi je prej uporabljala prej omenjeno konkurenčno aplikacijo. Zahvaljujoč tej potezi je danes organska rast bistveno lažja.

Letos v veljavo prihaja nova uredba o medicinskih pripomočkih (MDR), ki predvideva, da vsaka aplikacija, ki lahko potencialno vpliva na zdravje, spada med medicinske pripomočke in mora biti certificirana. Ste pripravljeni?

S postopkom certifikacije smo se začeli ukvarjati že avgusta 2018. Takrat je bilo še veliko neznank zaradi česar smo veliko časa izgubili v razumevanju zakonodaje. S postopkom smo uspešno končali januarja letos, torej po letu in štirih mesecih.

Kaj to pomeni za tiste, ki bi se certifikacije lotili šele danes?

Po moji oceni, če začneš danes, potrebuješ vsaj šest mesecev, da uspešno pripraviš vso potrebno dokumentacijo. Realno pa je tako, da je za podjetja, ki morajo biti certificirana do 26. maja edina smiselna opcija certifikacija pod že dolgo obstoječo direktivo o medicinkih pripomočkih (MDD), in še to samo za pripomočke, ki so Class I po tej starejši certifikaciji. Certifikacija pod to direktivo proizvajalcu prinese štiriletno tranzicijsko obdobje za ureditev skladnosti z uredbo (MDR). Tudi ta proces pa zahteva precej dela in investicije, saj se je vseeno potrebno prijaviti na JAZMP kot proizvajalec medicinskih pripomočkov, kar zahteva kar precej dokumentacije in regulativnih zahtev. Če regulativo ignoriraš, bodo regulatorji zahtevali umik produkta s trga, kar je lahko za proizvajalca uničujoče. Še posebej na področju mobilnih medicinskih aplikacij bo z 26. majem na tisoče proizvajalcev takih aplikacij v prekršku.

Kdaj ste se vi lotili procesa certifikacije?

Že zelo zgodaj smo se začeli pogovarjati z zunanjim ocenjevalcem. Sprememb in prenove procesov smo se lotili celovito, in šele kasneje ugotovili, da so v nekaterih primerih dovolj prilagoditve obstoječih načinov delovanja. Presojevalci za kakovost so bili na nekaterih področjih zelo strogi, ponekod pa so nam bili v veliko pomoč pri optimizaciji strukture naših procesov.

Kaj vam je certifikacija prinesla v smislu refleksije o lastnem delu?

Naš celoten proces dela je bolj predvidljiv in jasen. Če navedem primer: pri izdelavi orodja certifikacija zahteva validacijo vsake spremembe. Mi smo si predpisali, da morajo vsako spremembo validirati trije strokovnjaki, zdravniki. To sedaj za razliko od preteklosti konsistentno izvajamo pri vsakem orodju - preverjamo, ali so spremembe logične in jasne. Konsistentnost pri validiranju nam prinaša boljši vpogled v mnenje uporabnikov, kjer dobivamo ideje o optimizaciji. Certifikacija prinese optimizacijo delovnih procesov in pri nas je večina zaposlenih danes zelo zadovoljnih, ker so stvari bolj jasne. Proces sicer zahteva svoj trud, je pa delo nato lažje.

“Certification process increases employee satisfaction”

On 26 May the new Medical Device Regulation (MDR) takes effect. Among other changes, new regulation defines some software applications as medical devices that need to be certified. Slovenian company Mediately provides doctors with a convenient mobile app for drug information search, complimented with various tools for easier diagnostics and prescribing. Additionally, the company is diving into medical education sector.

We talked with the CEO Blaž Triglav about the scaling of the company and their experiences with the process of MDR certification.

Mediately is a seven years old company by now. For starters: what is your reflection of the past company development?

We designed our Drug Registry app after detecting a need among doctors for a more convenient search for drug information. We realized fairly soon that this was not a local problem and while technological solutions were available in the West, there were none in Central and Eastern Europe. These countries became our first markets. Over time we started thinking how to offer doctors additional support in their clinical practice. After all, medications are only a small part of the clinical challenges they face every day. We detected the need for decision support in diagnostics and determining disease activity. Consequently, we upgraded our drug registry app with clinical decision support tools useful in daily practice. We also started adding dosing tools for certain drugs. Instead of reading the long and unstructured instructions for use for a drug, doctors now enter a few key details and get the correct prescription calculated for them. 

How many tools do you offer so far?

We currently offer more than 70 tools, from generally useful ones for all doctors to specialized ones in the field of multiple sclerosis, inflammatory bowel disease, cancer, atrial fibrilation and many others. We are also adding many more, as we’re constantly expanding the areas we cover.

How does medical education fit into your story?

When we prepared decision support tools, we believed doctors are somehow automatically aware of new clinical guidelines, classifications, equations and other clinical updates. It turned out it takes a significant amount of time for these changes to become a standard in clinical practice and support in awareness and education would be more than welcome.

Our mission has always been  to offer doctors the best possible treatment advice for their patients. Education about important clinical updates supports that mission. We went about it in reverse, starting with medication, which is the final step in treatment, expanding to diagnosis, and now finally to the basics, education. We now cover the full learn-diagnose-treat range, and can help speed up improvements in the clinical workflow.

How many users do you currently have?

We are present in eight countries - Slovenia, Croatia, Serbia, Czech Republic, Slovakia, Romania, Bulgaria, and since last year also Italy. Our app is used by 100.000 doctors, on average at least once a day. The interesting thing is, that while we entered Italy last, it has become our biggest market, despite being present there for only a few months, and having quite a few competitors. For comparison: Italy has 240.000 doctors,, while there are around 170.000 doctors in all the other countries we are present in, combined, making it a significantly harder challenge.

How did you approach entering the Italian market, knowing competition there is strong?

A thorough analysis revealed there are quite a few small players on the market. We approached them with an acquisition proposal and one of them accepted our offer. This gave us an immediate access to around 10.000 users. That way, we had a much easier way of getting our first users compared to the classical marketing approach. We are used by 20.000 doctors in total in Italy at the moment, half of them from the app we acquired.

MDR goes into effect in May. How did you prepare for it?

We began the certification process already in August 2018. We spent a lot of time digging through the regulation requirements.  The whole process laster a year and 4 months and we successfully completed the process in January this year.

What does this mean for those that would like to start with the certification process hardly now?

I would sayit takes at least six months to go throughthe process, if you start today. Realistically, for companies which need to be certified by May 26th, the only option is to certify before that date under the existing MDD regulation, if they can certify as a Class I medical device. This gives you a 4-year transition period to move to the new MDR regulation. But even this process requires a lot of work and investment, because you still need to register as a medical device producer with the national drug and medical devices regulatory body. This step involves a significant amount of paperwork and regulatory hurdles. If you ignore the regulation, the regulatory body will sooner or later demand you remove your product from the market, which can be devastating for any company. Especially in the field of mobile medical apps, thousands of app makers will be breaking the law, starting with May 26th.

How did you approach the certification process?

We included an external consultant early in the process. We initially went overboard with changes and revamps of our internal processes. Through the certification process we discovered that we can in fact adapt a lot of the existing processes much more directly than we thought. The eventual evaluators of our quality management system were strict in some areas and very helpful in others, helping us optimize existing processes instead of developing completely new ones.

How did the certification process help you in your own contemplation regarding your work?

Our work processes are much clearer today than they were before. For example, the certification demands a validation step for each product change. In this regard, we decided to always validate our tools changes with three domain experts, doctors. This brought us consistency but also an improved regular contact with our users which results in our better understanding of our users and ideas for optimisation. The certification also raised employee satisfaction due to larger clarity in some of our workflows. The process demands a certain effort, but some of the work is much easier in the end.