It's a great pleasure to join the Easy Medical Device podcast series with Monir El Azzouzi! It's magic what Monir does to educate and put together information for those with limited resources to learn on #medtech#regulations. We at Lean Entries Ltd share this vision! Go listen to the podcast and find links to other valuable information, such as a free trial into #Entries, our digital regulatory runways!
It was an absolute joy to join the best in class #research to #business minds in this SPARK Europe session for #medicaldevicesoftware#SaMD! At Lean Entries we are grateful of the years of collaboration with SPARK Finland! Thank you and SPARK Poland for hosting the session, where we had the opportunity to share the most critical teachings at the early stage of #SaMD innovation! By learning the basics of the #regulatory constraints and conditions early, the #healthtech innovator enables months of savings in time to market!
Spring is already here and so is our new webinar!
In this SPARK Europe Webinar, Heikki Pitkänen will discuss the regulatory landscape of medical software solutions. He is the CEO and founder of Lean Entries Ltd., a group of regulatory experts in global medical device regulations providing unique digital regulatory services as well as traditional consulting for the MedTech sector from academies and startups to multinational enterprises.
The event is hosted by SPARK Finland/SPARK Poland.
SPARK Poland invites you to join our webinar on 10th of April at 16:00 CET. Online via MS Teams.
Registration for the webinar is required in advance. Please register by 9 April 2024, here: https://lnkd.in/eGVBXfNb
Thank you Zorg voor innoveren, Leo Jetten, Tess Rutgers van Rozenburg - Rottier and other stakehoders for organising this event and for inviting Lean Entries to demonstrate #Entries! Our #regtech solution received encouraging welcomes and feedback by your Dutch and international crowd!
There were a lot of insights and ideas shared at the event and a root cause analysis spirit to challenges. While most agreed that there should be some adjustments to the #EUMDR and #EUIVDR and their interpretation across the EU to provide well grounded leeway for innovation, everyone realized this process is slow and rocky.
Therefore, what resonates with me the most are the lower hanging fruits and especially the basic level of #regulatory knowledge to be reached at an early stage by all relevant stakeholders affecting #healthtech innovation. To simplify this finding, it's not only the Regulatory Manager in a team who needs to know at least the basics. It's the C-level, marketing & sales, innovator & developer, investor, grant writer & reviewer, business adviser and more. Having these stars aligned in critical knowledge, one team can save months and loads of funds.
I'm convinced that with the right tools, ours and others, this can be made the new default with the MDR, IVDR, #AIAct and many more!
Now that it is kicked off in the Netherlands, we and our collaborators in the Nordics are ready to host the next event in the autumn. There's power in collaboration to address the root causes to challenges in innovation!
Come and join the discussion on 14 March in Utrecht on how to de-risk #healthtech#entrepreneurship, make innovation more viable and save months of their time to reach the #healthcare market for the benefit of the European citizens.
MULTI-STAKEHOLDER DIALOGUE TO BOOST SUSTAINABLE HEALTH TECH
This event on 14 March in Utrecht (NL) is an opportunity for you as a stakeholder in #HealthTech Entrepreneurship. We will talk about risk mitigation in the go-to-market phase as well as boosting (business) development for the value chain as a whole. In particular this event will focus on sharing best practices and insights with regards to MDR/IVDR. The event is provided to you by Netherlands Enterprise Agency (RVO) | Partner in Sustainable Development, ZonMw, Zorg voor innoveren and the Dutch Ministry of Health, Welfare and Sport.
Here's what's in it for you as an entrepreneur:
1. Get a demo of regulatory runways for MDR/IVDR by Lean Entries
2. Let business advisors hear you out on your needs
3. Leverage the expert network for your (business) development goals
This is not a one-off event but we will define calls-to-collaborate and make concrete plans towards the next event. All stakeholders in the value chain from product to solution will benefit. We are in this together.
Expect at least the following experts to be there: Leo Jetten, Maroeska Rovers, Hayley Every, Carl Moons, Signe Ulrik Holm, Brian Hedegaard, Minna Komu, Maarten de Ruijter, Arjan Stok, Sander Holterman, Willem Schüngel, Esther Rodijk-Rozeboom and Heikki Pitkänen. Including the Entrepreneur and Health Care Providers panels. Looking forward to your participation in joint development for sustainable Health Tech innovation!
Please find further details and register below. And if you can't join in person, let us know, so we can send you the link to virtually attend.
I'd like to repeat my thanks to Zorg voor innoveren for the invitation! Lean Entries is honored to take the podium with the representatives from Danish Life Science Cluster, OuluHealth ecosystem and Novel-T / Oost NL to share our common experiences and visions! Not all innovation in this sector is #healthtech but also #regtech to help each and every healthtech innovator by providing instant actionable knowledge on #regulatorycompliance, #EUMDR & #EUIVDR. Let's discuss this and what more should we achieve to de-risk #entrepreneurship, make innovation more viable and save months of their time to reach the global #healthcare market. And furhermore, how could we best support healthcare organizations to get their hands on the timesaving and lifesaving innovations more efficiently for the benefit of the Dutch and European citizens.
See you all on 14 March!
Thank you for the invitation Zorg voor innoveren! It is our pleasure at Lean Entries to take the podium in your event! Not all innovation in this sector is #healthtech but this time also #regtech to help each and every healthtech innovator by providing instant actionable knowledge on #regulatorycompliance. Let's discuss this and what more should we achieve to de-risk #entrepreneurship, make innovation more viable and save months of their time to reach the global #healthcare market.
See you on 14 March!
Heb jij als zorginnovator te maken met de Medical Device Regulation (#MDR) of de In Vitro Diagnostic Regulation (#IVDR)? Markeer 14 maart alvast in jouw agenda voor hét MDR/IVDR event 📣
Tijdens dit evenement krijg je onder andere antwoord op deze vragen:
✅ Aan welke regels moet je voldoen met jouw zorginnovatie?
✅ Welke hulpmiddelen kun je hiervoor inschakelen?
Zorg voor innoveren organiseert deze bijeenkomst voor alle betrokken stakeholders. In Nederland en daarbuiten. Publiek of privaat. We gaan spijkers met koppen slaan om een gezonde toekomst waar te maken.
Kom je ook?
Het programma wordt binnenkort bekendgemaakt. Dan kun je je ook aanmelden.
Heikki Pitkänen#zorgtechnologie#zorginnovatie#zorg
Thank you Nederlandse AI Coalitie | NL AIC, AI-hub Oost-Nederland and Health~Holland for the invitation to speak in your AI in Health & Care event! I felt warmly welcome! My case example took the audience on a journey onto the #Entries platform of #regulatory runways: through explanation and education on the #EUMDR and the upcoming #AIAct principles for the #healthtech#AI innovator – and – to execute on their first, personalized, #regulatorystrategy.
The regulatory contraints and conditions are not new to #healthtech. Neither is the fact that they keep piling up, especially for data and digital products. In EU we now have a political agreement on the upcoming #AIAct, and more is in the short period pipeline, such as the #EHDS and the #DataAct. It's not only the innovator whose success is critically dependent on acknowledging and understanding how to navigate these contraints and conditions. They apply to the entire #healthcare system and its stakeholders at large, which again revolves back to the innovators to critically understand how their clients – the hospitals – are affected by these regulations.
This complexity is what we at Lean Entries transform into the #Entries format of instant actionable knowledge – to be exploited by innovators and every other health sector stakeholder. The new baseline of regulatory knowledge achieved enables more meaningful dialogue within the ecosystem and supports viable innovation.
The discussions initiated will continue into 2024. Meanwhile I would like to thank our current collaborators Tess Rutgers van Rozenburg - Rottier, Wil Philipsen, Oost NL, MedTech Twente, Thematic Technology Transfer and Health Valley Netherlands for the learnings we've made during the past year!
https://lnkd.in/dhV32R7c
Welcome our newest partner to our innovation network:
Lean Entries is committed to converting regulations and intricate information into concise digital pathways, providing immediate actionable knowledge for those new to the field. Initially focusing on the highly regulated health tech industry, this transformation is made possible through our proprietary ENTRIES platform.
Heikki Pitkänen, Wil Philipsenhttps://lnkd.in/eN3n_C3a
Slush is coming! ❄
Next week Wolt is co-organising a side-event with Sitra on "Regulations, compliance and tech – Oh My! The future of Europe’s digital economy" including the official launch of Sitra’s new report on RegTech by Paul Fehlinger! 🚀
Join us to hear from excellent speakers, including US Ambassador Douglas Hickey (U.S. Embassy in Finland), Karen Melchior, Aura Salla, Heikki Pitkänen 🔥
📅 Date: November 30th
🕒 Time: 14:30 UTC+2 (live stream begins at 15:00)
The event is being held both onsite at Maria 01 and online. Register for the event here: https://lnkd.in/djuYdQ2b
Founder & CEO at Easy Medical Device | Consulting Firm | Podcast Host
4yIt was a pleasure to have you. I hope people will get a lot of valie out of it.