Galen Data
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Accelerate SaMD Development While Reducing Cost
Navigating the landscape of Software as a Medical Device (SaMD) can be fraught with challenges, from meeting stringent technical requirements and managing high labor costs to adapting to ever-evolving regulatory changes and ensuring robust cybersecurity. To mitigate these common pitfalls and streamline development, it’s crucial to adopt a strategic approach. In this webinar with Weronika Michaluk from HTD Health, we’ll discuss the common pitfalls of SaMD development and share tips and tricks to help companies navigate the complexities of SaMD more effectively, bringing innovative solutions to market faster.
Key takeaways
1. Identify and Overcome Common Pitfalls: Learn about the most common challenges in SaMD development, from regulatory hurdles to cybersecurity concerns, and how to effectively address them.
2. Strategic Development Approaches: Discover proven strategies to streamline your SaMD development process, helping your company save time and resources while meeting stringent technical requirements.
3. Accelerate Innovation: Find out how to bring innovative SaMD solutions to market faster by implementing practical tips and tricks shared by industry expert Weronika Michaluk.
มุมมอง: 11

วีดีโอ

Galen Data & B Secur - An Accelerated Path for Cardiac Cloud Monitoring
มุมมอง 18หลายเดือนก่อน
In this webinar you'll discover the transformative potential of integrating FDA-cleared cardiac monitoring algorithms into a secure, compliant medical device cloud infrastructure. Listeners will learn how leveraging B-Secur's advanced clinical-grade cardiac (ECG) algorithms through Galen Data's platform can accelerate product development and reduce time-to-market for cardiac monitoring solution...
How to attain the lifeblood for MedTech SMEs
มุมมอง 65หลายเดือนก่อน
If you're a MedTech Founder or Executive, funding and hiring are likely the top two things on your mind. That's what this webinar is all about. Our guest, Giovanni Lauricella, has made over 2,000 hires and facilitated $300M in capital raised for MedTech startups. And he throws one hell of a MedTech party on “The Rock” of the Mediterranean. Discussion Topics: • What is the lifeblood of MedTech S...
Cybersecurity in the Cloud , HITRUST - Protecting Yourself and Your End Users
มุมมอง 433 หลายเดือนก่อน
Cybersecurity is paramount in medical device software development due to the critical nature of these devices in patient care. With the increasing connectivity of medical devices to networks and the internet, the risk of cyber threats such as ransomware, data breaches, and malware infections grows exponentially. Thus, prioritizing cybersecurity in the development process not only upholds patien...
IP and Patent Strategies for MedTech Companies: Building Device and/or Software
มุมมอง 333 หลายเดือนก่อน
IP can often become the bedrock for assessing a medical device or software-as-a-medical device's valuation. Though many founders realize its importance, a foundational knowledge of how the process works, how to select the right legal partner, how to evaluate your innovation's IP potential, and how counterparties might value your IP portfolio’s merit is often left in the hands of lawyers without...
Challenges of Clinical Data Collection in MedTech, and Why It's Worth It
มุมมอง 545 หลายเดือนก่อน
In this webinar, Chris Rush from @GreenlightGuru discusses regulatory requirements for clinical data collection for varying device classes, the challenges associated therein, and best practices for successfully planning and delegating the duties involved in running a study. Listen in to learn how to engage with partners, software vendors, and provide an answer to the question: “Is this all wort...
Plug and Play Hardware: Connecting Your Medical Device to the Cloud
มุมมอง 1046 หลายเดือนก่อน
For our March webinar, we were joined by Christoph Beck, CEO of mdeg. Whether you're looking to integrate cutting-edge connectivity into existing products or navigate the complexities of updating legacy devices, this webinar will help inform your future hardware decisions. Discover how to expertly classify and specify the connectivity component within your system architecture, ensuring seamless...
DFX The Secret Weapon the Best Medical Device Companies Use to Expedite Commercialization and Gain
มุมมอง 1096 หลายเดือนก่อน
Huge pressures and incentives exist at every hurdle for med device startups. Developing a product that not only gets to market but is produced quickly and cost-efficiently can maximize revenue and accelerate growth milestones - but proper planning must start NOW. DFX (Design For Excellence) is the secret weapon, leveraged at the design stage, that can set your company up for success not setback...
Keys to a Successful Exit: What do Strategics really value and which startups succeed
มุมมอง 1727 หลายเดือนก่อน
John Groetelaars was the CEO of Hillrom until its acquisition by Baxter for $12B in 2022. Throughout John’s career he has held leadership positions at BD, Bard, Boston Scientific, Ventrica and Guidant. Through his career he has led or contributed to over 60 strategic acquisitions and several divestitures, he shares his views on why some startups ‘get to YES’ with strategics, while others fail. ...
EHR Integration Through Live Demonstration of Galen's Cloud Platform
มุมมอง 1158 หลายเดือนก่อน
Successful integration into the Electronic Health Record (EHR) can be a core necessity of a medical device's commercial adoption. This endeavor can be daunting in terms of technology, hospital processes, and ensuring that data is presented as intended. Watch our CTO, Abbas Dhilawala, and Chief Evangelist, Elizabeth Hoff, as they discuss the EHR landscape, integration hurdles and demonstrate our...
Founder Stories - Cyberonics (Livanova)
มุมมอง 1949 หลายเดือนก่อน
Founder Stories - Cyberonics (Livanova)
Developing a SaMD Common Pitfalls, Software Development, and Regulatory Considerations
มุมมอง 1349 หลายเดือนก่อน
In this webinar, we are joined by Karandeep Singh Badwal, founder of QRA Medical. Karandeep dives into the critical world of regulations and best practices for Software as a Medical Device (SaMD). He presents common pitfalls and frequent mistakes that medical device companies make, emphasizing the importance of adhering to stringent regulations, standards and cybersecurity requirements best pra...
Revolutionizing Risk Management in MedTech: How to Integrate Risk throughout the Device Lifecycle
มุมมอง 639 หลายเดือนก่อน
With medical device regulatory agencies spotlighting risk management, knowing the rules and effective strategies for integrating risk across your device’s lifecycle is crucial. Whether you’re a seasoned expert or a newcomer, watch this webinar to find out how to overcome challenges like ownership confusion, data retrieval inefficiency, and poor documentation traceability.
Launching Disruptive Products and Building Your Commercialization Team
มุมมอง 4110 หลายเดือนก่อน
Galen Data is honored to have been joined by veteran MedTech innovator, board member, advisor, and venture capitalist, Ken Nelson of the MedTech Advantage Fund. In this webinar, Ken shares his career experiences spanning from advising prototype-stage companies, to helping raise major venture rounds, to taking companies through product launch. He describes the methods and thought processes he's ...
Founders Stories - Neuro Rehab VR
มุมมอง 4911 หลายเดือนก่อน
Founders Stories - Neuro Rehab VR
MedTech Now Lives at the Bleeding Edge of Innovation, Here’s How to Adapt
มุมมอง 60ปีที่แล้ว
MedTech Now Lives at the Bleeding Edge of Innovation, Here’s How to Adapt
Medical Devices in the EU Overcoming Challenges and Securing CE Mark
มุมมอง 138ปีที่แล้ว
Medical Devices in the EU Overcoming Challenges and Securing CE Mark
Founder Stories - Future Cardia
มุมมอง 187ปีที่แล้ว
Founder Stories - Future Cardia
Why 'Code Shopping' Isn't Ideal for Your Reimbursement Strategy
มุมมอง 67ปีที่แล้ว
Why 'Code Shopping' Isn't Ideal for Your Reimbursement Strategy
Founders Stories - Zibrio
มุมมอง 32ปีที่แล้ว
Founders Stories - Zibrio
No Code, Low Code, and Custom Code How to Evaluate your Software Options
มุมมอง 52ปีที่แล้ว
No Code, Low Code, and Custom Code How to Evaluate your Software Options
Founder Stories - Noninvasix
มุมมอง 107ปีที่แล้ว
Founder Stories - Noninvasix
Journey to the Cloud Olive Diagnostics A Success Story
มุมมอง 114ปีที่แล้ว
Journey to the Cloud Olive Diagnostics A Success Story
From Napkin to Prototype to Scale, an Innovation and Supply Chain Discussion
มุมมอง 65ปีที่แล้ว
From Napkin to Prototype to Scale, an Innovation and Supply Chain Discussion
Reducing AI Risk to Secure Regulatory Approval
มุมมอง 157ปีที่แล้ว
Reducing AI Risk to Secure Regulatory Approval
Implementing and Managing a connected PMS program throughout your product lifecycle
มุมมอง 86ปีที่แล้ว
Implementing and Managing a connected PMS program throughout your product lifecycle
Designing for Compliance: QMS & Validation Testing for SaMD vs. Physical Devices - Galen Data
มุมมอง 131ปีที่แล้ว
Designing for Compliance: QMS & Validation Testing for SaMD vs. Physical Devices - Galen Data
2022 Medtech & Healthtech Financing and Exit Trends with SVB - Galen Data
มุมมอง 135ปีที่แล้ว
2022 Medtech & Healthtech Financing and Exit Trends with SVB - Galen Data
Connected Everything and the Miniaturization of Hardware - Galen Data
มุมมอง 53ปีที่แล้ว
Connected Everything and the Miniaturization of Hardware - Galen Data
Medical Device Connectivity: Regulations, Privacy, and Cybersecurity - Galen Data
มุมมอง 174ปีที่แล้ว
Medical Device Connectivity: Regulations, Privacy, and Cybersecurity - Galen Data

ความคิดเห็น

  • @nis38
    @nis38 2 วันที่ผ่านมา

    This video would be great at 15min instead of an hour. Feels like wasting time on a busy day, while hoping you’ll move the conversation forward instead of the very slow and long sales pitch.

  • @exploreyourdreamlife
    @exploreyourdreamlife 10 หลายเดือนก่อน

    I've been considering starting my own business, and this founder story provided invaluable insights. Great job, creator, for the entrepreneurial wisdom! Liked and Subbed!

  • @lannyhancock214
    @lannyhancock214 11 หลายเดือนก่อน

    "Promo SM"