From Risk to Resilience: Practical Strategies for Proactive Medical Device Security

Free Online Webinar Series

Speaker: Natali Tshuva, Co-Founder & CEO - Sternum

Details: This session will explore practical strategies for building cyber resiliency into medical systems, enabling them to withstand and recover swiftly from cyber threats.

We’ll discuss the shift from focusing on the probability of attacks, to prioritizing the mitigation of exploitable vulnerabilities – while ensuring that security efforts target the most critical risks.

We will also touch on how best to leverage regulatory requirements for data collection and logging, in order to generate actionable insights - thus transforming compliance into a powerful tool for enhanced security.

Join us to learn how to stay ahead of threats and protect the integrity of your medical devices.

San Jose Networking Event

at Applied Engineering US Headquarters

Voler Systems invites you to join us for a casual networking event in San Jose, CA at Applied Engineering's US Headquarters.  

Relax and enjoy a cool drink and some light bites while connecting with peers who share your excitement for IoT solutions, medical devices, hardware engineering, and embedded systems.

We look forward to seeing you at our future networking events! 

Startup Legal Counsel Episode #2

Free Online Webinar Series

Speaker: Angel Orrantia, President, i2i Corporate Strategies

Details: Are you a founder, entrepreneur, or startup leader navigating the exciting but complex world of launching and growing your business? The Startup Legal Counsel is a webinar series sponsored by Voler Systems and i2i Corporate Strategies, designed specifically for you!

This informative series tackles broad, challenging topics faced by early-stage companies. Each session offers the opportunity to discuss real-world hurdles, equipping you with the knowledge and strategies to thrive.

During each session, industry experts will provide actionable insights and guidance on crucial topics like growth strategies, financial planning, marketing campaigns, legal compliance, and business operations.

Don't miss this opportunity to set your startup on the path to success!

Startup Legal Counsel

Free Online Webinar Series

Speaker: Angel Orrantia, President, i2i Corporate Strategies

Details: Are you a founder, entrepreneur, or startup leader navigating the exciting but complex world of launching and growing your business? The Startup Legal Counsel is a webinar series sponsored by Voler Systems and i2i Corporate Strategies, designed specifically for you!

This informative series tackles broad, challenging topics faced by early-stage companies. Each session offers the opportunity to discuss real-world hurdles, equipping you with the knowledge and strategies to thrive.

During each session, industry experts will provide actionable insights and guidance on crucial topics like growth strategies, financial planning, marketing campaigns, legal compliance, and business operations.

Don't miss this opportunity to set your startup on the path to success!

Embracing Change: Managing Medical Devices that are Never Finished

Online Webinar

Speaker: Aaron Joseph, Principal Consultant, Sunstone Pilot, Inc.

Details: How do we manage upgrades to a new medical device after product launch? If you don’t expect to ever make changes to the product then this may not be a concern at all. However, if you’re developing software-intensive, connected devices or capital equipment, then this IS a big concern!

These types of medical devices need to be upgraded throughout their lifetimes. Therefore, the majority of development projects will likely be product upgrades, not new product development - and your quality system should be designed with this in mind.

Aaron will discuss the challenges of managing post-market changes to medical devices, the shortcomings of traditional quality system approaches, what is meant by "re-entrant design controls," and more!

Sensors Converge

at the Santa Clara Convention Center

Voler Systems will be stopping by the booth of WCA (the Wireless Communications Alliance) at Sensors Converge, which is taking place at the Santa Clara Convention Center on June 24-26. Come by and say hi! More details on WCA’s site. Use WCA’s discount code 10173 for a free Expo Hall pass, or $100 off the Conference pass, at the Sensors Converge website.

Founded in 1994, the Wireless Communications Alliance (WCA) exists to enable collaboration between technology companies, solution and service providers, early adopters, and academia to drive the successful implementation of connected products and services within the global connected ecosystem, using AI based technologies. The WCA hosts seminars, webinars, and podcasts to help our members better understand the range of connected AI innovations and opportunities for both sponsors and members. Our work includes awareness, advocacy, thought leadership, and support of STEM initiatives. events@wca.org

IoT Tech Expo

at the Santa Clara Convention Center

Please visit Voler Systems at the booth of WCA (the Wireless Communications Alliance) at the IoT Tech Expo, which is taking place at the Santa Clara Convention Center on June 5-6. More details on WCA’s site. Use WCA’s discount code 25SANTACLARA for a 25% discount at the IoT Tech Expo site.

Founded in 1994, the Wireless Communications Alliance (WCA) exists to enable collaboration between technology companies, solution and service providers, early adopters, and academia to drive the successful implementation of connected products and services within the global connected ecosystem, using AI based technologies. The WCA hosts seminars, webinars, and podcasts to help our members better understand the range of connected AI innovations and opportunities for both sponsors and members. Our work includes awareness, advocacy, thought leadership, and support of STEM initiatives. events@wca.org

We'll see you back at the Santa Clara Convention Center for Sensors Converge on June 24th!

Montreal Networking Event

at Innovobot Labs office

Voler Systems invites you to join us for a casual networking event in Montreal, Quebec at Innovobot Labs.  

Relax and enjoy a cool drink and some light bites while connecting with peers who share your excitement for IoT solutions, medical devices, hardware engineering, and embedded systems.

We look forward to seeing you at our future networking events! 

Sticking to My Story: Silicon Valley Secrets to Power Pitching

Online Webinar

Speaker: Donna Griffit, World Renowned Corporate Storyteller, Pitch Alchemist, and Best-Selling Author

Details: The Winning Recipe for Pitches that have raised $1.5B.

With fewer face-to-face meetings, fluctuating markets, and a new reality - your story and how you tell it matters more than ever.

Especially when it comes to raising your next Round. You only get one shot – make it stellar!

World-renowned Corporate Storyteller and Pitch Alchemist Donna Griffit will share her winning recipe for the RIGHT story needed to get the meetings and the funding.

Toronto Networking Event

at Flatiron Pub

Voler Systems invites you to our first international networking event at the Flatiron Pub in Toronto, Ontario, with Innovobot Labs. 

Unwind with a refreshing beverage and appetizers as you engage with fellow enthusiasts who are just as passionate as you are about IoT solutions, medical devices, hardware engineering, and embedded systems.

We look forward to seeing you at our future networking events!

Reducing Compliance Risks in Medical Devices and Biotech: The Value of Audits and Validation

Online Webinar

Leah Jones, CEO QAConnect Mgmt Consulting	Renee Mikha, PMP Principal Consultant InsightQual Consulting Inc.

Speakers:

• Leah Jones, CEO
• Renee Mikha, Principal Consultant

Details: Leah will discuss internal, supplier, and process audits per ISO 13485, 21 CFR Part 820, and ISO 14971 regulations. She will review the framework of the risk-based approach to auditing, and why it is beneficial to medical device companies. Plus, the need to ensure that risk aligns with company goals. 

Renee will discuss how validation activities and data integrity are important for ensuring safety and efficacy of computerized systems and quality management systems, including 21 CFR Part 11
compliance. Plus, the benefits and bottom line for customer satisfaction.

Founders & Funders

IGNITE Monthly Meetup
Sponsored by Voler Systems
April 9, 2024

Meet & Greet, Chug & Hugs

Hello Friends!

Throwing together a casual event for folks near Los Gatos to get together and connect - Absolutely no pretense of any sort other than hoping to build community among people doing cool things and living the good life outside of the big city.

See you at the next one!

Drew, Jessica & Brian

About Us:

• Drew Gillam // Founder & COO // AutoCloud
• Jessica Kobilova // Investor Relations // Ignite
• Brian Sparkes // Head of Communications // Bay Angels

Sponsored by Voler Systems

Cybersecurity: Don’t Let the FDA Derail Your Medical Device Launch.

Online Webinar

Speaker: Christopher Gates, Director of Product Security at Velentium Solutions

Details: Have you heard that medical devices are now required to be secure before being approved by the FDA? If you haven't had the time to look into the details, then this presentation is for you.

Christopher Gates, a recognized leader in medical device cybersecurity and the Director of Product Security at Velentium, will be presenting a 30-minute overview of the current requirements for either your new or your modified medical devices to be approved for market.

The solution to meeting these requirements is to start implementing them as soon as possible – delaying this while developing your new medical device, will only create unnecessary trouble down the road. Christopher will also be available for a Q&A period following the presentation to address any other medical device cybersecurity questions that you may have.

Edge AI for Medical Devices: Transforming Healthcare.

Online Webinar

Speaker: Vijay Shyamasundar, Director, Solutions Engineering for V2 Solutions

Details: Miguel Adao, SVP of Sales & Marketing at Voler Systems, and Vijay Shyamasundar, Director of Solutions Engineering for V2Solutions, delved into the influential realm of Edge AI. Discover firsthand how Edge AI is reshaping the landscape of the Medical Devices Industry, fostering innovation, enhancing efficiency, and unlocking new possibilities.

What’s the Latest in Fundraising and Exit Strategies?
Tips & Tricks for the New Year.

Online Webinar

Speaker: Angel Orrantia, i2i Corporate Strategies

Details:  Miguel Adao, SVP of Sales & Marketing at Voler Systems, and Angel Orrantia, President of i2i Corporate Strategies, hosted an insightful and interactive session focused on fundraising and exit strategies in the new year.  
 
Whether you’re a new startup looking for your first round of funding or you're looking to either be acquired or go the IPO route, we’ve got you covered.
 
We’ll provide some useful tips for you, as well as current market trends. 

Real-life Challenges of Product Teams Developing Complex Medical Devices

Online Webinar

Speakers:

Russ Singleton President Russ Singleton Consulting	Aaron Joseph Principal Consultant Sunstone Pilot	Walt Maclay President Voler Systems

Details:

The challenges that product development teams and leadership face have to do with more than just technology. Complex medical devices take longer to develop, have bigger teams, and require a wider variety of expertise than developing simpler products.

Hear from a panel of medical device experts about how to address these problems, about the successes and failures that they’ve experienced, and about how to give every product team the best chance for success.

Do You Know What Your Competitive Edge Is? Creating the Potential for Persistent Returns.

Online Webinar

Speaker: Shmuel Silverman, CEO & Founder of Multi-Innovation

Details: Please join Miguel Adao, SVP of Sales & Marketing at Voler Systems, and Shmuel Silverman, CEO & Founder of Multi-Innovation, for an insightful session focused on creating your competitive edge.  

What does your company do that compels your clients to buy from you and no one else?  Most CEOs think they know. Some just assume that they have a competitive edge. But many don't.

At every growth stage of your business, understanding and protecting your competitive edge is imperative in order to leverage the market and protect your business from competitors.

During this presentation, attendees will understand what a competitive edge is and how to strategically use their IP portfolio to protect their business. Don’t miss out!

Learn from a Pro: Tips and Tricks on Fundraising, Exit Strategies, M&A, IPO Considerations, and More.

Online Webinar

Speaker: Angel Orrantia, President of i2i Corporate Strategies

Details: Please join Miguel Adao, SVP of Sales & Marketing at Voler Systems, and Angel Orrantia, President of i2i Corporate Strategies, for an insightful and interactive session focused on fundraising, exit strategies and succession planning.

Whether you’re a new startup looking for your first round of funding, or you're looking to either be acquired or to go the IPO route, we’ve got you covered.  

We’ll provide some useful tips for you, as well as current market trends.  Don’t miss out!

"Organizational Culture - Creating an Organization That Doesn't Suck Your Will To Live"

Online Webinar

Speaker: Kimberly Wiefling, Co-Founder of Silicon Valley Alliances

Details: An Organization’s DNA is the historical reason why groups of people behave the way they do. It is the genetic code at the root of these behaviors. You could spend 20 years, as Kimberly has, reading a pile of books, digging through data, experimenting, and exploring what makes for an effective company culture that produces predictable and repeatable results without sucking people’s will to live…or you could just implement the methods proven to work by years of statistically valid research!

A good place to start is your own personal commitment to absolute integrity in everything you say and do, and a passion for enabling others to achieve their greatest potential through your work together.

In this webinar, we'll explore how to engage your people in a personal journey to discover your organization’s unique identity, and then use that shared identity to create truly engaged employees and a truly cohesive team.

Learning from Bruce Lee: Applying Martial Art Philosophy to Business Management

Online Webinar

Speaker: Robert De Neve - Managing Director, Applied Manufacturing Group

Details: Entrepreneurs, engineers and executives alike can all benefit from Bruce Lee’s “Warrior Ethos”.

Robert will talk about how Bruce’s unique approach to martial arts can be translated into business:

• Human Capital
• Intellectual Capital
• Asset Capital
• Process Capital
• Financial Capital

These five types of capital determine the skills and experience requirements that business and technology leaders need to develop, in order to survive and thrive in today’s competitive high-tech landscape. 

Wearables for the Ear: Medical and Personal Applications for
Ear-Worn Devices

Online Webinar

Speaker: Gary Spittle – Founder & CEO, Sonical

Details: We use our ears to make sense of what is going on around us, to interact with other people, and to learn. And with the use of headphones, we can listen to music, podcasts, audiobooks, watch movies, make phone calls, and play games…

But in addition to listening to the world and listening to audio, we can also listen to our bodies! The ear is an incredibly rich source of information for our general health and wellness. We can gather metrics such as heart rate and heart-rate variability, oxygen level, motion, temperature, brain activity, voice metrics, and many other things. Regular monitoring of this data can provide essential insight and early warning signals, which can enable medical professionals to better diagnose and treat a variety of conditions.

The next generation of ear-worn devices is coming.

Mobile Health Mega-Trends Webinar

Online Webinar

Speakers: NowSecure Chief Mobility Officer   and Voler Systems President Walt Maclay

Brian Reed, Chief Mobility Officer at NowSecure	Walt Maclay, President of Voler Systems

Discussion topics include:

• Security & Privacy
• Interoperability & Connectivity
• Healthcare IoT (Internet of Things)
• Sensor-based Medical Devices
• Power Management & Motion Control

The Post-Pandemic ‘New Normal’ is Here to Stay: Remote Patient Monitoring

Online Webinar

Speaker: Sam Liu, VP of Marketing at VivaLNK

Details: The pandemic has accelerated the adoption of remote patient monitoring technologies in multiple medical domains around the world. In this session, we'll examine actual uses of remote patient monitoring in real-world applications for both virtual care and clinical trials.

How to Drive Success in IoT Product Development from a Designer's Point of View

Online Webinar and In-Person at the Voler Systems Office

Speaker: Arne Lang-Ree, Co-Founder & CDO at Spanner Product Development

Details: Devices in the IoT universe are at increased susceptibility to a technology-first approach to design since market acceptance places much value on bleeding edge technologies. Certainly, while optimal performance achieved with leading technologies can play an important role in the success of a new product, we will talk about other perspectives and practices driving success through design, maybe with even greater influence on product success than the specific technologies employed.

Adhesive Challenges with Wearables and IoT Devices

Designing a medical device has many challenges. Creating wearable medical devices that stick to the skin is high on that list of challenges. For wearable devices to function as intended, they need to have a secure, reliable hold for the desired duration of use. Adhesives play a crucial role in ensuring that devices don’t fall off or injure the skin.

JoAnne Moody explores selecting adhesives for Wearable & IoT Devices in this session. Based on the increasing trend for devices attached to the skin, it is essential to consider adhesive selection early in the design phase. Key factors to consider include device design and application needs, such as wear time, wear location, sterilization, and biocompatibility. Skin adhesive development steps involve mockup prototypes and tests.

Speaker: JoAnne Moody, Principal Consultant and President of Zeta Scientific LLC

8 Best Practices of Product Realization

Learn the 8 Best Practices of Product Realization to successfully launch your product into the market on time and within budget.

In this webinar, you will learn the critical warning signs of an unsuccessful product launch including:

1. Slipping schedule
2. Exceeding budget
3. Missing product requirements

Speakers: Michael Keer, Shirish Joshi, Jay Feldis, and Mark Frederick

How to Successfully Bring a Product to Market

Is your R&D on mute? Advances in component technology have enabled new design and development options for a host of medical and consumer medical devices.  Material science, miniaturization, higher capacities, and manufacturing process improvements all can contribute to better, faster, cheaper products. Wow!  But technology (and a great dev team) alone don’t ensure an on-time, on-budget launch nor market uptake.

 How do companies and entrepreneurs get ahead of the game, given equal access to new technologies?  Where and when in the development process should you double down your bets? How can you uberize your innovation, and for uptake among which segments and customers?

View the presentation and discussion on how to increase the odds of successfully bringing a product to market.

Speaker: Jessica Ching, Digital Health Commercialization Innovator, Speaker & Executive