Orthogonal Events

Upcoming Industry Events for SaMD, DTx and Connected Medical Devices

Connect with members of the Orthogonal team at upcoming industry events, including conferences, trade shows, workshops and webinars.

The Regulation of SaMD in the U.S.

Organizer: MATTER
Talk Title:
The Regulation of SaMD in the U.S.
Date: Wednesday, August 24, 2022
Time: 12:00 – 1:00 PM CDT
Venue: Virtual

Join MATTER partner Orthogonal for a discussion around the regulation of Software As a Medical Device (SaMD) in the U.S.

Join Orthogonal CEO and Founder Bernhard Kappe and Shriner and Associates Principal Quality and Regulatory Consultant Clay Anselmo as they discuss regulation around software as a medical device (SaMD) in the United States.

These industry experts will discuss how regulation is essential for companies seeking approval of their SaMD by clinical and payer groups. They will touch on the current status of SaMD regulation, understanding existing regulatory pathways, regulatory innovation at the FDA as well as development, launch and evolution of SaMDs under current regulatory frameworks and guidance.

This conversation will be facilitated by Randy Horton, Orthogonal VP of Solutions and Partnerships.

RAPS Convergence 2022

Organizer: RAPS
Date: September 11-13, 2022
Venue: Phoenix Convention Center, Arizona

RAPS Convergence is your regulatory meeting place to connect and interact with peers, health authorities and notified bodies across the healthcare products industry.

Pre-conference Workshop:

Workshop Name: Digital Therapeutics (DTx) – Introductory Overview of a Fast-growing (Yet Sometimes Nebulous) Class of Treatments
Date: September 11, 2022
Time: 8:30 AM – 4:00 PM MST

Orthogonal’s Randy Horton and Twill’s Brian Binkowski will be speaking at this pre-conference workshop.

HealthXL Global Gathering – Chicago

Business Models in Digital Health

Organizer: HealthXL
Date: Thursday, September 22, 2022
Venue: MATTER Chicago

Significant advancements have been made in working out novel business models for digital health products, but implementing a successful go-to-market strategy remains a major challenge.

We have seen a lot of trial and error, as well as migration between commercialization pathways. One of the critical crossroads on that pathway is whether companies should take the approach of delivering a service, a product, or a bit of both?

Each has pros and cons. A number of digital health products take a service approach, while traditional prescriptions are a product, which adds a layer of complexity to getting these to market.

At HealthXL’s next Global Gathering in Chicago, startups, pharma, and investors will break down the issues around the different approaches to getting a digital health product to market. ‍

2022 AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation

How are advancing and emergent technologies changing the delivery of healthcare and what are the implications for medical device standards and regulations?

Organizer: AAMI
Date: Monday, Oct 17, 2022 – Friday, Oct 21, 2022
Venue: Arlington, VA

For more than three decades, AAMI has hosted the AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation; the premier event for medical device experts who want to be up-to-date on the latest developments, changes, and trends in health technology standards and regulations.

Orthogonal’s Randy Horton will be presenting during a breakout session at this conference.

Talk Date: Wednesday, October 19, 2022
Talk Time: 1:00 – 3:15 PM ET
Talk Title: Case Study Supporting Medical Device Cloud Computing

AdvaMed MedTech Conference 2022

Organizer: AdvaMed
Date: October 24-26, 2022
Venue: Boston Convention & Exhibition Center, Massachusetts

Innovation begins with ideas — and The MedTech Conference is your opportunity to engage in the discussions that spark your next “aha!” moment. With a carefully crafted program featuring more than 100 sessions led by inspiring speakers, there’s no better place to hear perspectives and gain valuable insight into today’s hot topics.

Orthogonal’s Randy Horton will be presenting during a session at this conference.

MD&M Minneapolis

Organizer: Informa
Date: Wednesday, November 2, 2022 – Thursday, November 3, 2022
Venue: Minneapolis Convention Center, Minneapolis, MN

MedTech moves fast especially in a healthcare hub like Minnesota. Keep the pace with the latest innovations and immerse yourself in a community of visionaries and industry leaders at MD&M Minneapolis.

Orthogonal’s Randy Horton will be presenting during a session at this conference.

HLTH 2022

Organizer: HLTH
Date: November 13 – 16, 2022
Venue: The Venetian Expo, Las Vegas

HLTH 2022 is the preeminent event for health innovation, pushing boundaries to transform the next decade of health. In our fifth year, our vision is to accelerate engagement across the health ecosystem through a new interactive format that encourages deeper connections and thought-provoking discussion.

Orthogonal’s Randy Horton will be facilitating a panel discussion at this conference.

J.P. Morgan 41st Annual Healthcare Conference

Organizer: J.P. Morgan
Conference Date: Monday, January 9, 2023 – Thursday, January 12, 2023
Conference Venue: Westin St. Francis, San Francisco, CA

Orthogonal will be planning a workshop adjacent to this conference.

2023 Design.Engineer.Build and MD&M West Conferences

Organizer: Informa
Conference Date: Tuesday, February 7, 2023 – Thursday, February 9, 2023
Conference Venue: Anaheim Convention Center, Anaheim, CA

Orthogonal’s Randy Horton and Philips’ Pat Baird will be co-presenting at this conference.

Past Industry Events for SaMD, DTx and Connected Medical Devices

Greenlight Guru AMA

AMA Title: Operating Medical Devices on Amazon, Microsoft and Google’s Cloud
Date: Wednesday, August 10, 2022
Time: 1:00 – 2:00 PM CDT

From AI/ML to smartphones to cloud computing to web services, MedTech faces a growing imperative to leverage modern software technologies to support the core functions of regulated medical devices.

The vendors creating and operating these new technologies have an admirable focus and impressive track records on continuous improvement. But their relentless updating of their technologies isn’t compatible with MedTech’s traditional approaches to regulated change management.

So if you’re wondering how to handle the validation of your SaMD that is hosted on the cloud – come join the discussion on a new set of architectural approaches, best practices, and systems thinking that embrace a more modern approach to device safety and the meaning of the validated state.

We hope you find this to be a valuable session that is able to help you with the challenges you are currently facing!

Blending Agile with Industry Regulations: An In-Depth Q&A Webinar

Talk Title: Blending Agile Practices with Industry Regulations: An In-Depth Q&A Webinar
Date: Thursday, July 28, 2022
Time: 1:00 – 1:45 PM EDT

To commemorate the 10th anniversary of AAMI TIR:45 2012, Guidance On The Use Of AGILE Practices In The Development Of Medical Device Software, Orthogonal is proud to host a series of events and conversations aimed at sharing cutting-edge insights that will collectively help us move faster and break nothing in SaMD development.

Last month, we invited two highly successful practitioners of Agile SaMD, Michael Iglesias and Larkin Lowrey, to share their insights on how Agile has transformed – and will continue to transform – the MedTech industry. With so much to say, they didn’t have time to dive into many of the great (and detailed) questions that came in from our audience.

To give our experts the time to address these great questions, we’re holding a follow-up webinar, where Michael and Larkin will go into the nitty-gritty details on blending Agile practices with QMS, IEC 62304 and ISO 13485 at a tactical level.

Join us for this in-depth and highly informative session with two guests who have held roles at Roche, J&J, Eli Lilly, Novo Nordisk, Philips and Tandem Diabetes Care, as well as in automotive and telecommunications critical infrastructure – close cousins to MedTech.

Michael and Larkin will answer our audience’s detailed questions with practical advice and tactical steps to take to achieve Agile SaMD success. You’ll learn how you can take the best of Agile and the true intent of industry regulations and combine them in a way to raise the bar on the safety, quality and effectiveness of medical devices.

Webinar: Insights to Move Faster & Break Nothing with Agile

It’s been 10 years since AAMI published TIR:45 2012, Guidance On The Use Of AGILE Practices In The Development Of Medical Device Software. Over the last decade, Orthogonal and its colleagues have taken part in the broad Agile transformation of medical device software, particularly related to the development of Software as a Medical Device (SaMD) and connected medical devices.

Our industry has learned a tremendous amount about the best (and worst) practices for accelerating the development of medical device software using Agile, Lean and other iterative product and software development methods. Now we’re ready to innovate with these methods even further – to move faster while breaking nothing.

Orthogonal is marking the 10th anniversary of TIR:45 by hosting a series of events and conversations. In the second half of 2022, we will bring together industry leaders to share cutting-edge insights, so collectively we can improve patient outcomes and drive business results.

In this webinar, Roche’s Michael Iglesias and Tandem Diabetes Care’s Larkin Lowrey will share success stories and lessons learned from their careers. You will leave with actionable steps so that your organization can move faster and break nothing in SaMD development using Agile and other modern software and product techniques and tools.

 

Talk Title: Accelerating SaMD Development with Agile: Two Industry Experts Share Practical, Hard-Earned Insights
Date: Wednesday, June 22, 2022
Time: 12:00 – 12:40 PM EDT

True Quality 2022

Organizer: Greenlight Guru
Date: Monday, June 6, 2022 – Wednesday, June 8, 2022
Venue: San Diego, CA

Learn, connect, and find inspiration at the must-attend experience for MedTech professionals who drive innovation in the market today.

 

Orthogonal’s Principal Solutions Architect, Brett Stewart will be presenting a talk titled, “This Is Not Your Grandmother’s Validated State“.

As engineers, regulators and scientist, we need to adapt to a new set of software architectural approaches, best practices and systems thinking, embracing a more modern approach to device safety and the meaning of the validated state.

Date: Wednesday, June 8, 2022
Time: 10:15 AM – 11:00 AM PDT

Medical Device Safety And Regulations Compliance Forum

Organizer: Global BSG
Date: Thursday, June 2, 2022 – Friday, June 3, 2022
Venue: Hybrid – Berlin/Virtual

Medical Device Safety and Regulation Compliance Forum by GlobalBSG creates a collaborative platform for executives involved in the regulation, design, product safety, development, innovation, technology, monitoring, and quality aspects of medical devices. Industry professionals will exchange field knowledge and useful practices in producing high-quality medical devices and keeping the safety level at the highest level through advanced risk management strategies.

 

Orthogonal’s Randy Horton and Philips’ Pat Baird will be co-presenting a talk titled, “Medical Devices Using the Cloud and Other Computing Services You Don’t Control“.

Date: Thursday, June 2, 2022
Time: 7:00 AM CDT

European Health Tech Innovation Week 2022

Organizer: Giant Health
Date: Tuesday, May 17, 2022 – Saturday, May 21, 2022
Venues: Liverpool, Paris, Berlin, Stockholm, Barcelona

The European Health Tech Week 2022 solves the problem of cost-effectively discovering and meeting the most important partners you need to achieve business success.

Medical Device Software Development Summit 2022

Organizer: Hanson Wade
Date: Tuesday, May 17, 2022 – Thursday, May 19, 2022
Venue: Boston, MA

Orthogonal’s Randy Horton and Philips’ Pat Baird will be co-leading an interactive workshop titled, “Compliant Integration of 3rd-Party Computing Technologies“.

How to design safe & effective devices that leverage cloud computing, patient-owned smartphones, AI/ML & other modern computing technologies that you don’t control.

Date: Tuesday, May 17, 2022
Time:
9:00AM – 10:30AM CT

Join us for a highly interactive workshop where participants break out into teams and use a hypothetical but realistic case study of a connected medical device that uses several modern third-party computing technologies to perform different regulated functions.

MTI Webinar:
Connected Care: Digital Health, Wearables & Connectivity Series:
User Experience (UX) & Patient Engagement

Organizer: MedTech Intelligence (MTI)
Date: Thursday, May 19, 2022
Time: 12:00 – 2:30 PM EDT
Venue: Virtual

Digital technologies, including patient portals, secure messaging, social media, remote monitoring, and other forms of connected health are key to more active patient engagement and more dynamic interchanges between patients, their healthcare data, and clinicians.

This episode explores the increasing emphasis on patient engagement, digital technologies that have emerged, and a discussion of the future opportunities for patients, providers, and medical technology manufacturers.

Orthogonal’s own Director, UX & Human Factors, Bob Moll will be presenting at this webinar.

MTI Webinar:
Connected Care: Digital Health, Wearables & Connectivity Series:
Telemedicine & Healthcare Outside of the Hospital

Organizer: MedTech Intelligence (MTI)
Date: Thursday, May 12, 2022
Time: 12:00 – 2:30 PM EDT
Venue: Virtual

What will be the future of telemedicine? Which parts of healthcare will become totally virtual? How will telemedicine change the practice of medicine and the way that provider organizations operate? How will telemedicine blend into the larger continuum of care delivery options that providers and patients can access.

Also, if telemedicine largely remains “zoom with your doctor or nurse,” what are the upper limits on what can be accomplished over video conferencing or a phone call? s webinar will also look at what additional value we can deliver through virtual care if we can use it in tandem with powerful medical devices given to patients to use in non-clinical settings (i.e., their daily lives in the home, work, school, in transit). If we can use devices to remotely diagnose, monitor and treat, then can we accomplish more?

Orthogonal’s CEO Bernhard Kappe will be presenting at this webinar.

MedCon Conference 2022

Organizer: AFDO / RAPS Healthcare Products Collaborative
Date: Wednesday, May 4, 2022 – Friday, May 6, 2022
Venue: Virtual

At MedCon, global regulators and medical device manufacturers engage to increase speed to market and
product quality through innovation.

Orthogonal’s Randy Horton and Philips’ Pat Baird will be co-presenting at this conference.

Talk Date: Thursday, May 5, 2022
Talk Time: 11:00 – 11:40 AM CT
Track: Innovation/Digital Health Track
Talk Title: New AAMI Standard Emerging on Cloud Services in Regulated Medical Devices

There is a new standard emerging from AAMI.

2022 Design.Engineer.Build and MD&M West Conferences

Organizer: Informa
Conference Date: Tuesday, April 12, 2022 – Thursday, April 14, 2022
Conference Venue: Anaheim Convention Center, Anaheim, CA

Orthogonal’s Randy Horton and Philips’ Pat Baird will be co-presenting at this conference.

Talk Date: Wednesday, April 13th, 2022
Talk Time: 2:00 – 2:45 PM PST
Track: Quality & Risk Management
Talk Title: Maintaining a Validated State for Connected Medical Devices, SaMD & DTx in an Era of Chaotic Innovation

From AI/ML to smartphones to cloud computing to web services, MedTech faces a growing imperative to leverage these technologies to support the core functions of a regulated medical device. The vendor creating and operating these new technologies have an admirable focus on continuous improvement, but often isn’t compatible with MedTech’s traditional approaches to regulated change management.

We can no longer ignore this uncomfortable truth. Instead, we need to adapt to a new set of architectural approaches, best practices, and systems thinking, embracing a more modern approach to device safety and the meaning of the validated state. Join us to discuss/debate.

Medtech Innovations Webinar

Organizer: Ubiq Webinars
Date: Thursday, March 31, 2022
Webinar Time: 11:40AM CT
Venue: Virtual

Orthogonal’s Randy Horton and Philips’ Pat Baird will be co-presenting a webinar titled, “Cloud Computing, Smartphones, AI algorithms, and 3rd Party APIs: Ensuring Safe and Effective Medical Devices“.

Global Gathering – Basel

Digital Therapeutics (DTx), Telemedicine and Virtual Care Delivery

Organizer: HealthXL
Date: Thursday, March 24, 2022
Venue: F.Hoffmann-La Roche AG Wurmisweg, 4303 Kaiseraugst, Switzerland

2022 International Symposium on Human Factors and Ergonomics in Healthcare

Organizer: Human Factors & Ergonomics Society (HFES)
Date: Sunday, March 20, 2022 – Wednesday, March 23, 2022
Venue: Hilton New Orleans Riverside Hotel, New Orleans, LA

This educational event is your opportunity to learn insights on the latest science and best practices, understand innovations in the safety of health care providers and patients, sharpen the focus of HF/E initiatives, and improve your regulatory approaches.

Orthogonal’s  and Bob Moll will be discussing best practices on product analytics for SaMD, DTx and connected medical device systems on March 22, 2022 at 11 AM CT.

ViVE 2022

The Industry’s New Health Information Technology Event

Organizer: HLTH + CHIME
Date: Sunday, March 6, 2022 – Wednesday, March 9, 2022
Venue: Miami Beach, FL

ViVE merges the leadership of CHIME and the digital marketplace of HLTH to create a technology event focused on the business of transformation in healthcare.

Masterclass: The Regulation of SaMD in the US

Organizer: HealthXL
Date: Monday, February 14, 2022
Time: 10:45 AM EDT
Venue: Virtual

Regulation is an absolute essential for companies who want to get their SaMD accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your SaMD through regulatory pathways in the US?

Masterclass: Interoperability – How to connect your Digital Health product to Provider Systems in the US?

Organizer: HealthXL
Date: Wednesday, January 19, 2022
Time: 10:45 AM EDT
Venue: Virtual

Connecting digital health products to provider systems is essential to ensure HCPs adopt these solutions and that the best possible healthcare outcomes are facilitated. However, the industry doesn’t make it easy. Healthcare providers are running a lot of different EHR products, on different versions and configurations of each of these products, each with their own unique workflows and interpretations of various data elements.

40th Annual Healthcare Conference

Organizer: J.P. Morgan
Date: Monday, January 10, 2022 – Wednesday, January 13, 2022
Venue: Westin St. Francis, San Francisco, CA

This premier conference is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.

2022 Innovations in Regulatory Science Summit
Movers and Shapers: The Future of Drug and Device Development

Organizer: UCSF-Stanford CERSI
Date: Sunday, January 9, 2022
Time: 8:00 AM – 4:30 PM PST
Venue: Mission Bay Conference Center, 1675 Owens St, San Francisco, CA

A gathering of leaders from academia, industry and the FDA to discuss the role of regulatory science in medical product development.

MTI Bio-T Webinar:
Connectivity and beyond – transforming medical devices into personalized connected care solutions

Organizer: MedTech Intelligence (MTI)
Date: Wednesday, December 15, 2021
Time: 12:00 – 1:00 PM EST
Venue: Virtual

BioT Medical & Orthogonal partner to provide expert opinion and discuss the new frontiers of medical device connectivity in an exclusive webinar powered by MedTech Intelligence.

AAMI Standards Insider Webinar

Organizer: AAMI
Date: Thursday, November 18, 2021
Venue: Virtual

Please join the AAMI Standards team on November 18th for the second quarterly session of the AAMI Standards Insider webinar series. This one-hour free webinar is intended to provide news and updates about AAMI’s standards program and portfolio.

Move Faster and Break Nothing with Connected Medical Devices, SaMD & DTx

Date: Thursday, November 11, 2021
Time: 9:00 AM EST
Venue: Virtual

This event will feature a mix of industry leaders and pioneers, sharing first-hand lessons learned from their groundbreaking case studies on accelerating the development of medical device software at the dawn of the age of digital health. They’ll discuss the best and worst practices learned through their leading edge efforts.

MD&M Minneapolis

Organizer: Informa
Date: Wednesday, November 3, 2021 – Thursday, November 4, 2021
Venue: Minneapolis Convention Center, Minneapolis, MN

MedTech moves fast especially in a healthcare hub like Minnesota. Keep the pace with the latest innovations and immerse yourself in a community of visionaries and industry leaders at MD&M Minneapolis.

AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation

Organizer: AAMI
Date: Monday, October 18, 2021 – Wednesday, October 20, 2021
Venue: Virtual

HLTH 2021

Organizer: HLTH
Date: Sunday, October 17, 2021 – Wednesday, October 20, 2021
Venue: Boston, MA

HLTH 2021 is the preeminent event designed for the health industry, bringing together senior leaders to solve healthcare’s most pressing problems and realize the most promising opportunities to create health’s future.

Digital Therapeutics (DTx) Boston

Organizer: HealthXL
Date: October 15, 2021
Time: 10:00 AM EDT
Venue: WeWork Office Space & Coworking, 1 Lincoln St, Boston, MA 02111, United States