Upcoming Industry Events for SaMD, DTx and Connected Medical Devices

Organizer: Orthogonal
Date: Tuesday, August 27, 2024
Time: 11:00 AM CT
Venue: Virtual

At a recent well-respected MedTech conference, the concept of “Shift Left” was brought up in over half of the presentations. Coined in 2001 by software developer Larry Smith, Shift Left is the principle of moving activities such as design, testing and regulatory feedback from their traditional places later in the development life cycle to earlier stages, when misconceptions, misalignments and bugs can be more easily and cheaply fixed. It’s a powerful concept at the core of many innovations in product development, quality and software circles.

However, after hearing Shift Left discussed for the umpteenth time, we began to wonder – is there a limit to how much you can Shift Left on every aspect of medical device software design and development? At a certain point, if every activity is shifted all the way to the left, do we run the risk of a well-tuned Agile project essentially “tipping over” and reverting all the way back to clunky old Waterfall methods?

Join Orthogonal for a webinar where we’ll look at techniques for optimizing Shift Left across an entire MedTech organization while maintaining the fundamental flexibility of Agile. Our speakers will discuss how Shift Left can be applied across a variety of MedTech functions including R&D, software engineering, cybersecurity, quality and regulatory affairs, product management and corporate leadership.

Organizer: AdvaMed
Date: Oct 15-17, 2024
Venue: Toronto, Canada

Organizer: AdvaMed
Date: November, 2024
Venue: TBD

Organizer: RAPS
Date: Wednesday, August 14, 2024
Time: 11:00 AM PDT
Venue: Virtual

Organizer: Orthogonal
Date: Friday, June 28, 2024
Time: 11:00 AM CT
Venue: Virtual

We in MedTech are learning how to more rapidly evolve the software in our connected medical devices and Software as a Medical Devices (SaMD) while maintaining our quality standards for device safety and effectiveness.

Historically, it has been a challenge to minimize the regulatory burden of a full resubmission each time we’re ready to release a new software version. However, when compared with software’s ability to rapidly evolve, AI and Machine Learning (ML) algorithms take it to an entirely new level. These algorithms can continuously improve every time they are used based on real-world feedback. Regulators and manufacturers need to reconcile the instantaneous speed of AI learning with our methodical approach to updating devices.

As a first step in this process, the FDA has created Predetermined Change Control Plans (PCCP), giving manufacturers more latitude to make post-market algorithm changes without resubmission as long as they fall within specific guardrails and scope parameters established during the original device submission. How can the industry work with regulators to leverage this new regulatory framework so we can “move faster and break nothing” with AI/ML algorithms and medical device software in general?

Orthogonal held a webinar looking at the potential impact of PCCP on software-enabled medical devices and SaMD. We discussed the challenges organizations face trying to embrace PCCP, emerging best practices and the possibilities it opens up for medical device manufacturers going forward.

This webinar was built on a recent white paper developed by a group of seasoned industry professionals co-convened by Orthogonal titled “Making the Significant Insignificant: Implementing a Predetermined Change Control Plan (PCCP) for Class II SaMD Products Beyond AI/ML.”

Organizer: Orthoworld
Date: June 11 – 13, 2024
Venue: Donald E. Stephens Convention Center, Rosemont Chicago

Organizer: Orthogonal
Date: Tuesday, May 21st, 2024
Time: 11:00 AM CT
Venue: Virtual

Generative AI has been a massive buzzword across every industry since the release of ChatGPT a mere 17 months ago. Organizations are rushing to develop a wide range of applications for the technology, hoping to transform their businesses and how they serve their customers ahead of their competitors. In MedTech, there’s been significant efforts to apply generative AI to different parts of the industry. However, the discussion on the role of generative AI inside medical devices has been more measured. There are questions as to how this nascent technology would fit under the design controls of ISO 13485 and IEC 62304.

The emerging consensus among Orthogonal and many of our colleagues in the Software as a Medical Device (SaMD) space is that, barring very specific use cases, generative AI is unlikely to be a core component of medical devices anytime soon. The technology is simply too immature and unpredictable to meet the device industry’s benchmarks for safety and effectiveness. However, like other technologies over the last 100+ years, we expect that generative AI will eventually work its way into the functioning of medical devices.

What will it take for generative AI to become a tool in the toolbox of medical device manufacturers, and what does the history of MedTech teach us about how this might happen?

Organizer: Orthogonal
Date: Tuesday, April 30th, 2024
Time: 11:00 AM CT
Venue: Virtual

It takes a lot of work to prepare Software as a Medical Device (SaMD) for an initial launch – so much work that planning for subsequent releases can go overlooked, leaving companies to face significant technical, quality and regulatory debt when starting work on their product’s post-launch evolution. How do you take a forward-looking approach to developing SaMD that lays the groundwork for both short- and long-term success?

Join Orthogonal as we review best practices for developing SaMD under design controls with an eye towards ongoing releases. We’ll discuss ways to take advantage of software’s ability to evolve faster than hardware that allow you to rapidly expand your SaMD’s capabilities and improve both patient outcomes and your bottom line. Among other topics, we will look at how manufacturers and regulators are partnering around Predetermined Change Control Plans (PCCP) to promote and enable a future-forward mindset and device development stance.

Organizer: Human Factors & Ergonomics Society (HFES)
Date: Sunday, March 24, 2024 – Wednesday, March 27, 2024
Venue: Hilton Chicago Hotel, Chicago IL

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.

Organizer: Life Science Intelligence
Date: Monday, March 18, 2024 – Friday, March 22, 2024
Venue: Monarch Beach Resort, Waldorf Astoria, Dana Point CA

Organizer: Orthogonal & MATTER
Date: Thursday, March 14th, 2024
Time: 12:00 PM EST
Venue: Virtual

Organizer: Orthogonal
Date: Friday, February 2nd, 2024
Time: 12:00 PM EST
Venue: Virtual

The line between the device and non-device components of medical device software can sometimes seem blurry. Making the wrong choice to not develop a software module under design controls may lead to expensive, time-consuming rework.

How do you decide which parts of your device fall under your QMS umbrella, and which don’t? And how do you account for changes to your device during development as well as its potential changes in the future?

With good planning and forethought, you can lay the groundwork for a strategy that evolves with your device, keeps development on track and prepares you for any way the wind may blow.

Organizer: MATTER & Orthogonal
Date: December 6, 2023
Time: 1:00 PM CST
Venue: Virtual

Orthogonal co-hosted a webinar with MATTER on how to prepare your med tech company for an eventual acquisition. The webinar featured seasoned industry pioneers and experts, including Christian Johnson, co-founder of Seed Consulting Group, and David Van Sickle, co-founder of Propeller Health — which was acquired by ResMed — who shared case studies and hard lessons learned from their own experiences sitting on both sides of the table, as an entrepreneur and as an industry leader.

Organizer: AFDO-RAPS Healthcare Products Collaborative
Date: November 14-16, 2023
Venue: Cincinnati, OH

An artificial intelligence summit where world healthcare leaders come together.

Orthogonal’s Chief Solutions Officer, Randy Horton was in attendance.

Organizer: HealthXL
Date: November 9, 2023
Venue: Princeton, NJ

Organizer: AWS, BioT Medical, Orthogonal
Date: Thursday, November 9, 2023
Time: 12:00 PM EST
Venue: Virtual

AAMI, an ANSI-accredited standards organization focused on the medical device industry, has guidance under development (TIR115) to extend current guidance for building safe and effective medical devices when device functions now operate on public clouds.

There are certainly benefits for medical devices and public cloud services. However, new risks can be introduced when responsibility and lack of direct control for computing infrastructure shifts from the device manufacturer to a cloud services provider.

This introduces the need for new and modified approaches to change control for cloud-powered medical devices. Also, these approaches must address the ongoing needs of the many stakeholders associated with a medical device: Product/R&D, QA/RA, Enterprise Architecture, DevSecOps, Postmarket Surveillance & Support, etc.

This 1-hour webinar discussed introduced the in-development AAMI guidance (TIR115) and shared emerging best practice insights for stakeholder groups.

Organizer: Orthogonal, MedSec & Nordic Semiconductor
Date: Wednesday, November 8, 2023
Time: 12:00 – 12:50 PM EST
Venue: Virtual

Throughout 2023, Orthogonal and MedSec’s joint Bluetooth Low Energy (BLE) for Medical Devices Webinar Series has shared best practices that developers and manufacturers can implement in the here and now to address edge cases, cybersecurity risks, FDA requirements and mobile-side connectivity for Bluetooth-enabled medical devices. But wireless technology is always advancing, creating new opportunities and new challenges. What may the future hold for wireless medical devices, and how do we start preparing for that future today?

Orthogonal, MedSec and premier wireless chip maker Nordic Semiconductor hosted a webinar featuring a discussion on the future of wireless technology for medical devices. Kjetil Holstad, Executive Vice President of Strategy & Product Management at Nordic, gave his prediction on the trajectory of wireless technologies in the next 5-10 years and how it may affect the MedTech industry.

Kjetil was joined by Bernhard Kappe, Orthogonal’s CEO and Founder, Randy Horton, Chief Solutions Officer at Orthogonal, and Buddy Smith, MedSec’s Director of Technical Consulting.

Organizer: Orthogonal, MedSec & Blur
Date: Wednesday, October 25, 2023
Time: 12:00 – 12:50 PM EST
Venue: Virtual

MedTech makes use of advanced Bluetooth Low Energy (BLE) features in our Bluetooth-enabled medical devices, ones that require specialized technical knowledge to get right. You need experts on both the hardware and software side, so that when it’s time to link up the device hardware and the companion mobile app, they work together optimally. That’s why Orthogonal’s medical device software developers teamed up with the medical device hardware engineers and chip experts at Blur on a recent project.

Organizer: AdvaMed
Date: October 9 – 11, 2023
Venue: Anaheim Convention Center, Anaheim

Organizer: HLTH
Date: October 8 – 11, 2023
Venue: Las Vegas Convention Center (West Hall)

Organizer: Orthogonal & MedSec
Date: Wednesday, September 20, 2023
Time: 12:00 – 12:50 PM EST
Venue: Virtual

Despite a lack of specific guidance and constantly evolving standards, mobile medical apps and their companion Bluetooth Low Energy (BLE)-enabled medical devices consistently make it through the FDA clearance process. Manufacturers obtain clearance for their apps by meeting the FDA’s testing standards for mobile platform compatibility and cybersecurity. What are those standards, how do you fulfill them, and how do you keep that testing up when mobile platforms and cybersecurity threats inevitably change?

Orthogonal and MedSec hosted a webinar on understanding FDA requirements for Bluetooth testing in medical devices, part of our joint Bluetooth Low Energy for Medical Devices Webinar Series. Bernhard Kappe, Orthogonal’s CEO and Founder, Randy Horton, Chief Solutions Officer at Orthogonal, and Buddy Smith, MedSec’s Director of Technical Consulting, shared their insights and experiences gained through preparing Bluetooth-connected medical devices for FDA submission. 

Organizer: Hanson Wade
Date: Tuesday, Sept 5 2023 – Thursday, Sept 7, 2023
Venue: Boston, MA

The 4th Annual GxP Compliance Summit is a solution-focused conference that aims to help life science companies take full advantage of cloud computing while adhering to the FDA’s CSA draft guidance. The summit offers a platform for over 100 Life Science IT & Quality professionals to learn from regulatory, security and quality experts from leading life science companies, as well as cloud providers, auditors, and industry regulators. Participants will be able to validate their cloud in line with CSA, develop a practical roadmap to migrate their GxP regulated applications to the cloud, and implement business continuity measures to maintain data integrity and minimize risk to patient safety and product quality. The summit will also address challenges such as vulnerability of cloud environment, keeping sensitive information safe and secure, and minimizing risk to patient safety and product quality.

Organizer: Orthogonal & MedSec
Date: Wednesday, August 16, 2023
Time: 12:00 – 12:50 PM EST
Venue: Virtual

Bluetooth Low Energy (BLE) may be a convenient communication protocol, but dropping it into a connected medical device is nearly as easy. Depending on the complexity of the device, you could have dozens of “what if?” scenarios that need to be identified, thoroughly tested and mitigated. How do you solve these edge cases to create a safe, effective and consistent Bluetooth-enabled medical device?

Join Orthogonal and MedSec for a webinar on solving edge cases for Bluetooth-enabled medical devices, part of our joint Bluetooth Low Energy for Medical Devices Webinar Series. Bernhard Kappe, Orthogonal’s CEO and Founder, and Randy Horton, Chief Solutions Officer, will share highlights from Orthogonal’s library of edge cases, built up over 10+ years of developing connected medical devices with BLE. They’ll be joined by Buddy Smith, MedSec’s Director of Technical Consulting and Jim Keller, VP of Marketing and Business Development at MedSec. The 50-minute core content presentation will be followed by an optional Q&A.

Organizer: Orthogonal & MedSec
Date: Thursday, June 29, 2023
Time: 12:00 – 12:50 PM EST
Venue: Virtual

Bluetooth Low Energy (BLE) is a commodity protocol used by all kinds of devices for communication, connectivity and interoperability. Your sensitive BLE-enabled medical device will be sharing the same spectrum as unsecured, everyday consumer electronics. How do you address the security challenges that arise from running a device on BLE without compromising patient safety and device usability?

Orthogonal and MedSec held a webinar on cybersecurity for Bluetooth-enabled medical devices. Our expert speakers from MedSec shared their company’s approach to securing BLE device communications, insights into the common pitfalls that MedSec has helped clients overcome, and details on the threat modeling and testing expected by regulators.

Organizer: AdvaMed
Date: Monday, June 26, 2023 – Wednesday, June 28, 2023
Venue: Washington DC

Organizer: Global BSG
Date: Thursday, June 1, 2023 – Friday, June 2, 2023
Venue: Berlin

The conference highlighted the importance of technology and innovation throughout the healthcare industry’s supply chain. With changing regulations and compliance requirements, the conference explored the challenges faced by industry leaders in securing certification for new products.

Organizer: HealthXL
Date: May 25, 2023
Venue: Boston, MA

Organizer: Orthogonal & MedSec
Date: Wednesday, May 24, 2023
Time: 12:00 – 12:50 PM EST
Venue: Virtual

Medical device developers, manufacturers and R&D groups have experience implementing Bluetooth Low Energy (BLE) on the firmware side, where everything is under your control. But architecting BLE for the mobile side, where control rests firmly in the smartphone’s OS, is far more challenging. To arrive at the right solutions, you need the right understanding of the inherent complexities of mobile BLE connectivity.

Orthogonal and MedSec held a webinar crash course on BLE for connected medical devices: The challenges of device to phone communication, how to visualize those challenges and how to solve them while keeping product deadlines and budgets in check. Our panel of expert speakers discussed the BLE best practices and edge cases that have led to numerous successful connected device solutions.

This recording includes the 50-minute core content presentation, followed by a speaker Q&A.

Organizer: Hanson Wade
Date: May 16-18, 2023
Venue: Boston, MA

Orthogonal’s Chief Solutions Officer, Randy Horton spoke at this summit.

Organizer: UCSF Department of Orthopaedic Surgery
Date: May 3-5, 2023
Venue: San Francisco, CA

Now in its 7th year, The Digital Orthopaedic Conference San Francisco (DOCSF) in partnership with the Department of Orthopaedic Surgery at the University of California San Francisco (UCSF) will bring you THE DOCSF EXPERIENCE, our flagship premier event focused on the application, exploration, and application of digital technologies in Musculoskeletal care brought to you from the heart of Silicon Valley.

Organizer: CES
Date: May 1-4, 2023
Venue: Chicago, IL

The Technology & Standards Forum is an event where engineers, product managers and people from technology alliances gather to hear presentations, network, share information and develop standards.

Organizer: AFDO/RAPS Healthcare Products Collaborative
Date: April 24-27, 2023
Venue: Columbus, OH

For more than 13 years, MedCon has united the healthcare products industry to work for a better tomorrow for our patients. With a distinct focus on important issues that increase speed to market and product quality through innovation, the event brings together medical device regulators and industry experts from around the world for content-rich conference sessions that include uncommon collaboration, deep dialogue, and sharing.

Organizer: MATTER & Orthogonal
Date: Wednesday, April 26, 2023
Time: 12:00 – 2:00 PM CDT
Venue: Virtual

Using our smart watches, smart speakers and smartphones to aid in diagnosing ear infections, pneumonia and COVID-19 is just the beginning of an empowering clinical revolution. Will monitoring of our vital signs be as easy as popping in our AirPods? Could mapping the human body and assessing physical injuries be done with new 3D features on our smartphones?

Clinical Diagnostics on Consumer Electronics (CD-CE) are democratizing access to healthcare by moving diagnosis from Points of Care to Points of Living. Apps on our everyday devices could improve patient outcomes through earlier diagnosis, close the healthcare equity gap and bend the cost curve.

To get there, CD-CE manufacturers must address safety and clinical effectiveness concerns from regulatory bodies, as well as cost and ROI concerns from insurance providers – plus technical challenges that arise from a bring-your-own-device approach to device computing.

Organizer: Orthogonal
Date: Wednesday, April 19, 2023
Time: 12:00 – 12:50 PM EST
Venue: Virtual

Launching a successful Software as a Medical Device (SaMD) can be a complex process, involving technology, regulatory, and business considerations. SaMD Product Definition and Sizing is a crucial first step to de-risking the development process and ensuring a safe and effective device, delivered on-time and on-budget.

Orthogonal held a webinar featuring a discussion of the art and science of SaMD Product Definition and Sizing, the kinds of deliverables you can expect and the value they bring, and the benefits to mapping out development goals before the project begins.

This recording includes the 50-minute roundtable discussion, followed by an additional Q&A session with the speakers. The webinar was moderated by Randy Horton, Chief Solutions Officer.

Organizer: HLTH + CHIME
Date: March 26-29, 2023
Venue: Music City Center, Nashville, TN

Building upon the successful launch in 2022, ViVE delivered another unforgettable event experience around healthcare IT innovation and business transformation.

ViVE brought together senior and executive leaders in the digital healthcare space and provided an enjoyable engagement environment to drive growth opportunities through curated connections, personalized attendee journeys, and progressive programming.

Orthogonal’s Chief Solutions Officer, Randy Horton was in attendance.

Short and Long Term Bets in Digital Health

Organizer: HealthXL
Date: March 23, 2023
Conference Venue: JW Marriott Miami Turnberry Resort & Spa in Aventura, Florida

While we have seen significant growth in investments and partnerships between digital health companies and important healthcare players, progress is slow and we haven’t witnessed any groundbreaking success yet. What are the short and long term bets in digital health that will lead to the much expected transformation?

At HealthXL’s Global Gathering in Munich, startups, pharma, medtech and investors split up into several roundtables, with each tackling one of the following topics:

• ‍What technologies and indications are the most viable bets in the short and long term
• Innovative sales and pricing models to achieve ROI for life sciences and digital health companies
• New talent and sustainable organizational changes in the short and long term: balancing traditional and agile

Orthogonal’s Chief Solutions Officer, Randy Horton was in attendance.

Organizer: AdvaMed
Date: March 20-21, 2023
Conference Venue: JW Marriott Miami Turnberry Resort & Spa in Aventura, Florida

Orthogonal’s CEO, Bernhard Kappe was in attendance.

Organizer: The International Virtual Reality and Healthcare Association (IVRHA)
Date: March 3-5, 2023
Venue: Penn Medicine, 3400 Civic Center Blvd., Philadelphia, PA

Organizer: HealthXL
Date: Thursday, March 2, 2023
Time: 10:45-12:00PM EST
Venue: Virtual

Orthogonal’s Chief Solutions Officer, Randy Horton and Unconventional Concept’s President, Mike Hopmeier co-led the masterclass.

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

***

Orthogonal’s Chief Solutions Officer, Randy Horton will be speaking at the two talks below:

Balancing Usability & Security for Medical Devices

Date: Wednesday, February 8, 2023
Time: 11:15 AM – 12:00 PM PT

Clinical Diagnostics on Consumer Electronics (CD-CE): How AI is turning Smartphones into a Swiss Army Knife for Medical Diagnosis

Date: Wednesday, February 8, 2023
Time: 1:15 – 2:00 PM PT

Organizer: Orthogonal
Date: Thursday, January 26, 2023
Time: 12:00 – 12:50 PM EST
Venue: Virtual

How do we successfully bridge the chasm between tech and MedTech, and help our industry take advantage of what these tech experts working in other industries can bring to the table to rapidly evolve successful devices?

Orthogonal held a webinar featuring a discussion on how to successfully bridge the chasm between tech and MedTech, and help our industry take advantage of what these tech experts working in other industries can bring to the table to rapidly evolve successful devices. This recording includes the 50-minute roundtable discussion, followed by an additional Q&A session with the speakers. The webinar was moderated by Randy Horton, Chief Solutions Officer.

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

Organizer: UCSF-Stanford CERSI
Date: Sunday, January 8, 2023
Time: 9:00 – 4:00 PM Pacific Time
Venue: Hybrid – Virtual or Attend in Person at Robertson Auditorium, Mission Bay Conference Center, 1675 Owens Street, San Francisco, CA

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) was pleased to present the fourth annual Innovations in Regulatory Science Summit, a gathering of leaders in the academia, industry, and regulatory sectors to discuss the role of regulatory science in medical product development.

The 2023 CERSI Innovations in Regulatory Science Summit had a major focus on emerging issues in regulatory science including diversity in clinical trials, FDA/CMS decision making, and global drug development. In addition, they brought back their exciting panel from 2022 featuring former FDA Commissioners discussing the latest issues facing the Agency.

The goal of the summit was to stimulate discussion across sectors and to critically consider lessons learned and scientific issues that needed addressing to expeditiously and safely advance the development, approval, and monitoring of medical products.

Organizer: Orthogonal
Date: Wednesday, December 14, 2022
Time: 12:00 – 12:50 PM EST
Venue: Virtual

This webinar reviewed three classes of tools you need to use to succeed in the mobile SaMD app marketplace in 2023: Product Analytics, Crash Analytics and Mobile App Security. Together, they give early and detailed visibility into the operation of your medical device application, enable faster testing and deployment of app updates, and support ongoing monitoring of your apps after patients and providers use them.

Attendees heard from experts in the mobile application development ecosystem as well as experienced medical device mobile app developers on the value these tools can bring, and how you can quickly onboard them and rapidly gain the value they have to offer. An additional 40 minutes of Q&A with our expert speakers followed the 50-minute session.

Organizer: AdvaMed
Date: Monday, December 12 – Tuesday, December 13, 2022
Venue: Virtual

Medical device cybersecurity has never been more important than it is now, and as device capabilities advance and become more connected the threat landscape continues to grow. The virtual Cybersecurity Summit will address the future of medical device cybersecurity as well as recent changes in the industry landscape including issues related to FDA requirements and cybersecurity management practices.

Talk Title: Lessons Learned from Paylocity’s Ongoing Journey into DevSecOps
Date: Tuesday, December 13, 2022
Time: 1:50 – 2:50 PM EST

Orthogonal’s Chief Solutions Officer, Randy Horton co-led a discussion about DevSecOps (Developer Security Operations) at the summit with Michelle Jump, CEO, MedSec and Bruce Parr, Manager of Developer Security Operations, Paylocity.

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.

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.

Organizer: Orthogonal
Date: Wednesday, November 2, 2022
Time: 12:00 – 12:50 PM EDT
Venue: Virtual

What if we could use our consumer electronic devices, like smartphones, tablets and smartwatches, to aid in diagnosing ear infections, autism or COVID-19? Could we use our AirPods and our devices’ built-in microphones to monitor our lung health and body temperature? These scenarios, dubbed Clinical Diagnostics on Consumer Electronics (CD-CE), are quickly approaching reality.

CD-CE democratizes access to care by moving clinical diagnosis out of Points of Care and into our Points of Living. Using the smartphones in our pockets as a diagnostic tool could dramatically improve healthcare outcomes through earlier diagnosis, help close the healthcare equity gap and allow us to collectively bend the healthcare cost curve.

To realize this healthier, more equitable future, CD-CE manufacturers face safety and clinical effectiveness concerns from regulatory bodies, as well as cost and ROI concerns from insurance providers – plus a host of technical challenges when addressing the sheer range of diversity in the smartphone market.

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

Panel Title: This Is Not Your Grandmother’s Medical Device: What Happens When Medical Device Software, Data and Connectivity Spurs New Medtech Business and Regulatory Strategies?
Date: Wednesday, October 26, 2022
Time: 10:45AM – 12PM EDT
Venue: Room 259 AB

Cloud computing, AI/ML, smartphones and wearables, FHIR and web services integration and more. Medtech is eagerly incorporating modern computing technologies to enhance their Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems. These technologies can help our products improve patient outcomes and close inequities in our healthcare system. But first, we need to embrace new business opportunities and overcome new challenges.

In the first part of this session, we provided a framework for thinking about the larger business and clinical context of SaMD. In the second part, the audience learned about an emerging success story in adapting medical devices to a mainstay of the modern computing world, public cloud computing. And in the third and final part of this session, a seasoned group of MedTech executives, a leading health care expert from Big Tech and an expert in developing medical device software put this all together. They talked about what we can learn from the cloud computing example, and painted an exciting picture of what’s next for our individual companies and our industry as a whole.

Speakers:

• Stephanie Ainscow, Vice President and General Manager of Data Products, Insulet Corporation
• Steve Smith, VP of R&D, Haemonetics
• Andres Shogan, President, Multidisciplinary Oncology, Varian, a Siemens Healthineers Company
• Joe Petro, EVP for R&D & CTO, Nuance (a Microsoft Company)
• Josh Copp, McKinsey & Company
• Delphine Zurkiya, McKinsey & Company
• Randy Horton, Chief Solutions Officer, Orthogonal

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, Chief Solutions Officer, and Philip’s Pat Baird, Regulatory Head of Global Software Standards, presented during a breakout session at the conference.

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

Organizer: Orthogonal
Date: Thursday, September 29, 2022
Time: 12-12:45pm CT
Venue: Virtual

In the development of Software as a Medical Device (SaMD), there’s often a tension between moving at the speed of Agile and adhering to a Quality Management System that is document-based, which can be tedious to maintain.

An electronic Quality Management System (or eQMS), like the one recently deployed internally by Orthogonal, keeps up with the pace of Agile SaMD development by plugging directly into the tools that development teams already use for their work. This data-driven, automated approach to eQMS can give your organization a huge competitive advantage, enabling the production of a continuous stream of successful devices that improve the health and quality of peoples’ lives faster.

This live webinar on September 29th, 2022 featured senior technical leaders from Orthogonal discussing the effectiveness of an electronic Quality Management System (or eQMS), including a live demo of our in-house system.

Organizer: MATTER
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 this HealthXL’s Global Gathering in Chicago, startups, pharma, and investors shared different approaches to getting a digital health product to market. ‍

Orthogonal’s Bernhard Kappe and Randy Horton were in attendance to share insights that accelerate SaMD’s path to market.

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 spoke at this pre-conference workshop.

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

These industry experts discussed how regulation is essential for companies seeking approval of their SaMD by clinical and payer groups. They touched 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 was facilitated by Randy Horton, Orthogonal Chief Solutions Officer.

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!

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 shared success stories and lessons learned from their careers. Audiences were left with actionable steps so that their 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

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.

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.

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.

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

Orthogonal’s Randy Horton and Philips’ Pat Baird co-led 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.

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 co-presented 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.

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

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

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

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 Randy Horton and Bob Moll discussed best practices on product analytics for SaMD, DTx and connected medical device systems on March 22, 2022 at 11 AM CT.

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.

 Orthogonal’s Randy Horton, Chief Solutions Officer, partnered with Dr. Joseph West, CEO of the Florida Institute for Healthcare Innovation, to present “Natural Disasters, Response and Technology for Advancing Continuity of Care” at this inaugural ViVE 2022 conference in Miami, Florida.

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?

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.

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.

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.

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

The AAMI Standards team held its second quarterly session of the AAMI Standards Insider webinar series. This one-hour free webinar was intended to provide news and updates about AAMI’s standards program and portfolio.

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

This event featured 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 discussed the best and worst practices learned through their leading-edge efforts.

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.

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

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.

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