True Quality 22

Event Brief

Greenlight Guru held its inaugural True Quality 22 conference in San Diego, CA at the Paradise Point Resort from June 6 – 8, 2022.  

David DeRam, CEO at Greenlight Guru welcomed the attendees with a simple message, “the agenda for the next two days is aimed at helping you learn how to innovate faster, stay ahead of industry challenges and use quality to grow.”

By the Numbers

More than 250 attendees, representing more than 100 medical device companies, attended over 25 sessions and I set a new record for steps taken in one day – 13, 278.  The goal of the conference was simple: empower medical device leaders to emerge, connect, and be inspired by their peers.

Sandra K. Rodriguez, Sr. Industry Analyst at Axendia delivered the opening keynote address with a focus on emerging industry trends, what the age of continuous disruption means for medical device companies, and shared Axendia’s latest market research data on the ineffectiveness of requirements management processes and the consequences.

Dr. Daniel Kraft, Founder at CEO of Exponential Medicine, is a Stanford and Harvard trained physician-scientist, inventor, entrepreneur, and innovator took the mainstage to discuss the future of healthcare and medicine: where can technology take us? His presentation highlighted advanced medical products ranging from wearables to walkables and insideables.  Connected products offer the opportunities for healthcare professionals to glean valuable data from a plethora of devices that will help patients achieve improved outcomes.

The MedTech Lifecycle Excellence Platform

Nick Tippman, CMO at Greenlight Guru unveiled its MedTech Lifecycle Excellence Platform.

Image Source: Greenlight Guru

Days prior to the conference, Greenlight Guru announced the acquisition of SMART-TRIAL, the maker of the first and only Electronic Data Capture (EDC) platform designed for the medical devices and diagnostics industry. SMART-TRIAL offers a comprehensive data collection toolbox to comply with regulatory requirements on clinical data. These capabilities will be coming to the platform over the next few months.  “Market leaders are putting quality at the heart of everything they do,” said Tippmann. “We have created a new category of software and are the first to have an end-to-end platform.”

Greenlight Guru started as a design control and risk management tool.  It then transformed to a Medtech specific eQMS in 2018.   The new MedTech Lifecycle Excellence Platform is the result of the following product announcements, including the acquisition of SMART-TRIAL:

  • CANVAS GT was rebranded to Greenlight Guru Strategy in January 2022 and will be released by the end of 2022.  This is a powerful tool for collaboration, knowledge management, and outcome-driving thinking across all stages of a MedTech company’s journey.
  • Regulatory Intelligence is purpose-built for MedTech professionals to discover, manage and monitor insights in order to build a competitive regulatory strategy.  With the acquisition of Vertex Intelligence, a data science company, the team is developing a search and recommendation platform that is powered by AI and ML. “It offers users a Google-like contextual search experience to conduct meaningful, up to date regulatory research to support not just your company’s research, but also to support your development efforts and monitor the latest regulatory information,” explained Tippmann.
  • Available today and launched in May 2022, is Greenlight Guru Academy Advance – a learning and education platform. This is a one stop shop for MedTech education. Premium courses on quality, risk management, clinical practices, project management, etc., are all included.  Both individuals and teams can gain all access to premium content with the end goal to upskill teams and advance careers.

What MedTech Companies Can Expect in 2023 and Beyond

Francesca Cruz, Vice President of Sales and Customer Success at Greenlight Guru moderated a CEO Roundtable on the mainstage. Cruz was joined by Lishan Aklog, MD, Chairman and CEO of PAVmed, Inc. and Lucid Diagnostics; Justin Barad, Founder and CEO of Osso VR; and, Pall Johannesson, Managing Director of SMART-TRIAL. 

What does the future hold for MedTech start-ups? Barad offered a compelling and simple answer, “if you want to invent something, you have to understand the problem you’re solving first.”  

Aklog addressed the post-pandemic challenges of remote work and managing resources in multiple locations. “We’re still not really used to not seeing each other. The harder thing is figuring out what to do now – we need to find the right balance of remote work and how to get together on a regular basis.  Aklog also noted that the pandemic showed us the art of possible with digital health and telemedicine.

Johannesson drew quite a loud laugh from the audience when he stated, “In the beginning of the pandemic, we found out which meetings could have been emails.  Today, we’re getting closer to finding that equilibrium.”

Barad spoke of the near-term storm of uncertainty.  “The pandemic has shown us no one knows for sure what could happen. Don’t be overly reactive because you don’t know what’s happening in a month or two.”

Cruz also asked the executives what their teams will have to do in order to be successful in 2025.  Pall’s response was to maintain ownership of culture. 

Barad suggested executives eat a lot of pizza, avoid burn out and the crunch culture.  He suggested leaving space on your calendar for creative ideas since today boundaries are murkier than they used to be. “Don’t send emails or slacks after hours. When people feel the burnout, it’s too late… just like when you feel thirsty, you’re already dehydrated.”

MedTech’s Living Legend

The final keynote of the day was a fireside chat with Manny Villafana, Ph.D.Sc., Founder and CEO of Medical 21.  Villafana is also the founder of Cardiac Pacemakers Inc., (CPI) and St. Jude Medical, and is the co-developer of both the first long-life lithium-powered pacemaker and the mechanical bi-leaflet heart valve.  He also has the success of nine IPOs under his belt.

Spanning an extensive career, he’s not done yet.  Villafana’s new company, Medical 21 is a development stage company seeking to reshape the future of cardiac bypass surgery.  The aim is to revolutionize heart bypass survey with an artificial graft called MAVERICS. The graft allows the heart bypass procedure to be done without harvesting vessels from the body. 

Clinical Evidence Under EUMDR

Isabella Schmitt, Director of Regulatory Affairs at Proxima addressed the clinical evidence requirements under EU MDR, “It’s not just a regulatory requirement, it’s a good product and business strategy, too.  It’s easier to trust a product with evidence than it is without.”

Jon Bergsteinsson, Director of Sales EMEA at Smart-Trial offered a few words of caution, “Usually low-risk or Class 1 PMCF activities may not be needed, but you have to document that in your PMCF plan. At many companies, EU MDR is being handled like a project and clinical affairs specialists and medical writers are jumping from company to company. It will be interesting to see in the next few years whether companies who are taking a project approach to clinical evidence requirements will continue to succeed or fail.”

“EU MDR is only enforcing what we should have been doing for years to ensure continued compliance,” said Bassil Akra, CEO at AKRO team. “Similar to Amazon, as soon as you buy something, you get a message asking if you liked the product. If you have 0% complaints, you’re not doing what you’re supposed to do. And be sure to check for misuse or off label use of your product on the market.”

Akra also discussed best practices for regulatory pathways.  “What’s the market of interest? Obtaining 510K approval in the US is easier than Europe. Consider your strategy afterwards.  What’s your clinical data collection strategy for Europe? PMS activities in the US may not be sufficient for the EU. Clinical studies in the US are not relevant to the EU population per regulatory bodies.”

“Intended use populations have different demographical drivers,” cautioned Schmitt. “Most companies want to launch in the US first; the market is larger and pays better.  Reimbursements are easier to navigate in one country v. many, like the EU.  There are also differences regarding standards of care, how many trials are required, etc. Lastly, it is also easier to get feedback from the FDA in the US, with notified bodies being so busy right now, in the EU.”

Web 3.0, Blockchains, DAO’s and NFT’s – Oh My!

Omar M. Khateeb, Head of State and Host – The State of MedTech, joined Henry Peck, Director of Global Marketing at Altoida to discuss how NFT’s will change MedTech.  The fast-paced and thoroughly mind-spinning conversation sought to unravel what Web 3.0 is and why MedTech companies should pay attention. 

Khateeb and Peck laid the groundwork for the conversation focusing on terminology first.

Blockchain – a decentralized infrastructure on which things are built (NFT’s, etc.)

NFT – a non-fungible token (each token has its own intrinsic value)

DAO – a decentralized, autonomous organization

Khateeb shared his story of moving from one healthcare system to another, “It was a royal pain. I had to fill out forms and repeat everything about my family and patient history. Imagine if I could just update an NFT and it goes to any healthcare system.  A simple AI could even identify risks for any conditions. Or, you could sell your NFT to a pharma company.”

Peck cautioned, “Patient data ownership will be disrupted with Web 3.0.  We want decision making authority, ownership of our data and getting compensated for the value of our data.”

TINY GVS

Brett Stewart, Principal Solutions Architect at Orthogonal shared this thoughts on why ‘This Is Not Your Grandmother’s Validated State’ (TINY GVS) when embracing the cloud for medical devices.  He offered 6 key recommendations:

  1. Identify the intended function of the cloud computing resources
  2. Apply a risk-based approach to evaluation resources for your project or process
  3. Identify the typical frequency of updates
  4. Assess the vendor and its processes with the appropriate level of scrutiny
  5. Establish a plan incase an update adversely affects the software
  6. Develop a supplier monitoring process

In Brief

Greenlight Guru’s Inaugural Event: True Quality 2022 was a breath of fresh air. It is extremely rare to glance through a conference agenda and want to attend each and every session.  In addition to the sessions mentioned above, topics ranged from best quality practices for SaMD, including artificial intelligence and machine learning to assessing the proposed rule aligning FDA’s medical device quality system regulation with ISO 13485:2016. 

True Quality was not about Greenlight Guru’s MedTech Intelligence Excellence Platform. Instead, the company opted to stay true to the name of the conference and offered sessions aimed at solving the various challenges companies face when getting their products to market.

In addition to the number of steps taken, I also set a new record for travel time and not in a good way.  The round trip flight from San Juan, Puerto Rico to San Diego, California was 26 hours due to delays and mishaps along the way.  Greenlight Guru said to keep an eye out for True Quality 23 next year – at a location to be announced in the near future.  I vote for Puerto Rico!

For questions, contact research@axendia.com to schedule an Analyst Inquiry on this topic.

The opinions and analysis expressed in this Post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this report is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This report is not intended to endorse any company or product and should not be attributed as such.

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