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Recap of True Quality 2022

June 12, 2022

Recap of True Quality 2022

True Quality 2022 featured one incredible MedTech speaker or panel after another. 

If you couldn’t attend in person, or had to choose between multiple presentations throughout the conference, here’s a look at what you missed. 

Behind the Research: Overcoming the Barriers to Improved Quality

Presented by: Sandra Rodriguez, Senior Industry Analyst at Axendia, Inc. 

Sandra Rodriguez kicked off True Quality 2022 with a clear-eyed and revealing look at the state of quality in the MedTech industry. Using the most recent market research, Sandra’s keynote presentation showed that our industry is still lagging when it comes to viewing quality as a strategic advantage, rather than just a form of compliance. And while that’s a major problem for the industry, Sandra also offered examples of how companies can move away from a focus on compliance and toward an ethos of True Quality. 

Attendees learned about the importance of closing the loop across the product life cycle, getting on the right side of the digital divide, and leveraging collaboration tools for the future. This powerful presentation demonstrated why we need to shift from compliance to quality and set the tone for the rest of the day. 

The New Era of MedTech

Presented by: David DeRam, CEO of Greenlight Guru

Our second keynote presentation of the day was led by David DeRam. Picking up where Sandra Rodriguez left off, David got specific about what our industry needs to move its focus from compliance to quality. After a moving introduction that touched on the crucial role medical devices will play in all of our lives, David brought Greenlight Guru CMO Nick Tippmann to the stage to discuss the new era of MedTech.

Nick stated the problem clearly: we have a lack of insights, capabilities, and proactiveness in the medical device industry. Then he announced the solution. Greenlight Guru’s expansion across the entire product life cycle. Or, as we call it, a MedTech Lifecycle Excellence Platform. 

Finally, David sat down with Andrew DiMeo, CEO of Canvas GT (now Greenlight Guru Strategy), to talk about what this new era of MedTech means for the industry and everyone involved in it. 

Mindset Tools for High Performance Teams

Presented by: Kevin Bailey, CEO and Founder of Dreamfuel

MedTech is a difficult industry for even the most experienced professionals to succeed in. In his presentation, Kevin Bailey explored the mental side of success—or failure. Why do our minds sabotage us at the moments when we need to perform our best? What can we do to prevent that sabotage and reframe negative thoughts, feelings, emotions, and physiological responses in a positive light?

Kevin answered these questions and more, diving into the neuroscience behind our reactions to stressful situations and how we can work to maintain elite performance even under demanding circumstances. For an industry with as many ups and downs as MedTech, the tools Kevin outlined in his presentation are essential. 

The Future of Health and Medicine: Where Can Technology Take Us

Presented by: Dr. Daniel Kraft, Founder and Chair of Exponential Medicine

Our third keynote of the day was a beautiful whirlwind of a presentation by Dr. Daniel Kraft, a world-renowned speaker and expert on medical technology. Dr. Kraft presented one new technology after another, from wearables to “insideables”. But if there was one thing he wanted to get across, it was that there is no single new technology that will change healthcare. Instead, the convergence of many new and exciting areas of research will pull healthcare out of the industrial age and into the digital age. 

Artificial intelligence, augmented and virtual reality, wearables, genomics, behavioral therapies, and many more advances will converge to offer incredible insights into patient health that will forever change the way we view our health. Both insightful and engaging, this presentation was sparking conversations through the rest of the conference. 

Building Companies and Careers: Your Brand

Presented by: Joe Mullings, the Chairman and CEO of the Mullings Group Companies

In an industry life MedTech, the idea of a personal brand is often viewed with skepticism. Joe Mullings put that skepticism to bed early with this refreshingly BS-free presentation that covered exactly how both medical device companies and professionals can build a reputation and leverage it for growth. 

In fact, Joe’s presentation wasn’t just for companies or individuals. Instead, he carefully covered both sides of the coin, demonstrating how to elevate a brand and evaluate fitness for a role from both perspectives. Whether it was using LinkedIn to your advantage, networking effectively, or getting an offer accepted, Joe had clear, concise advice for every attendee in the room. 

This was the talk that MedTech professionals didn’t know they needed, and in just 45 minutes, Joe may have changed the course of every attendee’s career. 

Concept to Commercialization: Challenges, Lessons, and Triumphs in Bringing New Devices to Market

Presented by: Dan Purvis, CEO at Velentium, Shri Raghunathan, President and CEO at Noctrix, James Reinstein, President and CEO at Saranas, Molly Wade, Founder and CEO at Baralogics

Bringing a new medical device to market is a long and difficult trek. And when you’re in the middle of it, wondering how you’ll ever make it to the finish line, sometimes you just need some advice from those who’ve already done it.Dan, Shri, James, and Molly generously shared their experiences taking a medical device from concept to commercialization in this exceptional session. From the highs and lows of getting funded to the questions that every MedTech company needs to ask about reimbursement, the panel offered an inside look into the process of getting a medical device onto the market. Both educational and inspiring, this breakout session was the perfect post-lunch pick-me-up.

Best Quality Practices for SaMD, including Artificial Intelligence and Machine Learning

Presented by: Kyle Rose, President of Rook Quality Systems and Chandler Thames, Quality Manager at Rook Consulting

Software as a medical device (SaMD) is an interesting convergence of two industries. As Kyle Rose and Chandler Thames explained, there are a lot of software engineers without medical device backgrounds who are encountering FDA regulations for the first time. 

That can cause issues, but it doesn’t have to. Kyle walked attendees through the strategies they can take to ensure their SaMD development process is compliant with regulations and optimize for quality while still being as efficient as possible. A big first step? Using software like Greenlight Guru. As Kyle put it, “It doesn’t make any sense to have a software product and then document everything on paper.”

Chandler stepped in to discuss the many questions surrounding AI and ML, especially regarding changes to algorithms and the FDA’s policy on new submissions. The SaMD regulatory environment is still evolving, but Kyle and Chandler broke it down and answered audience questions with ease. 

Understanding the Critical Interdependence of Risk with Pre- and Post-Market Activities

Presented by: Carolyn Guthrie, Director of QA/RA at Kapstone Medical

Risk management practices will never be a “set it and forget it” process. However, as Carolyn Guthrie, Director of QA/RA at Kapstone Medical explained in her Tuesday afternoon breakout session, when it’s properly integrated into a medical device company’s QMS, you can rest a little easier knowing the appropriate actions are being taken care of. 

For Guthrie, this means ensuring that feedback loops are triggered at the appropriate times throughout the product life cycle. That means involving every department earlier, rather than later. “When it comes to risk management, you want to involve as large a team as possible, because you’re catching everything,” she said. Ultimately, these properly closed feedback loops can be fine tuned and something that can be managed, rather than constantly overseen. And this, Guthrie said, is the true reward to risk management: “Risk management is more than satisfying the reg requirements. It’s a chance to make safer and therefore more effective medical devices.”

Communicating with FDA: Is FDA Hearing What You’re Saying? Are You Sure?

Presented by: Michael Drues, Ph.D, President at Vascular Sciences

Anyone familiar with Greenlight Guru’s Medical Device Podcast will undoubtedly recognize Mike Drues. Known equally for his idiosyncrasies and his brilliant insight into the medical device commercialization path, Drues delivered another memorable presentation detailing some of the =nuances, frustrations, and solutions for engaging with FDA regulators.

Using case studies from a variety of clinical specialties, Drues detailed how the most common reason for delays, warning letters, recalls stem from not communicating effectively. Drues divides the types of communications manufacturers can expect into two categories: formal ones — such as pre-submissions, requests for information, and requests for designation — and informal ones, like direct messages and company requested meet-and-greets.

Though companies may not realize it, even these more unofficial interactions will play a big role in what he says is the most important task: establishing and nurturing an open and honest relationship with inspectors. “I like to justify what I'm doing,” Drues said. “But I also want to justify what I don’t do, because I want to give FDA every opportunity to agree with me and more importantly to disagree with me.”

Governance of Cybersecurity Program for Developing Medical Devices

Presented by: Christopher Gates, Director of Product Security at Velentium, Abbas Dhilawala, CTO at Galen Data, Mike Kijewski, CEO of MedCrypt, and Jason Smith, Sr. Strategist, Marketing, at Velentium

This panel discussion on cybersecurity includes some of the foremost experts in medical device cybersecurity today. Moderated by Jason Smith, this lively and entertaining discussion was an absolute must-see for anyone interested in cybersecurity. 

And as Mike, Chris, and Abbas made clear, that should be everyone in the medical device industry. Cybersecurity is not something that should be tacked onto your product at the end of development. As Abbas put it, “Security by design implies an intentional choice made up front and carried throughout the life cycle of the product.”

Throughout the discussion, the imperative was clear—you can’t afford to not take cybersecurity seriously. Patients are relying on secure devices, and so is your business model. Mike’s advice? “The most impactful thing you can do is set up a culture that understands cybersecurity is a thing and everyone needs to deal with this problem proactively.” 

Status of EU MDR and EU IVDR after 5Y of Publication

Presented by: Bassil Akra, CEO at Akra Team (Former VP at TÜV SÜD)

With the 5-year anniversary of EU MDR upon us, this was one of two True Quality sessions covering the radical impact of the regulations on medical and in-vitro diagnostic devices. In this Tuesday breakout, Basil spoke passionately to the mainroom audience about the dire circumstances facing the MedTech market with approaching IVDR implementation deadlines and the ongoing shortage of notified body capacity. 

“In the eyes of the EU MDR, if you screw up it’s your problem,” he said. “But the reality is that with so many yet-to-be-certified devices left, it’s likely they will not be able to digest it.”

He also expressed frustration with the legislation’s notoriously verbose and detailed requirements. In many ways, Basil said, that is one thing that is not changing.  “When they first wrote the EU MDR they said they kept it long because they wanted to avoid guidance documents. But, today we have over 80 guidances, and each guidance document is clarifying one sentence or two sentences for dozens of pages.”

While medical device manufacturers are understandably frustrated, Basil urged proactive strategies as opposed to delaying the process any longer. Things like COVID-19 have made remote audits nearly impossible, but Basil says companies need to plan ahead to avoid falling victim to EU MDR bottlenecks. 

“It’s the fault of the industry, of the holistic system and how we are dealing with the legislation. We [medical device manufacturers] are not looking for solutions, we’re looking for things to blame it on.”

Regulatory Pathways And Your Go-To-Market Strategy

Presented by: Michelle Lott, Regulatory Strategist, Principal and Founder - Lean RAQA | Savannah Sitton, Director of Regulatory Affairs - Milliken Healthcare | Isabella Schmitt, Director of Regulatory Affairs - Proxima Clinical Research

This Tuesday roundtable was one for the ages, as Michelle, Isabella, and Savanah had a lively discussion comparing the nuances, similarities, and differences between regulatory pathways in the US, EU, and other markets. Sitting down with Greenlight Guru’s Etienne Nichols, the three experts detailed how timelines, costs, and other considerations can play a big role in determining which markets to pursue and when to make your move. 

The panel reminded the audience that while regulatory pathways may be a headache, they’re for an overall greater good.  “Just ignoring these requirements never goes well,” said Michelle. “I say I’m a regulatory grief counselor, and I see companies going through all five stages of grief without spending enough time in acceptance.”  

Though the group discussed hot-button issues, such as the impact of global shifts like Brexit on the medtech community, they also shared moments of triumph, like the time one of Michelle’s clients implemented preemptive design controls for devices. “He voluntarily chose to implement a design process,” she said. “It was going to make it more sellable, and he knew it would be under Notified Body review. He really wanted to approach things with integrity.”

Is Your Use Related Risk Analysis Half Empty or Half Full?

Presented by: MaryBeth Privitera, Principal- Human Factors & Research at HS Design, Inc

The subject of risk management for human factors was the center of MaryBeth’s Tuesday breakout session, as she broke down the ways manufacturers could take both a “half full,” and “half empty” approach to managing risk when it comes to user requirements, the environment of use, logic of operator-device interaction controls, implantable devices, and labeling requirements in IFUs. 

Standards like ISO 13485, ISO 14971, IEC 62366 and FDA Human Factors Engineering were all major points of discussion But, at the end, MaryBet drove things home by illuminating the audience on how doing the right thing to consider human factors ultimately sets up companies for success. “One of the biggest drivers of the human factors process in medical device development is the need and requirement to reduce device hazards and associated risks,” she said. “Considering human factors is a risk management tool and when its done properly, it can be the driver of increased sales.”

MedTech Companies Will Never Be The Same: A Quality Leader’s Perspective

Presented by: Mitch Lewandowski, VP of Quality at GRAIL, Amit Relia, Sr. Director of Quality at iRhythm Technologies, and Patricia Setti-LaPerch, Director of Regulatory Compliance and Quality at Koios

Moderated by Greenlight Guru’s own Sara Adams, the panel of quality leaders discussed their perspectives on a number of important issues. Whether it was the effects of the pandemic on quality teams or how they expected the quality landscape to evolve in the coming years, Mitch, Amit, and Patricia spoke eloquently about their experiences as quality leaders. 

It was clear there were still plenty of challenges for quality teams. Global regulations need to become more consolidated. Companies need to move forward from just thinking about compliance to thinking about True Quality. And the attraction and retention of talent is a big issue right now. Despite all of that, our panelists were optimistic about the opportunities within the industry to promote quality and improve the quality of life for patients around the world. 

CEO Roundtable, Leading Your Medtech Company in 2023 and Beyond

Presented by: Dr. Lishan Aklog, Chairman and CEO of PAVmed Inc and Lucid Diagnostics, Justin Barad, Founder and CEO of Osso VR, and Páll Jóhannesson, Managing Director at SMART-TRIAL by Greenlight Guru

This incredible roundtable discussion touched on both the MedTech industry as a whole and the personal experience of the three CEOs on the stage. Lishan, Justin, and Páll offered the audience insights into how they view remote work, what MedTech companies will need to do to be successful in the next three years, and what trends they see within the industry. 

But they also touched on topics closer to home. What led them to start MedTech companies? How should leaders address burnout in an industry that demands excellence from those in it? What are the mantras that keep you going (and your team can recite by heart)? Intimate, funny, and insightful in equal measures, this roundtable offered a look at both the head and heart of successful MedTech companies. 

Fireside Chat with a MedTech Living Legend

Presented by: Dr. Manny Villafaña, Founder of Cardiac Pacemaker, Inc. (CPI)/Guidant and St. Jude Medical Inc. | Scott Pantel, Founder and CEO of Life Science Intelligence

We couldn’t wrap up day one of True Quality without a bang. And if you were in the audience for this chat with Dr. Manny Villafaña, you know you witnessed something special. Manny is an industry icon, launching companies like 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.

That may sound impressive, but the stories behind those medical devices are even wilder and more fascinating than you could possibly imagine. Manny held the ballroom rapt as he told story after story about how some of the most commonly used medical devices in the world were developed and commercialized. And of course, Manny isn’t done yet. He concluded with a brief overview of his newest company, Medical 21, which is developing artificial grafts for heart bypass surgery.

Global MedTech Innovation and Regulation in the Digital Age

Presented by: Jennifer McCaney, Executive Director at UCLA Biodesign

In Wednesday’s opening keynote presentation, Jennifer McCaney offered a look into the state of innovation and regulation in the medical device industry. Jennifer’s team surveyed over 100 medical device companies with plenty of global regulatory experience among them. They wanted to know how much it cost to get a product to market, how long it takes, and how the companies viewed regulatory bodies. 

The digital age has brought along with it an immense amount of data, and the digital transformation in healthcare is finally beginning to unleash the flow of that data. But how are regulations evolving with the times? What are the perceptions surrounding regulatory bodies around the world? The answers to these questions were eye-opening, and attendees got a first-hand look at how innovation and regulation are changing right now.

Clinical Evidence under the EU MDR

Presented by: Bassil Akra, CEO of AKRA TEAM GmbH, Páll Jóhannesson, Managing Director at SMART-TRIAL by Greenlight Guru, Isabella Schmitt, and Jon Bergsteinsson, CCO of SMART-TRIAL by Greenlight Guru

If you’re confused by EU MDR, wondering what constitutes sufficient clinical evidence, or just like hearing experts chat about a subject they’re passionate about, then this was the session for you. 

Bassil, Páll, Isabella, and Jon held a masterclass in the requirements for clinical evidence under EU MDR. This was one of the more technical—yet highly accessible—panels of the day, and the group did their best to make sure no one left the session thinking they could blow off the clinical evidence requirements. They torched misconception after misconception, explaining the regulatory and business rationale behind proactively collecting sufficient clinical evidence. 

As Isabella put it, “You need to go out and find that evidence as opposed to waiting for someone to knock on your door and tell you something about your product.”

This is not your grandmother's validated state!

Presented by: Brett Stewart, Principal Solutions Architect - Orthogonal

One of the most memorable and truly humourous sessions took place on Wednesday, as Brett used his charm and deep insights on the subject of incorporating new technologies into medical device software to provide detail on what he and his Orthogonal cohorts call: “TINY GVS.”

“As engineers, regulators, and scientists, 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,” said Brett.

Brett also broke down the recent AAMI Consensus Report on cloud computing and medical devices, as well as reviewed new systems engineering frameworks for new technology-enabled opportunities to improve patient outcomes, all while still responsibly mitigating risks. 

“The medical device manufacturers creating and operating these new technologies have an admirable focus on continuous improvement, but often it just isn't compatible with MedTech’s traditional approaches to regulated change management,” Brett said. 

Into the Unknown: A Look at Where Your File Goes When You Send it Off to FDA

Presented by: Allison Komiyama, Principal Consultant at RQM+ | Kate Dilligan, CEO at Cooler Heads | Michael Nilo, President and Principal Consultant at Nilo Medical Consulting

So many medical device companies fear the FDA submission process, and worry like it’s a black box. This panel of MedTech industry leaders and former FDA inspectors took time to break down barriers and unlock secrets in covering best practices, details, tips, and mistakes to avoid.

The panel encouraged attendees to not fear FDA, and instead try to leverage their relationships with regulators to provide better, cleaner submissions. As Michael said, “Requests for feedback can be a good conversation, and you can push back a bit if you have a point you really want to defend. But don’t go in unprepared because once it’s on the minutes, you’ll be expected to address it.”

Another important aspect of this discussion was how it provided a humanizing view of FDA inspectors. Alison explained that while FDA inspectors ultimately want the best for MedTech companies, companies making submissions need to consider how busy inspectors are. “It’s a lot of project management, you’re trying to manage so much, and sometimes after the 180 days companies have to respond, it’s possible that we might not entirely remember your device.”

The Wait is Over: Assessing the Proposed Rule Aligning FDA’s Medical Device Quality System Regulation with ISO 13485:2016

Presented by: Eric Henry, Sr. Quality Systems and Compliance Advisor, FDA & Life Sciences Practice at King and Spalding

This  was one of the more heavily attended breakout sessions, and for good reason. Eric Henry broke down one of the most anticipated events in MedTech: the harmonization of FDA’s QSR with ISO 13485. It’s been a long time coming, but after 26 years without a significant change the QSR will be undergoing a major update, incorporating ISO 13485:2016 by reference. 

Eric first explained how we reached this moment, noting that FDA missed five previous deadlines for the draft of the QMSR. But he also dove deep into the nuts and bolts of the proposal, explaining what it means to incorporate ISO 13485 “by reference”, clarifying the structure and content of the draft, and offering insight into the rollout of the final regulation. 

How NFTs Will Change Medtech

Presented by: Omar M. Khateeb, Head of State & Host of The State of MedTech | Henry Peck, Director of Global Marketing at Altoida 

The Blockchain. Bitcoin. Non-fungible tokens. Though these may sound like the utterances of influencers, this session detailed the way NFTs could represent new levels of security and patient care in the years to come. “We know a lot of these sound like buzzwords, and to an extent they are,” said Henry. “But they also represent the future in many ways for the industry.”

The panel discussed various implementations of blockchain technology on MedTech, such as authenticating counterfeit medication and protecting patient data. “NFTs have the potential to solve these various problems – giving the power of medical records back to the patient and streamlining the healthcare experience,” Omar said.

The two also discussed how the crowd-funding aspects of NFTs provide a new model for how startups and innovators receive funding from investors. “MedTech needs community support for their scientific projects to reach their full potential.”

Implementation of Risk Management Board for New Product Introduction & PMS

Presented by: Mike Baca, White Rook Consulting

Prior to closing out the conference with a keynote speech, Mike Baca got into the dirty details of risk management. He broke down the numerous requirements of ISO 14971 and TR 24971, and illuminated the crowd on exactly how they provide the framework for the Risk Management Program.

 But beyond this, he spoke about the obligation regulators have to the general public, and how important the risk management process is for product development and marketing. “The FDA can’t tell you what to do,” he said “But they can tell you what the regulation requires and you better believe that they’ll need you to address risk in your product.”

The Journey Continues: What to Know for US FDA Class I and other Global Regulator Requirements

Presented by: Gary Saner, Sr. Manager of Information Solutions-Life Sciences at Reed Tech

Unique Device Identifier (UDI) probably isn’t at the top of your list when you begin designing and developing a device. But despite that, it’s still an incredibly important aspect of getting your device to market and keeping it there. 

This session on UDI with Gary Saner was a technical but instructive look at what medical device companies need to know about global UDI requirements and how they relate to each other. Dates of implementation for FDA Class I devices, EU’s EUDAMED, China’s NMPA, and South Korea’s MFDS are fast approaching, and medical device companies need to understand and get ahead of these milestones. As Gary mentioned, “It’s very important this data is accurate, complete, and current. It’s very difficult to change it once it’s been sent to a health authority.”

Fireside Chat with Mike Baca on Leadership, Purpose, and Impact

Presented by: Mike Baca, former VP of QA/RA at Stryker and Medtronic and former Senior Director at Johnson & Johnson, David DeRam, CEO of Greenlight Guru

True Quality 2022 closed out with a fantastic discussion in the packed mainstage hall, as Mike Baca reviewed and reflected on his legendary career as a leader in MedTech. Mike joined Johnson & Johnson in 1981, working there for 22 years progressing through numerous assignments of increasing responsibility in the Quality and Regulatory disciplines through four operating companies and Johnson & Johnson Corporate as a Quality and Compliance Services Account Director responsible for Corporate oversight of several Medical Device Implant Divisions.

No matter how large the organization, Mike said that management of people should always be a point of service, not a function of hierarchy. “Leadership is a gift,” he said. “I made sure that every new employee had an hour and a half one-on-one. I also gave them what I call an ‘eyes wide open’ speech, which detailed everything I expected from them. And guess what, I told them to expect them from me and the rest of management, as well.”

That was all for True Quality 2022. It was two jam-packed days, filled with amazing speakers, networking opportunities, and insights. If you missed out, we hope you’ll join us next year. For now, check out our newly announced Medtech Lifecycle Excellence Platform to see how an end-to-end solution can help your medical device company grow and thrive.


Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your post-market activities with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →

 

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