Oct 10-12, 2018 • San Diego, CA
The 10x Medical Device Conference
– design, develop, manufacture, and commercialize smarter and faster –
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The Medical Devices Group
(345,000+ members)
The Medical Devices Group is the world’s largest medical device community and the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders.
On LinkedIn: linkd.in/MDGroup
On the web: MedicalDevicesGroup.net
Full schedule
Important Content for Designers, Developers, and Manufacturers
October 10
7:30 AM
Our medical device conference registration table will be open all day. We encourage you to check-in with us before 5:15 PM if you’re joining us for the keynote presentation at 5:30 PM.
8:30 AM
Uncovering User Needs for any Medical Product is now an important aspect for the FDA. However, for a typical startup, this means balancing the technology with usability. There is an increased demand for new devices ranging from combination products to medical devices. Products are crossing boundaries from pharmaceutical and biologic delivery systems forcing a need for increased collaboration in the design of complex systems in the medical and life science device development.
In certain cases, there is a need to capture a wide variety of technical and user information that is used by various disciplines including engineering and marketing. Opportunities exist to capture early user needs that can challenge the existing technological platform, leading to a product pivot.
This 2-hour workshop will focus on teaching user centered design, design thinking, and research methodologies to help develop real world requirements. Additionally, it will focus on the collaboration needed with systems engineering to concurrently develop and test minimally viable products prior to translating the user needs and technical requirements in formal documentation to Design and Engineering disciplines and creating a value proposition by defining user needs.
• Takeaway #1: Creating a value proposition
• Takeaway #2: Developing meaningful User need requirements
• Takeaway #3: Creating a pitch deck
• Takeaway #4: Establishing good procedures (Inputs, DHF, Risk)
8:30 AM
The revised ISO 13485 standard expects you to apply a “risk based approach” to all of your organization’s QMS processes, specifically stating you’ll need to apply risk management methods and techniques to every single QMS process, including outsourced processes as well.
This presentation will give product developers and manufactures a thorough insight into the specific risk-based changes they’ll need to understand to comply with the revised standard.
18-year medical device industry veteran and founder & VP of QA/RA at eQMS software platform greenlight.guru, Jon Speer covers:
• How to apply a “risk based approach” to all your organizations QMS processes
• An overview of the current risk management standard for medical devices: ISO 14971
• Relevance of ISO 14971 and ISO 13485:2016
• How to incorporate risk management throughout the design control process and why it matters
• An overview of key risk management terms & definitions
• How to use risk management as a tool during design & development, and not simply as a “checkbox” activity
1:15 PM
The introduction of the MEDDEV 2.7/1 Rev. 4, in June 2016, is part of the significant changes happening across the medical device regulatory landscape.
This particular change is connected to introduction of the EU MDR enacted in 2017 and will significantly impact the procedures surrounding post-market clinical information, device equivalence, and clinical evidence at medical device companies. Although writing of Clinical Evaluation Reports was already a requirement for EU compliance, the previous revision of this MEDDEV didn’t provide much structure – neither to the manufacturer or to the Notified Body. As such, Clinical Evaluation Reports were relatively easily accepted. This has been changed.
The MEDDEV update made the Notified Bodies change their process, focusing on detail and now expecting a considerable effort from the manufacturer. What does this mean for manufacturers? They must gather more data, provide more analysis, and update their existing reports for all the devices in their portfolio, in an almost unworkable short amount of time…
In this workshop, Christine Zomorodian and Anne Leijsen will guide you through the development of process and the creation of the new clinical evaluations.
Christine is the ideal person to guide the process of designing a clinical evaluation structure in the context of your company. With the increased focus on post-market medical device data, Clinical Evaluations have become a focus of notified body review efforts. When should your clinical evaluations be performed? What information needs to be collected? And how do you ensure that there is a continuous process that allows evaluation of all your currently-marketed devices?
At the same time, Anne would be the best person to provide you all information you need for the creation of clinical evaluations. She has been working on numerous Clinical Evaluation Reports, submitted to and been accepted by several Notified Bodies. She will guide you through the exact requirements of the data gathering and writing processes: What are the steps that are to be taken? Where should you put the focus of the evaluation? What data shall be captured, and what shall be done if there is not much data available on your device? Who should be involved in the clinical evaluation process to get the best results? And what are the differences between clinical evaluations for different device classes?
If your work remotely touches this area, you should be in this workshop.
1:15 PM
For medical device companies, ineffective communication with FDA often leads to time-consuming and costly delays. Manufacturers may assume a classification or regulatory pathway for a new device – only to learn later that FDA disagrees. Unfortunately, most of these delays are completely avoidable!
The ‘pre-sub’ program – an expansion of the pre-IDE program– allows manufacturers to request meetings regarding devices currently under development and/or regulatory review. Although CDRH issued guidance on the pre-sub program in 2014, many companies do not use this program effectively, and some don’t use it at all for fear their regulatory burden will be increased rather than reduced.
When used effectively, pre-subs can offer significant advantages to the manufacturer by getting their device to market sooner. But if not used properly, pre-subs can add tremendous burden by increasing time to market. This presentation will use the case study approach to present the pre-sub process in an interactive fashion including:
• When should the pre-sub program be used and when should it not be?
• How does the process work and what can the manufacturer expect?
• When is it better to meet formally or informally? Should you meet in person or via teleconference?
• What info should be provided in advance and what should be provided at the meeting?
• What happens after the meeting? How should the manufacturer follow-up? Are the results binding?
• Are there other ways to communicate with FDA beyond pre-subs and when should they be used?
In this presentation, participants will learn best practices to avoid timely and costly mistakes and creative ways to use the pre-sub program to their advantage! For additional information, check out:
• Column: How To Make The Most Of Your Pre-Sub Interactions with FDA (Med Dev Online, Feb, 2015) here.
• Column: Communicating With FDA: How (And When) To Get It Right (Med Dev Online, June, 2015) here.
• Editorial: 3 Tips To Vastly Improve Your FDA Communication Strategy (MDDI, May, 2014) here.
• Podcast: How To Make The Most Of Your Pre-Submission Interactions With FDA here.
• Podcast: How to Properly Use the FDA Pre-Submission Process and Why It’s So Important here.
• Podcast: When And How To Interact With The FDA (MED Device Online, March, 2015) here.
• Workshop: FDA Pre-Submission Meetings: Strategies for MedTech Entrepreneurs (MassMEDIC, March, 2017) description here / podcast and handout here.
• Webinar: Communication With FDA: What Do We Say and How Do We Say It? (GWU, Jan, 2016) here.
• Guerrilla Regulatory Strategy (MED Dev Online), GreenLight.guru podcast series and Mike on Medtech (MPO Magazine)
5:30 PM
Did you know Texas Medical Center is the world’s largest? And did you they spend millions annually on medical device innovation with players ranging from industry titans to the smallest of start-ups? No? Then you should hear what Medical Device Innovation Lead Dr. Lance Black has to say!
6:15 PM
• 2-hour reception and networking with our sponsors, exhibitors, and guests
• Two drink tickets, light food included
EVERYONE IS WELCOME!
Can’t make the whole event but want to mingle and learn? No problem, join us Wednesday night for our keynote and reception.
We’d love to see you!
October 11
8:25 AM
Conference Host Joe Hage welcomes you to the conference and sets the stage for a productive and enjoyable two-day event.
8:30 AM
What you need to know about recent FDA guidance regarding:
- Real World Evidence,
- reporting age-, race-, and ethnicity data in clinical studies,
- drug/device classification issues,
- the pre-submission process,
- De Novo submissions,
- the Breakthrough Devices Program,
- submission involving cybersecurity, and
- deciding when to submit a new 510(k) for changes to an existing device or for software changes within an existing device
We’ll discuss how these, in a process already strained by the pressure to reduce the cost of healthcare and improve outcomes across the board, will affect your product development efforts.
9:20 AM
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9:45 AM
10:00 AM
During our short break, meet exhibitors who have the technologies and skills to get you to market smarter – and faster!
10:55 AM
Outline To Follow
11:20 AM
Patients are driving the miniaturization on ambulatory devices with increased emphasis on more functionality, more comfort, portability and self-powered devices. This growing trend towards making devices smaller allows for less invasive procedural techniques and helps reduce the length of hospital stays which reduces costs.
With the development of smaller components and drive systems, we can easily develop custom solutions that deliver on OEM’s next big ideas. During this session, we’ll discuss the driving factors on miniaturization, technologies that enable the micro approach, design aspects that make it possible, best practice impact on assembly, robustness and cost factors.
With his in-depth knowledge of drive systems, Mr. Horn will use real application examples, to show how miniaturization have made things possible today that were not years ago. In addition, we will look at the following:
• Technologies on winding, magnets and PCB’s.
• The impact on implants and solutions based on titanium and ceramics.
• Design aspects and how to get started using the inside-to-outside design approach, replace tolerances by elasticity, divide functions, and reduce interfaces and integration.
• The impact on the risk status.
11:45 AM
1:00 PM
A case study will be presented that visually demonstrates how upstream contextual inquiry maps user experience to robust device requirements and design inputs resulting in a dynamic trace matrix. This case study demonstrates how to effectively apply a usability design process, employing human factors engineering methodologies (including task analysis and use risk assessment) integrated with industrial design techniques (such as User Experience (UX) mapping and participatory design). The case study then demonstrates how the trace matrix connects concept design features with user requirements, traceable all the way back to the original UX map.
Main Objectives and Takeaways:
• How Contextual Inquiry can map UX insights that drive requirements and design inputs
• Developing rationales for User Requirements in a dynamic trace matrix
• Reducing risk during concept development through pragmatic usability design techniques
1:25 PM
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1:50 PM
This is a case study which couples together technical theory of operation with applied human factors. While usability testing is a strong topic of conversation due to FDA human factors guidance, the application of HF principles is implemented in the initial product design.
This presentation will delve into the process of assessing anthropometry and biomechanics towards effective user interfaces. This includes discussion on the criteria for Ease of Use and why Ease of Use by itself is a poor design requirement. Overall themes and concepts will be presented using a case study model.
LEARNING OBJECTIVES:
• Takeaway #1: How to apply human factors to technical design through the development of concept theory of operation.
• Takeaway #2: Key principles that when combined contribute to overall ease of use.
• Takeaway #3: How to use AAMI HE 75 for preliminary heuristic analysis for design
• Takeaway #4: Why this process can expedite success in formative/summative usability studies
2:15 PM
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3:20 PM
Walt Maclay will discuss the issues involved with bringing wearable medical devices from an idea to FDA approval based on his firms many experiences. He will discuss areas including user interface issues, battery life, different sensing technologies, data security, and verification to meet FDA and CE requirements.
3:45 PM
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4:10 PM
When designing and developing a medical device, companies often consider labeling down the road, but they shouldn’t. Labeling can involve a variety of ways a medtech company markets a product. What presenter Michael Drues calls high-level labeling – indications for use, intended use and label claims – drives to the heart of a company’s regulatory strategy.
Depending on the high-level labeling, the same product could be a wellness device not regulated as a medical device – or a device requiring a 510(k), de novo or PMA. Companies also need to balance out how the labeling will affect winning reimbursement from public and private healthcare payers – not to mention product liability exposure.
The result is that medical device creators need to design their labels like they design their devices. Michael will discuss the importance of label design and share his four-step design process during this informative session.
4:35 PM
Medical device designs are becoming complex in nature with combined elements of electrical, mechanical and material sciences. The innovative functionality, ease of use, safety, and manufacturability, are given importance in the early stage of design process.
With the initial focus on design and functionality, testing requirements are not given the due consideration early in process. For example, the design in early stages is focused on meeting a flexible polymer device with a certain Fr size. The polymer material is selected and the design is completed for release to the next phase of product development, i.e. testing phase. It is during this stage, the test standard requirement that the device requires to meet a bend radius without permanent deformation; leading to change of durometer of the polymer material. The effort in the design process now changes from making a non-conforming device to a conforming device which could have been avoided. This later recognition of meeting test requirements adds time for product development.
The order of testing also needs to be considered during the design development process. The stacking of earlier electrical tests may affect material degradation which could lead to issues in later tests for mechanical performance.
The presentation will include strategies to blend test requirements with user needs and design input. The planning of test qualification during the design input process will aid in reducing time for design iterations. The attendees would learn to appreciate to bring elements of design verification, i.e. testing, early in the stages of design development for faster product development cycles.
Takeaway #1 Incorporating test requirement in early stages of design development
Takeaway #2 Understanding test methods and applying to your specific device
Takeaway #3 Importance of order of testing
October 12
8:30 AM
Medical Device Manufacturing has many requirements, including regulatory constraints, standardized practices, identification and precision. In the future, we’d want even shorter runs of specialized devices, customized to patient needs.
The use of IoT and Edge Computing will allow sensory systems, strategically implemented in the manufacturing chain to develop a feedback system for all floor activities including Manufacturing, QA, Maintenance and other activities. The use of robotics is already standardizing, automating and optimizing medical device manufacture and assembly.
The use of IoT sensory systems, and the use of both edge computing, and over the longer term, Machine Learning and AI will allow for more precise control of processes, defect reduction, quality and cost optimization and other benefits.
The goal of Factory 4.0 is to implement sensors, automate and collect immense amounts of data on all activities performed on the floor, and the use of edge/cloud computing to get nearly instantaneous results, as well as the long term pattern recognition through AI/ML algorithms and techniques. We’ll discuss how adopting the above mentioned technologies can lead to high quality, highly customized, compliant medical devices.
Takeaway #1: The advantages of a data-driven manufacturing establishment
Takeaway #2: The benefits of Edge Computing in driving instantaneous insights
Takeaway #3: IoT, ML and AI can help with maintenance, upgrades and customization
Takeaway #4: Robotics, along with the other tools can be used to customize production for shorter batches of precise medical devices (edited)
8:55 AM
Is printing a knee really any different than printing a drug? The regulatory strategies are exactly the same! Interested in 3-D printing applications in medicine, not just what we are doing today but what we could be doing in the future and how do we get there? For example, can we ‘print’ medical devices? can we ‘print’ permanent implants? can we ‘print’ combination products? can we ‘print’ drugs (i.e., new molecular entities)? can we ‘print’ living tissue? What are the technical and regulatory challenges these new technologies pose? Using case studies from a variety of clinical specialties, all of these and more will be discussed in this interactive webinar. Strategies for using regulation as a competitive advantage will also be discussed.
Key Takeaways:
• Understand what is currently being done in biomedical 3-D printing
• Appreciate the technical and regulatory challenges and how to address them
• Be aware of applications and technologies underdevelopment
9:20 AM
Have you started implementing the 2016 version of ISO 13485 yet?
If not, I’m afraid I have to tell you that you’re lagging behind at this point. You have one year to go before compliance is an absolute requirement.
Did you just break out in a cold sweat? Not to worry. You do have time to act, but you need to do so now.
This session will highlight:
• Updates to the standard you need to be aware of (including the risk-based changes)
• An explanation of how to adapt your quality management system (QMS) to ensure compliance
• Timeline of activities you should be completing now to meet the deadline
9:45 AM
10:30 AM
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11:20 AM
All sterilization methods have pluses and minuses and any given sterilization method is the best option depending on type of material or medical device.
In this session, Jeff will address the primary terminal sterilization methods of Ethylene Oxide, Gamma, E-beam/X-Ray as well as emerging sterilization technologies.
This will include the drawbacks and benefits of each method, industry landscape and why determining optimal sterilization method is of critical importance in early development of new medical devices.
11:45 AM
1:00 PM
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1:25 PM
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1:50 PM
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2:15 PM
As medical device development complexity and regulatory requirements increase, the timeframe for development and the budget to complete the work struggle to maintain pace. Additionally, evidence-based medicine requirements increase the need to quickly and clearly convey complex physical interactions to non-technical audiences in an environment of constant distractions.
Computational modeling of devices and their interaction with tissue can be leveraged to minimize these issues. Medical device simulation allows your organization to design to the desired medical effect, test modifications before prototypes are built, and capture the subtle effects of these design changes rather than losing them in the noise of tissue testing.
The FDA has recognized the value in simulation data, and in September 2016 issued written guidance regarding computational modeling study design, elevating it to the highest level of FDA strategic priority. The door is now wide open to work in partnership with the FDA to address safety and efficacy questions using simulation results. This significantly reduces physical testing requirements, sometimes as much as by 50%.
Simulation also provides compelling visualization of complex ideas or hard to grasp concepts and can be used to quickly communicate the value of your device to customers or other non-technical audiences. While computational modeling was once only the domain of large companies and universities that could absorb the cost overhead to develop professional expertise and maintain large computer systems, today’s cloud-based computational power can now be applied to your more complex problems.
Computational modeling and simulation are now within reach of even a small start-up to speed the time to market. Using computational modeling and simulation tools in medical device development slashes development time through virtual prototyping, reduces regulatory testing prior to release, and allows you to clearly communicate the technological advantage of your product – with measurable effects to your bottom line.
Takeaway #1 Modeling and simulation significantly reduces time to market for medical device development
Takeaway #2 Modeling and simulation reduces the regulatory load required by the FDA
Takeaway #3 Data visualization is an effective tool for communicating complex concepts
Takeaway #4 Data centers and cloud computing puts computational modeling and simulation within reach of a company of any size.
3:00 PM
Outline To Follow
Download schedule
Top Speakers
You'll Get To Know These Medical Device Leaders
Lance Black MD
Med Device Innovation Lead at Texas Medical Center, the world's largest med center
Jason Spencer
Expert in industrial manufacturing, assembly, and process optimization
MB Privitera
Expert in product design, contextual inquiry, research, human factors
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Low Risk: Generous refund policy if you need to cancel for any reason!
Discounts: Available for students, the unemployed, and groups of 3+.
Discounts: Available for students, the unemployed, and groups of 3+.
What Alumni Say About 10x
I hope other conferences “drop the pretense” and let people be themselves like 10x does. We have more fun, want to stick around, and have better discussions.
INCREDIBLE is the word I use would describe it. I’ve never been to a conference where I made connections like this one. Nothing comes close to it and I really appreciate how you go out of the way to help everyone connect.
Thank you, Joe, for the superb conference, you are the BEST!! Learned so many new things, important challenges/opportunities, and products on the horizon. Couldn’t ask for more.
Thanks again for a great time – access to your network is invaluable, but feeling like I’ve got a new professional family is even better.
The people you invited, the people you specifically pulled aside for us to meet, and the relaxed, collaborative tone of the conference were all excellent. We’ll absolutely be coming back next year.
It was the best conference I’ve attended, and I plan to be back next year. Maurizio Vecchione’s talk was inspiring, and several of the other presenters gave me perspectives on changes in medical devices I hadn’t considered. Thank you, Joe, for your attitude that keeps the conference fun, engaging, and constantly improving!
It just gets better and better. As soon as I got home, I realized I am never not going to go to 10x. From technology to trends, hard-won insights from panelists to challenges for the industry – this is a MUST ATTEND event.
