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Wearable Injectors and Connected Devices USA
September 13 - September 14, 2023
Wearable Injectors and Connected Devices USA

SAE Media Group’s Inaugural
Wearable Injectors and Connected Devices USA
September 13 - 14  2023 | Boston, MA
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SAE Media Group are proud to announce the Inaugural Wearable Injectors and Connected Devices USA Conference taking place on the 13th and 14th of September 2023.


Following the success of the Wearable Injectors and Connected Devices Europe conference, SAE Media Group will be bringing the conference to Boston to cater to Big Pharma, Biotech and Device Developers in the USA.
 

As the need for at home self-administration and routes for delivery of time-dependent and high-volume drug delivery grows, on-body injectors and connected devices hold great opportunity. The conference will delve into on-body device design and development, latest advances in connectivity and digital integration of wearable devices, and opportunities for enhancement of user-interface through human factors case studies. The conference will also address challenges in regulations surrounding wearable injectors and connected devices with case studies and an FDA keynote on cybersecurity.


As part of SAE Media Group’s leading Injectable series of conferences, we bring together high-level experts from big pharma and device developers to network and share knowledge to advance R&D. The two-day conference will not only bring you high-quality key insights needed to enhance your wearable devices and connected product portfolio but will also give you the opportunity to network with key players throughout the industry. We hope to welcome you to this must attend event in September 2023!
 

FEATURED SPEAKERS

Alexandra Benbadis

Alexandra Benbadis

Usability Leader, Sanofi
Alicia Douglas

Alicia Douglas

Human Factors Lead, Merck
Anthony Coston

Anthony Coston

Technical Lead, Biogen
E Guan

E Guan

Head of Injection Systems, Takeda
Jamie Tsung

Jamie Tsung

Director CMC Development, Alnylam
Jessica Mastropietro

Jessica Mastropietro

Device Development Engineer, Regeneron Pharmaceuticals Inc
Jessica Wilkerson

Jessica Wilkerson

Cyber Policy Advisor and Medical Device Cybersecurity Team Lead, FDA
Kyle Berman

Kyle Berman

Principle Engineer, Devices Centre of Excellence, Pfizer
Leya Bergquist

Leya Bergquist

Associate Director, UserWise
Ling Zheng

Ling Zheng

Assoicate Director, Alexion Pharmaceuticals Inc
Mark DeStefano

Mark DeStefano

Director, Combination Products and Device R&D, Teva Pharmaceuticals
Maximillian Dixon

Maximillian Dixon

Senior Applied Sciences Engineer, Crux Product Design Ltd
Paul Upham

Paul Upham

Head, Smart Devices, Roche/Genentech
Peter Dorski

Peter Dorski

Associate Director, Janssen, Pharmaceutical Companies of Johnson and Johnson
Sam Butler

Sam Butler

Director, Commercial Development - Advanced Drug Delivery Systems, BD Medical - Pharmaceutical Systems
Samir Shah

Samir Shah

Director, AstraZeneca
Simon Wilson

Simon Wilson

Device Development Lead, Pfizer
Sujani Nannapaneni

Sujani Nannapaneni

Senior Principal Research Scientist, Human Factors, AbbVie, Inc
Thomas James

Thomas James

Lead Mechanical Engineer, Key Tech

Alexandra Benbadis

Usability Leader, Sanofi
Alexandra Benbadis

Alexandra is a passionate human factors (HF) professional who loves everything about combination product usability. At Sanofi, she serves as the HF subject matter expert on several programs and advocates for implementing creative HF strategies, which are rooted in her strong understanding of applying HF principles to developing safe and effective combination products. Before working at Sanofi, Alexandra was a Senior Human Factors Specialist at Emergo by UL, where she was responsible for planning, managing, and conducting usability tests throughout the product development process. She has both a bachelor’s degree and master’s degree in human factors engineering from Tufts University.

 

Alicia Douglas

Human Factors Lead, Merck
Alicia Douglas

Alicia, a graduate of the University of Maryland, with a B.S in Bio-engineering, is a knowledgeable and passionate Human Factors leader. She has 16 years of experience in Pharmaceutical, Medical Device and Consumer Healthcare Industry. Throughout her career she has been focusing on devices and combination products within Oral Care to Oncology area. With a strong background in human factors, product development, and design controls she loves learn and present on these topics for devices and combination products.

Anthony Coston

Technical Lead, Biogen
Anthony Coston

Anthony drives the development of ASO combination devices and gene therapy delivery devices at Biogen. Anthony has over 25 years of medical device experience in the areas of product development, project management, marketing, new business development, and technology scouting.


Prior to his time with Biogen , Anthony was consulting with GSK and other Biotech companies in the Oral Solid Dosage CMC area pertaining to depression, oncology, and other therapeutic drugs. Anthony was also the Director of CMC Project Management at Alkermes.


In addition, Anthony was the Head of Medical Devices at Draper where he was responsible for New Business Development through leveraging the technical capabilities and expertise within Draper to provide technical solutions for unmet needs within the medical device and biotech communities. Anthony was responsible for obtaining a $16M neurological device development contract within the first year in this role which was the largest device contract obtained at Draper during that time.


Prior to Draper, Anthony worked for several medical device companies including Johnson and Johnson, Becton Dickinson, and Bard where he helped develop the leading fecal containment system, a portable urodynamic measurement system, a continuous glucose monitor and advanced the development of a thermal ablation technology to treat menorrhagia.


Anthony has four issued patents, several pending patents, and six publications. He has a PhD and a Master’s in Biomedical Engineering from Rutgers University and Penn State University respectively. His undergraduate degree is in Electrical Engineering from the University of Delaware, and he has an MBA from MIT.

 

E Guan

Head of Injection Systems, Takeda
E Guan

E is a passionate leader in building device development capabilities and improving combination product development processes. He is savvy in delivery device technology assessment, combination product development, manufacture process development, commercial scale-up and life cycle management. E currently holds the position of Head of Injection Systems at Takeda. Previously he was Director of device development with AstraZeneca. He built a very strong device team and managed multiple combination product programs in the therapeutic areas of respiratory, inflammation, autoimmune, cardiovascular, renal and metabolic diseases. Prior to AstraZeneca, he was device lead with Janssen Pharmaceuticals and Becton Dickinson, where he led and launched/relaunched a few injection device or combination product programs.
E obtained his Bachelor and PhD degrees in mechanical engineering and a master’s degree in polymer physics.
 

Jamie Tsung

Director CMC Development, Alnylam
Jamie Tsung

Dr. Jamie Tsung received her Ph.D. in pharmaceutical sciences from the University of Connecticut. Currently, she is an Associate Director at Alnylam Pharmaceuticals. Prior to Alnylam, she worked for Momenta, Shire, Baxter, and UCB. Her biopharmaceutical experience spans preclinical to marketed products, integrating formulation, characterization, processing technology, regulatory, and quality control providing a valuable perspective and creative approach to product development.

Jessica Mastropietro

Device Development Engineer, Regeneron Pharmaceuticals Inc
Jessica Mastropietro

Jessie Mastropietro is a Device Development Engineer within New Technologies Management, Combination Product Development at Regeneron Pharmaceuticals. She is responsible for analyzing and interpreting drug delivery system industry trends, competitive landscapes, and user needs to drive device strategy. She also characterizes devices through technical assessments and conducts user studies to inform and develop the drug delivery system portfolio. Jessie previously worked in product development to bring both primary container components and combination products from design input to commercialization.


Jessie graduated with BS and MEng degrees in Biomedical Engineering from Rensselaer Polytechnic Institute in Troy, NY.
 

Jessica Wilkerson

Cyber Policy Advisor and Medical Device Cybersecurity Team Lead, FDA
Jessica Wilkerson

Jessica Wilkerson is a Senior Cyber Policy Advisor and the Medical Device Cybersecurity Team Lead within the All-Hazards Readiness, Response, and Cybersecurity (ARC) team in the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). As part of ARC, she examines issues and develops policy related to medical device cybersecurity. Previously, she spent a year as a partial detail to the Office of the National Cyber Director (ONCD), representing medical device and health sector cybersecurity equities within the Executive Office of the President. She also worked as the Cybersecurity Research Director for the Linux Foundation, and spent over five years as a congressional staffer with the House Committee on Energy and Commerce, covering cybersecurity issues in the telecommunications, commercial, energy, and health sectors. As part of that work, she examined issues related to coordinated vulnerability disclosure, software supply-chain transparency, legacy technology risks, and cybersecurity governance models, among others. She received a B.A. in Policy Studies and minors in Computer Science and Mathematics from Syracuse University, and a J.D. from the Catholic University of America’s Columbus School of Law.

Kyle Berman

Principle Engineer, Devices Centre of Excellence, Pfizer
Kyle Berman

Kyle has a degree in Mechanical Engineering and over 10 years’ experience in design and engineering. His early career focussed on the development of tractors and heavy machinery before moving onto medical devices in 2016.

During his time working for Pfizer’s Devices Centre of Excellence he has been the Technical Lead on a selection of electromechanical device projects. He is involved in suitability assessments, specification setting, product development and verification testing from early-stage design through to pre-production.

Through his work on ‘smart’ injector projects, Kyle has acquired an interest in connected devices and how they can be utilised to improve Patient-Device interactions.
 

Leya Bergquist

Associate Director, UserWise
Leya Bergquist

Leya Bergquist is currently Associate Director, Human Factors Engineering at UserWise, a consultancy that helps medical device and combination product manufacturers and start-ups design safe and easy-to-use medical products.

Leya regularly works on human factors submission strategy and compliance documentation for FDA Human Factors Guidance and international standards related to usability engineering (e.g. IEC 62366-1, IEC 60601-1-6, and ISO 14971) for home and hospital use products.

Leya has been working the medical device industry for more than 20 years with experience in design controls, risk analysis, and V&V. She has focused on human factors engineering for the last 6 years.

 

Ling Zheng

Assoicate Director, Alexion Pharmaceuticals Inc
Ling Zheng

Ling Zheng is a device development lead at Alexion Pharmaceuticals, AstraZeneca’s Rare Disease Unit. She is currently working on developing drug delivery devices for combination products. She has many years of experience working on wearable injectors with focus on electrical and software design and development. She has hands-on experience on primary battery selection for wearable devices, including power budget management and battery characterization.

Mark DeStefano

Director, Combination Products and Device R&D, Teva Pharmaceuticals
Mark DeStefano

Mark DeStefano is the Director, Combination Products and Devices Research and Development for Teva Pharmaceuticals focusing on advanced technology identification and development for Teva pipeline and platform combination products. He is an experienced Device Development Professional with a demonstrated 32 yr. history of product innovation, design, development, and launch in many areas of the medical device industry from surgical devices to drug delivery devices and is the inventor / co-inventor on over 25 medical device patents. Mr. DeStefano has spent the last 23 years in drug delivery device development, including 13 years in the development of insulin pumps and infusion sets for Type 1 Diabetes and 10 years in the development of injection devices for parenteral drugs. Mr. DeStefano holds a Bachelor of Science in Mechanical Engineering from Drexel University.

Maximillian Dixon

Senior Applied Sciences Engineer, Crux Product Design Ltd
Maximillian Dixon

Max Dixon is a Senior Applied Sciences Engineer at Crux Product Design Ltd (Bristol, UK), where he routinely pioneers the development and application of cutting-edge numerical tools across the drug delivery and surgical spaces. He applies his knowledge and understanding of how digital tools have revolutionised other high-performance industries to the health care sector and advocates a data driven problem solving approach. He has a proven track record of generating ground-breaking insights for leading pharmaceutical companies, resulting in step changes in device performance at any point along a device’s life cycle; from concept through to mass manufacture.

 

Paul Upham

Head, Smart Devices, Roche/Genentech
Paul Upham

Paul is the Head of Smart Devices at Roche / Genentech. Paul has 20+ years of experience in medical device R&D, strategic marketing, product management, clinical research, and medical informatics.
Prior to Roche / Genentech, Paul was with Becton Dickinson(BD), as Worldwide Director of Strategic Marketing in their Pharmaceutical Systems business.

Paul was also the head of Product at WellDoc, Inc., where he led the product management activities for WellDoc’s portfolio of mobile health solutions. He was responsible for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for diabetes.

Paul’s prior experience includes 10 years in BD’s Diabetes Care business. Paul was responsible for the award-winning BD InterActiv® Diabetes Software, and was a member of the BD / Medtronic team that launched ParadigmLink®, the world’s first wireless blood glucose meter.

Paul holds four issued patents in medical software and drug delivery devices and has multiple patent applications. He is also an author of numerous peer-reviewed articles in medical informatics and diabetes. His education includes undergraduate studies in cognitive science and graduate work in health informatics and finance at the University of Minnesota and New York University.
 

Peter Dorski

Associate Director, Janssen, Pharmaceutical Companies of Johnson and Johnson
Peter Dorski

Peter Dorski is an Associate Director, CMC Regulatory Affairs at Janssen, at Pharmaceutical Companies of Johnson and Johnson. He has worked within the pharmaceutical and combination products industry for over 10 years, driving regulatory strategies based on industry best practices for global/major market product development and supporting advancement of complex, innovative delivery systems using leading-edge therapies.


Within the pharma industry, Peter works to understand and influence the continuously evolving regulatory landscape surrounding combination products to serve industry stakeholders and patients. Peter holds a BS in microbiology from The Ohio State University and an MS in Health Sciences from The George Washington University.
 

Sam Butler

Director, Commercial Development - Advanced Drug Delivery Systems, BD Medical - Pharmaceutical Systems
Sam Butler

Sam joined BD’s Commercial Development Team for Advanced Drug Delivery Systems in April 2023. He is focused on partnering with pharmaceutical and biotechnology companies to provide drug delivery solutions and services that help commercialize drug device combination product therapies through a range of innovative platforms.

Prior to joining BD and for the last 18 years, Sam has held senior business growth related roles in product development, engineering and Human Factors along with combination product development at organizations that include Veranex, Terumo and Owen Mumford. Having spent the earlier part of his career in Europe, Sam relocated to the USA in 2017 and resides in the Boston area.
 

Samir Shah

Director, AstraZeneca
Samir Shah

Dr. Shah guides teams on regulatory strategies to achieve worldwide approval of drug/device/software combination products. His approvals include the first three smart/digital inhalers, the DIGIHALERS. Currently at AstraZeneca, he previously worked at Teva. Prior to joining regulatory, he formulated respiratory products as a scientist at Merck. Dr. Shah earned his B.S. from Case Western Reserve University in Polymer Science Engineering and a PhD in Biomedical Engineering from Wake Forest University School of Medicine/Virginia Tech. He enjoys sharing tips on using technology to learn faster, improve productivity, and visualize complex ideas, all crucial to achieving regulatory success with software and electronics.

Simon Wilson

Device Development Lead, Pfizer
Simon Wilson

Simon has spent over 30 years developing a wide range of products since graduating with a degree in Engineering Product Design. These have included consumer goods, handheld computers and mobile communications devices as well as a stint at a major London design consultancy. He joined Pfizer’s Cambridge based Device Centre of Excellence, DCoE, in 2007.

 
Whilst working for Pfizer, Simon has managed parenteral device development projects through from initial concept to clinical trials and beyond. Simon has worked on several digitally ‘connected’ device projects, helping to liaise between teams developing devices and mobile apps or other digital elements.
 

Sujani Nannapaneni

Senior Principal Research Scientist, Human Factors, AbbVie, Inc
Sujani Nannapaneni

Sujani Nannapaneni is a Human Factors Senior Principal Research Scientist at AbbVie. In her role, she is responsible with human factors studies and documentation of FDA submissions. She has been working in Human Factors for the last 10 years and has over 23 years of experience working in various capacities within the pharmaceutical and biotechnology industry.

 

 

Thomas James

Lead Mechanical Engineer, Key Tech
Thomas James

Thomas James is a Lead Mechanical Engineer at Key Tech, where he is responsible for both the innovation and development of novel drug preparation and delivery devices. Over his tenure at Key Tech, he has contributed to several in-clinic and in-home infusion and injection systems, spanning emergency-use, low-cost disposables to highly accurate and flexible advanced-functionality delivery systems. Aside in-the-weeds engineering, Thomas also serves on Key Tech's business development team, focusing on the pharmaceutical and drug delivery industry. Thomas holds a B.S. in Mechanical Engineering from the University of Maryland.

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Paul Upham, Head, Smart Devices, Roche/Genentech

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9:10

Moving Towards Subcutaneous Delivery: Developing Wearable Injection Devices for Large Volume Drug Delivery

Anthony Coston, Technical Lead, Biogen

  • Strategies establishing optimal volume range for an on-body device
  • Assessing the impact of viscosity on injection force and best driving mechanisms for use
  • Maximising therapeutic effect, patient tolerance and user acceptability
  • Case studies on wearable device development
  • Insight into developing and commercialising of a portfolio of device and combination products
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    9:50

    Early-Stage Research: Best Strategies for Understanding Injection Device Needs in Patients

    Jessica Mastropietro, Device Development Engineer, Regeneron Pharmaceuticals Inc

  • The importance of meeting and understanding the specific challenges for patients with extra difficulties to design usable devices
  • Assessing the value of patient needs research at the early stage of device development
  • Best practices for maximising usability when designing and developing devices
  • Key insights and takeaways from findings from qualitative user research
  • Examining FDA guidance ‘applying human factors and usability engineering to medical devices’
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    10:30

    Morning Coffee

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    11:00

    The Benefits of a Smart Device with a Case Study on SMARTCLIC® Development

    Kyle Berman, Principle Engineer, Devices Centre of Excellence, Pfizer

  • Comparisons between purely mechanical and smart injectors
  • The benefits of smart injectors to the Patient, Pharma company and Device Development Team
  • Evolution of the SMARTCLIC’s design, graphical user interface and packaging through preference and usability studies
  • Challenges faced during development of SMARTCLIC: learnings and takeaways to apply to connected injector development
     
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    11:40

    State-of-the-Art Device Evaluation: From Virtual Injections to Advanced HF

    Maximillian Dixon, Senior Applied Sciences Engineer, Crux Product Design Ltd

  • Development and application of embedded microsensors for capturing use and abuse data for injectable medical devices.
  • Exploiting digital animals to understand how injection rate, drug viscosity and injection forces effect bolus formation.
  • Advanced HF: Leveraging novel eye tracking techniques to assess devices, instructional materials and digital interfaces.
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    12:20

    Cybersecurity is Critical: Making Connected Medical Devices Cyber Secure

    Jessica Wilkerson, Cyber Policy Advisor and Medical Device Cybersecurity Team Lead, FDA

  • Introduction to the cybersecurity risks surrounding medical devices and software validation of smart devices
  • Outlining the steps that should be taken to protect patients
  • Assessing role of global regulators in reducing cyber risks and how regulations can be implemented
  • Guidance on facilitating patient access to medical device innovations while also educating them on associated risks
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    13:00

    Networking Lunch

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    14:00

    De-risking combination product development for large volume biologics: a device partner’s perspective

    Sam Butler, Director, Commercial Development - Advanced Drug Delivery Systems, BD Medical - Pharmaceutical Systems

  • Making and executing a compelling business case for any new combination product can be a challenge. Balancing trade-offs of time, investment and innovation to commercialize a combination product and achieve market uptake requires close collaboration with experts both internally and externally.
  • Transitioning drugs from intravenous (IV) to subcutaneous (SC) delivery brings new requirements and impacts program considerations for combination product development. In this session, we identify trade-offs that pharma weighs to de-risk combination product developments involving large volume subcutaneous (LVSC) delivery.
  • Key issues can include: understanding the patient experience throughout the injection process with LVSC delivery, reducing risk of use variability to gain market confidence in successfully delivering LVSC formulations, leveraging partner capabilities, insights and data to inform combination product trade-offs and program risks, manufacturability of the combination product including the delivery system and integration into the pharmaceutical operation’s network, exploring the value of drug delivery technology used consistently from clinical development into commercial use.
  • Examples of how these issues can impact a combination product development program will be explored along with the functional experts that can be engaged.

     

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    14:40

    PANEL DISCUSSION: Enabling Successful Delivery of Drugs with Wearable Injectors and Emerging Technologies

  • What are the current biggest challenges and how can we overcome these?
  • How can teams across device and drug development work together to ensure speed to clinic?
  • As we look to advance technology and innovations, how can we ensure stakeholder buy-in for the evolution of the injectables landscape?
  • Looking into the future: what can we expect from industry and vendors?
     
  • E Guan, Head of Injection Systems, Takeda

    Jessica Mastropietro, Device Development Engineer, Regeneron Pharmaceuticals Inc

    Paul Upham, Head, Smart Devices, Roche/Genentech

    Anthony Coston, Technical Lead, Biogen

    Mark DeStefano, Director, Combination Products and Device R&D, Teva Pharmaceuticals

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    15:20

    Afternoon Tea

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    15:50

    Successfully Selecting your Wearable Injector Battery

    Ling Zheng, Assoicate Director, Alexion Pharmaceuticals Inc

  • Important criteria for battery selection
  • Ensuring effective power budget management
  • Exploring system power characterization and battery characterization techniques
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    16:30

    Connected Devices: Responding to Patient’s Expectations and Some Simple Rules to Deliver a Great Product

    Simon Wilson, Device Development Lead, Pfizer

  • Looking at the world in which we now live, do we the pharma industry, need to change to way we interact with our patients?
  • Should we expect them to record their treatment in paper diaries or should we get them to do it on their smart phones? How do we know what they want?
  • Well, we could ask them and then give them what they asked for. We should aim to give them a great experience with their treatment. If possible, this could be more than just an app.
  • Explaining how Swiss Army knives, Dyson air purifiers and trainspotting fit into all of this
     
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    17:10

    Incorporating Behaviour Design for Digital Health Solutions

    Paul Upham, Head, Smart Devices, Roche/Genentech

  • Introduction to behavioural science and applying key principles to connected devices and digital health products
  • Leveraging behavioural science to support patients and their self-management as well as increase adherence
  • Key considerations in creating a behaviour design service in pharma
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    17:50

    Chair’s Closing Remarks and Close of Day One

    Paul Upham, Head, Smart Devices, Roche/Genentech

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    8:30

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

    Paul Upham, Head, Smart Devices, Roche/Genentech

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    9:10

    Regulatory Perspectives on Wearable Injectors

    Peter Dorski, Associate Director, Janssen, Pharmaceutical Companies of Johnson and Johnson

  • Optimizing CMC and bridging strategies during clinical development
  • Health authority interactions: when should they occur and what is expected?
  • Platform approaches to wearable injectors
  • Recommendations for improved guidance and harmonisation of global regulations

     

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    9:50

    What manufacturers of electronic devices should know about electromagnetic labelling regulatory requirements

    Samir Shah, Director, AstraZeneca

  • The many sources of labelling requirements for electrical, wireless, and smart medical devices
  • Deciphering an immunity label (so you can create your own)
  • Resources for understanding symbol requirements
  • Changes to the standard on whether such labelling could confuse privates users
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    10:30

    Morning Coffee

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    11:00

    Practical Drug Product Development Considerations for Wearable Injector Development

    Jamie Tsung, Director CMC Development, Alnylam

  • Outlining storage challenges for primary drug containers
  • Critical design considerations: minimum waist and low depth space
  • How to control drug temperature to extend shelf life of wearable injection devices
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    11:40

    In-Vitro Insights: Guiding the Development of Reusable Injector Platforms

    Thomas James, Lead Mechanical Engineer, Key Tech

  • Review of parallels between In-Vitro Diagnostic (IVD) instruments and reusable on-body delivery systems (OBDS), to emphasize the relevance of learnings from the IVD industry.
  • Discussion of need for a comprehensive understanding of stakeholder requirements, ensuring efficient decision-making and a focused reusable device platform.
  • Considerations of the various value propositions that reusable systems offer, and when they’re most effective.
  • Guidance on navigating the intricate landscape of device construction, consumable development, and interface definition.
  • Recommendations for de-risk strategies to accelerate system development in the front-end innovation phase.
     
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    12:20

    Networking Lunch

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    13:20

    Human Factors Best Practices and Considerations for Wearable Injectors

    Alexandra Benbadis, Usability Leader, Sanofi

  • Discussing human factors requirements within regulatory frameworks and best practises for complying with these
  • Exploring the pitfalls relating to wearable injector development and usability
  • Insight into design validation for wearable injectors and important considerations
  • Evaluating human factors studies to ensure expectations are satisfied
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    14:00

    Developing Engaging Patient and Healthcare Provider Medical Device Training

    Alicia Douglas, Human Factors Lead, Merck

  • Assessment of wearable injectors and connected devices from a two-user perspective: patient and healthcare provider
  • Designing and developing user-centric training for patients and healthcare providers
  • Implementing digital training solutions that connect with patients and caregivers and discussion of digital tools and services to support patients as well as caregiver in using the devices
  • Case study examples
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    14:40

    Afternoon Tea

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    15:10

    Strategies to Consider During On-Body Device Development to Meet Patients Needs

    Sujani Nannapaneni, Senior Principal Research Scientist, Human Factors, AbbVie, Inc

  • On-Body Device criteria to consider evaluating during human factors research
  • Key takeaways from human factors formative user research and clinical studies
  • Leveraging human factors research for developing training materials
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    15:50

    Integration of Human Factors into the Product Life Cycle of Wearables and Connected Devices

    Leya Bergquist, Associate Director, UserWise

  • What types of human factors practices are appropriate for each stage of product development?
  • Considerations for training and training decay
  • Navigating human factors as it relates to your devices in an ecosystem
  • What to expect for human factors timelines and workload
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    16:30

    Chair’s Closing Remarks and Close of Day Two


    Usability Leader
    Sanofi
    Human Factors Lead
    Merck
    Technical Lead
    Biogen
    Head of Injection Systems
    Takeda
    Director CMC Development
    Alnylam
    Device Development Engineer
    Regeneron Pharmaceuticals Inc
    Cyber Policy Advisor and Medical Device Cybersecurity Team Lead
    FDA
    Principle Engineer
    Devices Centre of Excellence, Pfizer
    Associate Director
    UserWise
    Assoicate Director
    Alexion Pharmaceuticals Inc
    Director, Combination Products and Device R&D
    Teva Pharmaceuticals
    Senior Applied Sciences Engineer
    Crux Product Design Ltd
    Head, Smart Devices
    Roche/Genentech
    Associate Director
    Janssen, Pharmaceutical Companies of Johnson and Johnson
    Director, Commercial Development - Advanced Drug Delivery Systems
    BD Medical - Pharmaceutical Systems
    Director
    AstraZeneca
    Device Development Lead
    Pfizer
    Senior Principal Research Scientist, Human Factors
    AbbVie, Inc
    Lead Mechanical Engineer
    Key Tech

    Gold Sponsor

    Sponsors

    Exhibitors

    Official Media Partner

    Sample attendee list

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    Speaker interview: Alexandra Benbadis, Usability Leader, Sanofi

    Download

    Past Presentation: Wearables UK 2022 - Min Wei presentation

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    Past presentation: Wearables UK 2022 - Mudhar, AZ

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    Sponsors and Exhibitors


    Crux

    Gold Sponsor
    https://www.cruxproductdesign.com/

    Crux was founded to address challenging technical briefs and deliver compelling solutions for the drug delivery and medical device sectors. Based in Bristol, United Kingdom, our technical team champion evidence-based problem solving, coupling world-class equipment, software and facilities with a scientific approach to maximise success. Be it discovering unmet user needs, developing novel products or deploying new technologies, our team are dedicated to solving our client’s biggest problems..


    Sponsors


    BD Medical

    Sponsors
    http://www.bd.com

    As a partner of choice for pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of parenteral drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems as well as advanced drug delivery solutions that help ensure pharma meets its drug delivery goals while considering drug complexity, viscosity and dosing volume.

    With an emphasis on patient-centered innovations and strong technical expertise, BD Medical - Pharmaceutical Systems partners with pharmaceutical and biotechnology companies to help them achieve their combination product commercialization goals. We support product launch and life cycle management through a comprehensive set of services and solutions that help to de-risk the combination product development process.

    More information available @ drugdeliverysystems.bd.com Contact us @ drugdeliverysystems.bd.com/contact-us



    Key Techinc

    Sponsors
    https://www.keytechinc.com/

    Key Tech is an end-to-end product development firm specializing in the design of complex electromechanical devices and systems for medical applications. It is 100% employee owned and located in downtown Baltimore (MD, US). Key Tech employs 75 engineers and designers focused on transforming complex technologies into simple, intuitive solutions.

    Exhibitors


    Hawk Ridge Systems

    Exhibitors
    https://hawkridgesys.com/

    At Hawk Ridge Systems, we are imaginative, inquisitive, always testing the limits and breaking the mold. But most of all, we are constantly seeking opportunities for continued growth and change... in ourselves, for our customers, and for the world around us.

    While we know that most engineers are built on the do-it-yourself mentality, we also recognize that to truly build world-changing products, it takes much more.

    That's where we come in.

    As a team, Hawk Ridge Systems is driven by our customers’ success. To empower every customer to reach their highest goals, we partner with you to understand your unique challenges and then provide you with the right solutions, coupled with responsive, effective support and deep product and industry expertise to help ensure your long-term success.



    Lohmann

    Exhibitors
    https://www.lohmann-tapes.us/us/site__264/?

    Lohmann is a privately held company headquartered in Neuwied Germany. We are a pressure sensitive adhesive manufacturer and converter, specializing in component parts for wearable, ostomy, diagnostic and other medical related applications. With both US and EU manufacturing sites, we are a leading provider of adhesive and value chain solutions for the Medical Device Industry. We engineer our adhesives and technologies into usable forms that enhance our customer’s product performance, production efficiency and sustainability.



    ZwickRoell

    Exhibitors
    http://www.zwickroell.com

    ZwickRoell manufactures and supports a wide range of materials testing machines, systems and accessories for use in research, quality control, production environments and academia. Our extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopaedics and biomaterials.

    Media Partners


    On Drug Delivery

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    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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