Beyond the Hype: Integrating Connectivity and Wireless into Medical Devices Dirk Smith Co-Founder Minnetronix Inc.

Transcription

1 Beyond the Hype: Integrating Connectivity and Wireless into Medical Devices Dirk Smith Co-Founder Minnetronix Inc.

2 Let s Go Wireless! Explosion of connected devices IoT o Roughly 10 billion devices worldwide o Well over 1 billion smart phones o Abounding innovation

3 Connected Medical Devices Long history of connectivity efforts in medical devices Readily available wireless technology MIoT is underway.

4 Why Get Connected? What First Comes to Mind o EMR and HIS connectivity From admission to discharge to billing o Mobile/remote health and wellness applications Many additional workhorse opportunities.. From a recent Forbes.com article (9/3/14): 3 Ways the Internet of Things is Revolutionizing Healthcare 1. Reducing device downtime through remote monitoring and support 2. Proactive fulfillment by replenishing supplies before they are needed 3. Efficient scheduling by leveraging utilization to serve more patients

5 The Cognita Platform allows users to remotely manage, update, locate, and understand the use of an entire fleet of devices in the field.

6 Defining the Opportunity Wireless Connectivity in Medical Devices o Common first question: That s cool. How will I get paid for adding connectivity? o A better question: How will connectivity add value? o Like any new technology or product feature: Can connectivity ultimately enable better outcomes at reduced costs?

7 Defining the Opportunity: Examples Experience with a Flexible Connectivity Platform o Hospital-based Electrosurgical Generator Initial impression broad interest, not clear how it fit Significant value tracking use profiles, for clinicians and the company Sales force fleet management o Home-care Therapeutic Device Patient compliance tracking Better compliance tracking => improved reimbursement Device location tracking o Clinic-based Ophthalmology Diagnostic Device use conditions and compliance Real-time disposables inventory management

8 Defining the Opportunity: Examples Experience with a Flexible Connectivity Platform o Lab-based Embedded Hospital Equipment Service/performance prediction on complex systems Long-term device reliability benefit Incentive for additional embedded device diagnostics o Others. Pay-per-use/automated billing Tracking outcomes, wellness measures before and after treatment Extending reach of clinicians through real-time information Clinical trial data collection

9 Defining the Opportunity Where to start exploring opportunities o There is more value in information than data Are there existing problems that more information may solve? Can remote data tell us more about the device, patients, users? If we could access more information, could we significantly improve efficiency in the overall care delivery cycle? Are there other potential users/consumers of information? o Short-term connectivity investment may yield long-term gains, in clinical and financial outcomes Improved therapy Improved device performance reliability, usability, utilization o Justifying investment may require a holistic company view benefits (and costs) often spread across functional areas

10 Assessing Business and Technical Risks With the benefits of wireless connectivity come additional program-level risks (and costs) o Security integrity, availability, confidentiality Data and device o HIPAA and the HITECH Act Privacy and security o Overall regulatory impact What role does connectivity play in therapy/diagnosis? MDDS or a component of a Class II or III medical device o Technology evolution e.g. cellular 2G-3G-4G, what is our evolution plan/roadmap? Radio and UI platforms

11 Assessing Business and Technical Risks With the benefits of wireless connectivity come additional program-level risks (and costs) o Product requirements evolution (upgradeability) Collecting device data now, but in 5 years? o Market acceptance User perceptions and acceptance of remote connectivity barriers and opportunities o Radio logistics and geographies - providers, certification, etc. What locations will we be in now and in the future? How does this impact cellular providers, radio technology?

12 Technical Challenges o Incorporating radio(s) into a medical device Combining medical device regulatory with FCC licensing and cellular certifications Licensing/certification hurdles for multi-radio devices Optimizing radio performance challenges and trade-offs of off-the-shelf and custom antenna design Adding radios to existing products

13 Development and Scale-up Good medical device design practices remain critical From FDA s Design Control Guidance for Medical Device Manufacturers

14 Development and Scale-up Medical device design practices connectivity considerations o Requirements Information objective what connectivity is intended to achieve Data what data, how much, how fast Users and use case scenarios User security management Geographies Applicable standards Software updates o Product risk analysis (ISO 14971) Cybersecurity device and data security and integrity risks Quality of service (compromised connection and/or data) Coexistence with other wireless devices EMC Use/user risks unintentional or intentional misuse of information Bad data from device

15 Development and Scale-up Medical device design practices connectivity considerations o System architecture and integration Embedded data collection sensors, performance data, etc. Cellular, Wi-Fi or both (fixed assets vs. mobile/portable) Selecting cellular providers, then radios and antennas Cloud-base services, data storage and retrieval Data protocols and security Information processing (data -> information) User interface platforms, UI design

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17 Development and Scale-up Medical device design practices connectivity considerations o Verification and validation Good requirements, concurrent test development Partitioning software based on criticality (IEC 62304) Radio system performance to meet carrier requirements o DFM/DFT, Scale-up Account for provisioning and activating cellular radios Performance test plans for integrated radios Free data prior to field activation

18 Development and Scale-up Utilizing outside expertise o Cellular providers o Radio modules and antennas o Security and HIPAA experts o Cloud-based services Infrastructure and rack space Application-enablement platforms M2M solutions Standards and Licenses o Risk-based EMC design and verification, susceptibility and interference o FCC testing (CFR Title 47, Part 15, Subpart C) and carrier approval

19 Development and Scale-up Useful guidance and reference documents Radio Frequency Wireless Technology in Medical Devices. Guidance for Industry and Food and Drug Administration Staff. Document issued on: August 14, 2013 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Guidance for Industry and Food and Drug Administration Staff. Document Issued on: October 2, 2014 Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. Draft Guidance for Industry and Food and Drug Administration Staff. June 20, ISO/TR 21730:2005. Health informatics Use of mobile wireless communication and computing technology in healthcare facilities. IEC Human exposure to radio frequency fields from hand-held and bodymounted wireless communication devices Human models, instrumentation, and procedures. March 30, 2010.

20 Summary o Seek value-generating, problem-solving applications for wireless implementations o Understand and manage business and technical risks, including product and technology evolution o Combine solid medical device development fundamentals with industry expertise in connectivity technology

21 Questions/Comments?

22 Thank You!