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MEDICAL DEVICE CYBERSECURITY: IT’S TIME TO GET REAL AI COULD TAKE MEDTECH MANUFACTURING TO THE NEXT LEVEL

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CONTRIBUTORS

DYKEMAN

GOLDBERG

KAUFMAN

GRETZ

POTGIETER

DAVID J. DYKEMAN is a registered patent attorney with more than 20 years of experience in patent and intellectual property law, and co-chair of Greenberg Traurig’s global Life Sciences & Medical Technology Group. ELI GOLDBERG is a digital endpoint analytics (IDEA) data scientist at the Novartis Institutes for BioMedical Research (NIBR). As a data scientist and serial entrepreneur, Eli has a proven track record of transforming new ideas into real world innovations in healthcare. BRUCE GRETZ is EVP of Steinmeyer, joining the company in 2015 as national key account manager. He previously held sales and business development roles with several industrial firms in machine alignment, precision ceramics and plant floor data acquisition. He holds an MBA from The Wharton School at the University of Pennsylvania and an MS in aerospace engineering from Stanford University. FLORIAN HAAS and his team are responsible for product management, marketing and communication at Traco Power. Haas has worked more than 10 years in the medical device industry. In his roles as product manager he “translated” the requirements and wishes of surgeons and health care professionals to the engineering department. DEL R. LAWSON has over 25 years of experience at 3M in laboratory management, strategic product platform creation and Lean Six Sigma operations. His experience has involved new technology creation in advanced analytics and sensors, biotechnology solutions and medical adhesives. Lawson presently leads new product development and commercialization efforts in 3M’s Medical Solutions Division.

HAAS

REEDY

SPEER

THIELMAN

TONY KAUFMAN leads New Business Ventures for 3M’s Medical Materials & Technologies Business. With over 20 years of medical device experience at 3M, he leverages his manufacturing, product development and business knowledge to bring 3M Science & Technologies to help other device manufacturers deliver life-changing devices to the medical industry. LUKE POTGIETER is a technical editor and advisor with a formal education background in the sciences. He is the author of several introductory computing courses, health guides, pre-med materials, and has published content on numerous blogs. As a tech advisor for John Snow Labs, Luke has found a passion for data science. SCOTT REEDY is senior director of marketing for Arena Solutions. He spent a decade working in engineering and manufacturing and has held strategic roles with enterprise software companies in consulting, sales, product development and introduction, and marketing over the past 20 years. JON SPEER is the founder and VP of QA/RA at Greenlight Guru, a software company that produces a quality management software solution exclusively for medical device companies. Speer has more than 18 years of experience in the medical device industry and has helped dozens of devices get to market in a variety of roles including product development, project management, quality and regulatory. SCOTT THIELMAN is CTO and co-founder of Product Creation Studio. Thielman has participated in all aspects of product development for clients including Philips, Johnson & Johnson, and Lilly. He holds a PhD in mechanical engineering from the University of Washington and is a licensed professional engineer.

www.medicaldesign&outsourcing.com

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LAWSON

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HERE’S WHAT WE SEE

Medtech is going digital: So how do we keep it real?

ne of medtech veteran Mir Imran’s biggest claims to fame is that, as a young engineer in the early 1980s, he played a pivotal role in the development of the first implantable ICD. Imran told me a startling fact a few years ago: FDA officials back then were so hesitant to approve an implantable device with software that the first generation had to be almost completely analog. Things have changed a lot since then. Imran, presently CEO of Rani Therapeutics, is developing a swallowable robotic pill called the RaniPill, and the FDA is testing out a program in which companies such as Apple or Johnson & Johnson could receive a precertification to create digital health software. So much for analog. Imran’s firm is only one example. Smart devices linked to consumer products with sensors seem to be everywhere these days, and the heavily regulated, risk-averse medical device industry is turning to digital tools to better manage outcomes. Public and private healthcare payers, in fact, are demanding that providers boost results. Devices are part of the equation. But going digital presents a host of challenges, including cybersecurity, safety, patient privacy and intellectual property. There’s also the problem that anyone who invested in Theranos or bought tickets to the Fyre Festival should now recognize: What’s real, and what’s hype? This issue of Medical Design & Outsourcing takes a look at the issue: • Artificial intelligence’s potential comes with an incredible level of hype, Associate Editor Fink Densford reports. “AI has the most transformative potential of anything I’ve seen in my life, and I graduated medical school 40 years ago. It’s the biggest thing I’ve ever seen by far,” Dr. Eric Topol told him. “But it’s more in promise than it is in reality.”

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• The Healthcare & Public Sector Coordinating Council has a plan to boost medical device cybersecurity, Senior Editor Nancy Crotti found. Health providers and other customers buying connected medical devices should be able to remotely access a cybersecurity bill of materials (CBOM) that would list all commercial, open-source and custom-code software, the group told Crotti. • Assistant Editor Danielle Kirsh looked at medical device companies that are actively developing AI applications in their manufacturing and supplychain operations. • And I visited Hudson, Wis., and the headquarters of PhillipsMedisize, one of the largest medtech contract manufacturers in the world. Years ago, the company was all about the housings, assembly and packaging that went into finished drugdelivery devices. These days, its connected drug-delivery device focus has widened to include the data systems behind them. M

Chris Newmarker Managing Editor Medical Design & Outsourcing cnewmarker@wtwhme di a .c o m

| | | |

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CONTENTS

medicaldesignandoutsourcing.com ∞ March 2019 ∞ Vol5 No2 • • • • • THE DIGITAL ISSUE

COLUMNS 5

CONTRIBUTORS

HERE’S WHAT WE SEE

IP ISSUES

COMPONENTS

DATA

ON THE COVER CAN AI TRULY TRANSFORM MEDICINE?

How does medtech keep it real while going digital? Why connected medical devices require strategic patents

Artificial intelligence raises exciting possibilities for healthcare, but are companies promising more than they can deliver?

How innovative pump designs power intelligent balloon catheters The challenges of data prep for AI in medtech

22 DESIGN

How to design home healthcare devices that people will use

26 MATERIALS

Adhesives are key to unlocking wearable medical device innovation

FEATURES

30 REGULATORY

5 tips for post-market medical device compliance

34 STANDARDS

Here’s how standards enable safety for medical device power supplies

38 TUBING TALKS

Could this old-school manufacturing technology enable better catheter designs?

42 VALIDATION

How cloud QMS simplifies software validation Here’s what you could be missing

64 AD INDEX Medical Design & Outsourcing

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IT’S TIME TO GET REAL

Medical device makers, regulators and healthcare delivery organizations are increasingly working together to strengthen security against cyberattacks. But are they doing enough?

54 CAN AI TAKE MEDICAL DEVICE

MANUFACTURING TO THE NEXT LEVEL?

Artificial intelligence could improve medical device manufacturing efficiency and reduce risk, but it’s still a work in progress.

59 PHILLIPS-MEDISIZE IS OFFERING CONNECTED

62 DEVICETALKS

50 MEDICAL DEVICE CYBERSECURITY:

3 • 2019

HEALTH DATA SERVICES: HERE’S HOW

One of the world’s largest medical device contract manufacturers, Phillips-Medisize is making a business play to provide the technological back end for connected drug delivery devices. www.medicaldesignandoutsourcing.com

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IP ISSUES

Connected medical devices require strategic patents: Here's why When it comes to medical device intellectual property strategy, connected medical devices are changing the game.

onnected medical devices utilizing artificial intelligence (AI), the Internet of Things (IoT) and big data are starting a digital health revolution, transforming the way that patients interact with doctors and making healthcare services accessible to more people. AI and IoT technologies enable ordinary medical devices to collect more robust data, analyze symptoms and trends, support remote care and give patients greater control over their treatment. With these technological advances and the rapid adoption of wearables and digital health apps, medical device manufacturers are developing more connected medical devices. To maintain a competitive edge, connected medical device developers should build a strategic patent portfolio that focuses on protecting core technology, exploring new patent areas and establishing worldwide patent protection.

David J. Dykeman | G r e e n b e r g Tr a u r i g |

A growing market Connected medical devices use wireless or wired resources to monitor patients in near real-time. Driven by the prevalence of chronic diseases including asthma, sleep disorders and diabetes, the global connected health device market is expected to reach an estimated $36 billion by 2023, according to MarketResearch.com. For physicians and researchers, accurate and uninterrupted data collection is changing healthcare service delivery and creating new ways of understanding patients’ lives and behaviors. For patients, the ability to capture clinically relevant information

Eli Goldberg | Novartis Institutes for BioMedical Research |

Medical Design & Outsourcing

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outside of their doctor’s office provides actionable feedback to influence their behavior. Connected medical devices offer a wide range of powerful options for patients, physicians, researchers, and those simply interested in personal care. The most common types of connected medical devices focus on point-of-care diagnostics and remote patient monitoring, such as continuous blood glucose monitoring and insulin pens, heart rate monitors, pulse oximeters, blood pressure monitors, breath analyzers and even smart clothing. The next wave of connected medical devices includes connected inhalers, ingestible sensors, connected contact lenses, smart insulin pumps and hearing aids. There is also the rise of digital therapeutics (software to treat disease), where the app is the medicine. Novartis, for example, is collaborating with Pear Therapeutics to develop novel prescription digital therapeutics for patients with schizophrenia and multiple sclerosis. Lead the way with a comprehensive patent strategy A strategic patent portfolio protects a company’s core technology, which in turn helps secure funding and establishes a competitive advantage in the marketplace. A 2016 MIT study found that startup growth is 35 times higher for companies that apply for patents. Patents are extremely important for connected medical device companies in all stages. For earlystage companies, patents are often the only way for investors to place a value on a company’s technology before FDA regulatory approval. In

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MPD m e m o ry p r o t e c t i o n d e v i c e s

WITHSTANDING THE SANDS OF TIME b

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IP ISSUES

this way, patents make up a significantly greater portion of enterprise value for early-stage connected medical device companies. As a company grows, patents become the currency to secure financing through venture capital or private equity investment. They can also lead to business partnerships. For early-stage connected medical device companies (and young medtech companies in general), the key is to develop a strategic patent portfolio that has comprehensive patent coverage around the company's innovations. Build a picket fence of patent protection A major challenge for connected medical device companies is the complex and often multifaceted nature of the technology. Connected medical devices often incorporate or combine technologies and each component of the device must be protected. Where applicable, patent claims should be directed to the entire device, key components, mobile

applications, control systems, disposables, software, methods of manufacturing, methods of treatment and any other aspects of the invention. Design patents can also provide protection for the ornamental features of connected medical devices. As companies continue to improve their core technology, they should patent these incremental changes to form a “picket fence” of patent protection around all aspects of the core technology. By filing patent applications covering incremental improvements, connected medical device companies can expand their presence in the market and grow their patent portfolio. Cross-licensing with competitors is another method to enhance a patent portfolio. Cross-licensing opportunities arise when two companies have overlapping patents and practicing one patent results in infringement of another patent. With crosslicensing, companies can mutually agree to share patents without the exchange of license fees and with a promise not to sue.

Recent USPTO guidance may help ‘smart’ medical device patents In January 2019, the U.S. Patent & Trademark Office issued new guidance that may help connected medical devices that incorporate “smart” technology to secure patent protection. Since the major 2014 U.S. Supreme Court decision in Alice v. CLS Bank, the USPTO has been more cautious in granting softwarerelated patents. The Alice case focused on the threshold question of whether some software categories could be “eligible” for patenting, and the decision emphasized that wholly abstract ideas aren’t patentable. Because connected medical devices incorporate software and other computer elements, these innovations have been ill-affected by the Alice aftermath. The new USPTO guidance is expected to result in fewer software patent applications being rejected by the USPTO on patent eligibility grounds, which is welcome news for connected medical device developers.

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Be aware of IP ownership in joint ventures Traditional medical device manufacturers are partnering more frequently with digital health companies to develop connected medical devices. For companies entering into joint ventures, issues surrounding ownership of the connected medical device may emerge. For example, one company may claim ownership of the device, but a second company may claim ownership of the software code or app, thereby clouding ownership of the connected medical device itself. Therefore, companies entering into agreements with other companies to produce connected medical devices should establish at the outset of the relationship what rights each party will have related to the final product and what rights each party will retain upon termination of the agreement. Ownership disputes can be resolved by assigning patent rights entirely to one party or jointly between the parties. Alternatively, ownership disputes may be resolved by exclusive or nonexclusive licensing of the patent rights. Have a strategic patent approach The mobile and medical device industries continue to collide, bringing disruptive change to healthcare. Connected medical devices are the next wave in patient-centric healthcare. A well-planned, integrated patent strategy can address challenges unique to connected medical devices and ensure success in this fast-changing market. M

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COMPONENTS

How innovative pump designs power intelligent balloon catheters The next generation of intelligent balloon catheters depends on novel designs of ball-screw-driven pumps. and are limited to patients who can tolerate the highly invasive procedure. A key development in cardiovascular assist devices would be to combine the less-invasive approach of implantable balloons and external pumps with the high portability and reliability of fully implantable systems. This advance would allow the treatment of a much wider range of patients and conditions. One of the main challenges to this approach is designing a wearable pump that can carefully control balloon pressurization. The pump must meet a demanding combination of performance requirements, including:

A miniature ball screw made by Steinmeyer. Image from Steinmeyer

Bruce Gretz | Steinmeyer |

Medical Design & Outsourcing

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alloon catheters have long seen widespread use in cardiovascular applications. One of the first, decades ago, was intra-aortic. A balloon was implanted into the descending aorta and pressurized via a percutaneous catheter through the femoral artery. Helium was used as the working fluid because it presented a low risk of embolism in case of rupture. But the bulky system combined with the femoral entry made ambulatory use nearly impossible. More recent developments have focused on fully implantable ambulatory pumps serving as both the bridge-totransplant and destination therapies for patients. Among the first was HeartMate, developed by Thoratec and now owned by Abbott. The first generation, which received FDA approval in 1994, used a pulsatile pump to mimic natural heart function. Nextgeneration devices — such as HeartMate II (2008), Impella (2008) by Abiomed, and HeartWare (2009) by Medtronic — use continuous-flow pumps with rotors. These designs have enabled smaller size with higher durability and reliability. Fully implantable devices are very expensive to develop and produce 3 • 2019

• • • • • •

Precise control of pressure; Reversible pressurization; Low weight; Compact size; Quiet action; Continuous operation for at least one year.

Mechanical engineers working on designing such a pump faced a challenge. They built and tested early prototypes using traditional designs such as diaphragm pumps, which required both positive and negative pressure tanks. The resulting systems were far too large and heavy. Their main innovation was selecting a precision ball screw as the drive mechanism and pairing it with a custom-engineered metal bellows as the pressure chamber. A ball screw delivers exceptional thrust density while enabling high linear acceleration in both the forward and reverse directions. Surrounded by the bellows, this results in an extremely compact and quiet design. Ball screws are known for their high efficiency (>90%), smooth operation, and long life. Their efficiency enables the use of small motors with low power consumption, which in turn reduce the size and weight of the entire system.

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COMPONENTS

A system that incorporates Steinmeyer ball screws targets intraaortic applications and is currently in clinical trials. The pump's final version will include ball screws produced with a proprietary super-finishing process called Optislite to ensure the quietest possible operation. This process removes the largest irregularities left over from thread grinding of the shaft. The resulting surface yields a noticeably smoother and quieter operation. Friction torque is also lowered and made more consistent, resulting in enhanced servo performance. In most applications that employ Optislite, product lifetime should be increased.

In future applications, balloon catheters will incorporate intelligence. These devices will use flexible electronics along the catheter for sensing, connectivity, and therapeutics. Ball screwdriven pumps will be ideal for supporting these future systems as well. M

A key development in cardiovascular assist devices would be to combine the lessinvasive approach of implantable balloons and external pumps with the high portability and reliability of fully implantable systems.

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DATA

AI is data hungry: The challenges of data prep for medtech Artificial intelligence has tremendous potential for the healthcare system, but its success requires large quantities of accurate data. Luke Potgieter | John Snow Labs |

rtificial intelligence can provide insights that wouldnâ&#x20AC;&#x2122;t otherwise be evident to healthcare providers. AI can use both structured and unstructured data to find patterns. Furthermore, AI not only offers new insights but has capabilities far beyond what was previously thought. Artificial intelligence in healthcare requires a continual input of fresh data. Without new data, the models may change in an unpredictable way. New data are also needed since trends may change over time which needs to be accounted for by models. It is therefore crucial that we have new data for input for these AI models. However, there are concerns and challenges when it comes to the data needed for using AI in the healthcare industry.

Medical Design & Outsourcing

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We should be concerned about the integrity of the data that is used since we increasingly rely on AI models and their predictions, lest these predictions worsen over time. Interoperability The other problem is that electronic health record systems (EHRs) are often different from hospital to hospital. This means that the format and semantics (meaning) of data may not be the same with different EHRs â&#x20AC;&#x201C; or even different deployments of the same EHR. The consequence is that the data from different hospitals, clinics and trials are not interoperable so that all data collected from them must be converted into a standard form before further analysis can occur. The result is that data have to be integrated and normalized before being used. This adds more time and complexity to

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the process but is absolutely necessary. This was evident at Mass. General Hospital when it tried to change from an old system to a new Epic EHR system, discovering that data had to be extracted from the old system and converted before being incorporated into the new system. It was also tricky because staff had to be trained on the new system. Data in EHRs can have problems such as inconsistencies and incompleteness, as demonstrated by a study of the survival rate for pancreatic patients using adecade’s worth of data from Columbia University Medical Center’s EHR. The researchers found that a great deal of data was excluded or very incomplete, including duration of medical treatment, such as chemotherapy. There was no information on disease stage, such as tumor size, for 52% of patients in the study. Incomplete or missing data could start with the healthcare provider or the the patient, or both. Either way, it’s crucial that data be accurate and complete,

We’ve Covered All The Angles -Without Contact With more than a thousand different series, models, sizes, and options there is a Novotechnik non-contact rotary position sensor to match your application, and there’s one very good reason to choose Novotechnik: A level of precision that’s unmatched in the industry. Whether you’re looking for non-contacting, or even touchless, single-turn, or multi-turn rotary position sensors, Novotechnik has the sensor you need. Setting A Higher Standard: • Operating lives to: unlimited movements • Independent linearity to ± 0.3º • Resolution to 0.09º • Repeatability to <0.03% of signal range • Maximum rotating speed to: unlimited rpm • Sealed to protection class IP 69 • Absolute measurements to 360º • Housing diameters from 13 mm

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Artificial intelligence in healthcare requires a continual input of fresh data. Without new data, the models may change in an unpredictable way. not only for use in decision-making and healthcare management but also for secondary use in clinical research. Privacy and regulatory constraints Another challenge for AI in healthcare is that there are significant privacy issues that must be addressed when collecting and sharing health data. The privacy issue has significant ramifications and can cause access to data to be a difficult and timeconsuming process. It can be difficult and expensive to obtain data that is routinely used in clinical trials or research studies, including longitudinal studies. Healthcare data is extremely sensitive, so it’s understandable that most do not want personal records to be widely shared. Sharing data requires strict rules and regulations to protect the privacy of individual patients, and each country or jurisdiction can have itw own laws regarding the use of healthcare data. For example, British Columbia passed specific laws regarding the use of data with diverse levels of support. Data integrity Healthcare providers may be overworked and not have the time to focus on data entry. A lack of training may also mean that such providers don’t recognize the value of the data. The reality is that big data are critical for having an effective and useful AI system. Big data and AI in healthcare are projected to grow and will be worth more than $10 billion by the year 2024. Employees should be educated and trained not only on what data to enter and how to enter it correctly, but its relevance and importance. Models based on erroneous and inaccurate data will generate erroneous and flawed results. This can have costly 20

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ramifications for decision-making and healthcare management. Data need to be complete, clean and accurate in order to be used in AI systems. That has to happen in each clinic, hospital, lab or research center – since models often have to be turned for local variants in population or clinical guidelines. AI models can be useful and can improve the decision-making capabilities of doctors, but the value depends on the integrity of the local data. It’s possible that better education for healthcare providers on the tremendous value of this data will act to encourage healthcare providers to take data entry seriously. Data are useful and crucial in providing good care and even in evaluating disease trends. It’s also important to realize that unstructured data in free text form may be as important as structured data. A good natural language processing tool can deal with unstructured data. Data that are entered into systems have to be reliable and accurate. It’s therefore important that data improvement initiatives be introduced so that healthcare providers can rely on a system’s data. Conclusion Incorporating AI into healthcare presents unique challenges that other industries don’t face. Data have to be accurate, reliable and complete – but also have the same meaning as in other locations. It needs to maintain high quality over time. Ensuring that AI models keep learning over time and from local data is important to getting high-quality results. Privacy is another major concern, which can be resolved by following all regulations regarding data use. When building AI systems, it’s important to work with teams who have strong healthcare AI domain expertise, are aware of these challenges and have successfully addressed them before. M

Precision Welding For Critical Plastic Components

The Branson GSX Ultrasonic Welding Platform meets the growing demand for the assembly of smaller and more complex plastic components. Precise welds are achieved utilizing an advanced electro-mechanical actuation system that provides unprecedented control and position accuracy, while applying the industry’s lowest trigger force. The Branson GSX can also weld across multiple parameters, monitored in real-time to ensure quality. This is possible with a wide range of input materials and best-in-class repeatability across multiple Branson GSX welders.

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DESIGN

How to design home healthcare devices that people will use Meeting consumer demands for home healthcare technology requires a keen knowledge of user behavior.

Athelas’ home blood testing device resembles the Amazon Echo. Image courtesy of Athelas

T Scott Thielman | Product Creation Studio |

Medical Design & Outsourcing

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he global smart home healthcare market is exploding as more medical devices are designed for use wherever the patient is, including at home. A report by Research and Markets predicts sales of these devices to reach $30 billion by 2023, up from $4.5 billion in 2017. Fall prevention and detection devices hold the largest share of the market, which is expanding to include safety & security and health status monitoring, compliance aids and nutrition monitoring. Developing these devices is one thing. Designing them so users find their technology intuitive, accessible and easy to use is another. Patients and caregivers who are comfortable with digital consumer products expect their healthcare devices to be just as user-friendly. Ease of use boosts compliance – and in the world of consumer health, compliance is everything.

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A deep understanding of user behavior can have a significant impact on compliance. Here are some behavioral strategies that can improve compliance and create the ideal at-home healthcare experience. Make the technology invisible Developers are exploring ways to make home digital devices automatic and able to blend seamlessly into consumers’ lives. One example is Athelas, a next-generation immunity monitor that mimics technology already found in many homes. Athelas measures neutrophils, lymphocytes, platelets, white blood cells, morphology and cell activation within minutes from a finger-prick of blood. Its unobtrusive design as a 3-D printed black cylinder is reminiscent of Amazon’s Alexa device, featuring a small window to insert the test strips. Instead of focusing on flashy design, the developers tout the device’s transparent accuracy and scientific validity. Though not very “sexy,” another attention-grabber is a smart toilet seat. Developed by the Rochester Institute of Technology, this toilet seat measures diastolic and systolic blood pressures, stroke volume, blood oxygenation, heart rate, heart rate variability, QRS duration, corrected QT interval and patient weight. The device’s design uses an everyday activity to capture data that would otherwise require multiple devices that aren’t as easy to use. Make the technology automatic Diabetes treatment has made significant leaps with continuous glucose monitors. For example, Abbott’s FreeStyle Libre replaces a finger stick with a 14-day sensor patch worn on the upper arm. It automatically measures glucose readings and transmits them to a smartphone or reader for accurate insulin dosing.

www.medicaldesignandoutsourcing.com

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Remove barriers to use Anything that introduces a user roadblock can deter a device’s adoption, so detecting and eliminating those barriers is essential. As an example, ResMed’s human factors research revealed that even processes such as registering a new device could interrupt compliance. “You lose health adopters every time you ask a patient or provider to perform a set-up step, select a network or flip a switch,” ResMed CEO Mick Farrell told Medical Design & Outsourcing. ResMed connects each of its continuous positive air pressure (CPAP) sleep apnea treatment devices to the cloud before patients begin to use them. In-house research revealed that once the device gave users feedback, it improved patient compliance. Use of the company’s MyAir smartphone app helped nearly 84% of new CPAP users reach the necessary usage threshold for Medicare adherence in the first 90 days of treatment, according to the company.

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DESIGN

User behavior is key In many ways, the medtech industry is playing catch-up with consumer technology. The stakes are high, so getting the experience right is critical. Forward-thinking companies of all sizes are investing in user behavior. Consider that consumer digital health company Livongo Health recently acquired the behavioral health-focused myStrength to add digital tools for conditions such as depression, chronic pain, and opioid addiction. Moves like this signal that designing digital devices for user behavior may be critical to the success of a home medical product. Perhaps for the first time, the industry is seeing that in a competitive environment, focusing on user behavior is essential to innovation. While it raises the risk factor in developing medical devices, it also boosts the potential rewards. The design tips presented here are not new, but they are essential steps in gaining market share. M

Make user feedback part of the business model User feedback can reduce user errors and improving the user experience in a way that ties a patient population to a product. Clarify Medical believes so strongly in user feedback that it built it into its business model. Clarify makes a phototherapy tool for treating psoriasis and vitiligo (loss of skin pigment). Activating the device puts the Clarify team in close contact with the patient through a company-based (rather than outsourced) customer care center and a smartphone app. The email and phone calls Clarify employs to train users have also led to bug fixes, app refinements and even firmware updates. The app allows the company to monitor patient usage; non-compliant users receive additional coaching and training.

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MATERIALS

Adhesives are key to unlocking medtech wearable innovation

Image courtesy of 3M

Adhesives are a critical component to the success of wearables, providing solutions to design challenges and protecting users’ skin.

T To n y K a u f m a n | 3M |

Del R. Lawson | 3M |

Medical Design & Outsourcing

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3 • 2019

he healthcare landscape is constantly changing, with providers continuing to focus on delivering patient-centric care. Patients are increasingly able to access highly-tailored care and treatment options, with new technologies allowing them to play more active roles in managing their health. Wearable medical devices are a significant contributor to this movement. From blood glucose and cardiac rhythm monitors to fitness trackers and smart watches that know weight, gauge activity level, track heart rate and count calories, wearable devices are enabling users to stay active and manage chronic illness from the comfort of their own homes. Some manufacturers are already adapting to market needs by creating devices that are lighter, smaller and less invasive. In part, these advancements are made possible by adhesives – a seemingly small component. Whether adhesive is being used to stick a device to skin or different device features together, it’s a critical component to the success of wearables that provides solutions to design challenges and helps protect users’ skin from harm. But keep in mind: All adhesives are not created equal or are usable in every design. Here are but a few factors that are increasing the need for quality adhesives to support wearables: • Psychosocial influence. Unlike people using wearables to track fitness, those using a device to manage a medical condition may be less inclined to sport their wearable device or devices out in the open. These users may not want to draw attention to their condition, and for this reason, smaller and less obtrusive designs are better. Use of thin, clear, breathable films and adhesives can enable a more discrete design. www.medicaldesignandoutsourcing.com

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MATERIALS

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• Style and accuracy. In contrast, fitness wearable users often want to openly wear their device as a testament to what they’re working to achieve. Often these devices are worn as wristbands. They may be trendy and visually-appealing, but they lack the same level of accuracy required of a device meant for medical diagnostics and drug delivery. Bandstyle devices can allow sensors to slip, slide or rotate, causing an inaccurate measurement. Stick-to-skin devices, on the other hand, are innately more accurate because the sensor can be applied where needed, minimizing the potential for error associated with the adjustable fasteners used on wrist bands. They also allow for a “onesize-fits-most” design. • Information fatigue. In addition to appearance considerations, it’s important to be aware of how the device will collect and share data. Consumers are constantly inundated with data, and there comes a point when it’s hard to take more in. It’s important to strike a balance between keeping data detailed and accurate without inconveniencing and overloading the user by sharing constant alerts. Simplifying alerts and reducing noise as much as possible, in addition to using a smart adhesive system, will help ensure user satisfaction and accurate data collection. So how can adhesives enable wearable medical device innovation? Here are some key areas: • Resilience and durability. Users who engage in rigorous physical activities, such as running, weightlifting and swimming, need to be able to do so without their device being a nuisance. The prospect of a device coming into contact with water and moisture has historically been seen as a challenge, but with significant advancements in adhesive technology, this doesn’t have to be the case. Choosing an adhesive solution that provides durability and extended wear time will help devices stay intact and attached longer under these conditions. An acrylicbased adhesive with a nonwoven, breathable backing, for example, may be a suitable option. Adhesive 28

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manufacturers are constantly working to improve breathable adhesive and backing options that design engineers can utilize to increase the durability, resilience and wear time of devices that need to remain viable during physical activity. • Comfort. The skin should undeniably be a big factor when it comes to adhesive selection. Regardless of how long a device is worn or how long an adhesive needs to stick to skin, the comfort of both the device and adhesive is important. As a living, breathing organ, skin needs to expel moisture, flex and function as it normally would without a device stuck to it. If it can’t, it will do everything in its power to rid itself of the foreign object. A common design misstep is selecting an adhesive that will stay sticky but lacks breathability. This can cause moisture to get trapped underneath the adhesive, potentially leading to maceration

and other medical-adhesive-related skin injuries. As wear time increases, considerations of comfort and how the properties of the skin may influence the application become increasingly important. • Device size and weight. Consumers and patients alike want wearable medical devices that are smaller, lighter and less cumbersome. But wearable device creators can find it difficult to maintain accurate sensing capabilities while also reducing the risk of accidental removal from clothing tugs or wall and door impacts. Adhesives can help to keep accidental knock-offs to a minimum by use of an adhesive skirt and maintaining a low profile. Adhesive technology presents a number of solutions to design challenges, from helping to prevent skin injuries associated with the device to promoting accurate data collection.

www.medicaldesignandoutsourcing.com

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At the end of the day, the power of medical devices lies in their power to improve lives, and adhesives play a key role in ensuring that success. For more guidance on selecting the right adhesive for your next medical device project, check out 3M’s product selector tool at www.findmyadhesive.com. M

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REGULATORY

5 tips for post-market medical device compliance Post-market surveillance is an important process for medical device developers, with regulatory bodies expecting good follow-through and effective procedures.

Jon Speer | Greenlight Guru |

ost-market surveillance is a compliance issue that many companies get caught up with in audits or inspections. How comfortable is your medtech company with the process? The usual story is that the company doesn’t have a procedure in place, or, if they do, it’s ineffective with a lack of follow-up or important issues being missed. Any situation like this can land you in hot water, with work to do to get back in compliance. That work isn’t done once your device hits the market. What does it take to be compliant in a post-market environment? 1. Keep up with regulatory changes Who can honestly raise their hand and say they’re intimately acquainted with every regulatory change that has come out and affects their company within the last few years?

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Most people will know the basics of the big changes, but the truth is, there are small changes happening frequently. It’s easy for those things to slip through the cracks. Information is your friend in a postmarket surveillance environment, and in the medical device world as a whole. It’s important to take proactive steps to stay informed and understand how your company needs to be prepared for any key changes. Some suggestions to help facilitate a proactive approach include: • Attend conferences, trade shows, meetups, trade association meetings and training sessions. Engage with decision makers, regulatory advisors and people “in the know” at these meetings to get the low-down on any developments. • Monitor industry websites and forums. • Talk to any regulatory contacts you may have, or people who sit on advisory committees.

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REGULATORY

• Subscribe to industry publications (and take the time to read them). There are often nuggets of information to be found that can give you an idea of anything you should be preparing for. 2. Monitor feedback. Staying abreast of feedback is another challenge for medical device companies in a post-market phase. The issue is that feedback can be coming at you from multiple channels. For example, customers might file a complaint, but use different methods to do so – email, feedback forms, social media, a phone call… Feedback might also come from clinicians or caregivers who help the end users. It might come from service technicians, study groups or reports on non-compliances. It might even come from a resulting CAPA investigation and lead to changes having to be made. The point is that you’ve got to have a system in place to handle the various channels of feedback and ensure

3. Put systems in place. What systems do you have in place to ensure that feedback is scrutinized appropriately and everything is captured? What about other critical post-market activities – internal audits, CAPA management, updating your risk management file, change management and management of any non-conformances? Companies that end up with issues often have a fragmented approach, with customer service taking and filing complaints (perhaps in their own spreadsheet), someone else looking after internal audits or CAPA and no one updating the risk management file until there’s a pre-audit scramble. This can often lead to issues identified at audit that could have been prevented.

Most people will know the basics of the big changes, but the truth is, there are small changes happening frequently and it's easy for those things to slip through the cracks.

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Medical Design & Outsourcing

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that nothing slips through unchecked. Companies find themselves in trouble when there’s no sign of feedback having been followed up, for example.

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On the other hand, a system that centralizes all of those things in one easily accessible spot can keep you on top of compliance, allowing you to generate reports, manage feedback and generally be prepared for any audit or inspection. 4. Establish follow-up studies where needed Post-market surveillance studies (FDA) or post-market clinical follow-up studies (Europe) may be required, particularly among Class II or Class III devices. Their purpose is to monitor and assess any residual risk from the device. It’s often the case that data are limited during pre-market studies due to factors such as the length of the study or the number of participants. It can also be the case that studies are required due to significant changes to a device or its usage, new information or post-market surveillance data. Companies wanting European CE marking will need to have evidence of a post-market clinical follow-up (PMCF) study protocol or a justification for why a PMCF isn’t required.

… and the benefits It’s important to remember that postmarket compliance isn’t some checkbox activity to be marked off and filed under “we did this to be compliant.” It actually provides valuable benefits to your company and your customers. For example, a good surveillance program allows you to quickly identify necessary improvements. Post-market surveillance allow you to be proactive, taking steps that result in valuable learning for your company. This in turn can help to reduce your incidence of customer complaints, lower safety incidents and foster engagement with customers.

Implement a good system to monitor and analyze post-market activities and ensure that appropriate actions get taken. Manage these tasks centrally with a cloud-based QMS, such as that offered by Greenlight Guru, and ensure that you’re ready when the auditors or inspectors come calling. M

Final thoughts Post-market surveillance is a critical requirement for medtech companies with devices on the market. It’s easy to breathe a sigh of relief when your device hits the market and be tempted to just “cruise”, but stricter regulation on post-market activities means that you can’t really afford to.

5. Keep your team up-to-date. Your team plays a key role in how well you are able to handle post-market surveillance and any attendant issues. They’ll need to be kept up to date on any changes to policy, procedure or legislation and be supported through those changes. Another important task is keeping team members trained on investigative techniques, reporting and documentation procedures so that you stay ahead of the game. Include training on topics like spotting trends proactively monitoring devices. Know the risks… What happens if you fail to keep up with the steps outlined above and are found to be non-compliant during an inspection or audit? The consequences can vary depending on the gravity of the offense, ranging from an FDA Form 483 observation all the way to the worst-case scenario, potentially involving jail time for executives involved with the noncompliance. There’s also the risk of incurring very large fines, having special compliance contracts imposed, seizure of product or effectively having operations shut down.

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STANDARDS

Medical device power supplies: How standards enable safety IEC 60601 standards ensure that medical device power supplies are safe for both patients and healthcare professionals. Discover IEC 60601 basics, as well as new developments.

Florian Haas | Tr a c o P o w e r |

Traco Power’s TPP 40 series is available as both open-frame and enclosed. Image courtesy of Traco Power

Medical Design & Outsourcing

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eople and power don’t mix well, especially when the people are patients – either in a medical facility or, increasingly, in a home environment. To ensure the safety of patients and healthcare professionals, the healthcare business is regulated by a range of standards-based requirements and associated product testing. IEC 60601 is central to assuring patient and provider safety, providing a suite of requirements specifically for the electrical and electronic equipment used in healthcare. Originally published some 40 years ago, IEC 60601 has kept pace with industry changes. So, what are some of the key principles of IEC 60601 as they relate to the implementation of the power supply? What are some of the new requirements, such as the need for risk assessment? Also, what are practical ways of achieving compliance? What kind of support is available for medical device manufacturers? Introduction A key medtech safety concern is that the patient is often electrically connected to the device, such as by the conductive pads of an electrocardiograph. IEC 60601 defines these pads as applied parts (AP) — an important definition within the standard for a medical product’s overall requirements. Medical devices must incorporate at least one means of protection (MOP) to ensure that both the operator and the patient, if connected via an AP, are protected from the risks of electric shock, even under fault conditions. A MOP can be achieved through safety insulation, protective earth, a defined creepage distance, an air gap, other protective impedances, or by implementing a combination of these techniques. 3 • 2019

The standard treats operators and patients differently, resulting in the classifications “means of operator protection” (MOOP) and “means of patient protection” (MOPP) (Figure 1). MOPP requirements are more stringent because the patient may be physically connected via an AP and unconscious when the fault occurs. Each term is defined in terms of an isolation voltage, creepage distance, and insulation level. Evolving standards Although power supplies and modules are not medical devices, medtech manufacturers must design power solutions with medical applications in mind to meet the standards. Hospitals and clinics provide dedicated, clean power for use by their most sensitive medical devices. Issues such as electromagnetic compatibility (EMC) become more important for home-based medical devices because of the prevalence of technologies such as Bluetooth and Wi-Fi. IEC 60601’s latest

www.medicaldesignandoutsourcing.com

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STANDARDS

3rd Edition Requirements by Classification Classifications

Isolation

Creepage

Insulation

One MOOP

1500 V ac

2.5mm

Basic

Two MOOP

3000 V ac

5mm

Double

One MOPP

1500 V ac

4mm

Basic

Two MOPP

4000 V ac

8mm

Double

Figure 1: Definitions of MOOPs and MOPPs for IEC 60601

version (4th edition) has updated the testing procedures and acceptance levels for EMC accordingly. Medtech manufacturers must also conduct risk assessments according to ISO 14971, which defines best practices for all stages of a medical device’s life cycle. The EU’s Medical Device Directive further adds to the compliance burden, requiring manufacturers to implement a quality management system (QMS) that complies with ISO 13485.

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The typical approach to achieving IEC 60601 compliance is to use an AC/ DC power supply that is approved for medical use. However, body-floating (BF)-rated applications also require the AP instrument to meet the 2 x MOPP rating. Many of the medically approved AC/DC power supplies on the market today do not have a 2 x MOPP rating and are not appropriate as a stand-alone power solution for applications where BF compliance is required. In these cases, an IEC 60601-approved, 2 x MOPPrated DC/DC converter will support BF compliance for the AP. Another common example is medical appliances that have battery back-up capability and must fulfill the 2 x MOPP rating during AC failure. Medical appliances often require various DC voltages for the AP instrument that differ from the main system DC voltage provided. To avoid sourcing custom AC/DC power supplies, this can be resolved by combining IEC 60601, 2 x MOPP rated DC/DC converters with,

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Figure 2: Using a DC/DC converter to achieve 2 x MOPP protection

for example, an ITE 60950-rated AC/DC power supply. Alternatively, using 2 x MOPP, medical-grade DC/DC converters for the AP instrument may suffice, even when the selected AC/DC power supply has IEC 60601 approval. The primary requirements for 2 x MOPP (Figure 2) are 4000 V AC isolation, 8 mm creepage distance and double insulation. Most commonly available DC/DC converters (including those that carry EN60950 approval) offer between 500 V DC to around 1600 V DC of isolation and are, therefore, not suitable for medical applications. However, specialized DC/DC converters will meet the requirements for AP when used in conjunction with such standard off-the-shelf power supplies. By providing up to 5000 V AC of isolation, double insulation and 8 mm of creepage distance through its galvanicallyisolating transformer, a DC/DC converter can still protect the patient in the event of a failure of the main AC/DC power supply, thereby avoiding mains voltage levels appearing at any patient AP points.

Traco Power also implements its QMS in accordance with ISO 13485, which covers both the design and manufacturing processes. Because Traco Power manufactures power solutions rather than medical devices, it is not required to provide risk assessment data. However, the company is compliant with ISO 14971 and provides customers with risk assessment files covering crucial areas, including insulation breakdown, use while inverted, effects of fan failure, flammability, and mechanical shock. Having this data can save customers time and expense during the design process. M

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Medical Design & Outsourcing 37

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TUBING TALKS

The view down the barrel of an excimer laser Image courtesy of Proto Lase

Could this old-school manufacturing tech enable better catheter designs? Excimer lasers took a back seat to femtosecond and picosecond lasers in catheter manufacturing. It may be time to give this decades-old technology a second look.

Chris Newmarker | Managing Editor |

Medical Design & Outsourcing

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erial medical device manufacturing entrepreneur Brady Hatcher still remembers the moment years ago when he first saw Daryl Kiefer use an excimer laser to drill a hole only a few thousandths of an inch across into a polymer catheter. “It looked like it was magically removed, without heat effect – like it was molded that way,” Hatcher recently told Medical Design & Outsourcing. “Like it was made that way,” Kiefer added. It’s that type of miniature magic that has Kiefer and Hatcher betting that excimer lasers will have an important role to play as catheters grow increasingly smaller and more complicated to suit neurological applications and a host of other delicate medical procedures. Hatcher’s Twin Cities medical device design startup Switchback Medical last year bought Kiefer’s five-person Kiefer Manufacturing operation. Daryl Kiefer now runs Proto Lase, a quick-turn laser processing service that utilizes 3 • 2019

4,000 square feet of space adjacent to Switchback in the Minneapolis-St. Paul suburb of Maple Grove. With an excimer laser, Kiefer boasts that he is able to use his roughly 20 years of experience with the technology to get detailed jobs done in days that would take a larger outfit weeks to complete. Excimer lasers have been around for more than 40 years and work well for highprecision polymer ablation. The technology fell out of favor in catheter and other medical device manufacturing as cheaper manufacturing methods like femtosecond and picosecond lasers came along, Kiefer explained. Excimer lasers are high maintenance because they use a fluorine-and-neon gas mix that eats away at parts. Kiefer himself has to tear down Proto Lase’s machine every eight to 12 months. Still, an excimer laser in the hands of an experienced technician can accomplish design feats that would be extremely difficult if not impossible with other manufacturing technologies, he told us.

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TUBING TALKS

TOP: An excimer laser can create ablation holes through polymer tubes as small as 0.002 in., according to Daryl Kiefer at Proto Lase.

Kiefer can use an excimer laser to ablate a design you’d need an electron microscope to see. “The detail that you can produce on a catheter tube is incredible. You could ablate your logo or name on it,” Hatcher noted. It really comes down to the development engineer’s understanding of excimer laser capabilities, Kiefer added. “There are a lot of ways that we can help them with design, and the excimer tool is a great tool to do that.” Kiefer listed three things that excimer lasers are especially good at when it comes to catheter and medical tubing manufacturing:

BOTTOM: An excimer laser ablates a polymer tube. Images courtesy of Proto Lase

1. Detailed holes and surface patterns Kiefer can create a stainless steel mask to place in the path of the laser – which comes out about an inch long and a half inch tall – to create a specific type of hole in a single shot. “We can do any type of hole pattern you want: rectangular, square, round, oval,” he said. “Whatever we put on that mask, that’s what you’re going to get. You can shoot that.” One customer wanted a design on a polymer surface that would reduce surface contact between two substrates.

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www.medicaldesignandoutsourcing.com

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“We designed a custom screen to place in front of the path, and what comes out on the part is the exact same thing. It’s like milling on a lathe. It’s the same effect,” Kiefer said. It’s possible to create such effects at sizes as small as 0.002 in., or roughly 50 microns, according to Kiefer. “Femtosecond – there’s just so much energy that you’re not going to have that type of detail,” Kiefer said. Some manufacturers have started using mirrors to scan out a hole using femtosecond lasers, but it’s not the oneshot process you get with an excimer laser, he said. 2. Reducing outside diameter Another great excimer laser application involves reducing the outside diameter on a catheter shaft to a controlled depth – for example, going down from 100 thousandths of an inch to 90 thousandths of an inch. “We’re going to ablate it down to

a certain diameter and over a certain length,” Kiefer said. Perhaps there’s a catheter shaft with a PTFE liner with a polyamide layer on top. It’s possible to reduce the diameter down to the PTFE for a certain length and then replace the polyamide along the length with another material that accomplishes a particular design goal along the particular length of catheter, he explained. This type of capability makes excimer layers useful in stripping extremely tiny wires before welding them to onto an electrode for, say, a pacemaker, he added.

in the reduction of surface tension when the product needs to release or slide over the finished surface. M An excimer laser ablated this polymer jacket for an inflation hole. Image courtesy of Proto Lase

3. Surface finish It’s also possible to add extremely tiny surface patterns or to roughen a tubing surface in an extremely controlled way, according to Kiefer. This surface preparation can be beneficial when bonding materials together, as it adds surface area to increase bond strength. It can also benefit

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VALIDATION

How cloud QMS simplifies software validation

Scott Reedy | Arena Solutions |

DA requires validation to demonstrate that quality management system (QMS) software meets its intended use. Here’s how a medical device company can streamline its validation processes and focus on activities that generate revenue and win business. Why validate? Medtech manufacturers may use a paper-based quality system, on-premises software, or cloudbased software. FDA doesn’t specify the type of QMS system medtech manufacturers must use, just that they have a quality system that ensures products consistently meet applicable requirements and specifications. However, the agency does require manufacturers to prove, or validate, that their software-based quality system meets the 42

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Many manufacturers do not consider the cost and impact of software validation, but failing to do so can mean the difference between product introduction success or failure.

3 • 2019

requirements for its intended use. Depending on the type of QMS software, the validation process can increase burdens on teams, draining resources and adding costs. Cloud-based QMS software is designed to be validated easily, even with regular enhancements, and can deliver highquality, compliant products to market. Reduce the burden Medtech companies that purchase a cutting-edge QMS software solution expect to take advantage of capabilities that improve quality and increase transparency and historical tracking of information as they develop and release new devices. However, they too often forget to analyze the options for getting software enhancements or upgrades by failing to evaluate the initial impact and ongoing cost of validating the software.

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FDA mandates validation for the initial implementation of the software as well as for upgrades. Upgrading onpremises software systems can be tricky, leading some device manufacturers to rely on outdated paradigms to base future validation decisions. Quality teams may hesitate to upgrade their QMS software because of the associated burdens of validation. Traditional validation of onpremises solutions for each new software enhancement can lead to more than a drain on resources. For some companies, the time, expense and effort associated with validating new versions outweighs the desire to take advantage of new functionality, even when that functionality will streamline quality and productrelease processes. As a result, too many companies continue to rely on an outdated QMS software system that fails to keep up with technological advances, making it harder for the manufacturer to stay ahead of the competition.

Keep it simple As cloud-based applications become more sophisticated, secure and affordable, quality leaders should evaluate the advantages of using a multi-tenant cloud solution that adheres to current best practices in software validation, security and innovation. Cloud-based QMS software with multitenant architecture provides a way to take advantage of ongoing advancements in technology while providing the lowest total cost of ownership (TCO) with a simplified validation experience. With a multi-tenant cloud solution, medtech companies can leverage software enhancements regularly without the traditional validation “heavy lifting” required by older on-premises or singletenant QMS solutions. Multi-tenant QMS solutions provide a level of shared infrastructure. The validation process is made easier by leveraging common test protocols for both installation qualification (IQ)

and operational qualification (OQ) requirements. Paired with software provider’s validation maintenance service and validation experts, medical device manufacturers benefit from a better validation experience that reduces manual effort and timeconsuming work. Removing traditional validation barriers enables companies to keep pace with the latest technological and functional features and frees quality and regulatory resources to focus on innovation, market responsiveness and continual improvement to deliver highquality products. LNS Research found that software validation is one of the top challenges to speeding product development from early research and development to commercialization. When quality leaders don’t have to worry about validating software, they can focus on core competencies and, ultimately, accelerate the delivery of innovative and safe devices to market. M

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AI Can

truly transform medicine?

F I N K D ENS FO R D A S SO C IATE ED ITO R

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Artificial intelligence raises exciting possibilities for healthcare, but are companies promising more than they can deliver?

www.medicaldesignandoutsourcing.com

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A nurse examines the imaging screen of the IDxDR AI-powered diagnostic designed to screen patients for diabetic retinopathy. Image courtesy of IDx

could possibly fuel the future of medtech, enabling such thrilling innovations as implanted devices that instantly react to minute changes, software that can identify the best treatment options for individuals facing life-threatening conditions and fullyfunctioning autonomous surgical systems. But artificial intelligence’s potential also comes with an incredible level of hype. “AI has the most transformative potential of anything I’ve seen in my life, and

I graduated medical school 40 years ago. It's the biggest thing I've ever seen by far,” prominent cardiologist and author Dr. Eric Topol told Medical Design & Outsourcing. “But it's more in promise than it is in reality.” Topol is a professor of molecular medicine and EVP at Scripps Research and the author of the soon to be released book Deep Medicine, which explores the enormous potential that artificial intelligence could have on medicine. And although he’s optimistic that AI will improve healthcare in the future, www.medicaldesignandoutsourcing.com

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that functionality is still years away; Topol suggests that companies investing in AI-involved products need to perform prospective research and appropriately manage the hype around their offerings. “I think the hype is proportional to where AI could take us, but it hasn't taken us anywhere substantially yet. It will, I think. I'm confident it will. But we don't want to put the cart before the horse,” Topol explained. For small medtech companies, managing the hype around AI may seem difficult, but successfully doing so can make 3 • 2019

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AI HYPE

your products stand out from the crowd. “The first order of the day is to not over-claim, not over-promise, and just be truthful of what you can and cannot do. You know that AI isn’t perfect. Clinicians make errors, and the AI will make errors. That’s just the way it is. Be very open. Be transparent,” IDx CEO Dr. Michael Abramoff told us.

A nurse screens a patient using the IDx-DR AI-powered diagnostic designed to screen patients for diabetic retinopathy. Image courtesy of IDx

I think the hype is proportional to where AI could take us, but it hasn't taken us anywhere substantially yet

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He should know. Last April, Abramoff’s little-known company, IDx, won FDA clearance for its IDx-DR system, an autonomous computer-vision software product designed to analyze retinal images and provide a clinical diagnosis for mild diabetic retinopathy. The clearance marks the first time the FDA has approved an AI-based product that provides a diagnosis with no physician input or further examination required; it was a significant step forward for AI in medtech. “I founded IDx with some colleagues in 2010 to address many problems in eye care and healthcare in general, primarily the increasing cost of healthcare,” Abramoff said. “I saw autonomous AI, meaning a system that makes a clinical decision or clinical recommendations, as the key.” As the holder of both a specialized medical degree and a PhD in AI-based

image analysis, Abramoff said that he’s always been fascinated by the combination of AI and medical care, but he’s worried that the hype could hurt people’s trust in the tech. “As a physician, it’s so important that people trust it, that physicians trust it, that patients trust it. And what you don’t want to do is make all sorts of claims,” Abramoff cautioned. “You want to be careful not to make claims you cannot make real. I think, for me, the focus is on ‘let’s never overpromise.’ Let’s make sure what we say is true to the best of our knowledge. Let’s not over-claim, and as a field, not claim we do things we don’t do yet.” The fear is a backlash akin to what was seen in the autonomous vehicle industry after the first fatal pedestrian crash a year ago during an Uber selfdriving test in Phoenix. A similar scenario could unfold if medtech AI firms riding the wave of hype make promises they can’t deliver on, he added. “We cannot have that. It’s so important for healthcare, which is too expensive, to become more affordable and to drive quality and accessibility,” Abramoff said. “And if you have backlash, God forbid, it wouldn’t be allowed anymore. That will just harm patients.” In medtech, the backlash may be already be under way, in the form of significantly increased scrutiny. In late 2017, a STAT News report emerged suggesting that major AIbased player IBM Watson Health’s cancer product, Watson for Oncology, failed to effectively find the best treatment for cancer patients. Another report from STAT, released last July, suggested that Watson for Oncology often returned “multiple examples of unsafe and incorrect treatment recommendations.” The reports were joined by the Wall Street Journal, which claimed last August that “Watson cancer applications have had a limited impact on patients,” that the “tools didn’t add much value” and that in some cases, “Watson wasn’t accurate.” IBM media relations could not be immediately reached for comment, but the ensuing foofaraw saw the departure of Deborah DiSanzo as Watson Health GM, who moved to the strategy team for IBM Cognitive Solutions. When asked whether he believed that Watson provided appropriate

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AI HYPE

An example of a personalized 3D model of the coronary arteries created using HeartFlow’s AIpowered FFRct system. Image courtesy of HeartFlow

evidence to back up the functionality it promised, Topol said that the company relied too heavily on AI hype. “Certainly not with Watson. That's been a false start from the beginning, because they've been masters of marketing things that have not been accomplished. So they, unfortunately, set a bad precedent by being a front runner with a big profile and printing out a lot of things that were just pure hype,” Topol said. But Topol said that he believes that other companies – such as IDx – have begun to produce research, set realistic expectations and deliver on promises that are establishing AI’s role in healthcare. “I think that things are starting to get grounded. IDx is certainly one example. They performed a prospective clinical trial. They got FDA approval. It's in use,” Topol said. “I do think that it's on the right track. We need to do that a lot more.” IDx isn’t an anomaly: Many other medtech firms have also realized the importance of avoiding the hype around AI. “Where is it important to separate reality from hyperbole? At every possible opportunity. There is a lot of hyperbole,” HeartFlow chief medical officer Dr. Campbell Rogers told MDO. HeartFlow’s tech uses advanced imaging to create an anatomic rendering of the coronary vasculature, applying known data about coronary physiology to better reveal underlying patient physiology, Rogers explained. The process relies on machine learning to help create high-quality renderings by analyzing a wealth of images, including angiograms and intravascular images. After analyzing the images, the software can then infer what the actual anatomic structure of a patient looks like based upon the previous data.

It’s a direct application of machine learning that’s helping to save lives, and one that will continue to improve over time, he said. The technology is also “incredibly facilitating” for patient care, Rogers added, despite fears that AI-based tech could remove the art of medicine from the practice. “There’s just nothing that could be farther from the truth,” Rogers said. “I think of it much more as guiding the provider to the areas where he or she can provide the most good, the most wisdom.” Topol agreed that AI has the potential to significantly improve the relationship between physicians and patients, but cautioned that companies need to increase their investments in research to spark future innovation. “If you really believe in your algorithm, then you will want to do a prospective validation trial, and provide proof for the medical community. Because otherwise, this is not going to get legs.” M

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AI HYPE

H O W N E U R O M E T R I X S E E K S T O B E T T E R R E L I E V E PA I N W I T H A I

NeuroMetrix plans to add artificial intelligence to the latest iteration of its Quell transcutaneous electrical nerve stimulation (TENS) device. AI will allow Quell 2.0 to tailor treatment to each individual user, according to the Waltham, Mass.–based company. Launched in September 2018, Quell 2.0 is 50% smaller and 20% more powerful than the original Quell, which debuted in 2015. Quell is worn on the leg regardless of the site of pain and is designed to send neural pulses to the brain that trigger a natural pain relief response in the central nervous system. Patients control the device and track their pain using a smartphone app. Quell 2.0 is available over the counter for about $300. So how could AI help patients who use the device? NeuroMetrix chief commercial officer Frank McGillin recently discussed the decision to use AI and the future of Quell with Medical Design & Outsourcing. Neuro Metrix’s Quell 2.0 device

Image courtesy of NeuroMetrix

MDO: Why did the company decide to incorporate AI into Quell 2.0? McGillin: Early on, looking at Quell as a digital intervention, we realized that we had a lot of

Medical Design & Outsourcing

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valuable data from a macro- and a subpopulation standpoint, documenting how Quell was either working for them or how it may be working differently for different populations. So we initiated the Quell Health Cloud in 2016 to obtain that data. We have over 70,000 users who contributed enough data that we were able to start applying machine learning and looking at that dataset to find out what might improve the overall process. For example, the way a 40-yearold woman with fibromyalgia who’s in relatively good health is dosing Quell may be very different from an overweight smoker diabetic who’s 60. We characterized user phenotypes, such as back pain, knee pain, diabetes, height and weight, age, weather sensitivity, and attitudes about pain, such as catastrophizing. The first time someone uses it, there’s a calibration process to determine the dosage of electrical stimulation we’re providing. It looks at their sensation threshold based on nerve health, skin condition and body mass. If their sensation threshold is X, we apply a constant factor to that, and that’s their therapy dosage. With traditional TENS, you’re basically guessing. We’re applying basically Big Data to take a more intelligent approach to dosing for the individual. It’s really important to get to that right level of stimulation. If you understimulate nerves, it really won’t be effective. On the flip side, if you overstimulate, it becomes uncomfortable and the user will abandon.

MDO: What have been the company’s main challenges in device adoption? McGillin: The first was convincing consumers that a device worn on the leg can treat pain regardless of the source of that pain. A traditional TENS is a very localized technology that’s worn at the point of pain, but having it strapped to your back is inconvenient. We Nancy Crotti designed Quell for the leg Senior Editor because it’s an excellent place to stimulate sensory nerves and users can also dose from there over an extended period of time. A Harvard University study that was presented at the 9th World Congress of the Institute of Pain in Dublin, Ireland in May 2018 (and partially funded by NeuroMetrix) showed that Quell is good for lower back pain. The second challenge Frank McGillin was one of adherence. Some NeuroMetrix chronic pain sufferers may not see results for two or three weeks because the body is conditioned to be overly sensitive to pain. How do we make sure that we get that new user off to the right start? If they have a great experience in that first 30 days, they’re hooked. The contribution of AI is we’re making sure we‘re dramatically increasing the odds that they’re starting off correctly. Another challenge is getting people to use technology to treat chronic pain when most are accustomed to using medication. But with the opioid crisis, we did some research and found that people want new solutions. MDO: What’s next on the horizon for Quell? McGillin: We’re approaching 200,000 units in terms of sales, and we’re adding gamification techniques to the app to give the user a sense of accomplishment. Also, those who have bought Quell 2.0 before the addition of AI will be able to update the firmware on their device to manage it.

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Medical Device Medical device makers, regulators and healthcare delivery organizations are increasingly working together to strengthen security against cyberattacks. NA NC Y C R OTTI S ENIO R ED ITO R

But are they doing enough?

lmost no one in the medtech industry disputes the vulnerability posed by cyberattacks. How to go about boosting security is another matter – one on which those stakeholders have recently stepped up their collaboration. One group, the Healthcare & Public Sector Coordinating Council, thinks it has a solution: Health providers and other customers buying a connected medical device should be able to remotely access a cybersecurity bill of materials (CBOM) that would list all commercial, open-source and custom-code software. Available via remote access for customers, the CBOM would also include commercial hardware such as processers, network cards, sound cards, graphic cards and memory. The council’s recently issued joint security plan calls for more vulnerability disclosures, notices of breaches, software and hardware upgrades and security patch availability. Companies would also need to notify customers before they end technical support for older devices.

Image courtesy of istockphoto.com

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“It’s this voluntary framework that establishes best practice for cybersecurity at a medical technology company,” council member Rob Suarez, director of product security at Becton Dickinson, told Medical Design & Outsourcing. “This joint security plan establishes the common ground which many medical device manufacturers, health IT vendors and healthcare providers agreed on.” Some manufacturers have grumbled about providing hardware information in a CBOM, but an increasing number have pledged to publicly share vulnerability information should hackers breach one of their devices, including industry giants BD, Abbott, Siemens, Philips, Medtronic, Johnson & Johnson, Boston Scientific and Stryker. Responding to the problem Abbott is especially aware of cybersecurity challenges. It acquired St. Jude Medical in 2017, just months after short-selling investment firm Muddy Waters publicly claimed that St. Jude cardio devices are especially vulnerable to hacking. The crisis accelerated Abbott’s efforts to make cybersecurity a priority throughout the entire design and product development process, rather than tacking it on at the end when changes are more expensive and time-consuming, according to VP of cybersecurity Chris Tyberg. Abbott has cybersecurity experts working with its R&D, IT and engineering teams to ensure that they’re designing devices with the right threats in mind, and accommodating for those threats. Customers want more security, Tyberg told MDO. Abbott last year conducted a cybersecurity survey with the Chertoff Group in which 82% of 300 physicians and 72% of 100 administrators said they wanted industrywide standards so they know what to expect of medical device cybersecurity. Medtech manufacturers in general are employing measures similar Abbott’s, including BD. Although historically a syringe business, BD now has more than 220 software-enabled devices on the market with a framework designed to achieve security throughout their lifecycle. BD’s cybersecurity motto is security by design, in use, and through partnership, Suarez said. “We want to understand how clinicians and patients use these 52

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CYBERSECURITY

technologies and tailor our security controls to their environments,” he told us. Industry-wide transparency is key, Suarez added. “You can’t secure what you don’t know, so BD has made it a routine practice to deliver things like coordinated vulnerability exposure” information to the U.S. Homeland Security Dept. and to customers so they can protect patients. “Our approach is really prefaced on these principles and the capability that we’ve built up over the last two years, and that’s what you see reflected in the joint security plan,” Suarez said. Any progress? The FDA in recent years has increasingly paid attention to medtech’s cybersecurity challenges, publishing its first premarket cybersecurity guidance in 2014 and a postmarket guidance in 2016. In October

“The moves that the FDA has made have been monumental,” said Daniel Beard, CTO of medtech software developer Promenade Software. “When you think about the rate that the government moves, it’s like light-speed time.” Interventional cardiologist Dr. Leslie Saxon has been working with Abbott, Boston Scientific and Qualcomm to educate clinicians so they will accept the importance of cybersecurity similar to the way Americans warmed to environmentalism in the 20th century. Saxon believes collaboration by government and industry is helping medtech catch up with the financial and aerospace industries’ cybersecurity efforts. “You would never think of littering now, but it took a while for that to get though the culture,” said Saxon, executive director of the University of Southern California’s Center for Body Computing. Next, she’d like to see medtech companies standardize security breach notifications to providers and patients the way that banks have done for their customers, especially given the increasing numbers of people using connected medical devices in their everyday lives.

We want to understand how clinicians and patients use these technologies and tailor our security controls to their environments. 2018, the agency issued an updated draft premarket guidance that includes some postmarket information. It also held a public workshop in January to get feedback on that guidance and worked on the joint security plan. FDA rests its cybersecurity guidance on three principles: trustworthiness, transparency and resilience, according to Suzanne Schwartz, the agency’s associate director of science & strategic partnerships. “To bake security in and build it into the design early on in a thoughtful manner is what will enable throughout the entire product lifecycle the kind of resilience that is necessary so that we’re not dealing with some of the real legacy challenges that we have to deal with today,” Schwartz said. The FDA welcomed input from cybersecurity experts within and outside medtech – as well as from other industries, including the oil and gas sector. “We certainly don’t want to be working in a silo or reinventing what we do,” Schwartz said.

A real and present danger Ransomware and other cyberattacks have stunned the medtech world. In 2016, Hollywood Presbyterian Medical Center paid a $17,000 ransom in bitcoin to a hacker who seized control of the hospital’s computer systems, including blocking access to patient records. The 2017 WannaCry attack affected hospitals in the U.S. and U.K., including medical devices made by Bayer, Siemens and others, according to the Health Information Trust Alliance. And the Homeland Security Dept. issued an alert in 2018 indicating that several GE Healthcare imaging devices were vulnerable to cyberattack. Manufacturers need to grasp the importance of the CBOM and explaining its contents to healthcare providers, according to Martin Nappi, VP of business development for medical www.medicaldesignandoutsourcing.com

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at Green Hills Software. Nappi surveyed doctors and hospitals about medtech cybersecurity last year. “Most of the clinics and healthcare providers, smaller hospitals, even medium hospitals, didn’t have cybersecurity expertise,” Nappi said. “They really didn’t know what level of security had been built into a system. There’s no way of telling.” Health delivery organizations can protect themselves from vulnerable devices by requiring vendors to meet the criteria laid out in the joint security plan, according to Kevin McDonald, director of clinical information security for Mayo Clinic and a co-chair of the joint task force. “We have a process to be able to collect that data, prioritize it, measure the risks and make decisions on purchasing,” McDonald said. “If a device comes in and can meet those criteria, you can take a significant portion of the risk off the table.” What about older technology? Most of the recent published cybersecurity advice to medtech addresses new devices, while hospitals, clinics and patients continue to use legacy devices that manufacturers no longer support. Experts predict it will take five to 10 years for users to replace all of their older devices in favor of more secure ones. In medtech, it isn’t always a simple matter to make switches as soon as more secure devices debut. Swapping out a device might require surgery and the accompanying risk of infection and recovery time. “When you’re a patient who has an implantable cardiac or neuro device, every year, month, day, hour, second that that device lasts is a good thing,” noted Abbott’s Tyberg. “We also need to acknowledge that technology changes fast and cybersecurity changes fast, so we need to be focused on continuing to provide updates to these devices when they need them.” The pace of advances such as artificial intelligence and 5G cellphone networks will likely slow, but humanity is still in its technological infancy, added John Pappan, director of regulatory affairs and medical device and business strategy for Premier Research. “It’s significant that we find a balance between where we are and where we need to be,” Pappan said. “We’re too young to know when what we’re doing is too much for our own good.” M 3 • 2019

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Can AI take medical device manufacturing to the next level? DAN I ELLE K I R S H ASSI S TAN T ED I TO R

Artificial intelligence could improve medical device manufacturing efficiency and reduce risk, but it’s still a work in progress.

rtificial intelligence is driving the world and our habits. Some of the world’s most well-known companies are using AI: Apple in Siri, Tesla in self-driving cars, Amazon in Alexa and even Netflix. Now medical device companies including Medtronic are actively developing AI applications throughout their manufacturing and supply-chain operations. “We anticipate widespread application of AI to manufacturing, including within our supply chain,” Todd Morley, director of data science at Medtronic, told Medical Design & Outsourcing. Areas of focus include supplier and production quality control, supply-chain optimization, yield optimization and predictive maintenance, according to Morley. “Industrial engineers have applied statistical methods to manufacturing for decades,” Morley

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said. “However, the convergence of ubiquitous, inexpensive sensors; abundant computing resources; and powerful, highly accurate AI methods such as deep learning and graphical modeling creates new business cases for AI in manufacturing.” Artificial intelligence is the capability of a machine to perform tasks that would normally be done by a human. Through machine learning, computers are taking in troves of data and learning mistakes while enhancing the jobs of engineers in the manufacturing process. “Engineers have more time to do the important work,” said Carlos Meléndez, COO and co-founder of AI consulting company Wovenware (San Juan, Puerto Rico). “They don’t have to worry about things that they will not be able to fix.”

www.medicaldesignandoutsourcing.com

3/13/19 4:04 PM

www.medicaldesignandoutsourcing.com

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AI MANUFACTURING

For example, a predictive algorithm can gather data about a medical device that was taken out of a production line because of a problem with the device. Using data and performance records, AI can determine the probability of that particular device being scrapped. If the algorithm shows a 99% chance that the device is going to be scrapped, it won’t be sent to the engineering department. Engineers then have more time to dedicate to more important processes, said Meléndez, whose company has been working with medical device manufacturers. Will it take away jobs? Any time we talk about machines being incorporated into manufacturing, the topic of job security comes up. Henry Ford implemented the assembly line in the car manufacturing process in 1913. He went from manufacturing 100 cars a day to 1,000 cars a day and built more cars than

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his competitors with fewer workers. He also no longer needed craftsmen and was free to hire low-skill workers to work the assembly line instead. AI, though, won’t take skilled jobs away like the assembly line did, according to Prashant Jagarlapudi, director of product management at Sparta Systems (Hamilton, N.J.). “Automation and robotics will probably affect job displacement more than AI itself,” said Jagarlapudi, who specializes in product lifecycle management and software solutions. “Robotics is certainly seen as something that will displace jobs, but using AI to make decisions is not displacing jobs. It’s going to change the nature of jobs.” Jagarlapudi, in fact, suspects that AI could make medical device manufacturing jobs a lot more enjoyable. “AI-based tools can help quality and manufacturing professionals gain

insights in ways that were not possible in the past,” Jagarlapudi said. “We’re probably going to end up with more data scientists, and we’re already seeing that. Speaking to one of our medical device customers, they have data scientists on staff to help augment decision making.” Improving operational efficiency and reducing risk Manufacturers can use AI for a number of processes, including predictive maintenance and scrap production. When using it for predictive maintenance, the data being collected is about the state of the manufacturing equipment. Data scientists can then trend the data and make correlations to determine when the equipment should be serviced. AI in scrap production is looking at the equipment’s yield information in terms of how much was expected and how much the machine actually produced.

www.medicaldesignandoutsourcing.com

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AI MANUFACTURING

AI-based tools can help quality and manufacturing professionals gain insights in ways that were not possible in the past. We're probably going to end up with more data scientists, and we're already seeing that. “The goal is to improve operational efficiency. The goal is to reduce your cost of rework. You also want to be able to reduce risk,” Jagarlapudi said. “Reducing risk is an interesting one because that is not only being able to handle complaints that come from the field and using natural language processing to categorize them, but also being able to predict when things might go wrong.” The collected data helps train the machine and makes it smarter. It comes from IoT connected devices or the machines themselves. However, improperly labeled data could pose a challenge in AI models. Bad data means bad results. “We should continue to gather clean and good data from the manufacturing process and from IoT devices that we have in the manufacturing process so that we can now feed this into that algorithm,” Meléndez said. AI could also provide more shop floor mass customization — and could take custom orders to add and remove components from standard procedural trays, for example, according to Mark Bonifacio, president of Bonifacio Consulting Services (Boston). “The convergence of intelligent automation, coworking robots, AI/machine learning and IoT together will certainly be part of the manufacturing of the future and taking it to the ‘next level,’” Bonifacio said. Still a work in progress There is still resistance to adopting AI in manufacturing. With no clear policies in manufacturing, AI is still in a proof of concept phase for a lot of manufacturing processes. Another obstacle of adopting AI in medical device manufacturing is explainability. Black box models for AI might not be sufficient enough in real life productions. Being able to give clear explainability of the results of an AI engine can help people adopt more AI models in their manufacturing process, Jagarlapudi said. Despite the challenges, Bonifacio thinks AI will win a place at the table in medical device manufacturing, and manufacturing in general. “We will probably begin to see the early adopters implement some AI in larger scale.” AI is helping to drive our cars and suggesting which movies we should stream. As it moves into the manufacturing space, it could become so omnipresent that people won’t even notice it’s there, according to Meléndez. “It’s completely transformative. It’s going to become something very similar to the Internet where everything, a lot of services and a lot of what we do everyday, is connected to the Internet. We don’t even see that. We take it for granted,” Meléndez said. Said Meléndez: “I think the same thing will happen with AI. Everything is going to have a predictive algorithm at some point of the process to help us.” M 3 • 2019

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S U M M I T

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PHILLIPSMEDISIZE IS OFFERING

connected

health data services: HERE’S HOW

CH R I S N EW MAR K ER MAN AG I N G ED I TO R

One of the world’s largest medical device contract manufacturers,

Phillips-Medisize is making a business play to provide the technological back end for connected drug-delivery devices.

Image courtesy of Phillips-Medisize

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hillips-Medisize used to be all about the housings, assembly and packaging that went into finished drug-delivery devices. Electronics was something that other contract manufacturers did. Within a few years, the situation has dramatically changed. Phillips-Medisize — a Hudson, Wis.–based contract manufacturer with thousands of workers at dozens of facilities around the world — has become not only focused on connected drug-delivery devices but also on the data systems behind them. Company officials say they already have more than 25 potential customers in the pipeline for their thirdgeneration Connected Health Platform, an FDA-registered medical device data system that rolled out in October 2018. How Phillips-Medisize got into the data systems business is an example of medtech contract manufacturers adapting to an age in which every product seems to have some kind of digital or connected feature.

www.medicaldesignandoutsourcing.com

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PHILLIPS-MEDISIZE

In the case of drug-delivery devices, a number of factors came together at once, according to Kevin Deane, Phillips-Medisize’s VP of innovation. The proliferation of smartphones and IoT-based technical solutions made pharmaceutical company executives aware of what was possible. Plus, more blockbuster medicines were combination products requiring injection or inhalation devices that were easier to connect. Perhaps most important of all, there was the shift toward outcome-based reimbursement in healthcare systems in the U.S. and around the world. “If you’re thinking about outcome, you need ways to measure that your drug is effective – and also know that people are taking the drug as intended,” Deane told Medical Design & Outsourcing. Phillips-Medisize officials saw a business opportunity when it came to providing the data systems behind connected drug-delivery devices, according to the company’s CTO, Bill Welch. “The very same reason that they’re coming to us for their device combination product manufacturing is the exact same reason why they’re coming to us for this service. Focus on the drug, on the go-to-market part of it, and let service providers handle the other activities,” Welch said.

How the Connected Health Platform happened Two business deals in 2016 provided Phillips-Medisize the resources to not only become a connected drugdelivery device maker, but also a data services company. First, it purchased Medicom Innovation Partner, a development outfit in Denmark and the U.K. with a focus on connected drug-delivery devices. Within months, the Koch Industries company Molex bought Phillips-Medisize, an acquisition that gave Phillips-Medisize access to Molex’s extensive electronics manufacturing capabilities. “We’ve got that full ability to manufacture the complete device from mechanical, electronic as well as other supply chain components — and in the case of combination products, putting the drug into the device,” Welch said. “So, it’s giving you a finished, package-labeled combination product that in some cases could include electronics.” Medicom had already helped Bayer with the data platform management behind the Betaconnect autoinjector for people with relapsing forms of multiple sclerosis. The system includes a mobile app for patients and a web portal that enables specialist health providers, based on each patient’s specific consent, to review a patient’s injection history and provide support.

Image courtesy of Phillips-Medisize

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A second project with an undisclosed pharmaceutical company is in the validation stage. “If you’ve done the same thing twice, and you can see the market building in this area, it’s foolish to develop the same thing a third time,” Deane said. “It made sense to look at something that was a broader platform that we could reuse. This is the project that we’ve been working on over the last year and a half.” Avoiding pitfalls Phillips-Medisize’s Connected Health Platform has information-sharing and analytics capabilities, as well as cybersecurity and streamlined regulatory documentation. One thing Deane, Welch and others at the company consciously decided not to provide in the base package was a mobile app. “Our belief is that every application in every disease state is going to require a slightly different interface. Since that interface will then be targeted directly to the need of the patient within that disease area, it will require a separate mobile app,” Deane said. Not including the apps in the base package also allowed PhillipsMedisize to avoid a greater level of regulatory burden, since apps can involve healthcare decision-making and could be classified as a mobile medical device application. Phillips-Medisize also avoided reinventing the wheel. The foundation of the Connected Health Platform’s information-sharing and analytics comes from Cambridge, Mass.–based InterSystems HealthShare, which also counts electronic patient records giant Epic among its customers. InterSystems indicates that their technology supports the electronic health records of 500 million people around the world, with customers in more than 80 countries. “InterSystems has their business figured out: interoperability, global deployments and security. … It only made sense for us to take advantage of that,” Welch said. Patient anonymity is also an important part of the Connected Health Platform. “We’re serving the data in a secure fashion, but we’re not analyzing or manipulating that data ourselves,” Deane said.

www.medicaldesignandoutsourcing.com

3/13/19 4:10 PM

PHILLIPS-MEDISIZE

If you've done the same thing twice, and you can see the market building in this area, it's foolish to develop the same thing a third time.

Phillips-Medisize is also making the investments needed to maintain the system as it grows. “What we’ve been investing in is the service and support that is needed to deploy and maintain a system like this. The inherent challenge is synchronizing the rapidly changing mobile comms sector with the slower, but longer lasting, pharma and healthcare sector. This goes beyond just call center and technical support. We are incorporating postmarket surveillance and customer complaint handling in line with expected medical device practices,” Deane said. “And we’re being very proactive in testing new mobile OS releases and phone models against our platform and apps, continually making the changes and modifications in a way that is seamless from our customers’ point of view.” Moving up the value chain Phillips-Medisize isn’t the only company seeking to provide the technological plumbing needed to make connected drug-delivery and other medical devices work, according to Tim Gee, principal at Medical Connectivity Consulting in Beaverton, Ore. For example, Validic (Durham, N.C.) for a number of years has provided a technology platform for digital health data. “I think Phillips-Medisize saw that and decided, ‘Out of all these different areas it’s something that plays to our strengths,’” Gee said. “They’re moving up the value chain.” M 3 • 2019

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DEVICETALKS

DeviceTalks: Here's what you could be missing

Chris Newmarker | Managing Editor |

"Payers are constraining total costs per treatment episode, so we have to do all of this innovation and lower the total cost to treat per patient episode. There are a bunch of people who think that the way to do that is to make things as cheaply as possible. Product cost matters, but innovation is going to be a lot more important." – Gary Guthart, CEO, Intuitive Surgical DeviceTalks West 2018

"I think medtech is one of the most exciting areas that you can go into in engineering in general. We're looking a lot more at digital health solutions. We're looking at how artificial intelligence and data can play a role in medical devices." – Dr. Robert Greenberg, chairman, Alfred Mann Foundation DeviceTalks West 2018

Medical Design & Outsourcing

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or eight years now, DeviceTalks has featured the biggest names in medtech in an intimate, personal forum that goes beyond the typical business interview. From its humble beginnings as the Big 100 event, DeviceTalks has grown

3 • 2019

"A trend that will truly set innovation apart … is how we apply technology to health problems that remain unsolved even today. But solving the problem isn't enough – we need to add value to the equation so that physicians, hospitals and payers can capitalize on the benefit of these therapies. We're still in the early innings in terms of applying information to drive efficiency." – Michael Pederson, SVP of cardiac arrhythmias and heart failure, Abbott DeviceTalks Minnesota 2018

to involve three annual meetings in Boston, Minneapolis and California. Last year's roster was no exception. As we prepare for another exciting year in 2019, our staff looked back at some of the more memorable and insightful quotes from our slate of esteemed guests:

"When you walk in the door for the sales meeting, if you get the, 'Oh, it's too expensive, oh it's not flexible enough, oh it doesn't do enough,' turn around and walk out the door. That's not an early adopter. You need to find the customers who get the value proposition." – Reggie Groves, CEO, Reva Medical DeviceTalks West 2018

"I think ego, which is linked to insecurities, can lead to a lot of bad decisions and create a non-conducive environment, because then things can become competitive. By developing an awareness of when ego takes over, one can focus on good decisions that are in the best interests of everyone involved." – Jeff Karp, Professor of Medicine at Brigham and Women's Hospital, Harvard Medical School DeviceTalks Boston 2018

www.medicaldesignandoutsourcing.com

3/13/19 3:22 PM

Don't miss these speakers at DeviceTalks Boston 2019

SHACEY PETROVIC

SCOTT WHITAKER

President & CEO; INSULET

President & CEO; ADVAMED

KEVIN BOURQUE

JACLYN LAUTZ

VP R&D; ABBOTT

VP R&D; IVWATCH

DAVID KNAPP

VP Corporate Research; BOSTON SCIENTIFIC

DAN WETMORE

Director, Clinilar & Research Partnerships; CTRL-LABS

And stay tuned for a surprise announcement coming soon…

www.medicaldesignandoutsourcing.com

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3 • 2019

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