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6Future of Healthcare

299Managing Medical Devices within a Regulatory Framework. http://dx.doi.org/10.1016/B978-0-12-804179-6.00017-4Copyright © 2017 Elsevier Inc. All rights reserved.

CHAPTER

The Future of Health Technology Management

B.A. FiedlerIndependent Researcher, Jacksonville, FL, USA

1717.1 INTRODUCTIONWhat do consumer technology, Star Trek—the science fiction television and movie series—bioengineering, fortune-tellers, and social networks have in common? The future of health technology management (HTM)!

Still, that is a whopper of a statement. But is it true? Stakeholders are optimizing consumer technology (eg, smart phones, tablets) for medical use, bringing forth medi-cal tricorder prototypes to measure physiological functions (eg, heart rate, stress levels), 3-D printing techniques using various natural and synthetic materials to replace organs and bone, and to gather data to predict the best patient outcomes. Social networks also already help clinicians understand adherence to medication and other methods of behavior modification for patients who struggle with asthma, obesity, heart disease, depression, and posttraumatic stress disorder.

Talk to An Expert, Inc. (www.talktoanexpertinc.com) offers online therapy that is compliant with privacy legislation for patients with limited access to mental healthcare due to their remote location, physical condition, or needs that require access to consulta-tion outside of normal business hours. Of course, digital assistance is not just for patients. Doximity (www.doximity.com) offers physicians access to online peer consultations.

Take a moment to view the healthcare landscape at websites such as medGadget (www.medgadget.com), choose your software application by various device oper-ating platforms (eg, Android, Blackberry, iPad, iPhone, and Windows Phone) at Quixey Health (https://quixey.studio.quixey.com/search/health) or at iMedicalApps (www.imedicalapps.com/#), and you may find that the future is already here. An organization called Future for All offers a “layperson’s view” of medical technol-ogy development that is accessible at http://www.futureforall.org/futureofmedicine/medical_technology.htm.

Many clinical and medical device development experts, such as innovators and original equipment manufacturers (OEMs), concur that the convergence of con-sumer technology supplementing physician care will continue to stimulate extensive modifications in how and where healthcare is delivered (Kraft, 2015; KraMer and Schwartz, 2015; Satava, 2015; Schwartz and KraMer, 2015). Modifications in the healthcare system can be expected, in turn, to impact HTM.

CHAPTER 17 The Future of Health Technology Management300

Traditional definitions indicate that HTM consists of a variety of professionals (eg, clinical engineers, biomedical equipment specialists, laboratory technicians, and imaging technicians) who generally address “financial stewardship, medical technology and patient safety” (AAMI, n.d., p. 2). Their main tasks are to maintain medical devices and technologies at high performance standards through acquisition planning and procurement, preventive and corrective maintenance, and by supporting clinicians and other departments, such as information technology, with technical advice and training that contributes to increased quality of care profiles for safety, efficiency, and effectiveness (AAMI, n.d.).

The progression of personal applications and tracking systems to medical grade is expected to lead to greater access to improved patient data (Kraft, 2015; KraMer and Schwartz, 2015), voluntary submission of data gathered from personal technolo-gies (Kraft, 2015), and increased utilization of that medical device data to support positive patient outcomes and optimize valuable physician time (Satava, 2015). Even this small range of evolving methods of healthcare must be absorbed by the wide range of personnel in HTM. But this transition must overcome even seemingly easy questions such as, “What constitutes a medical device?” that has been the topic of debate for a variety of novel products. They include health and wellness products (FDA, 2015a), medical device data systems (FDA, 2015b), and personal computers and other mobiles device applications (FDA, 2015c), prompting the US Food and Drug Administration (FDA) to generate new guidance to keep pace with emerging medical devices (Kim et al., 2015).

The digital health transition from personal to medical grade tracking systems may also have to overcome more difficult obstacles to achieve a sustainable health system meeting three key attributes: (1) affordability, (2) acceptability, and (3) adapt-ability (Fineberg, 2012, p. 1020). Several obstacles to achieving these overarching objectives beyond privacy and security include (1) technologies that will not overwhelm physicians or their patients with options and data, (2) boundaries for alert notifica-tions to support staff, (3) usability for seniors, and (4) the quest for interoperability that must proceed with physician input (KraMer and Schwartz, 2015). These tech-nology leaders warn that, “If we do not address this need with innovative design solutions, patients will begin to use consumer level vital tracking systems for self-diagnosis” (KraMer and Schwartz, 2015, p. 18). They believe that halting this trend can improve on the systemic problem of patient–physician communication and reduce further declines attributed to the digital health phenomena.

Thus, active participation of diverse stakeholders contributing to device innova-tion is widening the playing field for HTM to incorporate more people, products, processes, and performance into the clinical workflow. Dr. Satava, Professor Emeritus of Surgery at the University of Washington, points to some problems that could be remedied. For example, many surgeons are required to dictate operative reports despite the capacity of robotic surgical units to record, collect, and potentially report more precise material (Satava, 2015). This and other problems relating to optimizing existing systems represents another important aspect of innovation for HTM that is also linked to IT collaboration. In this case, stakeholders must combine their

17.2 Emerging Technologies: Seeing the Future Now 301

understanding of how innovative technology creates new forms of data driving con-nectivity, data standards, and quality of information, which must be generated, main-tained, and more easily retrieved by users. Therefore, interoperability (Fineberg, 2012) introduces a burgeoning scope for HTM within a thriving innovative medical device environment, contributing to the evolution of healthcare that will undoubtedly continue to redefine the profession.

Many researchers and clinicians believe that optimizing existing information and new ways to access and analyze real-time patient behavior will promote better treatment options for patients with similar comorbidities and characteristics. Some practitioners also suggest that these aspects may provide the biggest leap from evidenced-based medicine to practice-based medicine (Kraft, 2015; Satava, 2015). Evidenced-based medicine is the practice of qualified personnel who use a reputable scientific research method for evaluating medical devices, pharmaceuticals, and procedures, resulting in the accumulation of acceptable research evidence from which to base a decision on existing or newly introduced alternatives. Practice-based medicine is a clinical treatment option decision-making process utilizing stored patient information from others with the same condition, genotype, and/or pharmaceutical regimen (Kraft, 2015).

In this introduction we have hinted at the evolution of HTM. In the remainder of this section, we introduce some areas of technology development that is impacting healthcare, HTM, and the paradigm shift towards practice-based medicine: mobile technology, cloud computing, and bioengineering. Then, we take a glimpse at emerging technologies, such as remote patient monitoring systems, how smart phones and tablets are driving an application-based information economy, and the impact of biomaterials on technology development. Next, we review how planning medical device development, incorporating both old and new design methods, can improve clinical outcomes, leading to coveted federal funding and quicker paths to marketing and reimbursement. Finally, we summarize the important topics that were discussed in the manuscript.

In so doing, we do not negate the scope of the unpredictable and disruptive nature of medical technology development and implementation, but instead concede that this arena can be characterized in light of many other elements. Some important challenges in HTM, such as securing and managing new technology, are discussed elsewhere. The emphasis here is on how the effect of individual consumer devices and their cumulative contribution can have far reaching impact on multiple aspects of healthcare, the healthcare system, and personnel from a wide range of stakeholders.

17.2 EMERGING TECHNOLOGIES: SEEING THE FUTURE NOWEmerging technologies provide a glimpse into the future of healthcare and HTM. What we see is a local uptick in remote patient monitoring (RPM), an application-based information economy, and a boom in biomaterial development. Clearly, a key to unlocking “future” technology is resolving how to transition local solutions to


wide-scale applications evident in the push for electronic medical records (EMRs) and the ongoing quest for secure access, transparency, and interconnectivity.

17.2.1 REMOTE PATIENT MONITORINGAccording to the Center for Connected Health Policy (http://cchpca.org/remote-patient-monitoring), RPM collects medical and health information from patients using digital technologies at home or other places away from traditional medical facilities (eg, doctor’s office, clinic, hospital), then securely transmits the electronic information to healthcare providers located elsewhere. They, in turn, access, assess, and recommend treatment based on the information. Tracking and reporting vital sta-tistics and other information through RPM for the aging population and/or patients with a variety of conditions and comorbidities (eg, chronic obstructive pulmonary disease, heart failure, and diabetes) is becoming a cultural mainstay to reduce costly emergency room visits and payouts for more expensive devices. Devices that use sen-sors to track blood oxygen saturation levels and other vital signs, such as Samsung’s SimBand (www.simband.io), offer cost efficiencies because they run on inexpensive software applications appealing to consumers, caregivers, and payers (KraMer and Schwartz, 2015).

Information Week reports a wide variety of RPM devices are hitting the mar-kets or are close to FDA marketing approval. They include the Touch-free Life Care System (TLC) sensor mat from BAM Labs (www.bamlabs.com) that is able to wirelessly monitor sleep patterns and breathing rate, Watermark Medical Sleep-Quest products (www.sleepquest.com/) that are used to diagnose obstructive sleep apnea, and wireless technology, such as Air Strip Sense4Baby (http://www.airstrip.com/fetal-monitoring), that monitors high-risk mothers and the fetus’s heart rate. These also serve as examples of the wide variety of methods that data is captured and viewed. For example, the TLC sensor is positioned under the patient’s bed and data is streamed through an Internet connection. Watermark Medical products have the capacity to record and store multiple nights of sleep events, helping to create a more comfortable environment and to reduce the high-cost clinical observation due to an overnight hospital or laboratory stay. Finally, the Sense4Baby data is collected and directed to physicians through a cloud-based web connection (Rudansky, 2013).

Portable medical technologies and the medical device ecosystem they are cre-ating are not only increasing RPM demand, but opening the door wide for cloud computing. The National Institute of Standards and Technology (NIST) provides a definition of cloud services, including a variety of specific characteristics, service models to position the technology, and deployment models (NIST, 2011).

Cloud computing is a model for enabling ubiquitous, convenient, on-demand net-work access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.

NIST (2011, p. 2)


Several reasons point to the explosion of remote data storage accessible by the Internet being marketed by Microsoft Cloud applications and many others (see Bort, 2013 for more information on leading companies and three types of cloud computing). They include the benefits of remote locations versus local storage that reduce the risk in disaster management and security breach at nominal cost by eliminating prohibitive capital investments in hardware and personnel, especially for small medical offices, to monitor the large amounts of data being accumu-lated from digital devices (Koptykoff, 2012).

Digital information and cloud computing are also driving innovation in other areas. For example, Bioniq Health, Inc. (www.bioniqhealth.com/about), a newly formed venture source for comparing the latest digital technology, will also provide physicians with a platform to prescribe connected health services (Kraft, 2015). “In the near future I may ‘prescribe’ you exercise with a ‘Fitbit’ or others most relevant to the patient, or a BP Cuff to help manage your hypertension,” according to Bioniq co-founder Dr. Daniel Kraft in a www.techcrunch.com interview at the 47th Annual Consumer Electronics Show held in Las Vegas in 2014.

The onslaught of information being generated in the age of digital health is quickly changing the familiar adage “location, location, location” to “data, data, data.” Many would say, “And more of it,” leading to the question of, “Once we have it, what can we do with it?”.

17.2.2 APPLICATION-BASED INFORMATION ECONOMYResearchers from Harvard Medical School and Boston Children’s Hospital believe that healthcare data, driven by a boom in funding for health information technology (HIT), EMRs, and digital health, is prompting the move towards open software interfaces. They suggest that “these interfaces could lead to improved healthcare by facilitating the development of software applications (apps) that can be shared across physicians, healthcare organizations, translational researchers, and patients” (Mandl et al., 2015, p. 1). In short, the interfaces create a path for data access through software application development, fulfilling the need for new point of care models for the increasing number of homebound patients.

Challenges, such as patient privacy and data accuracy through secure channels, indicate that the path is not exactly clear, as a variety of stakeholders contend with the “largest source of individual health data…from sensors or information about a person continuously for days or even years” (Mandl et al., 2015, p. 2). Overcoming patient privacy is a major hurdle to access to private medical information. However, the unprecedented amount of personal medical data has brought forth methods to overcome patient privacy. For example, the application of “data donors” (Kraft, 2015), similar to the consent-based, volunteer organ concept already widely in use, is emerging in the healthcare landscape. However, subject matter experts (SMEs) indicate that the influx of unregulated data without global standards to ensure accuracy represents a systemic and continually expanding problem in health data management that is not as easily traversed (Mandl et al., 2015; Redmond et al., 2014).


Nevertheless, application programming interfaces (API) that facilitate interoperabil-ity with cloud computing, physician access to EMRs, or patient access to their medical information can facilitate the push toward data standards and accuracy (Mandl et al., 2015) [see Mandl et al., 2015 for resources on App Builders for clinical data such as SMART API (http://docs.smarthealthit.org/), Validic API for normalizing data from digi-tal health and fitness devices (http://validic.com/api), and others for medical research and purchasing HIT systems]. Further, mobile access computing and reporting innovations riding the wave of digital health can also change the notion of how we collect and analyze data for clinical trials, postmarket surveillance, and practice-based medicine. The boost in knowledge sharing and knowledge management may be the commodity to make the sweeping changes necessary in the health system, healthcare system, and HTM.

17.2.3 BIOMATERIAL DEVELOPMENTInnovative materials have been created and used in medical device development to address unmet medical needs for decades. Modern twists on conventional biomaterial (stable and biologically inert materials such as oxide ceramics, titanium alloys, and acrylic polymers) has brought forth wearable robotics and exoskeletons developed by Ekso Bionics in Berkley, California (www.eksobionics.com), to enhance the func-tion of paralyzed limbs. But the future of biomaterial development merely includes this incredible innovation (Fig. 17.1). Today, new medical technology materials are expanding possibilities and bringing forth alternative solutions to the systemic

FIGURE 17.1

Healthcare solutions are expanding traditional boundaries of care to include exoskeleton technology and beyond.

Drawing used by permission-Olivia Grace Adams.


problems inherent in the existing reliance upon donated transplant tissue and biocom-patibility between implant technology and human tissue.

However, the materials revolution is most evident in regenerative medicine where “self-assembled, nanoscale materials rather than conventional engineering materials” (Williams, 2011) are the building blocks and architects of new tissue. Thus, regen-erative medicine (eg, synthetic biology, tissue generation, stem cell) is the utilization of biomaterials that are able to induce the human body to self-restoration (Williams, 2011). The biggest difference between implant technology comprised of conven-tional biomaterial restoring human functionality (eg, pacemakers that restore heart rhythm) and regenerative medicine is that the latter offers solution to unmet medical needs (eg, Alzheimer’s, diabetes) through mechanisms that “restart” tissue develop-ment realized in fetal growth (Williams, 2011).

Of course the progress of regenerative medicine comes with major challenges, a large portion of which involve industry regulation in a novel arena. “Engineered life forms…pose [unknown] risks to human health and the environment” (Mandel and Marchant, 2014, p. 157). “Exactly what those hazards are and how they might be controlled cannot be fully determined in advance of the very research necessary to develop this novel science in the first instance.”

Though product development is governed through the FDA following various legislative acts [eg, Federal Food, Drug, and Cosmetic Act of 1938; 1976 Medical Device Amendments, Safe Medical Device Act (SMDA) of 1990, SMDA Amendments in 2002], material development is largely governed by voluntary consensus standards. The consensus standards are written by organizations such as American Society for Testing and Materials (ASTM) and the more readily recognizable International Standards Organization. Notable is that consensus teams are comprised of a variety of stakeholders with SMEs that guide the industry with the same goal of improving clinical outcomes under standards of medical ethics.

Table 17.1 provides several online accessible portals for material standards. For example, material standards for acrylic bone cement used in prosthetic implants can be found in ASTM F453, while mechanical testing methods for rubber proper-ties in tension or compressive properties of rigid plastic are found in ASTM D412

Table 17.1 Organizational Resources for Material Standards

Organization Website

American Dental Association (ADA) www.ada.orgAmerican Society for Testing and Materials (ASTM)

www.gsa.gov/portal/content/101059

ASTM International www.astm.orgAmerican National Standards Institute (ANSI) www.ansi.orgAssociation for the Advancement of Medical Instrumentation (AAMI)

www.aami.org

International Standards Organization (ISO) www.iso.org


and ASTM D95M, respectively (Brown et al., 1999). Other ASTM standard guides include biomedical and tissue-engineered medical product applications for specific starting materials such as hyaluronan, ASTM F2347-15, and other healthcare and medical device standards accessible at http://www.astm.org/industry/health-care-and-medical-devices-standards.html.

“Hyaluronan (hyaluronic acid) is a high-molecular-mass polysaccharide found in the extracellular matrix, especially of soft connective tissues, [that] is synthesized in the plasma membrane of fibroblasts and other cells by addition of sugars to the reducing end of the polymer” (Laurent and Fraser, 1992, p. 2397). One of the applications is a treat-ment called viscosupplementation for patients that suffer from osteoarthritis in the knee. In this instance, the substance is injected into the knee joint to supplement synovial fluid (ie, natural fluid lubricant in the human body) when other treatment options, acetamino-phen regimen or physical therapy, fail to reduce pain or restore motion.

The Federation of American Societies for Experimental Biology (FASEB) (www.faseb.org), comprised of 30 scientific societies, is a policy advocate and rich resource for the bioscientist community. FASEB reports that their membership is the largest body of biological and biomedical researchers providing education and publication opportunities for innovative developments spanning bioengineering to women’s health.

17.3 PLANNING MEDICAL DEVICE DEVELOPMENTThe complex healthcare system struggling with a shortage of clinical professionals (eg, nurses, physicians), transitioning electronic records, and dynamic regulatory changes must also address the aging patient population who require services close to home and/or at home. This, in turn, influences the planning and development of new medical devices intended for use in environments outside established medical venues for clinical care. Despite the optimism that leads to the feasibility of a global “digital doctor bag” filled with items previously only available at the physician’s office (Kraft, 2015), the element of “when” seems to be the pivotal problem in a room filled with an overdose of who, what, why, where and how.

One area where timing is a bone of contention is the US regulatory process. Though there have been delays to the US market for many items approved in the EU with various thoughtful positions supporting both sides of the argument, we consider the 2013 surgery in which a patient received a biocompatible implant comprised of poly-etherketoneketone to replace 75% of his skull. Oxford Performance Materials (OPM), at http://www.oxfordpm.com/cmf-orthopedics, a Connecticut-based medical device innovator, utilized 3-D printing and materials that were osteoconductive, capable of stimulating bone growth (Hayhurst, 2014). Impressive, but the successful surgery prompts some pause for two reasons: (1) the OPM technology had been applied in the EU a year prior to the US procedure, and (2) the problem of translation scanning data from technology, such as MRI and computed tomography (CT), to 3-D printers suggests that HTM may be increasingly called upon to resolve difficulties that may presently be out of their expertise. The problem was prominent in the skull replacement

17.3 Planning Medical Device Development 307

surgery. Understanding the “when” here is twofold: (1) regulatory variance in time to market is going to occur as a normal part of the process, and (2) HTM must learn methods to optimize the delays in technology transition to the US, which can help prepare them for their future duties now. We suggest two methods in the next sec-tion, (1) gaining greater awareness of both existing and innovative design methods to improve clinical outcomes, and (2) increasing access to federal funding and reimburse-ment paths, to reach the objective.

17.3.1 DESIGN METHODS TO IMPROVE CLINICAL OUTCOMESHTM personnel can deploy some fundamental guidance to gain insight into the direc-tion of their morphing craft, beginning with addressing their likely increase in activity related to medical device design. Understanding where to obtain information leads to the first proposed HTM objective: never underestimate what has come before. Insight into the conduct of a systematic literature review and a list of medical literature data-bases, such as those found at the George Washington University (GWU) Medical Center (ie, Himmelfarb Health Sciences Library at http://libguides.gwumc.edu/c.php?g=27797&p=170444), provides a starting point. Note that GWU recommends several databases, but they may not be directly accessible unless you have certain access rights. However, some quick searches on the name of the database can yield more user-friendly locations and offer direct access to information (ie, PubMed at http://www.ncbi.nlm.nih.gov/pubmed). Two other methods will help gain access to information. First, contact the reference librarian of your alma mater for assistance; second, request funds to be allocated to your department budget for membership/per fee access to prominent literature databases.

Literature unveils how the product development process (PDP) incorporates business process modeling, flowcharts, and the unified modeling language (UML), representing a foundation for comprehending process modeling (Santos et al., 2012). In turn, process modeling helps to understand the gaps in existing design methods. “Clinical and biological contexts often drive both customer and design requirements, and similarly, can impose significant restrictions on the set of viable engineering solutions” (Hagedorn et al., 2015, p. 218). Given the importance of incorporating this observation, formulating a formal method to “facilitate the inte-gration of medical knowledge and an understanding of clinical practice and environ-ments into the design process” (Hagedorn et al., 2015, p. 218) is important to the filling the gaps between stakeholder objectives.

Researchers at the University of Massachusetts use UML and PDP to introduce a formal method to exchange knowledge between the medical and the engineering communities demonstrated through a case study on fat grafting (Hagedorn et al., 2015). What is significant in this example is the use of Systemized Nomenclature of Medicine, Clinical Terms (SNOMED-CT), a language developed by the College of American Pathologists in 2003 to codify clinical data that identifies the proce-dures, substances, and body structure. The researchers also incorporate functional basis ontology to illustrate the procedures and functional models for grafting that


supplement the existing codes. This particular study was selected to demonstrate how HTM can utilize existing coding structures obtained from the National Library of Medicine’s Universal Medical Language Systems at https://www.nlm.nih.gov/research/umls/.

The University of Massachusetts research team used SNOMED-CT medical lan-guage knowledge in engineering design to “construct models that aid in [repeatable] concept development and innovation in the medical realm [permitting] rapid creation of detailed functional models based on a pre-defined [sic]understanding of how a procedure is carried out” (Hagedorn et al., 2015, p. 229). Understanding domain-specific knowledge, such as clinical terminology, is important to research, clinical decision-making process, and interoperability. The application of clinical terminology may also inform other device communication problems, as in the earlier example of generating operative reports from robotic surgical units. Thus, HTM personnel could benefit from an introductory course in existing coding structures, physiology, and business modeling procedures to gain a better understanding of clinical needs and to generate a path to data utilization between man and machine.

Next, never underestimate patient and clinical safety. Developing new ways or optimizing old ways in a new environment to reduce the risk in the application of medical devices is an important consideration for HTM and the healthcare community at large. Researchers in the UK, the Netherlands, and Italy introduce the concept of “safety cases” derived from safety-critical industries (eg, nuclear, air traffic, railways), highlighting the need for medical device developers and HIT to address systemic safety concerns attributed to medical devices. Here, the underlying concern is to overcome the misconception that clinicians and other stakeholders have access to the OEM’s risk management file (RMF) results. They discuss how OEM requirements to share the RMF with clinicians and clinical support personnel can help quantify risks for particular devices by identifying important hazard and risk parameters for their particular device. To overcome this problem, they suggest that, “safety cases have the potential to provide greater transparency and confidence in safety certification and to act as a communication tool between manufacturers, service providers, regulators and patients” (Sujan et al., 2013).

The Clinical Safety Case is an argument, supported by a structured body of evi-dence, in the clinical risk management file, that provides a compelling, compre-hensible and valid case that a system for deployment and use is, as far as the clinical risk management process can realistically ascertain, free from unaccept-able clinical risk for its intended use.

Sujan et al. (2013)

(See Sujan et al. (2015) for examples of the application of safety cases for healthcare services).

In line with safety, never underestimate the value of simulation, not just in surgi-cal or flight training, but in medical device design and the development of methods to successfully integrate full functionality of novel equipment. The echo of “see one, do one, teach one” in traditional surgical training is shifting to “see one, sim one,

17.3 Planning Medical Device Development 309

sim one, sim one until you get it right” (Kraft, 2015). Simulation offers long-term benefits in modeling patient reaction during a simulated surgical procedure, but can also safely view the interaction and impact of multiple layers of medical device tech-nology and the capacity to complete extended activities beyond the actual procedure. In short, simulation should not stop short of the surgical activity, but envelop many of the various environmental considerations inherent in the environment of care from multiple perspectives. That includes residual duties of surgeons who must dictate an operative report and those of HTM who must maintain equipment.

Finally, never forget that someone has to pay for all of this! This leads us to the next section on increasing access to funding that relieves some of the financial risk in medical device development and may pave the way to reimbursement.

17.3.2 INCREASING ACCESS TO FEDERAL FUNDING AND REIMBURSEMENT PATHS

Money makes the world go round. We may not like it, but without funding, innovation can come to a hard stop in the medical device community at the front end of research and development (R&D). The back end of R&D reimbursement is also important to the success of innovative companies. Thus, the capacity to identify, create, and implement new codes for novel technology so that OEMs and physicians can get paid for their product or services is dependent on organizations in the US, such as the FDA Centers for Medicare and Medicaid Services, to make informed and more rapid reimbursement decisions. A new division of the Center for Devices and Radiological Health (CDRH) and growing awareness of opportunities to optimize existing facilities and funding at organizations, such as the Defense Advanced Research Projects Agency (DARPA), can help to expedite safe development and speedier reimbursements that can keep innovative device companies in business.

The introduction of regulatory science knowledge sharing at the CDRH offers one method to facilitate the speed of development and reimbursement. Improving efficiencies in the regulatory approval process and thus, expediting the reimburse-ment process, is a goal of the newly founded Medical Device Innovation Consortium (MDIC) at the CDRH. The MDIC, comprised of stakeholders from industry, FDA, and nonprofits, introduced a precompetitive phase in medical device development in which clinical chemists, clinical laboratory scientists, and other SMEs contribute to development (Kampfrath and Cotten, 2013). “The pre-competitive phase functions to solve technical issues related to safety and effectiveness on behalf of the entire medical device community” (Kampfrath and Cotten, 2013, p. 1320). An annual fee for MDIC membership (www.deviceconsortium.org) will offer access to shared resources and results that may appeal to stakeholders short on funding or those with-out access to specialized personnel to conduct required testing.

DARPA is another overlooked avenue for funding assistance in the medical device community. Dr. Satava, who served 23 years as a combat surgeon in the US military and 14 years at DARPA, offers some key advice for those seeking federal funding: first, do not waste time submitting clinical trial (CT) proposals to DARPA


because they are legally unable to participate in a CT, and second, learn to speak in the language of program managers (Satava, 2015). In this instance, program managers are more likely to grasp the relevance of your proposal if submissions contain language that is most familiar to them. Dr. Satava indicates that including recognizable information on the “level of technology readiness” is important to this process (Satava, 2015).

MDIC and DARPA serve to highlight the value of collaboration in untapped personnel and financial resources. But they are also important because they dem-onstrate how taking the time to conduct a keyword database search for relevant literature, webinars, and other resources can extend the understanding of multiple stakeholders and develop new insight for the future of HTM.

17.4 SUMMARYIn summary, this chapter has introduced the far-reaching implications of the impact of consumer technology on the health system, healthcare, and HTM. We empha-size how the digital health transition from personal to medical grade tracking systems serves as a conduit to understanding the relevance of developing collabor-ative strategies to keep abreast of dynamic changes that blend divergent approaches into a common sensibility for communicating accurate medical data. In the process, we provide examples of emerging technology, regenerative medicine, and a general overview of methods in which patient data is captured, viewed, and shared. Together, these notions brought forth suggestions on how HTM can better position itself for the future. First, learn from the past by accessing other resource options that expand your knowledge base and optimize existing information, and second, create your own future by turning seemingly negative delays in technology use in one health system into learning opportunities to resolve medical technology problems in another.

CASE STUDY: STAGNANT MEDICAL DEVICE INNOVATION FOR WEIGHT LOSS PUSHING DIGITAL ALTERNATIVES?Obesity, literally a growing public health problem in the US, faces challenges in the development of medical devices and/or medical technology to address the problem. To date, only two of three medical devices approved by the FDA under the Class III Premarket Approval regulatory pathway are still available to consumers (Lerner et al., 2013). They are the Allergan LAP-BAND Gastric Banding System (Allergan, Inc., of Irvine, CA, at www.allergan.com) and the Realize Gastric Band (Ethicon Endo-Surgery, Cincinnati, OH, at www.ethicon.com).

While the FDA has proposed a benefit–risk paradigm for the clinical trial design of obesity devices to “help industry assess the anticipated risk of their devices and to size their study better so that the data will be sufficient for a regulatory decision” (Lerner et al., 2013, p. 706), there remains a limited number of alternatives to obesity other than surgical procedures that alter the gastrointestinal anatomy. Few, if any, address the long-term sustainability of weight loss for the target population.

While medical device developers chew on the possibility of addressing the needs of this mar-ket, what else is on the horizon for this patient population? Introducing a nonsurgical, smartphone

311Definitions

application enhanced solution, HAPIfork (www.hapi.com). This widget is an actual fork designed to help the user eat more slowly in order to reap the health benefits of enhanced digestion, reduction in gastric reflux, and feeling satisfied without overeating (Fig. 17.2).

HAPIfork can work independently as a timing monitor while users thoroughly chew their food, or they will experience an alarm if they take another bite before the appropriate time has elapsed. How-ever, HAPIfork can be linked through Bluetooth to a smartphone app using iOS or Android platforms. Together, they allow users to collect data on the duration of meals or the number of fork servings (ie, times that the fork has entered the mouth). The organization also provides an online dashboard to set goal, track progress, and manage meal statistics (see more information at www.slowcontrol.com).

DEFINITIONSApplication-based information economy Recognition of the inherent value software appli-

cation development using open interface solutions to remedy the variance in operating system platforms that cause problems with data exchange.

Biomaterials Stable and biologically inert materials used in implant technology; growing field of materials in regenerative medicine (bioengineering).

Chronic obstructive pulmonary disease (COPD) A long-term medical condition effecting lung function.

FIGURE 17.2

HAPIfork is a consumer electronic Bluetooth-enabled mobile application for weight management.

Photo used by permission, HAPILABS Ltd., at www.hapi.com.


Evidence-based medicine Practice of qualified personnel who use a reputable scien-tific research method for evaluating medical devices, pharmaceuticals, and procedures, resulting in the accumulation of acceptable research evidence from which to base a decision.

Fat grafting Common method of removing fat tissue from parts of the body (eg, belly, thighs, buttocks) where excessive fat may be stored through a liposuction process, and then trans-ferring processed fat to another area, such as the breast, for reconstructive or other surgery; also called autologous fat transfer.

Hyaluronan (hyaluronic acid) Naturally occurring substance found in the soft, connective tissue in the human body and is often injected as a joint lubricant.

Interoperability The ability of one system (eg, simulator, medical device) to facilitate the exchange information and otherwise communicate with another system (ie, cloud computing enhances interoperability by facilitating the exchange of data from patients using digital devices to caregivers who can access that information from another location).

Ontology Developing branch of medicine derived from metaphysics that studies the problem of existence to reveal properties of disease; method to identify root cause of disease.

Osteoconductive Capable of stimulating bone growth.Osteoarthritis A common form of arthritis also known as degenerative joint disease; the

condition results from wear of joint cartilage causing exposed bone to rub against bone.Practice-based medicine A clinical treatment option decision-making process utilizing stored

patient information from patients with the same condition, genotype, and pharmaceutical treatment.

Regenerative medicine The utilization of biomaterials/bioengineering that is able to induce the human body to self-restoration through mechanisms that “restart” tissue development realized in fetal growth; associated with stem cell, synthetic biology, and tissue generation to overcome obstacles in organ transplant and implant technology that uses traditional biomaterials such as titanium alloys.

Remote patient monitoring Uses digital technologies to collect medical and health data from patients in environments that are external to typical medical facilities, such as hospitals, clinics, or a doctor’s office, and electronically transmits the information through secure networks where health care providers can access, assess and make recommendations based on the information.

Synovial fluid The natural fluid in the human body that lubricates joints to reduce the negative impact of friction.

Viscosupplementation Treatment process where natural fluids in the knee are supplemented by hyaluronic acid injections to relieve pain and increase motion in patients with osteoarthritis.

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