Category: Health and medicine

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The impact that pediatric medical devices have on the world of healthcare

Pediatric medical devices are used in treating or diagnosing conditions and illnesses from birth to the age of twenty-one. There is an extensive range of pediatric devices ranging from imaging machines to tongue blades. While a number of products are designed particularly for children, other products are borrowed from adult applications or are made for more general utilization (Samuels-Reid & Blake, 2014).

This paper provides an exhaustive evaluation of the way in which pediatric medical devices in health care have changed over time. The paper also provides an analysis of the extent to which pediatric medical devices have affected the diagnoses in healthcare. Furthermore, this paper provides an assessment of how target markets have changed with pediatric medical devices.

Medical devices essentially include the items which are utilized in diagnosing, curing, mitigating, treating, or preventing a disease. There is an extensive assortment of medical devices ranging from simple tools such as surgical clamps and bandages to complex ones such as pacemakers. Pediatric patients are amongst those a medical device is designed to treat and include persons aged from birth to not more than 21 years (United States Government Accountability Office, 2016).

Designing medical devices for paediatrics could be difficult. This is because children are by and large smaller and more active compared to adults, their functions and body structures change during childhood, and children might actually be long-term users of medical devices which brings new concerns with regard to longevity of device and lasting exposure to implanted materials (Field & Tilson, 2015).

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Pediatric medical devices in healthcare have changed over time

The history of pediatric medical devices in healthcare is fascinating in terms of how advancements have been made over time to address the unmet needs of paediatrics. As more children continued to suffer from illnesses, medical device manufactures started to make pediatric medical devices that are tailored to youngsters and babies. These devices were vital for improving not just health, but also the quality of life for babies and young people (Zimmerman & Strauss, 2010).

From the 1930s through to the 1940s and 50s, adult respiratory intensive care units (ICUs) were set up for the purpose of battling the blight of the polio outbreak with iron lung ventilators. These respiratory intensive care units, out of necessity, also cared for pediatric patients who had the polio disease (Epstein & Brill, 2012).

In their newly created neonatal ICUs, neonatologists developed procedures for environmental and nutritional support for premature toddlers and sick babies along with ventilation methods and monitoring for the treatment of respiratory distress syndrome, which is also commonly called the hyaline membrane disease. It is worth mentioning that the understanding and utilization of the surfactant and continuous positive airway pressure mechanical ventilation improved to a great extent the survival of babies with hyaline membrane disease (Downes, 2013).    

In the 1960s, advancements in pediatric congenital heart surgery resulted in a need of developing intensive care units and devices for providing complex postoperative care. This need was accelerated by the introduction of cardiopulmonary bypass for repairing congenital heart lesions. The first pediatric ICU medical devices were developed by Goran Haglund in the year 1955 and utilized in Europe at Children’s Hospital of Gotenburg in the northern European nation of Sweden (Samuels-Reid & Blake, 2014).

In 1967, John Downes opened a pediatric Intensive Care Unit at Children’s Hospital of Philadelphia, which had a few pediatric ICU devices. Over the next 4 decades, hundreds of pediatric Intensive Care Units were established in many community hospitals, children’s hospitals, and academic institutions across Europe and North America. By 1995 for instance, there were about 306 general pediatric intensive care units in America with pediatric medical devices and that number rose to 349 in the year 2001 (Waugh & Granger, 2011).

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John Gibbon at the Jefferson Medical College Hospital in the state of Philadelphia in the year 1953 carried out the world’s first open heart surgical operation on an infant using the total cardiopulmonary bypass machine that he had designed and developed. Prior to that surgery, adolescents and babies who had congenital heart disease were considered inoperable or they were treated with closed heart surgery (Epstin & Brill, 2012).

In 1938 at Children’s Hospital in Boston, Robert Gross carried out the very first ligation of a patent ductus arteriosus in a young child aged 7 and in 1944, he repaired an aortic coarctation. Still in the year 1944, Swedish professionals Nylin and Craafort carried out a repair of an aortic coarctation (Downes, 2013). In the year 1945 at Johns Hopkins Hospital, Vivien Thomas and Alfred Blalock conducted an extracardiac shunt between the ipsilateral pulmonary artery and the subclavian artery in an infant girl aged fifteen months with tetralogy of Fallot (Epstin & Brill, 2012).

These procedures, in addition to the introduction of cardiopulmonary bypass, served to revolutionize the treatment of heart disease in children and in fact stimulated the development of pediatric cardiac ICUs and medical devices, and helped to improve perioperative care. Noninvasive Mechanical Ventilation was initially introduced during the late 1980s for pediatric patients who had nocturnal hypoventilation (Cheifetz, 2013).

Noninvasive Mechanical Ventilation uses a mask placed over the mouth and/or nose or prongs which are inserted into the nares in order to provide positive pressure ventilator assistance. Either continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) which produces differing expiratory and inspiratory positive airway pressures might be utilized (Epstin & Brill, 2012).

Noninvasive Mechanical Ventilation is utilized in augmenting impaired respiratory effort in various illnesses and conditions such as congestive heart failure, asthma, neuromuscular disorders, and cystic fibrosis. In treating adolescents and babies who have hypoxemic respiratory failure with Noninvasive Mechanical Ventilation, professionals have found low incidence of intubation and improvement in dyspnea, ventilation, and oxygenation (Cheifetz, 2013).

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The other respiratory-assist, noninvasive pediatric medical device which has become more and more popular lately is the humidified, high-flow gas that is delivered to the infant through a nasal cannula. In essence, 1 unit of the Vapotherm 2000i delivers about 40 L/min of gas flow with over ninety-five percent humidity (Waugh & Granger, 2011). The high humidity serves to increase comfort at the higher levels of gas and prevent nasal mucosal drying.

In principle, the high-flow system generates continuous positive airway pressure. It is worth mentioning that this device – the high-flow nasal cannula – has been utilized in babies who are premature in order to prevent apnea of prematurity and generates the same distending pressures as nasal continuous positive airway pressure. This pediatric medical device became highly popular owing to its anecdotal success as well as comfort because of subjective improvement of respiratory distress and prevention of intubation of teenagers, children and babies who have respiratory difficulties (Sreenan et al., 2011).   

Many children and infants who are severely sick require mechanical ventilation and endotracheal intubation for cardiorespiratory failure or postoperative care. The first mechanical ventilation was designed and developed in the year 1910 by Sievers and Lawen. This ventilator provided negative and positive pressure through a piston cylinder. Iron lungs were the next mechanical ventilators. They were negative-pressure, electrically powered body tanks which were utilized widely for polio pediatric patients in the 1920s, 30s, 40s and even 50s (Downes, 2013).   

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Modern mechanical ventilators utilize computers in providing various ventilation modes – volume versus pressure –, to synchronize with the ventilator effort of the patient, and to adjust patterns of inspiratory flow in order to improve gas flow distribution. Initially conceptualized in the year 1972, High-Frequency Oscillatory Ventilation (HFOV) is popular in the treatment of refractory to conventional ventilation in children and babies (Lunkenheimer et al., 2011).

This pediatric device basically delivers a tidal volume not more than the dead space volume at a rate of over a hundred-and-fifty breaths every minute and a higher mean airway pressure (Cheifetz, 2013). High-Frequency Oscillatory Ventilation maintains an open lung but avoids large pressure changes and phasic volume, which minimizes the cyclical stretch of the pediatric patient’s lungs and ventilator-induced lung injury.

Researchers have reported that using High-Frequency Oscillatory Ventilation in the first twenty-four hours of mechanical ventilation decreases the mortality by 47 percent compared with its use after twenty-four hours of mechanical ventilation (Fedora et al., 2010). Moreover, using High-Frequency Oscillatory Ventilation has been shown to improve oxygenation and survival by eighty-nine percent in children without increasing the risk of air leaks and pneumothorax. On the whole, the HFOV pediatric medical device has helped to improve mortality in children and babies, although its efficacy has not been proved in premature babies.    

Ventricular Assist Devices (VADs) are utilized in pediatric patients with heart failure. Matsuda and Matsumiya (2012) noted that ventricular assist devices are utilized in patients who have cardiomyopathy with heart failure or severe cardiogenic shock as a bridge to recovery or to heart transplantation. These devices are attached surgically to the failing ventricle with an implantable or extracorporeal pneumatic or electric pump which brings about improved blood flow.

In essence, Ventricular Assist Devices allow for improved quality of life and mobility in adolescents and babies who have failed medical management for their heart failure (Goldman et al., 2013).  

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Extracorporeal Life Support (ECLS) pediatric medical device was first employed in the year 1976 in children and babies who had postoperative cardiac failure, persistent fetal circulation, massive meconium aspiration and infant respiratory distress syndrome (Bartlett et al., 2010). This device supports a pediatric patient in circumstances in which the respiratory and/or cardiac disease cannot be medically managed through conventional means and ensures sufficient tissue oxygen delivery for supporting end-organ function.

It is notable that Extracorporeal Life Support involves surgical placement of cannulae into a main artery or vein for veno-arterial Extracorporeal Life Support, or only a main vein for veno-venous Extracorporeal Life Support (Bartlett et al., 2010). In children and older babies, Extracorporeal Life Support has been utilized for support during very serious sepsis, Acute Respiratory Distress Syndrome, or cardiac failure because of cardiomyopathy/myocarditis, hemodynamic instability following congenital heart surgery palliations/repairs, and at times as a bridge to heart transplant (Walker, Liddell & Davis, 2014).

The survival rates for Extracorporeal Life Support pediatric medical device for patients who require cardiopulmonary resuscitation is sixty-four percent in youngsters who have cardiac arrest following open-heart surgery and sixty-one percent in newborns without congenital heart disease (Chen et al., 2011).     

Pediatric patients are of many different sizes, ranging from over 100 kilograms to less than 1 kilogram. This creates the need for a wide range of bronchoscopes, endotracheal tubes, catheter sizes, in addition to other pediatric medical devices. Pediatric critical care would today not be possible without the development of size-appropriate pediatric medical devices.

Prior to the 1950s, Shann, Duncan and Brandstater (2013) noted that endotracheal tubes were made with the use of rubber or metal material. Introduced during the ‘50s, plastic polyvinyl chloride endotracheal tubes become less rigid at body temperature and they soften. They are also less probable to bring about subglottic stenosis. When smaller-sized uncuffed and cuffed endotracheal tubes were developed and introduced into the marketplace, prolonged intubation of adolescents and babies was actually made possible (Shann, Duncan & Brandstater, 2013).  

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Likewise, intravenous access is of great importance for the administration of medicines and fluids to pediatric patients who are severely sick. During the mid-1940s, plastic catheters replaced metal needles which were rigid thereby making long-term intravenous access possible. In the late 1950s, the current flexible, intravenous catheter-around-the-needle pediatric medical device was developed by George Doherty (Zimmerman & Strauss, 2010).

During the ‘60s and ‘70s, percutaneous central venous access developed. It is notable that the launch of pediatric-sized equipment facilitated monitoring of central venous pressures, placement of catheters for parenteral nutrition, as well as placement of pulmonary artery catheters for measuring hemodynamic variables including pulmonary artery pressure, vascular resistance, and cardiac output (Zimmerman & Strauss, 2010).   

When designing the pediatric medical devices which could be implanted into the body of a child, the key factors that have been taken into consideration by medical device manufacturers over the years are as follows: (i) how the pediatric medical device would fit the body of the child as he or she grows; (ii) how the pediatric medical device is absorbed by the child’s body; and (iii) the durability of the medical device (Cheifetz, 2013).

When a medical device manufacturer designs a respiratory medical device for adult patients, the manufacturer could focus on the particular physiologic condition of the patient. However, when the manufacturer designs a respiratory device for the youngest infants, the manufacturer has to think holistically. The manufacturer should think about the baby’s entire body since everything is actually interrelated.

In addition, each aspect of an infant’s growing body has been taken into account over the years in developing effective medical devices for this population. When using surgical tape for instance, the fragile skin of the child is of particular importance. Materials utilized in developing these products are made without detrimental toxins and are gentle on the child’s skin (Shann, Duncan & Brandstater, 2013).  

On the whole, in the area of pediatric medical devices, a substantial amount of progress has been made over the years. In making this progress, medical device manufacturers have ensured that they develop products which are tailored to accommodate the lifestyle, activities and growth of a child. Chen et al. (2011) reported that long-term pediatric medical devices are today designed to fit within the lifestyle of children as much as possible and not forcing the children to fit to the medical devices as it used to be the case in the first half of the 20^th century when children were forced to fit into medical equipment for adult patients.

Even with chronic diseases, children should be allowed to be children. Over the years, professionals have exploited the opportunity for growth and development in pediatric biomedical engineering as they do their best to create innovative medical devices which improve the quality of pediatric care for children and babies. 

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Pediatric medical devices have affected the diagnoses in healthcare

The pediatric medical industry is a very fragmented industry that comprises giant corporations and start-up companies. The Food and Drug Administration regulates many different diagnostic medical devices under specified procedures. It is notable that diagnostic medical devices for pediatric patients range from items such as cardiac monitors, vision evaluation instruments, and blood pressure cuffs to complex imaging equipment.

Basing upon their complicatedness, pediatric diagnostic medical devices are usually assigned to one of 3 classifications – Class I, Class II and Class III – and regulated by the Food and Drug Administration accordingly (Food and Drug Administration, 2016). In addition, diagnostic medical devices for pediatric patients comprise a diverse range of products commonly referred to as in-vitro diagnostic devices: they are essentially systems, instruments, and reagents used in the diagnosis of illness or other conditions.

The Food and Drug Administration regulates pediatric in-vitro diagnostic medical devices in the United States which are manufactured and sold by medical device manufacturers and other tests which are vital in diagnosing a number of uncommon conditions and illnesses (Food and Drug Administration, 2016). 

An oxygen machine helps the pediatric patient to breath and a heart pump helps in bringing blood from the heart of the child to the rest of his or her body. These and other pediatric medical devices have helped to save so many children lives. According to the Food and Drug Administration (2016), pediatric medical devices are crucial in treating sick children and infants who are affected by various diseases, including uncommon illnesses.

Pediatric medical devices are helpful in the prevention of premature death and each year, they greatly improve the quality of life for numerous youngsters and infants. Some medical devices are developed particularly for children and infants and some are developed specifically for patients who are above a particular age. Many times however, healthcare providers modify medical devices meant for adult patients for usage in pediatric patients (Samuels-Reid & Blake, 2014).

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Pediatric medical devices are crucial in treating adolescents and infants who have heart disease. Modern examples include ventricular assist medical devices, atrial septal defect occluders, defibrillators, balloon catheters, pacemakers, prosthetic heart valves, endovascular stents.

Epstein and Brill (2012) stated that together with improvements in medical and surgical practice over the last 2 decades, pediatric medical devices have contributed very much to decreasing the overall burden of mortality and morbidity seen in adolescents and babies who have heart disease. Almond (2013) reported that the majority of cardiac medical devices utilized in adolescents and infants nowadays are utilized off-label in which the risk-benefit of those medical devices has not been characterized properly.

In essence, medical devices designed for pediatric patients face a number of challenges to Food and Drug Administration approval linked largely to ethical considerations of device testing in adolescents and babies, heterogeneity of the patient population, and the small target population. Even though comparatively few cardiovascular medical devices have actually been approved by the Food and Drug Administration for use in children, the number of pediatric medical devices that are successfully being approved by the FDA is on the rise (Food and Drug Administration, 2016).

Many FDA approvals of pediatric medical devices are being given via the Humanitarian Device Exemption pathway, which is in fact designed for uncommon conditions which make it appropriate for medical devices that treat pediatric congenital heart disease.  

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One major pediatric medical device used by medical professionals and organizations for diagnosis and which has been very helpful in saving the lives of very many babies and children is the Vertical Expandable Prosthetic Titanium Rib (VEPTR). This pediatric medical device has actually been influential in saving the lives of over 320 young children and babies who would have otherwise died due to the lack of breathe considering that they suffered from thoracic insufficiency syndrome (TIS) – a rather rare disease (Shann, Duncan & Brandstater, 2013).

The VEPTR pediatric medical device is basically curved like a ribcage. Moreover, it has holes which allow the surgeon to expand this pediatric medical device in outpatient surgery each 6 months. This device is implanted in adolescents and babies – who could be as young as six months of age – until skeletal maturity, often 16 years in boys and 14 years in girls.

VEPTR was invented by Dr. Robert Campbell and it actually took him thirteen years to obtain approval from the federal drug administration given that it took a very long period of time in accumulating many pediatric patients with rare sicknesses. The VEPTR is intended for a number of purposes which include: treating scoliosis, which refers to a sideways curve within the spine; stabilizing the ribs and spine in adolescents and infants who have serious chest wall deformities to allow these children to breathe better; reconstructing the chest when a number of ribs need to be taken out for some kinds of cancer surgical operation (United States Government Accountability Office, 2011).

On the whole, VEPTR is used in treating adolescents and babies with a group of conditions commonly referred to as thoracic insufficiency syndrome. In this thoracic insufficiency syndrome, the thorax of the pediatric patient – which consists of breastbone, rib cage and spine – are not able to support normal breathing. One of the treatment options entails the placement of a titanium rib. A number of other medical devices have been developed or are currently being developed for use in the diagnosis of pediatric patients in healthcare. Some of these pediatric medical devices are illustrated in the table below (United States Government Accountability Office, 2011):

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Target markets have changed with pediatric medical devices

Target markets have changed considerably since medical device manufacturers now have to focus also on pediatric medical devices to satisfy the unmet needs and not focus solely on medical devices for the adult patient population. Even so, the development of pediatric medical devices lags five to ten years behind the development of medical devices for adult patients (Food and Drug Administration, 2016).

As is true for manufacturers of biologics and medicines, medical device manufacturers naturally look for business opportunities in markets of adequate profitability and size in order to merit the investment risk. In particular, if the Food and Drug Administration demands far-reaching clinical data for approval of the medical device, manufacturers might be discouraged from making medical devices for small markets such as pediatric patients by the practical and expense challenges of carrying out satisfactory trials to show efficacy and safety of the device.

Even so, the Safe Medical Devices Act 1990 allowed the Humanitarian Device Exemption (HDE) to promote both the development and introduction of sophisticated medical device technologies to satisfy the unmet needs of small patient populations including adolescents, neonates and infants (Food and Drug Administration, 2016).

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A Humanitarian Device Exemption application contains a sufficient amount of information for the Food and Drug Administration to establish that the medical device does not create a significant or unreasonable risk of injury or sickness, and that the likely benefit to health of the targeted patient population really outweighs the risk of disease or injury from its utilization.

To qualify for a Humanitarian Device Exemption, medical device manufacturers should initially request that the medical device must be designated as a Humanitarian Use Device by the Office of Orphan Products Development. A Humanitarian Use Device refers to a medical device that is designed to benefit patients in diagnosing or treating a condition or illness which is manifested in or affects less than four-thousand people annually in America (Fedora et al., 2010).

If a medical device is to be utilized for diagnosis of diseases, the documentation in a Humanitarian Device Exemption application should show that less than four-thousand patients annually would be subjected to diagnosis by that particular medical device in America.      

The Humanitarian Device Exemption provides various incentives for start-ups to manufacture pediatric medical devices which have enabled a number of companies to focus on the pediatric patient target market. For instance, unlike companies that make other products such as drugs and biologics, pediatric device makers are not required to provide clinical evidence that demonstrates the efficacy or effectiveness of their devices (Food and Drug Administration, 2016).

This is a major incentive that has allowed device makers and start-ups to focus on the pediatric patient target market since clinical trials to support efficacy claims often take a number of years to carry out and are costly. Furthermore, the period of time specified for regulatory review of an application is often shorter for Humanitarian Device Exemptions compared to the time period for other premarket approval applications.

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The other incentive for pediatric device manufacturers is certainly the waiver of filing fees often demanded as per the Medical Device User Act, which is more than $200,000 (Food and Drug Administration, 2016). Partly because of these incentives, entrepreneurs at a number of small start-up firms are now developing several ground-breaking and inventive medical devices, focusing on the target market that comprises children aged <21 and these device makers and start-ups seek to address the unmet needs of small patient populations particularly pediatric patients.

Certainly, medical device makers have changed the focus of their target market somehow, from focusing on medical devices for the adult patients to making devices for adolescents, infants and neonates to take advantage of the HDE incentives.        

Today, manufacturers of pediatric medical devices are largely entrepreneurs at small, start-up firms. These start-up firms design and produce a number of revolutionary medical devices including medical devices which address the medical needs of small population of patients. Field and Tilson (2015) reported that there are a number of motivations for companies to make pediatric medical devices for small patient populations.

Some start-up firms focus on addressing unmet needs in the society and contribute to the society without the need to navigate the processes of decision-making common with complex, big medical device manufacturers. In other cases, the projected business opportunity is extremely risky or extremely small to be worth attention from current large companies though is still lucrative enough to attract small groups of entrepreneurs or venture capitalists.

It is notable that in exchange for partial ownership of the start-up firm, most venture capitalists and angel investors usually offer the required funding aimed at bringing promising and ground-breaking innovations into the marketplace (Goldman et al., 2013). Besides infusions of capital, venture capitalists and angel investors who have previously worked with other new firms might offer strategic advice and management expertise to guide managers of start-up medical device companies.

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In healthcare, technological innovations could save lives of patients and even increase the quality of life. Artificial hips and knees allow patients to be able to get back to their feet, stents prop open weak arteries, and pacemakers help in restoring rhythm to the patient’s heart. Nonetheless, these medical devices have largely been meant only for adult patients, not children.

For a lot of years, Downes (2013) reported that pediatric patients have been dealing with ill-fitting medical devices which were designed for adults. Healthcare providers were forced to adapt medical devices made for adults to adolescents and babies and the resultant improvisations have usually been far from ideal, not just in terms of safety, but also in terms of efficacy.

However, over the past few years, target markets have changed with more professionals and medical device makers being more willing to produce devices that are particularly customized for infants and children. More and more focus is now being put on the designing and making of appropriate state-of-the-art pediatric medical devices. For instance, the consortium Southern California Centre for Technology and Innovation in Pediatrics (CTIP) was formed in the year 2011 for the purpose of bringing together the best experts to accelerate the development of pediatric medical equipment – a path, which, as Almond (2013) pointed out, has not been lucrative or simple to tread.

In essence, these experts give advice to aspiring developers of medical devices on the process of manufacturing, protection of intellectual property, funding opportunities, regulatory oversight, commercial partnerships, as well as clinical trial design. The CTIP is basically a consortium between Children’s Hospital Los Angeles and the University of Southern California (Children’s Hospital Los Angeles, 2016). It is of major importance to have best advisers given that there are a number of intrinsic challenges in commercializing medical equipment and devices for paediatrics – a field which is typified by usually vulnerable and small patient populations.

There are also a number of contests organized in order to foster innovation which would advance pediatric healthcare and address the unmet medical and surgical device needs for babies and adolescents. For example, there is the yearly contest held by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System in Washington, DC (Sheikh Zayed Institute for Pediatric Surgical Innovation, 2016).

This contest is part of the institute’s 3^rd yearly symposium and from 8 finalists, 2 pediatric medical innovators, Prospiria from Texas and AventaMed from Ireland were selected to get a fifty-thousand dollar award. Acknowledging that pediatric ear tube surgical operation is the main reason that youngsters and babies undergo surgical procedure which necessitates general anesthesia, AventaMed designed and created a hand-held ear tube pediatric medical device which does not necessitate full general anesthesia.

On the other hand, Prospiria presented to the contest a non-invasive pediatric medical device utilizing optoacoustic imaging for monitoring endotracheal tube positioning for pediatric life support patients (Sheikh Zayed Institute for Pediatric Surgical Innovation, 2016).

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Conclusion  

To sum up, pediatric medical devices consist of the items which are employed in diagnosing, curing, mitigating, treating, or preventing a disease in adolescents, babies and neonates. In healthcare, the history of pediatric medical devices is quite exciting in terms of how progress has been made over the years aimed at addressing the unmet needs of paediatric populations. As more youngsters and infants continued to suffer from various ailments, medical device makers began developing medical devices specifically designed for pediatric patients.

Today, these pediatric medical devices are crucial for improving both the health as well as the quality of life for youngsters comprising adolescents, infants and neonates/newborns. Pediatric medical devices are critical in diagnosing and treating ailing adolescents and babies who are affected by many ailments, including rare ailments. These devices are useful in the prevention of premature death in children.

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