Category Archives: patient management

Technologies at Recently Identified Medtech Startups

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It was a robust month for medtech startups being founded (or at least getting on our radar) with a wide range of technologies under development. Below is a list of technologies under development by these companies:

  • Device to assist in early detection of melanoma.
  • Small molecules for skeletal tissue regeneration.
  • Intubation device.
  • Device for the point-of-care treatment of chronic central pain.
  • Technologies for detection of perforated bowel.
  • Prosthetic heart valve technology.
  • Catheter-based approach to carotid body modulation for treatment of sympathetic nervous system-mediated disease.
  • Sheaths, snares and other devices in interventional cardiology.
  • Device for non-invasive and reversible treatment of presbyopia.
  • Drill device to reduce complications in orthpedic and spine surgery.
  • System for evacuation of surgical smoke.
  • Minimally invasive technologies for the treatment of stroke.
  • Surgical device technology.
  • Robotic system for use in spine surgery.

The companies are included with all available details in our Medtech Startups Database.

Successful wound closure and management depends upon multiple intrinsic and extrinsic factors

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The formation of a wound, whether by surgical incision, trauma, or disease, sets up a complex set of conditions that may variously result in rapid healing, a local or systemic infection, a decubitus ulcer or other chronic, non-healing wound. A range of factors can and will dictate which course will ensue, and it is the focus of medical product manufacturers to develop increasingly effective products for debridement, hemostasis, prevention of infection, wound closure, wound sealing, moist (but not too moist) environment, negative (or positive) pressure as necessary, control of temperature and other roles in wound management.

Below are illustrated the fundamental factors affecting wound healing.

Factors Affecting Wound Healing

Factor
Impact
MoistureThe lack of sufficient moisture, or conversely an excess of moisture, can slow down repair. Lack of moisture often occurs with dry wound healing approaches; this stops cellularity, dries out cells and prevents the flow of humoral factors essential for removal of for pathogens and cell communication. It ultimately prevents the movement of keratinocytes for epithelialization. Too much moisture can lead to maceration, which causes osmotic damage to cells and slow healing, as well as breakdown of surrounding tissues.
InfectionInfection by micro-organisms can significantly slow down healing, leading to an extended inflammatory phase and cell necrosis. Some organisms in the wound are not detrimental, and evidence suggests that some microbes accelerate healing. However, organisms like Staphylococcus aureus and many anaerobic microbes are pathogenic and will live off the tissues.
DebrisThe presence of debris within the wound will delay healing. It is essential to remove any contaminating material that may be a source of infection, or which may delay healing through chemical or physical obstruction.
TemperatureTissue healing tends to be optimal at higher than normal physiological temperature. The exact reasons are not clear, but at higher temperatures enzymes and cell metabolism tend to achieve faster removal of pathogens and greater catabolic activity.
PressurePressure is a major extrinsic factor that can be detrimental to healing. This is why significant effort has gone into development of pressure relief products for use in situations involving mechanical stress. In addition, a number of devices have been evolved which are designed to modify the pressure around a wound to facilitate healing.

Source: MedMarket Diligence, LLC; Report #S190.

It is important to close a wound rapidly and to create a moist wound healing environment that is not disturbed by adverse temperature and other effects. The successful application of surgical closure and securement products can serve to accomplish this goal, maintaining the natural tissue continuity and integrity, and helping to control bodily temperatures within optimal healing conditions.

There are several new technologies, delivery systems and products in development, some of which may come onto the market during the forecast period or shortly thereafter. In parallel with the invention of new products, in several instances new delivery systems have had to be developed. For example, new delivery systems have evolved to spray liquid hemostat solutions such as thrombin onto surgical sites to improve speed of hemostasis. Fibrin sealant is supplied as two powders that need to be solubilized and then mixed immediately prior to application to the surgical site. This has led to the development of a number of sophisticated medical delivery devices, while some companies are developing single component systems that are already solubilized for immediate use in the surgical theater.

Underestimating obesity

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Obesity Co-Morbidities

  • Cardiometabolic syndrome
  • Type 2 diabetes
  • Hypertension
  • Dyslipidemia
  • Coronary heart disease
  • Osteoarthritis
  • Stroke
  • Gall bladder disease
  • Obstructive sleep apnea
  • Gastroesophageal reflux disease (GERD)
  • Some cancers (endometrial, breast, and colon)

Current estimates of obesity prevalence in the U.S. are based on body mass index (BMI) and account for  20% obesity rate in the 50 states, with 12 states having rates of over 30%, according to the CDC.  However, recent research carried out by researchers at New York University School of Medicine and other institutions have indicated the imprecision of BMI is resulting in a high number of false negatives for obesity.  In the research studying a sampling of men and women and comparing BMI to an alternative method for determining obesity by employing specific biomarkers and duel-energy x-ray absorptiometry (DXA), the BMI measurement concluded that 26% of the subjects were obese, while DXA concluded that 64% of the patients were obese.

Body mass index has previously been challenged as a measure of obesity due to its inability to effectively differentiate between body types regarding obesity. Whether the DXA ultimately becomes a more reliable standard measure for obesity remains to be seen, but what is clear is that any measure that results in higher counts of the obese will be met by healthcare (and the medical product industry) as justification for increased spending in the treatment of obesity. Further research, of course, will be necessary to evaluate the relationship between the increased sensitivity to detection of obesity and the identification of associated morbidity or, as is often the case with obesity, the co-morbidities of diabetes, heart disease and other expensive healthcare challenges.

For further information on obesity drugs and devices, see the 2011 MedMarket Diligence report #S835, "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019".

Diabetes prevalence, risk continue to increase, driving up global costs

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The International Diabetes Federation released its latest findings on the global picture for diabetes, which is foreboding: 366 million diabetics worldwide (a 22% increase over 2009), an annual death count of 4.6 million, and a health care bill of 465 billion.

The diabetes market, which includes both pharmaceuticals and medical devices, is large, and is growing steadily for four main reasons. First, the prevalence of diabetes is increasing, particularly that of type 2 in developed countries and those with increasing prosperity. Type 1 diabetes is also increasing, though less dramatically. Second, type 2 diabetes is responsive to drug therapy, and there is a continuing search for newer, better pharmacological agents. Third, insulin, required for all cases of type 1 and some of type 2 diabetes, poses administration problems, offering opportunities for new delivery systems. Fourth, patients with diabetes must monitor their condition by frequently checking the level of glucose in their blood, and there are ongoing attempts to make this process easier and more user-friendly by developing more advanced (and expensive) devices.

A fifth driving factor in the diabetes marketplace is the search for a fundamentally better way to manage the disease. Some options are mainly surgical—transplants of pancreatic cells, for example. Another focus for research is to combine glucose monitoring with insulin administration in a self-controlled wearable device. And farther in the future are prospects for using stem cells to grow new beta cells, and for using genetic knockout techniques to block the metabolic processes that cause diabetes.

A Many-Sided Market

The diabetes market includes both pharmaceutical and medical device elements. The pharmaceutical aspect is again divided between insulin and oral antidiabetic drugs. The medical device aspect is made up of instruments for diagnosis and monitoring with their attendant consumables, and a range of devices for administering insulin. Some of these devices contain prepackaged insulin, so that they may be regarded as both medical devices and pharmaceuticals.

See IDF story at Medical News Today: 366 Million Diabetics Worldwide, Alarming Death Rates As Epidemic Continues To Worsen.

The global market for products in the management of diabetes is detailed in the MedMarket Diligence Report #D510, “Diabetes Management: Products, Technologies, Markets and Opportunities Worldwide 2009-2018.”

Future diabetes treatment approaches

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Research in the diabetes field has taken two main directions: improving current therapies, and exploring radical new approaches. Improvements in current therapy include making glucose monitoring and insulin delivery less invasive and more patient-friendly, and many significant advances have been made in this context in the past two decades. Among these have been the development of insulin pumps and of non- or minimally-invasive techniques for sampling blood. New, fast-acting forms of insulin have been introduced. There has been considerable research in non-injection dosage forms for insulin, and the first inhaled insulin product has recently been approved. This could herald a new era in insulin therapy.

Another ground-breaking development will be the successful development and regulatory approval of an “artificial pancreas.” This is the term used to describe a system in which continuous glucose monitoring is linked electronically to continuously variable insulin delivery, effectively making diabetes control automatic and freeing the patient to get on with his/her life. The technology behind an artificial pancreas is still being developed but it is at an advanced stage.  While the major components — an insulin pump and a continuous glucose monitor — are already on the market, and as a combined system by one manufacturer (Medtronic), the FDA has not approved a unified system in which the system runs autonomously by glucose readings driving insulin infusion rates.  The algorithms, software and other systems necessary are likely to gain approval in only 1-2 years.

More radical approaches to diabetes mellitus, also the subject of vigorous research, include ways of replacing the whole cumbersome business of glucose testing and insulin administration. Transplantation of healthy pancreatic islets into diabetic patients has been explored, but the problems of rejection are a significant hurdle. More promising is the modification of adult or embryonic stem cells so that they develop into pancreatic beta-cells capable of being implanted in the patient and serving as a replacement for the insulin-secreting cells that have been destroyed.

Further in the future are developments based on genetic manipulation. Several gene anomalies have been identified as related to the development of type 1 diabetes in particular, and these may present targets for intervention to prevent the disease from developing.

The global market for products in the management of diabetes (monitoring, anti-diabetic drugs and insulin) is a $5 billion market currently and is growing at over 9% annually, a rate that is unlikely to slow while rates of obesity prevalence keep climbing.

Source: MedMarket Diligence, LLC; "Diabetes Management: Products, Technologies, Markets and Opportunities Worldwide 2009-2018." Report #D510.

Obesity’s outlook unchanged

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Drugs for the clinical treatment of obesity have taken hits over the past year.  Denied regulatory approvals, market withdrawals and the resulting industry moves, if projected going forward, leave an overall negative impression of the market.  However, describing the "current" market for obesity drugs based on the "past as prologue" would be an incomplete picture.  Certainly, the attitude of the FDA in rejecting Arena's Lorcaserin and Orexigen's Contrave, as well the withdrawal by Abbott of Meridia and similar developments have tempered the "optimism" of obesity drug developers.  But optimism remains, stemming from an overwhelming need and therefore opportunity for obesity drugs.  

 

Source: "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019." Report #S835 (copyright 2011, MedMarket Diligence, LLC).

Simultaneously, medical device development — restrictive devices, artificial fullness, malabsorption, gastric emptying, and appetite suppression devices — continue to see strong growth (i.e., double-digit CAGR) as approved devices see expanded indications (e.g., Lap Band) and new devices are steadily introduced to the market.

Surgical procedures and device implantation, however much they may avoid the challenges of drug complications (or just the FDA's perceptions), are not free of challenges (including, of course, the need for surgery that is in many cases invasive), such as that there is a growing recognition that these are not permanent fixes and may require that expensive repeat procedures by done.

The short-term view of the obesity drug market is that it is "dead", or at least on life support, but given the current market for obesity management products ($billions) and the indisputable accelerated growth in obesity prevalence and the recognition in the healthcare arena of obesity's co-morbidity costs, one must conclude that the short-term view is not going to hold for very long, at least not by many who are motivated by opportunity.

Diabetes and obesity driving global treatment markets

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Diabetes drives many healthcare costs and is now part of a trend that encompasses increasing prevalence of obesity and its co-morbidities. The result is that any improvements (read "technology advances") in the management of diabetes (and obesity) will have a dramatic effect  on healthcare costs, even if that effect is to simply stem an otherwise accelerating rate of growth in complications.

The subject of diabetic complications looms so large in the total perspective of diabetes management that it should not be ignored. The importance of diabetic complications may be assessed from the fact that diabetic patients are generally accepted to have twice the normal incidence of cardiovascular disease and stroke; 25 times the normal incidence of blindness; 20 times the normal incidence of gangrene, and a significantly increased risk of developing neurological and renal disease.

The rates of increase in diabetes and its complications are by no means uniform geographically.  The greatest increases in diabetes expected over the next twenty years will occur in Africa, the Middle East and South-East Asia, as shown below.

 

Source: MedMarket Diligence, LLC, Report #D510; and IDF Diabetes Atlas, 4th Ed., International Diabetes Federation, 2009

 

Patients with longstanding diabetes may develop complications affecting the eyes or kidneys (microvascular complications), nerves, or major arteries. The major arteries are affected by diabetes in two ways. Coronary artery disease is commoner in diabetic people than in non-diabetic people. The greatest risk of large vessel disease occurs in those diabetic patients who develop proteinuria or microalbuminuria, suggesting widespread vascular damage. The distribution of arterial narrowing tends to be more distal than in non-diabetic people, whether in the coronary arteries or in the peripheral arteries affecting feet and legs. The cause of the microvascular complications is not understood, but the most important influence is probably the quality of diabetic control over many years. There may also be a genetic influence, which can be detected in identical twins. Fortunately not all diabetic patients develop these complications, and probably as many as one-fifth are spared altogether even after 40 or 50 years of diabetes. Curiously, both retinopathy and neuropathy may occur in isolation, but serious nephropathy is always accompanied by retinopathy and usually by neuropathy as well.

Selected new medical technologies with big potential impact

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One of our readers at nursingschools.net sent along an interesting set of medical technologies that are good examples of new and evolving technologies impacting patient care.  

  • Faster MRIs. Cutting MRI imaging time seven-fold will yield great research and clinical benefits.
  • Water fleas as new human testing models.  Genetic homology with humans may make these valuable human test subject.
  • Molecular imaging. Bridging the gap between molecular biology and imaging to elucidate molecular level precursors to organ failure.
  • Magnetic molecules. Room temperature control of the magnetic state of molecules may lead to a variety of medical and non-medical applications.
  • Bioengineered blood vessels.  Faster graft generation, better than synthetic.  (This has also been the subject of tissue engineering in our Report #S520.) 
  • STEM microscopes. High-speed, 3D recording of individual neurons firing could dramatically improve understanding of neural pathologies.
  • Blurring man/machine. Brainwave control of machines. (See also "2045: The Year Man Becomes Immortal", Time Magazine.)
  • Laser biopsies. Painless, noninvasive.
  • Wireless heart monitoring.  Potential for earlier detection of heart failure events to  dramatically reduce readmissions.

For the full review of these advances at nursingschools.net see link.

Co-morbidities of obesity

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Overweight and obesity have been linked to a number of conditions which can have profound impacts on the life of the individual. Many obese people have to deal with health issues, as well as social isolation, financial challenges and social prejudice on a daily basis. If the underlying obesity is not treated, the individual’s physical situation will worsen, possibly to the point of death.

In spite of the treatment options available, obesity is said to be the second leading cause of preventable death in the US, responsible for up to 400,000 deaths each year, depending on the estimates. The relative risk of mortality is directly linked to BMI for both men and women, as the figures below show.

 

Source: Freedman DM, Ron E, Ballard-Barbash R, Doody MM, Linet MS (May 2006). "Body mass index and all-cause mortality in a nationwide US cohort". Int J Obes (Lond) 30 (5): 822–9.

 

The list of co-morbidities, the serious nature of each, and their associated costs, support arguments for obesity representing the single most serious challenge to a financially constrained healthcare system:

  • Metabolic syndrome
  • Immune function
  • Type 2 diabetes
  • Hypertension
  • Cardiovascular disease
  • Dyslipidemia
  • Gastroesophageal reflux disease (GERD)
  • Osteoarthritis
  • Non-alcoholic fatty liver disease
  • Obstructive sleep apnea
  • Cancer

The above is drawn from the December 2010 MedMarket Diligence Report #S835, "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019."

Obesity Treatment: From Gastric Emptying Devices to Malabsorption Drugs

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The size of the patient population and the cost of the condition and its co-morbidities are testimony to why so many treatment options are being pursued, developed and marketed by manufacturers for the treatment of obesity.  Already a huge market for both drugs and devices, the market is expected, through a steady stream of product development and introductions, to change its makeup of treatment options while in the aggregate quadrupling in size by the year 2019.

Below is a bubble chart illustrating the size (by bubble size and horizontal position) and growth (bubble vertical position) of the major drug and device options for the management of obesity.

Source: MedMarket Diligence, LLC; Report #S835, “Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019.”