Category Archives: stem cell

Reference reports in Ophthalmology, Coronary Stents and Tissue Engineering

MedMarket Diligence is making available previously published, comprehensive analyses of three different medtech markets. The markets covered in the three reports are:

Ophthalmology Diagnostics, Devices and Drugs (see link)
Coronary Stents: Drug-Eluting, Bare, Bioresorbable and Others (see link)
Tissue Engineering, Cell Therapy and Transplantation (see link)

Termed “reference reports”, these detailed studies were initially completed typically within the past five years. They now serve as exceptional references to those markets, since fundamental data about each of these markets has remained largely unchanged. Such data includes:

Disease prevalence, incidence and trends (including credible forecasts to the present)
Clinical practices and trends in the management of the disease(s)
Industry structure including competitors (most still active today)
Detailed appendices on procedure data, company directories, etc.

Arguably, a least one quarter of every NEW medtech report contains background data encompassing the data listed above. Therefore, the MedMarket Diligence reports have been priced in the single user editions at $950 each, which is roughly one quarter the price of a full report.

See links above for detailed report descriptions, tables of contents, lists of exhibits and ordering. If you have further questions, feel free to contact Patrick Driscoll at (949) 859-3401 or (toll free US) 1-866-820-1357.

See the comprehensive list of MedMarket Diligence reports at link.

Advice to forward-looking medtech manufacturers (and their competitors)

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Will Rogers said, “Even if you are on the right track, you’ll get run over if you just sit there.” The current challenge for medtech manufacturers is that, as a result of a wide range of forces, trends and developments, the train that threatens to run them over has gotten a whole lot faster. Below is a short list of perspectives that is needed by medtech manufacturers and their competitors in order to stay ahead of the train.

Focus on your competitors’ solutions, not their products. Stent manufacturers (and this is just an example) are not competing only against stent manufacturers; they are also competing against drug-eluting balloon angioplasty, atherectomy, percutaneous myocardial revascularization, atherosclerotic plaque-reducing drugs, myocardial stem cell therapy and other device, drug, biotech and other options. The focus is on the disease and all the alternative ways to treat it (even preventing it). And it bears reminding that a duty of your market intelligence is to keep a watchful eye on the broadest possible definition of potential competitors – gene therapy, holistic medicine, eastern medicines.

Be careful where you draw the line on your product’s features. There are many choices to be made in designing and engineering a medical product. The more you build into the product (being resorbable, being intelligent, having biocompatibility coating, having embedded drug(s), etc.), the more benefits you can potentially claim, but the more arduous the engineering, testing and regulatory approval will be. The traditional advantage medical devices have over drugs has been that devices are “inert”, accomplishing their therapeutic endpoint without the large scale side effects possible with systemically active drugs. The more devices are imbued with drugs, made of resorbable material or have any kind of interactive capability with the tissue around them, the more likely will be occurrence of adverse effects.

Directly or indirectly, your product must be viewed as lowering healthcare cost. In real terms, a product that demonstrably lowers costs compared to alternatives has a decided advantage. However, your product has only to give the appearance of saving money, or at least clearly suggests that it will not raise healthcare costs. Directly, if you can point to units per patient and average selling price and you can point to explicit cost saving compared to currently used products, you’ve gained an advantage. Short of that, you can gain advantage if you can make a defensible cast that your product leads to indirect cost savings such as in less trauma, less collateral damage, faster healing times and similar.

“Zero invasiveness” is the target. Expect increasing numbers of percutaneous and “natural orifice” procedures at the expense of not only open surgical procedures but also laparoscopic procedures. Too many surgical and interventional formats, and support systems for them, have been developed that signal the end of the need for invasive procedures. And whether the procedure is done laparoscopically, endoscopically, percutaneously, or even radiosurgically, the need to cut, resect/excise or otherwise physically alter anatomy or morphology to address pathology will be obviated by, and be less attractive than, effective non-surgical/non-interventional approaches.

“Personalized medicine” may be largely theoretical, or at least largely unrealized, BUT the potential to be able to predetermine when therapies will or will not work is too significant in its implications to ignore. (Looking at this another way, I recently spoke with a pharmaceutical colleague who noted that blood markers in patients with a particular condition could help them screen out 97% of the diagnosed patients for whom their therapy would be ineffective. Their conclusion was not that the drug was 97% ineffective but that, for 3% of the diagnosed population, the drug would be highly effective and therefore highly profitable.)

The pace of change is accelerating. Developments in material sciences, the growth in applied understanding of basic life sciences, the emergence of “paradigm-shifting” industries like stem cell and tissue regeneration, the rewards being reaped by genome sequencing, the integration of advanced information technologies in drug discovery, simulated device prototype testing and other advances are dramatically shortening the gap between idea and market introduction, reducing product life cycles (accelerating obsolescence) and increasing the intensity of competition for all manufacturers.

The advice for any medtech manufacturer — or, for that matter, any manufacturer of a product competing against a “medtech” product — is that they must continually address the view of their competitive landscape to recognize and be prepared to respond to real and perceived competition, trends, forces and opportunities.

Wound management market remains fragmented

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One of the key aspects to the global wound management market that is often overlooked is the actual diversity of products and technologies in use and in development. Despite the fact that wound management is arguably the oldest area of medicine, an incredibly wide range of approaches have been developed to optimize conditions for wound healing or otherwise facilitate the healing of wounds that range from acute, surgically created to chronic, disease-linked wounds.

With a wide range of active competitors exhibiting a correspondingly wide range of strengths in different wound care product areas, the distribution of the market varies widely by product type.

Below is illustrated the market shares of companies in wound management by product segment. As is clear from an overview, there are a few segments in which select competitors dominate, but the general rule is that each segment is dominated or distributed across a varying list of competitors.

Legend:

A: JNJ
B: 3M
C: Beiersdorf
D: Smith & Nephew
E: Others
F: B. Braun
G: Systagenix
H: Mölnlycke
I: Covidien
J: ConvaTec
K: Hartmann
L: Coloplast
M: Lohmann
N: UDL Laboratories
O: Argentum
P: Integra LifeSciences
Q: Sanofi Biosurgery
R: Organogenesis
S: Shire Regenerative Medicine
T: KCI

Source: MedMarket Diligence, LLC; Report #S249: “Wound Management, Worldwide Market and Forecast to 2020: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”

See also “Worldwide Surgical Sealants, Glues, Hemostats, Other Wound Closure and Anti-Adhesion,” Report #S190.

Technologies at recently identified medtech startups

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Below is a list of the technologies under development at startups that MedMarket Diligence recently identified and added to the Medtech Startups Database.

Tissue regeneration technologies for non-invasive skin care.
Biomaterials supplied to medical device and pharma manufacturers
Trans-reflective fetal EKG.
Surgical instrumentation.
Undisclosed medical technology.
Technologies for autologous tissue collection.
Stem cell therapy.
Novel, implantable ring to prevent parastomal hernia in abdominal surgery.
Transcatheter repair of mitral valve regurgitation.
Synthetic cartilage implant for treatment of osteoarthritis or cartilage damage.
Device-based treatment of congestive heart failure.
Clamping device to control bleeding in trauma.
Tissue matrix composition for tissue regeneration and wound care.
Spinal pain relief devices.
Wireless remote arrhythmia monitoring and diagnosis.
Undisclosed medical technology.
Surgical tools for arthroscopic procedures.
Fractional flow reserve guidewire method to obtain FFR measurements during coronary catheterization procedures.
Technology to ensure accurate intraoperative placement of hip and knee implants.
Neurological diagnostics to measure biomarkers, regulate drug dosage, others.
Respiratory monitoring devices, such as a “sleep sensors” shirt to enable less invasive monitoring for apnea or other respiratory conditions.
Endoscopic, minimally-invasive harvesting of veins used for coronary artery bypass grafting.
Ophthalmology diagnostics; binocular device for eye exams.
Device-based treatment for respiratory disease.

Medtech trends, current and future

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Medtech Trends map.
We are working on a long range view of medical technology developments. Since one tool to conceptualize ideas with priorities, subsets and linkages is “mind mapping”, we have used mindmapping software to construct a map of medtech trends involving the main elements of current trends, future trends and drivers.

The map is illustrated below in a Flash version. You may resize (zoom in/out) of the map and otherwise navigate it via the controls below right (and just above the map on the right). You may also move about the map it in all directions by clicking on the map and moving it in the desired direction with your mouse/touchpad.

Elements of the map that contain embedded notes with additional information show a text box icon on the side, so that if you move your cursor over it, the text will display.

We welcome your feedback.

Much of technology development over the course of the medtech industry’s history has been of the “product line extension” variety in which incremental improvements are made in devices and their composite materials in order to refine or otherwise increase their performance. Periodically, development has taken larger, more sudden leaps when re-examination of the fundamentals underlying medical technology generated new concepts that precipitated wholly new technologies. For example, surgery took a sudden leap forward in the late ’80s and ’90s when a recognition took place that (1) open abdominal surgery has inherent disadvantages stemming from trauma, risk of infection and other adversities and (2) endoscopic technology merely lacked the surgical instrumentation and design of a procedural format (e.g., via the use of insufflation) necessary to convert laparotomy to laparoscopy. The recognition that new technology obviated the need for trauma of laparotomy coincided with the obsolescence of virtually hundreds of years of traditional surgery. This development was only possible due to the emergence of a brand new paradigm called laparoscopic surgery, in which a host of abdominal procedures could be performed that avoid the trauma inherent in open abdominal surgery.

(And now, another leap is taking place by replacing laparoscopy with NOTES procedures in access is provided by existing orifices rather than any kind of incision or surgically-created port.)

Incremental improvements continue to enable manufacturers to sustain market shares and price premiums, but the nature of economic forces demanding better outcomes for every dollar spent and the proliferation of opportunities arising from technology advances on multiple fronts (with those fronts often combining synergistically) are precipitating leaps in medtech development beyond incremental improvement.

Below is illustrated an overall outline and map of the developments and drivers we see in medtech.

Get the Flash Player to see this player.

Source: MedMarket Diligence, LLC

2013 Medtech Outlook

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The 2013 Medtech Industry — Some General Predictions

In 2012, much has been made of the Affordable Care Act or, more precisely, the 2.3% excise tax on medical devices used to fund the addition of 30 million new patients to the U.S. healthcare system. Despite a chorus of voices for a repeal of the tax, with repeal arguments that range from credible to absurd, the tax is likely to stay in place. With the influx of new patients in 2013 and beyond, the cost versus benefit will become clear, but we forecast that the debate on the excise tax will linger well into the new year.

The U.S. and global economy have been recovering with growing momentum following several stagnant years. Just as a rising tide floats all boats, the stronger economy in 2013 will help drive medtech though more available capital leading to increased spending by healthcare systems for increased inventories and investment in new technologies.

Investment in medtech will likely show modest increase as money that has been previously stored in the “safe harbor” of medtech investment will shift back to non-medtech investment targets that have now been made more attractive by the stronger economy. In the recessionary economy of post 2008, medtech investment has favored later stage (i.e., “less risky”) technologies — those already in or about to enter the market. Now, with hunger for larger returns in the stronger economy, the money that will flow into medtech in 2013 will be more inclined to fund earlier stage products and companies.

Physicians and companies will not part ways, but in 2013 they will not be so cozy, given the Sunshine Act’s intention to reveal how cozy they actually are in order to eliminate financial bias in physician endorsement of new technology. Even before the Sunshine Act, the writing has been on the wall that the links between physicians and companies have been too close. Greater scrutiny of these links will create challenges for medtech to ensure that clinical validation of new technologies will be unbiased.

Trends associated with the FDA include steady progress in reducing review times, closer scrutiny of off-label uses, more stringent attention to false or misleading claims and, in general, an uptick in enforcement. We forecast that the regulation of medical devices will become increasingly complex as the FDA seeks to address deficiencies in the 510(k) process and, in general, complete reviews more efficiently to satisfy the needs of industry and needy patients without compromising device safety.

The regulatory process will also become further challenged as it faces new definitions (or lack thereof) for “medical devices”, since the marriage of drugs and devices (i.e., hybrids), the growth of resorbable implants and other innovation trends blur the previously distinct boundaries between drug, device, biotech and other products.

2013 will also see the emergence and/or expansion of multiple medtech markets.

Expect a growing number of developments in neurology-focused therapeutics such as neuromodulation, the expanded use of hybrid devices in cardiology (including bioresorbable stents).
The press for minimal invasiveness and the capacity of medtech to respond through innovation will drive development and adoption of new technologies paradigms such as NOTES (natural orifice transluminal endoscopic surgery) technologies; transcatheter technologies and other medical/surgical technologies that dramatically reduce the need for surgical incisions or other invasiveness; non-invasive diagnostics such as glucose meters in diabetes
Surgical and interventional procedures are increasingly being integrated with more sophisticated pre-operative and intraoperative (“real time”) imaging systems that enhance the physician’s ability to direct therapy more effectively at pathologies with less collateral damage, reducing complications, accelerating recovery and otherwise improving patient outcomes. Some of these systems, such as intraoperative MRI, are very sophisticated and accordingly expensive, so benefit/cost may limit adoption but for the most at risk caseload.
The blessing in disguise that was the Bush administration’s ban on federal funding of embryonic stem cell research led to a burst of research in adult stem cells that bypassed the embryonic stem-cell ethical dilemma. With the Obama administration’s subsequent lifting of the federal ban, both embryonic and adult stem cell research is proceeding at breakneck pace. 2013 is therefore likely to see an equally powerful burst of advances leading to practical therapies based on stem (or pluripotent) cell technology.
Driven by research indicating important, patient-specific differences in physiology that impact the effectiveness of medical devices and other medtech, 2013 will show an increase in customized or personalized medicine. The diagnostic component will include genetics-driven predictors of disease while the therapeutic will include a wide range of product types, from the development of autologously cultured tissues or stem cell-derived tissues, and custom-fitted implants in cardiology, orthopedics, general surgery and other specialties.
3D printing is being applied to medtech in both prototype development and in such seemingly far-fetched ideas as organ printing, which is actually in active development.
Biomaterials, or materials technology in general, increasingly expand the number of possibilities of what can be achieved with medical devices and other medtech products. Drug-coated devices, drug-delivery devices, extracellular matrices, bioresorbable implants, nanotechnology-based and other coatings and a wide range of other materials technologies are enabling medtech products to be more disease-specific, less toxic, less prone to biocompatibility issues, less likely to be associated with procedure-specific collateral damage and otherwise more effective in achieving high quality outcomes at lower overall cost.

There will also be secondary forces impacting medical technologies. By this, we mean forces in the innovation of non-medical technologies or other forces that are changing the use and/or implementation of medical devices. First among these is forces for the integration of information technologies in medical devices encompassing infusion pumps and other “smart” devices, radiofrequency identification systems, wireless telemetry and others.

While we are more focused on medical technologies than on technologies like information systems that affect more of the logistics than the clinical delivery of healthcare, it should not be overlooked that healthcare in 2013 will also be characterized by steady growth in the application of information technology. At its simplest level, information technology in healthcare is the management of healthcare information — electronic medical records, healthcare information systems, picture archiving and retrieval, etc. But to a much greater degree, information technology is impacting healthcare through several key areas:

Computer aided design and prototype development. Conventional use of computer aided design in the development of medical devices is already common, but increasingly sophisticated programs and systems are being developed to optimize device design to reflect a more comprehensive understanding of the forces, dynamics and anatomy of patients, as well as the more thorough understanding of pathology. With the use of CAD and 3D printing, prototypes can be quickly produced that, if not functional, can facilitate the development of ideas toward functional prototypes. In cardiology, flow dynamics have been recognized as a critical aspect effectively applied through computer aided design of vascular stents, catheters, embolic protection, aneurysm repair and many others. In orthopedics, the use of CAD is facilitating customized implants.
Systems biology and the demand for multivariate analysis. One of the most significant long term objectives of medical device (or medtech) development is the innovation of products that more comprehensively address disease states (or wellness) by integrating understanding of anatomy, physiology, chemistry, genetics, physics and all other possible disciplines having potential impact on the long term efficacy of a medical product. While there is fundamental science to be learned to achieve such a multivariate understanding/solution, and this is a long-term goal well beyond 2013, the increasing recognition of diverse factors impacting product efficacy is incrementally improving each new product embodiment — and such work is a part of product development already. The concurrent interplay of alternative device (or other medtech product) configurations with myriad biological, physical and other forces demands information technologies that are able to predict downstream effects of each possible innovation.

[Please note we are continuing to review new medtech development efforts and analyze their potential impacts so that we may update our 2013 forecast here.]

Cell therapy and tissue engineering global market development

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Tissue engineering and cell therapy comprise a market for regenerative products that is expected to grow worldwide to almost $32 billion by 2018. This market spans many specialties, the biggest of which is therapies for degenerative and traumatic orthopedic and spine applications. Other disorders that will benefit from cell therapies include cardiac and vascular disease, a wide range of neurological disorders, diabetes, inflammatory diseases, and dental decay and/or injury. Key factors expected to influence the market for regenerative medicine are continued political actions, government funding, clinical trials results, industry investments, and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications.

Source: Report #S520 (MedMarket Diligence, LLC).

On a country-by-country basis, there is considerable variation in the forces impacting the clinical practice and industry of cell therapy especially, but also tissue engineering, and these forces are fluid over time. Certainly among the most significant was President Bush’s Presidential Executive Order in 2001 banning federal funds for embryonic cell therapy other than for existing cell lines, an order that President Obama promptly rescinded after the 2008 election. The 2001-2008 hiatus impeded development of embryonic cell therapy solutions, while shifting the emphasis of development toward adult stem cell technology. Now, in 2012, development is moving rapidly on both fronts.

Source: Report #S520 (MedMarket Diligence, LLC).

The overall challenges in development of future cell/tissue therapy products, regardless of clinical area, can be grouped into those associated with material-based tissue replacements, allograft-derived tissue replacements and cell and tissue-engineered products.

Material-based replacements. The search for synthetic-based biocompatible materials has posed particular problems for researchers in that no synthetic material is completely accepted and integrated by the body. Therefore, the goal has been to create a replacement tissue that closely mimics natural tissue and will activate normal body healing and tissue reconstruction, and eventually be resorbed harmlessly into the body after normal healing has begun.

Allograft-derived tissue replacements. Allograft (donated cadaver) tissues, are in short supply and must be thoroughly processed to remove any viruses, bacteria and other possible sources of transmission of disease. In addition to stringent cleanliness standards, companies must adhere to strict national laws regulating the donation of organs, and the harvesting and processing of such organs. Each country determines its own ethical standards for organ donation.

Cell and tissue engineered products. The biggest hurdle remaining to the creation of viable, commercialized embryonic or adult stem cells is to develop the ability to differentiate cells into various types of cells and to determine how these differentiated cells behave when cultivated in large numbers in the laboratory. In many cases, researchers are still uncertain whether the cells retain their characteristics over time or if they will degenerate into a different or earlier version of a cell.

Given the number of clinical applications — across multiple clinical specialties — that emerge from advances in basic cell therapy and tissue engineering research, the opportunities are obvious and are therefore the focus of intense commercial development by drug companies, biotech companies, device companies and every other type of company. The distribution of actual cell/tissue revenues across such a diverse array of companies has ensured that the as yet unrealized potential will be the focus of a highly competitive list of companies.

Cell therapy and tissue engineering global markets are the subject of MedMarket Diligence’s report, “Tissue Engineering, Cell Therapy and Transplantation: Products, Technologies & Market Opportunities, Worldwide, 2009-2018.” (See link for details.)

Tissue engineering & cell therapy markets, 2012 and 2018

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The varied technologies underpinning the market for “tissue engineering & cell therapy” are diverse — even more so than people in the industry often recognize. Frequently, both tissue engineering and cell therapy are presumed to be purely developmental in current “markets”, a far cry from when such technologies will be so advanced as to make organ replacement a retail market. The truth is that, on the one hand, tissue engineering has become a very routine part of clinical practice (as in skin grafts and orthopedic tissue grafts) and, on the other hand, while cell therapy still has vastly more clinical (and commercial) potential than it has as yet demonstrated, it has nonetheless demonstrated sufficient advance that several obstacles to cell therapy benefits have been greatly diminished: (1) the issue of the Bush-era ban on federally-funded embryonic stem cell research was promptly lifted by the Obama administration and (2) advances in the use of adult stem cells and the reversion of cells from a differentiated to undifferentiated state (i.e., creation of pluripotent cells) have made limitations on embryonic stem cells largely moot.

Consequently, the great struggle for anyone seeking to assess the “commercial potential” in tissue engineering and stem cell therapy is overcoming the presumption that these technologies are still a long way off from attaining any level near their potential commercial success.

The solution has been to track actual company revenues especially, but not limited to, readily verified SEC 10(K) company reports on revenues generated from these technologies. This has been our experience in characterizing worldwide markets for tissue engineering and cell therapy in our Report #S520.

The aggregate worldwide market for tissue engineering and cell therapies, representing an already stunning range of clinical applications, stands at roughly $12 billion in 2012. This market, through commercial introduction of new products and expanded applications of approved products, will reach almost $32 billion by 2018. See our 2012 and 2018 estimates, below.

Source: “Tissue Engineering, Cell Therapy and Transplantation: Products, Technologies & Market Opportunities, Worldwide, 2009-2018″, Report #S520.

Pardon my medtech ADD — it’s an occupational hazard

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Now, to be clear, I have never actually been diagnosed with attention deficit disorder. But that doesn’t mean that I don’t exhibit an awful lot of its traits, especially when it comes to advanced medical technologies, which I have witnessed evolve at a feverish pace that dares one to linger on one milestone too long.

Mankind has come up with some extraordinary technologies — the internal combustion engine, flight, splitting the atom, taking us to the moon and, seemingly just in my lifetime, accomplishing every manner of amazing feats in medicine, all of which only presage more and greater accomplishments in the near future. Surgery has moved from the now seemingly almost barbaric approach of slicing the abdomen wide open to accomplishing complex surgery with access limited to one port, even if that “port” is a pre-existing natural orifice. Cell and tissue engineering technologies, only too recently limited to rudimentary replacement of skin and bone in trauma and disease, are now capable of generating complex orthopedic, cardiac and other tissues and are on the cusp of replacing whole organs. The human genome has been mapped and the complex processes underlying its expression in normal and pathological development are being steadily clarified and understood, with the goal now much closer to when we might intervene in these processes and “cure” genetic diseases, harness the body’s own recuperative potential and otherwise unleash a host of new options in medicine.

While in college some several decades ago, my genetics professor gave a lesson on a Tuesday that he was forced to replace and update by Thursday, since mid-week advances in molecular biology had suddenly expanded our understanding (thank you, Dr. Doe). After college, I was inescapably drawn to a nascent biotech industry that saw vast commercial potential in the diagnostic and therapeutic products that might be spun out of advancements in biological science, only to see that there was a much bigger gap between scientific advance and feasible commercial application.

But between then and the end of the millennium, and twelve years hence, biotech, medical device, pharmaceutical and other practical scientific applications in medicine have proceeded at breakneck speed in setting, breaking and setting again new milestones.

I now stand at a point in examining medical technologies that considers the clinical endpoint for so many conditions to be one that might readily be reached from multiple widely different directions.

I see coronary artery disease that might be addressed by transcatheter coronary artery bypass surgery, angioplasty and drug-eluting stents, atherosclotic plaque-reducing drugs, myocardial tissue regeneration and others.

I see type 1 diabetes on the verge of being met by either stem (or other) cell transplant cure or by a self-contained, closed-loop, artificial pancreas employing biofeedback-based insulin delivery to regulate blood sugar.

I see drugs embedded in devices, devices that stimulate cell migration and tissue growth before these devices are simply resorbed in the tissues. I see a rapid convergence of information technology with biological science leading to a dramatically accelerated pace of discovery, advancement and application.

I also see a rapidly maturing biotech industry that has learned hard lessons in closing (or at least understanding) the gap between a scientific advance and its commercial application.

So, yes, I have a certain attention deficit, since It is hard to concentrate when new developments of significance arise at such a rapid rate. It is also for this reason that every new patent, every new technology entering the pipeline, and every new product gaining approval and entering the marketplace must be evaluated in the light of so many simultaneously advancing fronts. The key is that no scientific or medical advance is absolute — each can only be measured by the extent to which it actually advances knowledge or application relative to other competing developments, of which there are many more than ever before.

Success of Advanced Diabetes Management Technologies

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Recent research by scientists at Johns Hopkins University has found that patients with type I diabetes who use the advanced technologies of continuous blood glucose monitors and infusion pumps fare better then those patients who use finger stick blood glucose testing and insulin injection to, respectively, measure blood glucose levels and administer insulin.

In their study, Sherita Hill Golden, M.D., M.H.S., an associate professor in the division of endocrinology and metabolism at the Johns Hopkins, and her colleagues reviewed and re-analyzed data from 33 randomized controlled trials that compared the newer technologies to conventional methods of monitoring and controlling blood sugar levels. The new technologies they looked at were primarily real-time continuous glucose monitoring devices and insulin pumps.

The researchers found that children, teens and adults with type 1 diabetes who used continuous monitoring had lower blood glucose levels than those who used finger stick testing alone. They also spent less overall time with too much blood sugar (hyperglycemia). Both methods worked equally well to control hypoglycemia, the condition that results when blood sugar levels are too low.

While hypoglycemia was adequately managed by both conventional (finger stick and insulin injection) and advanced (insulin pumps and continuous blood glucose monitoring) methods, hyperglycemia was managed better with continuous blood glucose monitoring and insulin pump infusion. Since more frequent hyperglycemia correlates directly with higher HbA1C levels, overall type I diabetes management is therefore consider better with the more advanced technologies.

Diabetes management is moving toward the state when the combined use of continuous blood glucose monitors and infusion pumps — often described as the “artificial pancreas” — will be the norm for management of this disease, at least until the emergence of cost-effective and otherwise practical stem cell therapy or other pancreatic cell replacement, which may ultimately “cure” type I diabetes.

See the MedMarket Diligence report #D510, “Diabetes Management: Products, Technologies, Markets and Opportunities Worldwide 2009-2018″ for a complete analysis of the worldwide market for diabetes diagnosis, management and treatment products.