Category Archives: neurology

covers neurology, neurosurgery and the products and procedures used in clinical practice

Where will medicine be 20 years from now?

My answer from this question on Quora.

I can answer this question, at least speculatively, from the perspective of clinical practice and medical technology. The other side of “where medicine will be” is the question of healthcare delivery systems, reimbursement, etc. To get that part of it out of the way, it is clear that some form of reform in healthcare will result in a consolidation of the infrastructure paying for and managing patient populations. The infrastructure is bloated and expensive, unnecessarily adding to costs that neither the federal government nor individuals can sustain. This is not to say that I predict movement to a single payer system — that is just one perceived solution to the problem. There are far too many costs in healthcare that offer no benefits in terms of quality; indeed, such costs are a true impediment to quality. Funds that go to infrastructure (insurance companies and other intermediaries and the demands they put on healthcare delivery work directly against quality of care. So, whether it is Obamacare, a single payer system, state administered healthcare (exchanges) or some other as-yet-unidentified form, there will be change in how healthcare is delivered from a cost/management perspective.

From the clinical practice and technology side, there will be enormous changes to healthcare. Here are examples of what I see from tracking trends in clinical practice and medical technology development:

  • Cancer 5 year survival rates will, for many cancers, be well over 90%. Cancer will largely be transformed in most cases to chronic disease that can be effectively managed by surgery, immunology, chemotherapy and other interventions.
  • Diabetes Type 1 (juvenile onset) will be managed in most patients by an “artificial pancreas”, a closed loop glucometer and insulin pump that will self-regulate blood glucose levels. OR, stem cell or other cell therapies may well achieve success in restoring normal insulin production and glucose metabolism in Type 1 patients. The odds are better that a practical, affordable artificial pancreas will developed than stem or other cell therapy, but both technologies are moving aggressively and will gain dramatic successes within 20 years.
  • Diabetes Type 2 (adult onset) will be a significant problem governed by different dynamics than Type 1. A large body of evidence will exist that shows dramatically reduced incidence of Type 2 associated with obesity management (gastric bypass, satiety drugs, etc.) that will mitigate the growing prevalence of Type 2, but research into pharmacologic or other therapies may at best achieve only modest advances. The problem will reside in the complexity of different Type 2 manifestation, the late onset of the condition in patients who are resistant to the necessary changes in lifestyle and the global epidemic that will challenge dissemination of new technologies and clinical practices to third world populations.
  • Cell therapy and tissue engineering will offer an enormous number of solutions for conditions currently treated inadequately, if at all. Below is an illustration of the range of applications currently available or in development, a list that will expand (along with successes in each) over the next 20 years.
  • Gene therapy will be an option for a majority of genetically-based diseases (especially inherited diseases) and will offer clinical options for non-inherited conditions. Advances in the analysis of inheritance and expression of genes will also enable advanced interventions to either ameliorate or actually preempt the onset of genetic disease.
  • Drug development will be dramatically more sophisticated, reducing the development time and cost while resulting in drugs that are far more clinically effective (and less prone to side effects). This arises from drug candidates being evaluated via distributed processing systems (or quantum computer systems) that can predict efficacy and side effect without need of expensive and exhaustive animal or human testing.
  • Most surgical procedures will achieve the ability to be virtually non-invasive. Natural orifice translumenal endoscopic surgery will enable highly sophisticated surgery without ever making an abdominal or other (external) incision. Technologies like “gamma knife” and similar will have the ability to destroy tumors or ablate pathological tissue via completely external, energy-based systems.
  • Information technology will radically improve patient management. Very sophisticated electronic patient records will dramatically improve patient care via reduction of contraindications, predictive systems to proactively manage disease and disease risk, and greatly improve the decision-making of physicians tasked with diagnosing and treating patients.
  • Systems biology will underlie the biology of most future medical advances in the next 20 years. Systems biology is a discipline focused on an integrated understanding of cell biology, physiology, genetics, chemistry, and a wide range of other individual medical and scientific disciplines. It represents an implicit recognition of an organism as an embodiment of multiple, interdependent organ systems and its processes, such that both pathology and wellness are understood from the perspective of the sum total of both the problem and the impact of possible solutions.


There will be many more unforeseen medical advances achieved within 20 years, many arising from research that may not even be imagined yet. However, the above advances are based on actual research and/or the advances that have already arisen from that research.

Applications, global markets in tissue engineering and cell therapy

Screen Shot 2014-04-17 at 7.37.44 AMThe market for tissue engineering and cell therapy products is set to grow from a respectable $8.3 billion in 2010 to nearly $32 billion by 2018. This figure includes bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration, products that often represent a combination of biotechnology, medical device and pharmaceutical technologies. The largest segment in the overall market for regenerative medicine technologies and products comprises orthopedic applications. Other key sectors are cardiac and vascular disease, neurological diseases, diabetes, inflammatory diseases and dental decay and injury.

Cell-tissue-applications

Factors that are expected to influence this market and its explosive growth include political forces, government funding, clinical trial results, industry investments (or lack thereof), and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications. Changes in the U.S. government’s federal funding of embryonic stem cell research has given a potentially critical mass of researchers increased access to additional lines of embryonic stem cells. This is expected to result in an increase in the number of research projects being conducted and thus possibly hasten the commercialization of certain products.

regional-forecast

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

Another factor that has influenced the advancement of regenerative technologies is found in China, where the Chinese government has encouraged and sponsored cutting-edge (and some have complained ethically questionable) research. While China’s Ministry of Health has since (in May 2009) established a policy requiring proof of safety and efficacy studies for all gene and stem cell therapies, the fact remains that this research in China has spurred the advancement of (or at least awareness of) newer applications and capabilities of gene and stem cell therapy in medicine.

Meanwhile, stricter regulations in other areas of Asia (particularly Japan) will serve to temper the overall growth of commercialized tissue and cell therapy–based products in that region. Nonetheless, the growth rate in the Asia/Pacific region is expected to be a very robust 20% annually.


MedMarket Diligence’s Report #S520 remains the most comprehensive and credible study of the current and project market for products and technologies in cell therapy and tissue engineering.

Growth in Sales of Products in Cell Therapy and Tissue Engineering

Tissue engineering and cell therapy comprise a market for regenerative products that has been growing and will continue to grow at over 20% annually through 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.

The current high rate of growth in cell therapy and tissue engineering product sales is due to the confluence of multiple market drivers:

  • Advances in basic science revealing the nature of cell growth, differentiation and proliferation
  • Advances by industry to manipulate and determine cell growth toward specific therapeutic solutions
  • Low barrier to entry for competitors in the market
  • Broad range of applications of cell/tissue advances to many different specialties with modest adaptation needed
  • Strong venture funding

The dominant clinical area driving cell therapy and tissue engineering product sales is orthopedics and musculoskeletal, wherein bone grafts and bone graft substitutes are well-established. Below is the projected balance of cell therapy and tissue engineering product revenues by clinical area through 2018.

Screen Shot 2014-04-08 at 9.26.25 AM

Source: MedMarket Diligence, LLC; Report #S520.

While orthopedics, musculoskeletal and spine applications will remain a huge share of this market, more growth is coming from cell/tissue products in most other areas, which have only recently (within the last five years) begun to establish themselves.

Screen Shot 2014-04-08 at 9.34.50 AM

Source: MedMarket Diligence, LLC; Report #S520.

Use of Surgical Sealants for Cranial and Spinal Dura

Surgical sealants have an enormous range of applications in the treatment of acute and chronic wounds, but while the majority of sealant revenues derives from their use in the hemostasis, closure and sealant of tissues to prevent blood loss…

Screen Shot 2014-04-07 at 9.44.39 AM

 

Source: MedMarket Diligence, LLC; Report #S190

… a different niche use of sealants is stopping cerebrospinal fluid leaks and other dural wound treatments associated with cranial and spinal procedures. These include their use in:

  • Cranial and spinal dural plastic surgery to prevent CSF fistulas.
  • Dural plastic surgery in residual cavities following tumor removal.
  • Dural lacerations in hemilaminectomy operations

Of this, most of the use is currently in cranial applications, but use in spinal applications is growing considerably faster:

Screen Shot 2014-04-07 at 9.44.53 AM

Source: MedMarket Diligence, LLC; Report #S190

 

 

 

Reference reports in Ophthalmology, Coronary Stents and Tissue Engineering

MedMarket Diligence has added three previously published, comprehensive analyses of  medtech markets to its Reference Reports listings. 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.

 

Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Market, Forecast to 2017

Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide

This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, including tapes, sutures/staples/mechanical closure, hemostats, fibrin sealants/glues and medical adhesives and anti-adhesion products. The report details current clinical and technology developments, with data on products in development (detailing market status) and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The report provides full year actual data from 2011. The report provides a worldwide forecast to 2017 of the markets for these technologies, with emphasis on the market impact of new technologies through the forecast period. The report provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World. The report provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies. The report establish the current worldwide market size for major technology segments as a baseline for and projecting growth in the market through 2017. The report assesses and projects the composition of the market as technologies gain or lose relative market performance over this period. The report profiles 122 active companies in this industry, providing data on their current products, current market position and products under development.

See description, table of contents and list of exhibits at http://www.mediligence.com/rpt/rpt-s190.htm Published February 2012..

Harsh questions for complex medtech

robotic_or_scalpelOn the one hand, as I track medical device technology development, I see the increasing trend toward a reduction in the complexity of approaches to accomplish therapeutic ends. The underlying force seems to be, “healthcare technology is expensive, so let’s minimize the technological complexity, minimize the invasiveness, reduce collateral damage, make treatments more specific to the resolution of symptoms and/or disease…” The result is that, for example, endoscopic surgery leads to laparoscopic surgery, which leads to single port laparoscopic surgery, which leads to natural orifice transluminal endoscopic surgery, potentially competing in its minimally invasiveness against alternatives like transcatheter interventional procedures — even for procedures like cardiac valve repair or replacement or coronary artery bypass grafting.

Then, on the other hand, I see technological development moving in the entirely opposite direction of increasing complexity with developments like robotic surgical systems, intraoperative imaging and others, all of which raise the question as to whether we are simply developing technologies for technology’s sake. Do these increasingly complex technologies provide a clinical endpoint not achievable with alternative technologies, or more importantly, procedural approaches? Certainly, I think that technologies that enable a surgeon to perform a procedure that he otherwise simply could not perform, such as those involving the use of intraoperative imaging technologies that enable the surgeon to see healthy versus pathological tissues and differentiate his actions accordingly can arguably result in a better clinical outcome. And as part of this process, one must consider the cost of the accompanying technology such as imaging systems.

Accordingly, when one considers the range of different complex robotic surgical technologies on the market or under development, one has to ask whether these systems truly allow the performance of procedures that the average, well-trained surgeon could not perform without that technology. Certainly, there are complex surgical procedures, such as delicate neuro procedures that, if not performed with extremely precise accuracy, might result in serious collateral damage. But hernia repair? Appendectomy? Colon resection? Hysterectomy? Some of these fairly high-volume procedures have indeed been presented as justification for the enormous expenditure needed to acquire robotic surgical systems.

Forgive me for stating the obvious, but it seems incumbent upon healthcare systems to critically evaluate the cost/benefit of new technology, given the limited resources in healthcare.

For this reason, it does not surprise me in the least that recent reports of complications or, in the least, device problems associated with the use of Intuitive Surgical’s robotic systems have promptly led to a precipitous decline in that company’s stock value. If a technology can’t enable the performance of a procedure that otherwise could not be performed, then its value is in question. Further, if the technology cannot perform a procedure flawlessly, and without complication or error that can arguably be performed without that technology, then its value is seriously in question.