Category Archives: electrosurgery

Where will medicine be 20 years from now?

My answer (edited) from this question on Quora.

I can speculate on this from the perspective of clinical practice and medical technology, but it should be first noted that another, important determinant of “where medicine will be” is the set of dynamics and forces behind healthcare delivery systems, including primarily the payment method, especially regarding reimbursement. 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.

Incremental advances and game-changing innovation in medtech

Medical technology development is driven by a variety of factors. The most common drivers are to extend or improve the capabilities of existing technologies:

    • Addressing under-served clinical need
      • enabling treatment of “untreatable” patient types
      • enabling shift of procedures to outpatient or doctors’ offices
    • Reducing cost
      • less expensive device
      • faster healing time
    • Improving performance
      • reducing operating time
      • lowering the rate of complications

These drivers underscore much activity in medical technology development, since they typically focus on designing products that are improvements upon existing, FDA-approved or CE-Mark technologies. The hurdles to these developments are (relatively) few, requiring little more than being able to construct an argument that a newly developed medical product provides a feature that is “better” than available technologies. (This, of course, represents the putative reason for high healthcare costs, with only nominally “new” technologies commanding price premiums over established ones, but that is the focus of a different discussion.)

In reviewing the formation of new medtech companies that we have recorded in our data over the past three years, there are a number of very common drivers:

  • Intraoperative imaging, monitoring, disease detection

- gas spectroscopy of electrosurgery smoke (e.g., “iKnife”)
– real-time imaging (ultrasound, MRI)
– intraoperative microscopy

        • Polymers, biomaterials, biologics and cell or tissue regeneration to replace diseased or traumatic tissue

- biomaterials
– growth factors
– extracellular matrices
– synthetics (e.g., cartilage)

        • “Back-filling” in endoscopic surgery

- development of surgical instrumentation for use in laparoscopic surgery, single-incision (or single-port) laparoscopy, NOTES (arguably, NOTES is not a radically new approach but the embodiment of what “minimally invasive” endoscopy is when pushed to its logical limits) and other endoscopy .

- endoscopic and surgical instrumentation to allow/facilitate office-based procedures

        • “generic” medical devices
        • biodegradable implants
        • transcatheter technologies

Among the less common of these technologies are those that emerge from the application of a fundamentally different approach to healthcare (call it “paradigm shift” or “game-changing” or whatever your preferred buzz-term).  These technologies consider treatment from a very different perspective that fundamentally change the rules of the game. To some degree, radical change stems simply from the emergence of a new technology that enables radically different treatment, such as the use of stem cells to restore pancreatic function in diabetes. In other cases, medtech manufacturers have recognized the law of diminishing returns in pursuing incremental innovation of established technologies and have instead forged entirely new paths to treatment, as in the use of neuromodulation for pain management (and other clinical end-points) or transcatheter procedures to replace invasive cardiovascular surgery.

Examples of game-changing technologies:

  • Transcatheter alternatives to surgery
  • Treatment of hypertension via ablation of sympathetic nerve
  • Neuromodulation or neurostimulation for relief of chronic pain or treatment of hypertension and other conditions
  • Intraoperative pathology detection (ultrasound, iKnife mass spectrometry, optical coherence tomography)
  • Stem cell or induced pluripotent stem cells applied to treatment of diabetes, other diseases

In the end, the bulk of medtech developments arise from innovative improvements on existing technologies to create competitive advantage, but the mistake for any current market participant is to not remain vigilant in considering the developments of current or potential competitors pursuing radical alternatives to more effectively satisfy clinical (and economic) need.


MedMarket Diligence maintains a dynamic database of Medtech Startup Companies that details very new, highly innovative companies focused on current and emerging medtech markets.

 

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.

 

Ablation technology regional growth to 2019

In our analysis of the global market for the spectrum of ablation technologies — Electrical, Radiation, Light, Radiofrequency, Ultrasound, Cryotherapy, Thermal (other than cryo), Microwave, and Hydromechanical — we assessed the size and growth of sales of these technologies with specificity to a large number of regions and countries:

  • U.S.A.
  • Canada
  • Brazil
  • Mexico
  • Germany
  • United Kingdom
  • France
  • Italy
  • Spain
  • BeNeLux
  • Japan
  • China
  • India
  • Australia
  • Rest of World

Below, we illustrate, ranked from low to high, the compound annual growth rates of each geography/technology combination.  This data reflects the strong trends that exist for clinical adoption and sales growth of specific technologies, driven by the unique combination of country-specific and technology-specific forces.

Source: Report #A145, MedMarket Diligence, LLC.

Global Energy-based Ablation Devices Markets, Forecast to 2019

The global market for energy-based ablation devices in 2011 stood at $11.5 billion.

“Ablation” is considered in the context of medical technology to be a therapeutic destruction and sealing of tissue. As general as this effect on tissue can be, its clinical applications — from cancer to cardiology, urology to ophthalmology and all manner of general surgical procedures — is as broad a therapeutic range as any medical technology on the market.

The technologies represented in clinical practice are, by type of energy:

  • Electrical
  • Radiation
  • Light
  • Radiofrequency
  • Ultrasound
  • Cryotherapy
  • Thermal (other than cryotherapy)
  • Microwave
  • Hydromechanical

The MedMarket Diligence report #A145, “Ablation Technologies Worldwide Market, 2009-2019″, is considered the most comprehensive global report on the products, technologies, and the current and forecast global, regional and country-specific markets.  In this report, the market for the spectrum of ablation technologies has been analyzed, considering current and emerging products and companies, by modality (energy type) and country to 2019.

The dominant market is the U.S., representing a full 43% of the global market (and for this reason needs to be shown on a different y-axis scale than all other country markets for ablation) :

US_Ablation

Source: Report #A145.

 

Clinical Applications of $11.5 Billion Ablation Technologies Market Mapped

The performance of surgery has undergone a steady evolution over the past 40 years, moving from procedures employing scalpels and sutures to procedures employing a dizzying number of product types — reusables/disposables, devices/biologics/hybrids, percutaneous/endo-laparoscopic, real-time MRI and other image-guidance and the whole spectrum of devices and equipment in the $11.5 billion ablation technology market.  This last field harnesses the capabilities of instruments differentiated largely by energy type to therapeutically treat tissue by destruction, excision, sealing and other means.

For reference, a dictionary definition of tissue ablation is “the removal of a body part or the destruction of its function, as by surgery, disease, or a noxious substance.” From a device/instrumentation standpoint (as opposed to, for example, chemically-based ablation), ablation is the therapeutic destruction and sealing of tissue or creation of other therapeutic effect in tissue. The predominant forms of device-based ablation technologies include:

  • Electrical
  • Radiation
  • Light
  • Radiofrequency
  • Ultrasound
  • Cryotherapy
  • Thermal (other than cryotherapy)
  • Microwave
  • Hydromechanical

While the tissue effects produced by these different modalities have potential for use in virtually all clinical applications, their emerging use is concentrated in a fairly well defined but detailed list.  The largest share of the market for energy-based ablation devices, driven to a significant extent by its long history in clinical practice, is in cancer therapy, primarily via radiation therapy. General surgical applications represent the next most common use of ablation technologies, especially those using electrocautery and electrosurgical devices, radiofrequency ablation and cryotherapy, etc. Cardiovascular applications then represent the next most active area of ablation technologies, especially given the often acute nature of cardiovascular disease.

Most of the universe of ablation technology clinical applications is illustrated in the map, below.

Source: MedMarket Diligence, LLC (Report #A145)

Ablation technologies in cancer

Cancer represents a major target of the clinical applications of ablation technologies, as illustrated by the share of each modality’s 2011 revenues that are used in cancer:

Source: Report #A145, “Ablation Technologies Worldwide Market 2009-2019″, MedMarket Diligence, LLC.

Considering the utility of the different ablation types for treatment of cancer, it’s not surprising that radiation is the dominant source of ablation technology revenues for cancer in 2011.

Share of All Ablation Revenues in Cancer, by Modality, 2011

Source: Report #A145, “Ablation Technologies Worldwide Market 2009-2019″, MedMarket Diligence, LLC.