Category Archives: radiation therapy

Medtech from incremental to quantum leap advances

Advanced medical technologies become advanced by the application of innovation that results in more effective, less costly or otherwise arguably better outcomes (including reduced risk of complications or disease recurrence) for patients, including in some cases enabling treatment when none was previously possible. It is intrinsic to every entrepreneur that the idea he/she is pursuing accomplishes this.

Manufacturers of products on the market have an imperative to either improve upon those products or make them obsolete. This imperative is manifested in a spectrum of planned innovation from simple incremental innovations to the quantum leap of a radically new approach.

There is an enormous amount of technology development, often applicable to multiple different clinical applications, that will be realized in product markets in the future. For the moment, though, I would like to look beyond “incremental improvements” or “product line extensions” or other marginal advances that serve little more than superficially addressing shortcomings of existing products on the market. I would like to look at waves of innovation coming in the short to long term that are expected to impact medtech in ways that are increasingly “radical” or represent varying orders of magnitude of improvement in results.

Three categories spanning short, mid, and long reflect what I see in medtech development. Below, I outline the nature of each and the specific examples that are or will be emerging.

Short term. With change encompassing technologies that are just sufficiently different so that they cannot simply be called incremental innovations, some short term advances often combine two or more complementary and/or synergistic technologies in new ways to advance healthcare. Examples include:

  • Image-guided surgeries to augment the surgeon’s ability to navigate complex anatomy or discern the margins of healthy versus disease tissue.
  • Natural orifice endoscopic surgery (and shift in general from invasive to interventional and intraductal procedures) to either drastically reduce or eliminate the trauma of surgical access
  • Non-invasive therapeutics (like lithotripsy, gamma knife, others) to treat disease without trauma to collateral tissues.
  • Genome-driven treatment profiling (prescreening to determine ideal patients with high probable response).
  • Personalized (custom) implants. These already exist in orthopedics, but the potential for customized implants in gastroenterology, cardiology, and many other clinical areas is wholly untapped.
  • Regenerative technologies (bone, skin, other). These technologies represent introductory markets with lowered challenge compared to more complex functional anatomy (e.g., vital organs).
  • Smart devices (implantable sensors, RFID-tagged implants, etc.) to provide data to clinicians on implant location and status or, in the extreme respond diagnostically or therapeutically to changes in the implant’s immediate environment.

Mid-term. These are new therapeutic options that are fundamentally different than those in current use for a given treatment option. These are technologies that have demonstrated high probability of being feasible in large scale use, but have not yet accumulated enough clinical data to warrant full regulatory approval.

  • Nanotech surface technologies for biocompatibility, localized treatment delivery or other advantages at the interface between patient and product.
  • Materials that adapt to changes in implant environment, to maintain pH, to release drugs, to change shape.
  • Artificial heart. A vital organ replacement that currently has demonstrated the capacity to be a bridge to transplant but has also advanced sufficiently to open the possibility of permanent replacement in the not-too-distant future.
  • Cell/device hybrids. These are organ replacements (e.g., kidney, lung, liver) performing routine function or natural organs, but configured in a device to address unresolved issues of long term function, immune response and others.
  • Artificial organs (other than heart) — closed loop glucometer/insulin pump (artificial pancreas). These are not even partial biological representations of the natural organ, but completely synthetic “organs” that intelligently regulate and maintain a steady state (e.g., blood glucose levels) by combining the necessary functions through combined, closed-loop mechanical means (an insulin pump and glucometer with the necessary algorithms or program to independently respond to changes in order to otherwise maintain a steady state.

Long-term. Orders of magnitude, quantum shift, paradigm shift or otherwise fundamentally different means to serve clinical need.

  • 3D implant printing. In a recent example, in an emergency situation a 3D implant for repair of a infant’s trachea was approved by the FDA. These implants, as in the case of the trachea repair, will most often be customized for specific patients, matching their specific anatomy and may even include their (autologous) cells. They may also be made of other materials including extracellular matrices that will stimulate natural cell migration followed eventually by bioabsorption of the original material. Depending upon type of material and complexity of the anatomy, these technologies may emerge in the near or distant future.
  • Gene therapies. Given the root cause of many diseases has a genetic component or is entirely due to a genetic defect, gene therapies will be “permanent corrections” of those defects. An enormous number of hurdles remain to be crossed before gene therapies are largely realized. These deal with delivery and permanent induction of the corrected genes into patients.
  • Stem cell therapies. The potential applications are many and the impact enormous of stem cell therapies, but while stem cell technology (whether for adult or embryonic) has made enormous strides, many challenges remain in solving the cascade of differentiation while avoiding the potential for aberrant development of these cells, sometimes to proliferative (cancerous) states.
  • “Rational” therapeutics. Whether by stem cell therapies, gene therapies or other biochemical or biological approach, “rational” therapeutics represent the consummate target for medical technology. Such therapeutics are “rational” in the sense that they perfectly address disease states (i.e., effect cures) without complication or need for recurrent intervention.

There are certainly more holes than fabric in this tapestry of short-, mid- and long-term technology innovation, but this should serve to illustrate the correlation between the sophistication of the potential medtech solution and the level of technical challenge in order to achieve each.

 

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.

Ablation technologies global growth (electrical, radiation, light, RF, ultrasound, cryo, thermal, microwave, hydro)

The global market for ablation is in steady growth, but also is shifting in the balance of technologies employed.

The global market for energy-based ablation Devices in 2011 was estimated at almost $11.5 billion. For purposes of definition, ablation is considered to be a therapeutic destruction and sealing of tissue. The technologies that fall into this segment to nine different types based on the energy modality employed:

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

Below is illustrated, first, the 2009 and 2019 revenues ($millions) for ablation by energy type and, second, the 2009 and 2019 revenues by energy type as a percent of total.

 

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

 

Although the applications of ablation devices include a number of aesthetic treatments, the majority of applications remain chronic disorders in areas which include cancer, cardiovascular, urology, gynecology and orthopedics. Many of these disorders are age-related, and the related device segments are driven by the aging of the global populations.  Other market drivers include the Chinese government’s push to modernize its healthcare facilities by building 400 hospitals per year, and developed country populations which are demanding anti-aging treatments, to which physicians are responding by purchasing equipment