Category Archives: gynecology

Medtech from incremental to quantum leap advances

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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

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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.

 

Harsh questions for complex medtech

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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.

Clinical Applications of $11.5 Billion Ablation Technologies Market Mapped

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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)

Medical and surgical sealants/adhesives clinical indications

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Medical/surgical sealants and adhesives are being adopted in a large and growing number of procedures.  Sutures, clips and staples, by comparison, hold a large share of procedure volume and are stubborn to give ground against sealants and adhesives.  There is no doubt, however, that the relatively higher growth rates for the novel closure products are steadily eroding the century-long hold dominance of sutures in wound closure.

Below are illustrated selected (the full list including "Others" is given in Report #S190) procedural indications for sealants and adhesives by clinical area,

 

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Source: MedMarket Diligence, LLC; Report #S190.

 

Medical and surgical procedures with potential use of sealants, glues, hemostats

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The extent to which medical and surgical procedures may potentially employ emerging fibrin (and other) sealants, glues, hemostats, wound closure and anti-adhesion products is driven by the utility offered by these products in specific clinical applications, which may be grouped by the following consideration:

 

Category I: Important and Enabling Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood.
Category II: Improved Clinical Outcome Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery).
Category III: Cost-Effective and Time-Saving Immediate reduction in surgical treatment time and follow-up treatments.
Category IV: Aesthetic and Perceived Benefits Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.

Source: MedMarket Diligence, LLC; Report #S190.

 

MedMarket Diligence has assessed the procedure volumes, worldwide, that fall into these categories based on the utility offered by adjunctive surgical sealant and glues products for each of the major clinical categories:

Source: MedMarket Diligence, LLC; Report #S190.

Applicable caseloads for surgical sealants, glues and related products

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The potential for the application of adjunctive wound management products is driven by the nature of the medical or surgical wound type, the vascularization at the site, the tensile strength needed and capable with available medical/surgical glues and the extent to which manufacturers have developed products that clinicians have adopted, or may soon adopt, in their practices.

Below are illustrated key procedures worldwide that applicable for use of adjunctive wound management products — fibrin and other sealants, high strength glues, hemostatic agents and anti-adhesion products.

Source: MedMarket Diligence, LLC; Report #S190, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017"

High strength medical and surgical glue applications, growth

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High-strength glue products were approved for topical closure applications in the United States in the late 1990s, but have been used considerably more outside the USA. In other countries, such as the major markets of the EU, high-strength glues and adhesives were approved several years ago and have built up a track record of use in internal surgery. Today, high-strength glues are being used in a wider range of procedures both in the US and outside the US. Physicians and researchers are exploring how these glues may be utilized in current or new procedures to produce more cost-effective, better outcomes with reduced morbidity and mortality.

The unmet need for non-toxic, high-strength, resorbable glues is clearly demonstrated by adoption of existing glue products outside of the United States. The table below displays selected applications (see report #S190 for the comprehensive list) for commercially approved products and illustrates the growing potential for these high-strength glues once they gain universal approval and adoption within the surgical community worldwide. These products have high-strength sealant and adhesive properties is leading to their increasing adoption by clinical practitioners, starting with surgical closure and specific internal procedures for which there is no good alternative. Recent data shows increasing usage for tissue adhesives in vascular, neurological, spinal, orthopedic, and other procedures.

Selected* Surgical Indications for High-Strength Glues 

Surgical Field
Applications
CNS surgery:Adhesive agent in CNS tissue surgery. CNS tissue cannot be sutured. Fibrin glue is almost equivalent to microsurgical suture. Fibrin glue works as a sealant but not a nerve barrier.
Repair of dural defects.
(Others)
Eye surgery:Conjunctival closure in strabismus.
Wound closure in glaucoma.
Lower blepharoplasties (for lower eyelids).
(Others)
ENT surgery:Myringoplasty in large persistent tympanic membrane perforation.
Repair of laryngotracheal separation with cricoidectomy.
Narrowing of nasal fossa in atrophic rhinitis.
(Others)
Oral and dental surgery:Local hemostatic measures in patients with bleeding disorders and patients on anticoagulants.
Sealing of oro-antral fistula.
(Others)
Head and neck:Parotidectomy closure.
Axillary dissection in carcinoma of the breast. Reduces adhesion, bleeding and serous drainage with earlier drain.
(Others)
Cardiovascular thoracic surgery:Reduced postoperative bleeding and intrapericardial adhesion.
In cardiothoracic surgery using fibrin glue significantly reduced postoperative bleeding.
(Others)
Chest surgery:Sealing of prolonged air leak after thoracotomy in lung cancer.
Bronchopleural fistula.
Percutaneous lung biopsy.
(Others)
Vascular surgery:Microvascular anastomosis: Suture may induce vascular narrowing, foreign body reaction, intravascular thrombosis but are less common in those with fibrin glue application.
Arterial bypass surgery.
(Others)
Gastrointestinal surgery:Gastrointestinal sutureless anastomosis-stent.
Esophagus perforation.
Esophago-jejunal anastomosis.
Recurrent tracheo-esophageal fistula.
Upper gastrointestinal tract fistula: Endoscopic obliteration.
(Others)
Liver surgery:Liver resection in benign and malignant diseases.
Liver transplantation.
(Others)
Uro/Gynecological system:Colpofixation in stress urinary incontinent.
Intractable transplant-ureteral fistula.
Transvaginal colpo-urethropexy.
(Others)
Gynecological surgery:Recto-vaginal and ano-rectal fistula.
Anastomosis of the fallopian tube in animals.
(Others)
Bone & orthopedic surgery:Joint replacement.
Brachial plexus injury repair.
(Others)
Plastic surgery:Face lift procedure. Fibrin glue reduces major hematomas and ecchymoses.
Musculo facial plastic surgery, dorsal hand burns, infected skin graft.
(Others)

*See Report #S190 for the comprehensive list.

Source: MedMarket Diligence, LLC, Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017.”

Competition, investment and markets in cell therapy, tissue engineering

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Competition in the field of tissue engineering and cell therapy is intense, whether it be attracting top scientists, obtaining licenses to university-owned patents, being the first to reach market with a particular technology, obtaining coveted investment funding, or gaining the attention of larger companies with deeper pockets.

With new companies being founded every day, competition is intense among these new enterprises to obtain these coveted prizes. Meanwhile, most large medical device and pharmaceutical companies are still choosing to cautiously evaluate which companies, if any, they might acquire or partner with.
Licensing a patented academic technology for further development is one way biotechnology companies can expand their intellectual portfolio. It is also a way to defend one’s turf by preventing a competitor from using that patented information. Thorough networking can work to the company’s advantage here, because it can yield insights about research progress, about who to contact for licensing discussions, and what other companies may be sniffing around for a good licensing opportunity.

If a company is considering licensing, then it should examine the quality of the patent (whether it is both broad enough and defensible), how much access the company will have to the inventors, rights to publish further research and the rights to sublicense out the work. The company must decide if the technology could form the basis for a new company or if it is an assistive technology that may broaden core strengths the company already possesses. The technology should also be examined to see how far from market an end product likely is. Of course, the details of dividing up any monetary awards must also be addressed. Licensing involves fees, which may include upfront fees, fees or royalties to be paid on a milestone or quarterly basis, and annual maintenance fees. The patent holder naturally expects value for licensing out the patent, whether that value is harvested at the beginning of the relationship or at the end.

Industry Focus. The majority of biotech companies involved in this industry are focusing on disease areas that have the most patients and the largest unmet needs. These include cancer therapies, diabetes, orthopedics and cardiovascular products. Some companies are taking a different approach, attempting to carve out a niche for themselves in a disease state with a smaller population and a less crowded playing field, such as Alzheimer’s, ophthalmology or central nervous system disorders.

Investment Levels. As the debate on health care reform nears resolution, the market will likely see a modest increase in mergers and acquisitions among pharmaceutical, medical device and biotechnology companies.

In terms of investment dollars, the stock market crash of 2008 had a major impact on the amount of investment dollars available to fledgling businesses. In the case of biopharmaceuticals, the typical drug development process for drug candidates that make it to market can take more than 12 years and $1.2 billion. Unfortunately, nearly 90% of drug candidates will fail in development.

Typically, venture capitalists provide five to eight years of equity to start-ups who may or may not amount to a successful enterprise. Because of downturns in financial markets for the last two years or so, venture capitalists and investment banks have increasingly been choosing to fund their prior investments rather than new start-ups.

Investor Returns. Primarily because of the lengthy and costly rigorous clinical trial process required, biomedical companies require great deals of capital to support them until their innovative product reaches market. Biotechnology companies may need as much as $1 billion to allow it to survive a 10–12 year time span to reach market. Because of the tightening of financial markets, less money has been available for new companies, forcing some either to license to larger companies future rights to their technologies or to sell their technology outright. Others less fortunate have been forced to close their doors.

Investing in biomedical enterprises has always been risky as only a small percentage ever make good on the investment. In the face of a global recession, investors are only getting more difficult to find and many new companies are struggling to stay afloat. For instance, in California, 334 biotechnology companies with an aggregated market cap of $352.1 billion were traded publicly on major U.S. markets in the third quarter of 2009, according to PricewaterhouseCoopers. Of these, 135 had less than one year of cash remaining and 42% had less than six months of funding left.

Below is illustrated the 2009 to 2018 forecast for the global markets in tissue engineering, cell therapy and transplantation, by clinical area.

Source: MedMarket Diligence, LLC, Report #S520, "Tissue Engineering, Cell Therapy and Transplantation: Products, Technologies & Market Opportunities, Worldwide, 2009-2018."

Surgical procedures penetrated by sealants, glues, hemostats and anti-adhesion products

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Approximately 140 million wounds (acute and chronic) are created annually worldwide that offer potential for use of adjunctive surgical closure and securement products; approximately 42 million of these wounds are created during surgical procedures in the United States.

Although healing of all these wounds might be improved through use of adjunctive surgical closure and securement products, it is likely that increased usage of these products will be limited, on clinical, economic and other grounds, to a fraction of procedures. It is realistically estimated that 10%–15% of these procedures would benefit from increased use of newly developed adjunctive surgical closure and securement products.

The criteria driving which surgical procedures take up adjunctive surgical closure and securement products include clinical utility, cost effectiveness, aesthetic/perceived benefits and others, and (for the sake of understanding) can be grouped into the following categories:

 

The relative numbers of surgical procedures, grouped by these categories and clinical area, are illustrated below.

Source: MedMarket Diligence, LLC; Report #S190.