Category Archives: ophthalmology

products, technologies and practices in the management of vision disorders and eye-related diseases

Where will medicine be in 2035?

(This question was originally posed to me on Quora.com. I initially answered this in mid 2014 and am revisiting and updating the answers now, in mid 2015.)

An important determinant of “where medicine will be” in 2035 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.
    [View Aug. 2015: Cancer has been a tenacious foe, and remains one we will be fighting for a long time, but the fight will have changed from virtually incapacitating the patient to following protocols that keep cancer in check, if not cure/prevent it.]
  • 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.
    [View Aug. 2015: Developments in the field of the “artificial pancreas” have recently gathered considerable pace, such that, by 2035, type 1 blood glucose management may be no more onerous than a house thermostat due to the sophistication and ease-of-use made possible with the closed loop, biofeedback capabilities of the integrated glucometer, insulin pump and the algorithms that drive it, but that will not be the end of the development of better options for type 1 diabetics. Cell therapy for type 1 diabetes, which may be readily achieved by one or more of a wide variety of cellular approaches and product forms (including cell/device hybrids) may well have progressed by 2035 to become another viable alternative for type 1 diabetics. See pending report.]
  • 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.
    [View Aug. 2015: Despite increasing levels of attention being raised to the burden of type 2 worldwide, including all its sequellae (vascular, retinal, kidney and other diseases), the pace of growth globally in type 2 is still such that it will represent a problem and target for pharma, biotech, medical device, and other disciplines. See pending report.]
  • 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.

    [View Aug. 2015: Cell therapy will have deeply penetrated virtually every medical specialty by 2035. Most advanced will be those that target less complex tissues: bone, muscle, skin, and select internal organ tissues (e.g., bioengineered bladder, others). However, development will have also followed the money. Currently, development and use of conventional technologies in areas like cardiology, vascular, and neurology entails high expenditure that creates enormous investment incentive that will drive steady development of cell therapy and tissue engineering over the next 20 years, with the goal of better, long-term and/or less costly solutions. See Smithers Apex report.]
  • 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.
    [View Aug. 2015: It’s a double-edged sword with the human genome. As the human blueprint, It is the potential mother lode for the future of medicine, but it remains a complex set of plans to elucidate and exploit for the development of therapies. While genetically-based diseases may readily be addressed by gene therapies in 2035, the host of other diseases that do not have obvious genetic components will resist giving up easy gene therapy solutions. Then again, within 20 years a number of reasonable advances in understanding and intervention could open the gate to widespread “gene therapy” (in some sense) for a breadth of diseases and conditions.]
  • 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.
    [View Aug. 2015: The development of effective drugs will have been accelerated by both modeling systems and increases in our understanding of disease and trauma. It may not as readily follow that the costs will be reduced, something that may only happen as a result of policy decisions.]
  • Most surgical procedures will achieve the ability to be virtually non-invasive. Natural orifice transluminal endoscopic surgery (NOTES) 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.
    [View Aug. 2015: By 2035, technologies such as these will have measurably reduced inpatient stays, on a per capita basis, since a significant reason for overnight stays is the trauma requiring recovery, and eliminating trauma is a major goal and advantage of the NOTES technology platform. A wide range of other technologies (e.g., “gamma knife”) across multiple categories (device, biotech, pharma) will also have emerged and succeeded in the market by producing therapeutic benefit without collateral damage.]
  • 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.
    [View Aug. 2015: There are few technical hurdles to the advancement of information technology in medicine, but even in 2035, infotech is very likely to still be facing real hurdles in its use as a result of the reluctance in healthcare to give up legacy systems and the inertia against change, despite the benefits.]
  • 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.
    [View Aug. 2015: This orientation will be intrinsic to the development of medical technologies, and will increasingly be represented by clinical trials that throw a much wider and longer-term net around relevant data, staff expertise encompassing more medical/scientific disciplines, and unforeseen solutions that present themselves as a result of this approach.]

The breadth and depth of advances in medicine over the next 20 years will be extraordinary, since many doors have been recently opened as a result of advances in genetics, cell biology, materials science, systems biology and others — with the collective advances further stimulating both learning and new product development. 

Wound Sealant and Securement Procedure Volumes by Clinical Area and End-Point

Sealants, glues, hemostats, and other products in wound closure and securement offer benefits that vary by clinical area, but the nature of that benefit also varies by the type of end-point (benefit) the product achieves — does it provide a life-saving benefit? A time-saving? Cost-savings? A cosmetic or aesthetic benefit?

Accordingly, by examining the volume of procedures for which closure and securement products provide which kind of benefit is crucial to understanding demand, especially between competitive products.

Below is a categorization of benefits ranging from the critical (I) to the aesthetic (IV).

Criteria for Adjunctive Use of Hemostats, Sealants, Glues and Adhesion Prevention Products in Surgery

Screen Shot 2015-06-23 at 7.24.29 AM

Source: MedMarket Diligence, LLC (Report #S192)

Considering these different categories, below are the volumes of procedures distributed by category across each of the major clinical disciplines.

Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Wound Closure Products, Worldwide (Millions), 2014

 

 

 

 

Screen Shot 2015-06-23 at 7.28.36 AM

Source: MedMarket Diligence, LLC (Report #S192)

Growth of Ablation Technologies, Applications, Worldwide

The growth in sales of a medical technology is dictated by a unique combination of a specific technology in a specific clinical application in a specific geographic market.

In the Smithers Apex report, The Future of Tissue Ablation Products to 2020, the markets for the different ablation technology types were assessed per application in each of the major world geographies. See the groupings, below:

Ablation Types and Clinical Applications:

  • Electrosurgical/radiofrequency
    • Cardiac
    • Surgical
  • Microwave
    • Oncologic
    • Urologic
  • Laser
    • Aesthetic
    • Ophthalmic
    • Surgical
  • External Beam Radiation Therapy (EBRT)
    • LINAC Systems
    • Cobalt-60
  • Cryoablation
    • Cardiac & Vascular
    • Oncologic Surgery
    • GYN Surgery
    • Dermal/Cutaneous Surgical
  • Ultrasound
    • Ophthalmic (Cataract) Surgical
    • Multipurpose Surgical
    • Urologic Surgical
    • Multipurpose High Intensity Focused Ultrasound (HIFU)

Geographic Areas:

  • United States & Other Americas
  • Largest Western & European States
  • Major Asian States
  • Rest of World

The Smithers Apex report contains the detailed assessment of ablation technology sales in each combination of technology, geography and clinical application. Below is illustrated graphically, sorted by compound annual growth rate in sales, each of the combinations.

Growth of Ablation Technologies by Clinical Application and Geography, 2014-2020

image001

Source: Smithers Apex

 

New technologies at Medtech Startups, November 2014

Below is a list of the technologies under development at companies recently identified and included in the Medtech Startups Database.

  • Handheld ultrasound, MRI imaging device.
  • Needle-free injection drug delivery.
  • Lenses designed to correct imbalance between eyes and brain that cause certain migraines.
  • Continuous blood glucose monitoring in diabetes.
  • Customized prosthetic aortic valve.
  • Cystoscope-implanted, stent-like device to treat urinary obstruction associated with benign prostatic hypertrophy.
  • Endovascular treatment for abdominal aortic aneurysm.
  • Respiratory therapy device based on “high frequency chest wall oscillation” for treatment of COPD, other respiratory disorders.
  • Treatment of arrhythmia.
  • Medical device commercialization company active in cardiovascular care, tissue ablation, medical infusions, hand surgery and laparoscopic surgery.
  • Surgical visualization systems.
  • Arthroscopic bone tunneler and other orthopedic surgical instrumentation.
  • Brain stimulation to treat multiple disorders.

See link for a month-by-month listing of the technologies at companies in the Medtech Startups Database.

New technologies at medtech startups, October 2014

Below is a list of the technologies under development at medical technology startups recently identified and included in the Medtech Startups Database.

  • Prosthetic disc nucleus in spine surgery.
  • Device and non-device technologies based on dynamics of blood flow.
  • Magnetic and fluorescent technology point-of-care device to detect heart attack.
  • Technologies for tissue reconstruction.
  • Adult stem cell therapy in orthopedics, aesthetics, and chronic diseases (diabetes, COPD, heart disease, multiple sclerosis, stroke/cerebrovascular disease).
  • Vagus nerve stimulation for neuromodulation treatment of various inflammatory autoimmune diseases.
  • Surgical devices including for endoscopic access closure.
  • Device to measure sympathetic nerve activity and produce ECG.
  • Simultaneously track electrical measures that indicate brain, heart, optical and musculoskeletal activity.
  • Needle-free pediatric withdrawal of blood.
  • Ventilation systems for improved delivery of gas, moisture and nebulized medication.
  • Broadly focused medical technology company active in osteoarthritis, cardiovascular, stroke, diabetes, infection control and spine surgery.

For a historical listing of technologies at medtech startups, see link.

Funding in medical technology, October 2014

Funding for medical technologies in October 2014 totaled $332 million, led by the $59 million funding of Ivantis, Inc., and the $55 million funding of PureTech.

Below are the top fundings for the month:

Company, funding Product/technology
Ivantis, Inc., has raised $58.87 million of a $71.37 million round of fundng according to a regulatory filing Stent-based treatment to lower intraocular pressure in glaucoma
PureTech has raised $55 million in a round of funding according to the company Medical device and other technologies spanning treatments in immunology, metabolism, neuroscience, drug delivery and consumer digital health
VytronUS, Inc., has raised $31.6 million in a Series B round of funding according to the company Integrated imaging and ultrasound ablation for treatment of cardiac arrhythmias
Respicardia, Inc., has raised $25.09 million in a round of funding according to a regulatory filing Electrical pulse-based implant treatment for sleep apnea
Magnus Life Science (Magnus Life Ltd) has raised £15.5 million ($24.96 million) in a round of funding according to regulatory filing Device and non-device technologies based on dynamics of bloodflow
Medrobotics Corp. has raised $20 million in a preferred stock offering according to the company Computer-assisted access and visualization system for minimally invasive robotic surgery

For the complete list of medtech fundings in October 2014, see link. For a historical list of the fundings in medtech, by month, since 2009, see link.

New Medical Technologies at Startups, September 2014

Below is a list of new technologies under development at medtech startups recently identified and included in the Medtech Startups Database:

  • Robotics for ophthalmic surgery.
  • Dynamic force generation for bone repair.
  • Neursurgical brain simulation system.
  • Orthopedic technologies including pedicle screw that does not require a guide wire.
  • Synthetic bone graft materials.
  • Minimally invasive mitral valve replacement.

For a historical listing of the technologies under development at medtech startups, see link.

New Technologies Under Development at Medtech Startups, August 2014

Below is a list of the technologies under development at newly identified medtech startups and included in the Medtech Startups Database.

  • Technology for the repair of rotator cuff tears.
  • Technologies for intravenous cannulation and phlebotomy, and an otorhinoscope.
  • Implant for the treatment of urinary incontinence.
  • LED (light) treatment of acute, dry macular degeneration.
  • Esophageal cooling device to manage patient temperature.
  • Surgical robotics.
  • Patient positioning system for orthopedic surgery.
  • Device to treat macular degeneration by delivering microcurrent to the eye.

For a historical listing of medtech startup technologies included in the database, see link.

Effective technologies for wound hemostasis, sealing and closure

See the pending 2014 Report #S192, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2013-2020”.

Tourniquet, pressure and sutures have been used for controlling excessive bleeding during surgical procedures for many hundreds of years. Fibrin sealants represented a revolution in local hemostatic measures for both bleeding and nonbleeding disorders. Fibrin sealant has the potential to provide life-saving control of excessive bleeding in many critical surgical operations and during a number of elective procedures. The terms “sealant” and “glue” are frequently used interchangeably in the surgical context, but there is actually a difference in adhesive strength between sealants, pioneered by fibrin products (sometimes homemade) and the later, stronger glues of which cyanoacrylate-based products are the most common.

In order for a sealant to be effective, the product should meet several parameters, depending upon the application. Among these are:

  • Ability to close the wound
  • Strength of bond
  • Speed of curing
  • Protection of the wound from infection
  • Low surface friction
  • Breathability in order to aid healing
  • Lack of adverse side effects to skin and internal tissues
  • Cost-effectiveness
  • Ease of handling

Fibrin and other sealant products have been approved and used outside the United States for many years and their use has created strong awareness of their surgical and economic benefits in Europe, Latin America and Asia. As a result, many such products have been marketed in these regions for 20 years or more, and have been developed for a variety of surgical uses. In the U.S., these products were initially approved as hemostatic adjuncts to suturing. They are increasingly being used for sealing of tissues, but their use beyond simple hemostasis (i.e., as sealants and low-strength glues) lags that of markets outside the U.S.

Despite the development of novel sutures (e.g., resorbable), endoscopically applied clips and other innovations, fibrin sealants will remain a versatile option available to surgeons to achieve hemostasis and sealing of wounds (alone or adjunctively with sutures/staples). Their clinical track record, biocompatibility and ready availability match high demand. Their limitation in adhesive strength, however, does put some limit on their sales potential, since significant demand exists for tight sealing and strong bonding of tissues under stress, such as in lung and bowel resections, cardiovascular and other anastomoses and adhesion of muscle, that go beyond what fibrin sealants can achieve. For this reason, other naturally-occuring “bioglues” are under development that will achieve tighter tissue bonds than fibrin sealants, but without the toxic effects of cyanoacrylates (“superglues”).

There are more than 30 companies worldwide developing fibrin sealants and driving a market that will exceed $2.2 billion by 2017.

sealants-regional-forecast

 Source: MedMarket Diligence, LLC; Report #S190. (This report is being updated by the pending 2014 Report #S192.)

For complete analysis of the global market for fibrin sealants, see the MedMarket Diligence Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017.”

Medical technologies and recently identified startups (June 2014)

New medical technologies under development at recently identified startups span ophthalmology, gastroenterology, cardiology, spine surgery, orthopedics, patient monitoring and surgical instrumentation.  Below are the technologies at the recently identified medtech startups that have been included in the Medtech Startups Database.

  • Intraocular lens for presbyopia.
  • Portable, wireless EKG device.
  • Tissue engineering in peripheral and central nervous system injury.
  • Micro transtympanic drug delivery to the ear.
  • Diagnosis of functional GI disorders.
  • Spinal implants and instrumentation systems.
  • Surgical suction devices.
  • Calcium phosphate bioceramic implants for bone defects.
  • Intervertebral fusion cage.
  • Monitoring of neural activity during sedation.
  • Surgical instrument positioning systems for minimally invasive and robotic surgery.
  • Critical care monitoring technologies.

For a historical listing of medical technologies under development at startups, see link.