Where will medicine be in 2035?

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, in the U.S., whether Obamacare persists (most likely) or is replaced with 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. Cancer and genomics, in particular, has been a lucrative study (see The Cancer Genome Atlas). Immunotherapy developments are also expected to be part of many oncology solutions. 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.

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.

  • 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.

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.

  • 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.

    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.
  • 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.

    As the human genome is the engineering plans for the human body, it is a 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 –> Case in point, the recent emergence of the gene-editing technology, CRISPR, has set the stage for practical applications to correct genetically-based 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.The development of effective drugs will have been accelerated by both modeling systems and increases in our understanding of disease and trauma, including pharmacogenomics to predict drug response. 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.

    By 2035, technologies such as these will measurably reduce 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 minimally invasive technologies (e.g., especially the NOTES technology platform). A wide range of other technologies (e.g., gamma knife, minimally invasive surgery/intervention, etc.) across multiple categories (device, biotech, pharma) will also have emerged and succeeded in the market by producing therapeutic benefit while minimizing or eliminating 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.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.

  • Personalized medicine. Perfect matches between a condition and its treatment are the goal of personalized medicine, since patient-to-patient variation can reduce the efficacy of off-the-shelf treatment. The thinking behind gender-specific joint replacement has led to custom-printed 3D implants. The use of personalized medicine will also be manifested by testing to reveal potential emerging diseases or conditions, whose symptoms may be ameliorated or prevented by intervention before onset.
  • 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.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.Other technologies being developed aggressively now will have an impact over the next twenty years, including medical/surgical robots (or even biobots), neurotechnologies to diagnose, monitor, and treat a wide range of conditions (e.g., spinal cord injury, Alzheimer’s, Parkinson’s etc.).

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. 

See the 2016 report #290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.”

Medtech succeeds by responding to multiple demands

Medtech is resilient, adapting to the changing demands of patients, payers, regulators, and the economy, but only in the hands of the innovators who keep a finger in the wind on these demands.

  1. Comprehensive outcomes versus symptomatic intervention. Competition in medtech, heightened by cost pressures in particular, is characterized by the demand for comprehensive solutions to disease/trauma rather than technologies that simply ameliorate symptoms. Manufacturers are focusing on longer term solutions, competing against the full spectrum of therapeutic alternatives rather than incremental improvements in their widgets.
  2. Whatever the cost, make it lower. Cost is poorly understood in healthcare (hence the problem!), but it is recognized as important simply by the rate at which premiums increase, the percentage of GDP adding to healthcare spending, the cost of Medicare and other similar benchmarks. Cost is difficult to assess in medical technologies, because there are long term, unforeseen implications of nearly every medtech development. Nonetheless, the manufacturer who does not only bow down in homage to cost but also makes cost at least an implicit part of its value proposition will be quickly put out of business.
  3. The life spans of “gold standards” of treatment are getting shorter and shorter. Technology solutions are being developed, from different scientific disciplines, at such a pace as to quickly establish themselves, in a broad enough consensus, as new gold standards. Physicians are increasingly compelled to accept these new new standards or find their caseload shifting to those who do.
  4. Many manufacturers strive for being able to claim their products are “disruptive” — overturning existing paradigms. However, few medtech manufacturers really ever achieve anything more than marginal improvements. Note the relative amount of 510Ks versus PMAs in regulatory approvals (not that a PMA denotes a “disruptive” development).
  5. Materials technologies are defining what is a “device” as well as what they can accomplish. Competitive manufacturers are aggressively gaining a broad understanding of materials technologies to encompass traditional device, pharma, biopharma, biotech, cell biology and others, ensuring their success from a broadly competitive position.
  6. Interest in startup innovations by VCs and large-cap medtech companies has never been more intense, but funding still demands concrete milestones. Proof-of-concept gets entrepreneurs excited, but 510(K) or better is what gets the money flowing. This is not the credit-crunch of 2008, when the sour economy caused funding to largely dry up. Money is indeed flowing into medtech now, as evidenced by the IPO market and the volume of early stage funding, but potential investments — especially at very early stages — are no less intensively vetted. Startups must therefore carry the risk well into the development timeline, when the prospect of their products reaching the market has been demonstrated far more effectively.
  7. Medtech markets are influenced by many forces, but none more strongly than the drive of companies to succeed. Reimbursement. Regulatory hurdles. Healthcare reform. Cost reduction, even a 2.3% medical device excise tax, et cetera, et cetera. None of these hold sway over innovation and entrepreneurship. And the rate of innovation is accelerating, further insulating medtech against adverse policy decisions. Moreover, that innovation is reaching a sort of critical mass in which the convergence of different scientific disciplines — materials technology, cell biology, biotech, pharma and others — is leading to solutions that stand as formidable buttresses against market limiters.
  8. Information technology is having, and will have, profound effects on medical technology development. The manufacturers who “get” this will always gain an advantage. This happens in ways too numerous to mention in full, but worth noting are: drug and device modeling/testing systems, meta-analysis of clinical research, information technology embedded in implants (“smart” devices), and microprocessor-controlled biofeedback systems (e.g., glucose monitoring and insulin delivery). The information dimension of virtually every medtech innovation must be considered by manufacturers, given its potential to affect the cost/value of those innovations.

This is not a comprehensive list of drivers/limiters in medtech, but these stand behind the success or failure of many, many companies.

Patrick Driscoll is an industry analyst and publisher of content on advanced medtech markets through MedMarket Diligence.

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.


Medtech technologies that are gaining traction (funding, other commitment)

Developments in medical technology span a stunningly diverse set of applications enabled by an equally diverse range of technologies.  To hone in on the developments that “matter”, it is worth considering those that have garnered, at a minimum, a level of financial or other commitment to move them toward commercialization.  Here, we highlight technologies under development at companies that have recently (Feb. 2013) received fundings as well as technologies under development at startups recently identified.

Several common themes underly the companies gaining funding, stemming from advances with versatile applications (cell/tissue, info tech), technologies that succeed in providing clinical advantage (minimal invasiveness) or otherwise increase the efficacy of existing treatments (imaging, diagnostics):

  • Tissue/cell-based technologies
  • Minimally invasive or less-invasive approaches to treatments
  • Neural based treatments (e.g., neurological stimulation, denervation)
  • Wireless technology and information technology embedded in device function
  • Imaging, diagnostic or other procedural enhancement to surgery or other treatment

Technologies at companies funding in February 2013:

  • Ocular surface interferometry and thermal pulsation system for diagnosis and treatment of evaporative dry eye
  • Sinus treatment implants
  • Regenerative medicine therapies for orthopedics and wound care
  • Satiety device for the treatment of obesity
  • Microstent for treatment of glaucoma
  • Catheter-based treatment of heart failure
  • Minimally invasive treatment for uterine fibroids
  • Wireless vital signs monitoring
  • Neuroscience-based device company focusing on obesity and metabolic disease
  • Wireless, transdermal continuous glucose monitoring system
  • Magnetic resonance imaging guidance of surgical and interventional procedures
  • Nonsurgical interstitial laser therapy for treatment of breast cancer
  • Ophthalmic drug delivery
  • Lung denervation
  • Deep brain stimulation.
  • Intra-ocular implants (glaucoma, severe infection) and intra-articular implant osteoarthritis)
  • Technology providing real-time, high resolution imaging of cancer cells
  • Targeted drug delivery in ophthalmology
  • Surgical adhesives
  • Device technology for treatment of respiratory disease
  • Neurological cooling to reduce the impact of trauma
  • Minimally invasive treatment for mitral valve regurgitation
  • Devices for use in cardiac and vascular markets
  • Supersaturated oxygen therapy to reduce myocardial necrosis following heart attack
  • Left ventricular access and closure devices
  • Intravascular continuous glucose monitoring
  • Amniotic membrane-based biomaterial technology
  • Needleless intramuscular drug injection device
  • Binocular device for ophthalmology diagnostics
  • Stem cells for use in regenerative medicine
  • Intraoperative ophthalmology diagnostics using wavefront aberrometry
  • Devices for the diagnosis and treatment of arrhythmias
  • Neurostimulation for treatment of chronic pain
  • Collagen-based implants
  • Needleless drug injection technology
  • Endoscopic vein harvesting
  • Undisclosed technology in ophthalmology
  • Nanotechnology-based, injectable wound healing scaffold for treatment of diabetic foot ulcers
  • Surgical robotic technologies integrated to digital 3D imaging for applications in spine, brain, and musculoskeletal procedures

Technologies at recently identified startups (recent additions to startups database):

  • Tissue regeneration technologies for non-invasive skin care.
  • Biomaterials supplied to medical device and pharma manufacturers
  • Trans-reflective fetal EKG.
  • Surgical instrumentation.
  • Undisclosed medical technology.
  • Technologies for autologous tissue collection.
  • Stem cell therapy.
  • Novel, implantable ring to prevent parastomal hernia in abdominal surgery.
  • Transcatheter repair of mitral valve regurgitation.
  • Synthetic cartilage implant for treatment of osteoarthritis or cartilage damage.
  • Device-based treatment of congestive heart failure.
  • Clamping device to control bleeding in trauma.
  • Tissue matrix composition for tissue regeneration and wound care.
  • Spinal pain relief devices.
  • Wireless remote arrhythmia monitoring and diagnosis.
  • Undisclosed medical technology.
  • Surgical tools for arthroscopic procedures.
  • Fractional flow reserve guidewire method to obtain FFR measurements during coronary catheterization procedures.
  • Technology to ensure accurate intraoperative placement of hip and knee implants.
  • Neurological diagnostics to measure biomarkers, regulate drug dosage, others.
  • Respiratory monitoring devices, such as a “sleep sensors” shirt to enable less invasive monitoring for apnea or other respiratory conditions.
  • Endoscopic, minimally-invasive harvesting of veins used for coronary artery bypass grafting.
  • Ophthalmology diagnostics; binocular device for eye exams.
  • Device-based treatment for respiratory disease.
 Companies represented by these technologies are:
AFcell Medical, ArthroCAD, BAROnova, BeneChill, Bioject Medical Technologies, BioSig Technologies, Blaze Bioscience, CardioKinetix, Cartiva, Ceterix Orthopaedics, Clearside Biomedical, Cohera Biomedical, Cotera, Cytomedix, Diagnostic Biochips, Echo Therapeutics, Enteourage Medical Technologies, EnteroMedics, Envision DIagnostics, Evolus, Excelsius Surgical, First Pulse Medical, GluMetrics, Guided Interventions, Gynesonics, H & M Innovations, Handsome Ltd., HighLife SAS, Holaira, InfoBionic, Innocoll, Innovative Trauma Care, Insight Surgical Instruments, Intersect ENT, IsoStem, Ivantis, Kala Pharmaceuticals, Koring GmbH, Magenta Medical, Mardil, MRI Interventions, MxBiodevices, Neuros Medical, Novian Health, Parios Regenerative Sciences, PharmaJet, PLC Systems, PolyActiva, Rest Devices, Saphena Medial, Sapiens BV, Sotera Wireless, StemBioSys, TearScience, TELA BIO, TherOx, Uro Lasers, Ventec Life Systems, Vornia, Wavetech Vision Systems

Medtech trends, current and future

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Medtech Trends map.
We are working on a long range view of medical technology developments.  Since one tool to conceptualize ideas with priorities, subsets and linkages is “mind mapping”, we have used mindmapping software to construct a map of medtech trends involving the main elements of current trends, future trends and drivers.

The map is illustrated below in a Flash version. You may resize (zoom in/out) of the map and otherwise navigate it via the controls below right (and just above the map on the right).  You may also move about the map it in all directions by clicking on the map and moving it in the desired direction with your mouse/touchpad.

Elements of the map that contain embedded notes with additional information show a text box icon on the side, so that if you move your cursor over it, the text will display.

We welcome your feedback.

Much of technology development over the course of the medtech industry’s history has been of the “product line extension” variety in which incremental improvements are made in devices and their composite materials in order to refine or otherwise increase their performance. Periodically, development has taken larger, more sudden leaps when re-examination of the fundamentals underlying medical technology generated new concepts that precipitated wholly new technologies. For example, surgery took a sudden leap forward in the late ’80s and ’90s when a recognition took place that (1) open abdominal surgery has inherent disadvantages stemming from trauma, risk of infection and other adversities and (2) endoscopic technology merely lacked the surgical instrumentation and design of a procedural format (e.g., via the use of insufflation) necessary to convert laparotomy to laparoscopy. The recognition that new technology obviated the need for trauma of laparotomy coincided with the obsolescence of virtually hundreds of years of traditional surgery. This development was only possible due to the emergence of a brand new paradigm called laparoscopic surgery, in which a host of abdominal procedures could be performed that avoid the trauma inherent in open abdominal surgery.

(And now, another leap is taking place by replacing laparoscopy with NOTES procedures in access is provided by existing orifices rather than any kind of incision or surgically-created port.)

Incremental improvements continue to enable manufacturers to sustain market shares and price premiums, but the nature of economic forces demanding better outcomes for every dollar spent and the proliferation of opportunities arising from technology advances on multiple fronts (with those fronts often combining synergistically) are precipitating leaps in medtech development beyond incremental improvement.

Below is illustrated an overall outline and map of the developments and drivers we see in medtech.

[freemind file=”http://blog.mediligence.com/wp-content/uploads/2013/02/MedtechTrends2.mm” /]

Source: MedMarket Diligence, LLC

2013 Medtech Outlook

The 2013 Medtech Industry — Some General Predictions

In 2012, much has been made of the Affordable Care Act or, more precisely, the 2.3% excise tax on medical devices used to fund the addition of 30 million new patients to the U.S. healthcare system. Despite a chorus of voices for a repeal of the tax, with repeal arguments that range from credible to absurd, the tax is likely to stay in place.  With the influx of new patients in 2013 and beyond, the cost versus benefit will become clear, but we forecast that the debate on the excise tax will linger well into the new year.

The U.S. and global economy have been recovering with growing momentum following several stagnant years.  Just as a rising tide floats all boats, the stronger economy in 2013 will help drive medtech though more available capital leading to increased spending by healthcare systems for increased inventories and investment in new technologies.

Investment in medtech will likely show modest increase as money that has been previously stored in the “safe harbor” of medtech investment will shift back to non-medtech investment targets that have now been made more attractive by the stronger economy. In the recessionary economy of post 2008, medtech investment has favored later stage (i.e., “less risky”) technologies — those already in or about to enter the market.  Now, with hunger for larger returns in the stronger economy, the money that will flow into medtech in 2013 will be more inclined to fund earlier stage products and companies.

Physicians and companies will not part ways, but in 2013 they will not be so cozy, given the Sunshine Act’s intention to reveal how cozy they actually are in order to eliminate financial bias in physician endorsement of new technology. Even before the Sunshine Act, the writing has been on the wall that the links between physicians and companies have been too close. Greater scrutiny of these links will create challenges for medtech to ensure that clinical validation of new technologies will be unbiased.

Trends associated with the FDA include steady progress in reducing review times, closer scrutiny of off-label uses, more stringent attention to false or misleading claims and, in general, an uptick in enforcement. We forecast that the regulation of medical devices will become increasingly complex as the FDA seeks to address deficiencies in the 510(k) process and, in general, complete reviews more efficiently to satisfy the needs of industry and needy patients without compromising device safety.

The regulatory process will also become further challenged as it faces new definitions (or lack thereof) for “medical devices”, since the marriage of drugs and devices (i.e., hybrids), the growth of resorbable implants and other innovation trends blur the previously distinct boundaries between drug, device, biotech and other products.

2013 will also see the emergence and/or expansion of multiple medtech markets.

  • Expect a growing number of developments in neurology-focused therapeutics such as neuromodulation, the expanded use of hybrid devices in cardiology (including bioresorbable stents).
  • The press for minimal invasiveness and the capacity of medtech to respond through innovation will drive development and adoption of new technologies paradigms such as NOTES (natural orifice transluminal endoscopic surgery) technologies; transcatheter technologies and other medical/surgical technologies that dramatically reduce the need for surgical incisions or other invasiveness; non-invasive diagnostics such as glucose meters in diabetes
  • Surgical and interventional procedures are increasingly being integrated with more sophisticated pre-operative and intraoperative (“real time”) imaging systems that enhance the physician’s ability to direct therapy more effectively at pathologies with less collateral damage, reducing complications, accelerating recovery and otherwise improving patient outcomes.  Some of these systems, such as intraoperative MRI, are very sophisticated and accordingly expensive, so benefit/cost may limit adoption but for the most at risk caseload.
  • The blessing in disguise that was the Bush administration’s ban on federal funding of embryonic stem cell research led to a burst of research in adult stem cells that bypassed the embryonic stem-cell ethical dilemma. With the Obama administration’s subsequent lifting of the federal ban, both embryonic and adult stem cell research is proceeding at breakneck pace.  2013 is therefore likely to see an equally powerful burst of advances leading to practical therapies based on stem (or pluripotent) cell technology.
  • Driven by research indicating important, patient-specific differences in physiology that impact the effectiveness of medical devices and other medtech, 2013 will show an increase in customized or personalized medicine.  The diagnostic component will include genetics-driven predictors of disease while the therapeutic will include a wide range of product types, from the development of autologously cultured tissues or stem cell-derived tissues, and custom-fitted implants in cardiology, orthopedics, general surgery and other specialties.
  • 3D printing is being applied to medtech in both prototype development and in such seemingly far-fetched ideas as organ printing, which is actually in active development.
  • Biomaterials, or materials technology in general, increasingly expand the number of possibilities of what can be achieved with medical devices and other medtech products. Drug-coated devices, drug-delivery devices, extracellular matrices, bioresorbable implants, nanotechnology-based and other coatings and a wide range of other materials technologies are enabling medtech products to be more disease-specific, less toxic, less prone to biocompatibility issues, less likely to be associated with procedure-specific collateral damage and otherwise more effective in achieving high quality outcomes at lower overall cost.

There will also be secondary forces impacting medical technologies. By this, we mean forces in the innovation of non-medical technologies or other forces that are changing the use and/or implementation of medical devices. First among these is forces for the integration of information technologies in medical devices encompassing infusion pumps and other “smart” devices, radiofrequency identification systems, wireless telemetry and others.

While we are more focused on medical technologies than on technologies like information systems that affect more of the logistics than the clinical delivery of healthcare, it should not be overlooked that healthcare in 2013 will also be characterized by steady growth in the application of information technology.  At its simplest level, information technology in healthcare is the management of healthcare information — electronic medical records, healthcare information systems, picture archiving and retrieval, etc. But to a much greater degree, information technology is impacting healthcare through several key areas:

  • Computer aided design and prototype development. Conventional use of computer aided design in the development of medical devices is already common, but increasingly sophisticated programs and systems are being developed to optimize device design to reflect a more comprehensive understanding of the forces, dynamics and anatomy of patients, as well as the more thorough understanding of pathology. With the use of CAD and 3D printing, prototypes can be quickly produced that, if not functional, can facilitate the development of ideas toward functional prototypes. In cardiology, flow dynamics have been recognized as a critical aspect effectively applied through computer aided design of vascular stents, catheters, embolic protection, aneurysm repair and many others. In orthopedics, the use of CAD is facilitating customized implants.
  • Systems biology and the demand for multivariate analysis. One of the most significant long term objectives of medical device (or medtech) development is the innovation of products that more comprehensively address disease states (or wellness) by integrating understanding of anatomy, physiology, chemistry, genetics, physics and all other possible disciplines having potential impact on the long term efficacy of a medical product.  While there is fundamental science to be learned to achieve such a multivariate understanding/solution, and this is a long-term goal well beyond 2013, the increasing recognition of diverse factors impacting product efficacy is incrementally improving each new product embodiment — and such work is a part of product development already.  The concurrent interplay of alternative device (or other medtech product) configurations with myriad biological, physical and other forces demands information technologies that are able to predict downstream effects of each possible innovation.

[Please note we are continuing to review new medtech development efforts and analyze their potential impacts so that we may update our 2013 forecast here.]


Pardon my medtech ADD — it’s an occupational hazard

Now, to be clear, I have never actually been diagnosed with attention deficit disorder.  But that doesn’t mean that I don’t exhibit an awful lot of its traits, especially when it comes to © 2018, MedMarket Diligence, LLC -- advanced medical technologies, which I have witnessed evolve at a feverish pace that dares one to linger on one milestone too long.

Mankind has come up with some extraordinary technologies — the internal combustion engine, flight, splitting the atom, taking us to the moon and, seemingly just in my lifetime, accomplishing every manner of amazing feats in medicine, all of which only presage more and greater accomplishments in the near future.  Surgery has moved from the now seemingly almost barbaric approach of slicing the abdomen wide open to accomplishing complex surgery with access limited to one port, even if that “port” is a pre-existing natural orifice. Cell and tissue engineering technologies, only too recently limited to rudimentary replacement of skin and bone in trauma and disease, are now capable of generating complex orthopedic, cardiac and other tissues and are on the cusp of replacing whole organs.  The human genome has been mapped and the complex processes underlying its expression in normal and pathological development are being steadily clarified and understood, with the goal now much closer to when we might intervene in these processes   and “cure” genetic diseases, harness the body’s own recuperative potential and otherwise unleash a host of new options in medicine.

While in college some several decades ago, my genetics professor gave a lesson on a Tuesday that he was forced to replace and update by Thursday, since mid-week advances in molecular biology had suddenly expanded our understanding (thank you, Dr. Doe).  After college, I was inescapably drawn to a nascent biotech industry that saw vast commercial potential in the diagnostic and therapeutic products that might be spun out of advancements in biological science, only to see that there was a much bigger gap between scientific advance and feasible commercial application.

But between then and the end of the millennium, and twelve years hence, biotech, medical device, pharmaceutical and other practical scientific applications in medicine have proceeded at breakneck speed in setting, breaking and setting again new milestones.

I now stand at a point in examining medical technologies that considers the clinical endpoint for so many conditions to be one that might readily be reached from multiple widely different directions.

I see coronary artery disease that might be addressed by transcatheter coronary artery bypass surgery, angioplasty and drug-eluting stents, atherosclotic plaque-reducing drugs, myocardial tissue regeneration and others.

I see type 1 diabetes on the verge of being met by either stem (or other) cell transplant cure or by a self-contained, closed-loop, artificial pancreas employing biofeedback-based insulin delivery to regulate blood sugar.

I see drugs embedded in devices, devices that  stimulate cell migration and tissue growth before these devices are simply resorbed in the tissues.  I see a rapid convergence of information technology with biological science leading to a dramatically accelerated pace of discovery, advancement and application.

I also see a rapidly maturing biotech industry that has learned hard lessons in closing (or at least understanding) the gap between a scientific advance and its commercial application.

So, yes, I have a certain attention deficit, since It is hard to concentrate when new developments of significance arise at such a rapid rate. It is also for this reason that every new patent, every new technology entering the pipeline, and every new product gaining approval and entering the marketplace must be evaluated in the light of so many simultaneously advancing fronts.  The key is that no scientific or medical advance is absolute — each can only be measured by the extent to which it actually advances knowledge or application relative to other competing developments, of which there are many more than ever before.



OneMedForum, healthcare and life sciences investment, San Francisco Jan 9-12, 2012

OneMedPlace will be holding its fifth annual forum for healthcare and life sciences investment, "OneMedForum San Francisco 2012", at the Sir Francis Drake Hotel in San Francisco on January 9-12, 2012.

“Our objective is to give investors insight into areas of opportunity and the chance to meet the management of some of the most promising growth companies in the world,” said OneMedPlace founder Brett Johnson. “The financial sector has undergone extraordinary stress, yet opportunities abound for long-term investors in promising companies. The healthcare sector is dramatically evolving, and the future belongs to innovative companies with new approaches which is the focus of this conference.”

In addition to panels of leading investors and analysts discussing areas of greatest opportunity, the event will feature presentations by CEOs of more than 100 medical technology, biotechnology, and health technology companies on both public and private company tracks. The best technologies from leading universities ready for commercialization will also be featured along with workshops on finance and operations.

Panels include: “Investment Trends in Medical Devices,” which will provide an overview of major developments in medical device investing including Cardiology, Neurology, Orthopedics, Nanotechnology, Ophthalmology and Diabetes. A panel on “Investment Trends in Biotechnology” will share major developments in biotechnology investing; including regenerative medicine, neurological disorders, vaccines, and infectious diseases. In the panel “What the Healthcare System Needs,” the largest consumers of healthcare in the U.S. will describe areas of unmet need. The panel “Mobile Health and Medical Devices,” will discuss how the Internet has ushered in a new era in medical device development. OneMedForum’s “Diagnostics and Personalized Medicine” session will evaluate the risks and opportunities as personalized medicine becomes integrated into the healthcare system. A session entitled “Novel Health Information Technologies” will address how the transformation of healthcare delivery is having a critical strategic impact on large healthcare organizations. The event will consider international issues with a panel on India and the China Forum II, an afternoon of panels on January 9th focused on how Western companies can enter this rapidly growing market. Additionally a panel on ”The Globalization of Healthcare” will provide insights from CEOs of some of the world’s leading global medical technology companies.

Companies confirmed to present (as of 11/21/2011) include: Del Mar Pharmaceuticals, EpiCept Corp. [EPCT], ADVENTRX Pharmaceuticals [ANX], ImmunoGenetix Therapeutics, Hepregen, WaferGenBiosystems [WGBS], Spherix Inc. [SPEX], ADS Biotechnology Ltd., SEA Medical Systems Inc., GlySure, Soft Tissue Regeneration Inc., VisionCareOphthalmic Technologies Inc., Bmeye, NanoViricides [NNVC], Cardium Therapeutics [CXM], CVAC Systems, ThermoGenesis [KOOL], Wound Management Technologies Inc. [WNDM], Biovista, Excelimmune, Bacterin International [BIHI], PLC Medical Systems [PLCSF], International Holdings Inc., Mirna Therapeutics Inc., DATATRAK International [DATA.PK], TONIX Pharmaceuticals Inc. [TNXP], AP Pharma, Novadaq Technologies Inc. [NDQ.TO], CytoSorbents [CTSO], Neovasc [NVC.V], Cytograft Tissue Engineering, Castlewood Surgical, Cyclacel Pharmaceuticals [CYCC], SpectraScience [SCIE], LoneStar Heart, Interface Biologics, NeoGenomics [NGNM], Vigilant Biosciences, Vimecon GMBH, AvitaMedical [ASX:AVH], Genta Inc. [GNTA], CorInnova Inc., Fibrocell Science [FCSC], 2B Blackbio, Advaxis Inc. [ADXS], Cervilenz Inc., Microvisk Ltd., Intellect Neurosciences [ILNS], RadLogics, MiraCor Medical System GMBH, Histogenics Corp., Symetis, InfoBionic, HyGreen Inc., Strohl Medical, Biocept Inc., ISCHEM Corp., Active Implants Corp., QLIDA, Colby Pharmaceuticals, Genomic Expression, CeQur. Profiles on the companies can be found on the conference web site: www.onemedforum.com

Public company presentations will be video-webcasted live on the Internet by OneMedTV starting 8:00 A.M. Tuesday January 11th.

About OneMedForum

Founded in 2008, OneMedForum is a biannual event held in San Francisco and in New York. OneMedForum creates a platform for emerging companies to connect with strategic partners and investors. Sponsors for 2012 include the international consulting and audit firm Grant Thornton, the engineering and design firm MPR, the medtech PR/IR firm Ronald Trahan Associates Inc., Torreya Partners, The Wallace H. Coulter Foundation, Aurora Capital, Canada, New York Biotechnology Association and AdvaMed2012 the MedTech Conference. For more about OneMedForum SF 2012 visit www.onemedforum.com. To apply to present or for information about sponsorship opportunities, contact: forum@onemedplace.com.

About OneMedPlace

OneMedPlace is a virtual community that connects emerging companies seeking capital, distribution, and visibility with investors and strategic partners looking for health and medical innovations to invest in, acquire, license, distribute, purchase or utilize.


Melody Wilding, +212-734-1008