Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts from the ‘Medical Devices’ category

Contrary to popular opinion, innovation is not dead in the biomedical industry, as evidenced by news of a novel drug-delivery system published as a Rapid Publication in Science Translational Medicine (STM) on February 16, 2012.

The paper from Robert Farra of MicroCHIPS, Inc. and research collaborators, describes a first-in-human testing of a wirelessly controlled drug delivery microchip.

Farra et al., report the results of a clinical trial with 8 women in whom microchips were implanted for 103 days. The data showed that the pharmacokinetic profile of microgram-quantities of the anti-osteoporosis drug, teriparatide (FORSTEO), delivered by the microchip was similar to subcutaneous injections.  However, the device did fail in one of the 8 women, so data is only reported for 7 patients, a very small patient sample.

Picture Credit: MicroCHIPS, Inc.

The drug delivery device is an array of 600-nL micro reservoirs in which the drug is stored, that is associated with a 13.0 mm x 5.4mm x 0.5mm silicon chip.

The microchip was implanted beneath the skin (subcutaneously) in the abdomen by creating a 2.5cm incision, performed during an outpatient visit.

This paper is also interesting for its use of telemedicine. A remote operator was able to establish a wireless link and send instructions directly to the implant on dosing schedule as well as receive information back on operation of the chip.

John T. Watson, Professor of Bioengineering at the University of California San Diego  commented in the accompanying editorial that:

“The microchip represents more than 10 years of engineering design and development efforts to arrive at a programmable, implantable device for subcutaneous release of a therapeutic agent in discrete doses.”

Multiple engineering design advances were made along the way.

He also noted the results from the quality-of-life surveys administered during the trial; the majority of women stating they often forgot they had the device implanted and would readily consent to a fresh implant if needed.

Innovations in drug delivery offer hope of an improved quality of life to patients with chronic disease who require daily injections.  In 2010, there were approximately 50,000 teriparatide users, not an insignificant market opportunity.  People with diabetes who require daily injection of insulin is another potential market that springs to mind.

The first-in-human results reported in Science Translational Medicine show promise and the potential of a novel implanted wireless drug delivery system.

However, many questions remain unanswered by this research including the reliability & durability of the microchip device, given that it failed in 1 out of 8 women implanted.

Further work on validating the technology, and confirming its safety, reliability and efficacy in a larger sample size will be needed before it can obtain regulatory approval.


ResearchBlogging.orgFarra, R., Sheppard, N., McCabe, L., Neer, R., Anderson, J., Santini, J., Cima, M., & Langer, R. (2012). First-in-Human Testing of a Wirelessly Controlled Drug Delivery Microchip Science Translational Medicine DOI: 10.1126/scitranslmed.3003276

Watson, J. (2012). Re-Engineering Device Translation Timelines Science Translational Medicine DOI: 10.1126/scitranslmed.3003687

Regenerative Medicine and the science behind replacing body parts with synthetic tissue engineered versions took another step forwards today after researchers announced they had transplanted a trachea made of a nanomaterial covered with the patient’s own cells.

Professor Seifalian and Clare Crowley UCL

Researchers from University College London led by Prof. Alexander Seifalian designed and built a polymer based nanocomposite tracheal scaffold, which was then seeded with the patient’s own stem cells.

After two days in a bioreactor (Harvard Bioscience), the cells and the synthetic trachea scaffold were transplanted last month at the Karolinska University Hospital in Stockholm by Prof. Paolo Macchiarini and colleagues, into a patient with late stage tracheal cancer.

As reported by BBC health, and the press releases of University College London (UCL), Karolinska Institute and Harvard Bioscience, the 36 year old man is doing well and because the cells on the trachea were his own, no immunosuppressive drugs were needed.

In the UCL press release, Professor Seifalian said:

“What makes this procedure different is it’s the first time that a wholly tissue engineered synthetic windpipe has been made and successfully transplanted, making it an important milestone for regenerative medicine. We expect there to be many more exciting applications for the novel polymers we have developed.”

While this is still experimental research that needs to be validated in a clinical trial with more subjects, there is the potential for Professor Seifalian’s nanomaterial based tissue scaffold to be used for commercial medical devices such as coronary stents and grafts.

In addition to the development of a nanomaterial that can be used as a tissue scaffold, key to success of the transplant was the ability to grow and cover the engineered material with the patient’s own stem cells.  Harvard Bioscience have specifically designed a bioreactor to culture cells onto a graft for airway tissue reengineering.

As innovation in science drives new milestones in regenerative medicine, we can expect the market for tissue engineered products to grow as companies seek regulatory approval for commercial products.

Above all else, regenerative medicine offers major benefits for patients and the restoration of function and improved quality of life. Today’s news is yet another milestone that highlights the promise of regenerative medicine.

I would like to thank Victor Pikov, a neurophysiologist and biomedical engineer at Huntington Medical Research Institutes (HMRI) for drawing my attention to his NeurotechZone Blog that has a really fascinating post on the manufacturing of the next generation of artificial retina, the Argus™ 111, by the Lawrence Livermore National Laboratory (LLNL).

If you have an interest in this area, then Victor is also co-chair of 3rd International Conference on Neuroprosthetic Devices (ICNPD-2011) to be held in Sydney from November 25-26, 2011. Further information can be found on NeuroTechZone.

Second Sight Medical Products recently obtained a CE mark and European Market Approval for the Argus™ II system that incorporates 60 electrodes into the retinal prosthesis.

However the next generation of artificial retina, the Argus™ III is already in development.  It has 200 electrodes – a quantum leap forwards.  It’s hard not believe that an array that is four times as densely packed with sensors, will not provide improved vision.

Second Sight will no doubt be planning clinical trials for Argus™ III and it sounds like it will provide a further leap forward in the technology to restore some sense of vision to patients who have lost their sight through age-related macular degeneration (AMD) or retinitis pigmentosa (RP).

I have taken the liberty of embedding below, the excellent YouTube video that Lawrence Livermore National Laboratory (LLNL) have produced about their manufacturing of the Argus™ III artificial retina. It is well worth watching!


Detecting a door or a window may not be a big deal for all of us with normal vision, but for those who lose their sight, e.g. through retinitis pigmentosa (RP), a new “artificial retina” now provides hope of a better quality of life.

The Argus™ II Retinal Prosthesis System from California based company Second Sight, has just received CE marking.  This innovative device can now be sold and marketed within Europe, but it remains investigational in the United States. It is the first such device to be approved.

While this blog is mainly focused on the biotechnology industry, I’m very interested in innovation and bringing novel products to market. I also have a personal interest in the ophthalmology market.  Earlier in my career, I spent three years at Alcon working with leading European ophthalmologists on intra-ocular lens clinical trials, including the IDE registration trial for AcrySof®.

In the same way that a cochlear implant does not restore hearing, the “artificial retina” or so-called “bionic eye” from Second Sight is not intended to restore vision, instead it artificially provides electrical signals that it is hoped the brain can learn to interpret as shapes.

The “artificial retina” has three parts, a small video camera worn in a pair of glasses that captures visual images.  This transmits the electronic images to a video processing unit worn by the patient.  Data is then transmitted wirelessly to an implant that is located on top of the retina.

The array of electrodes resting on the retina stimulates those rods and cones that remain functional to generate electrical impulses that are then transmitted down the optic nerve to the brain.  Patients learn to interpret the patterns of light that are generated, and in the process gain some sense of visual perception that improves their daily life.

In an interview broadcast on French radio station, RTL one of the four French patients in the clinical trial, Thierry, talks about how this retinal stimulation device has improved his autonomy and quality of life.

When faced with blindness, any progress is noteworthy and it will be interesting to see the extent to which this technology can be further developed.  I expect that more clinical trial data will be forthcoming at the annual meeting of ARVO (Association for Research in Vision and Ophthalmology) in May.

Update August 23, 2012:  FDA Panel to review whether to recommend of approval of Argus II artificial retina in the United States

The FDA Ophthalmic Devices Panel will review on September 28, 2012 the Humanitarian Device Exemption (HDE) market approval application by Second Sight for its Argus II Retinal Prosthesis System with an indication for patients with severe to profound retinitis pigmentosa (RP) who have bare or no light perception in both eyes.

What is a Humanitarian Device Exemption? 

“An HDE is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application, however, must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.”  U.S. Food & Drug Administration

Given the lower standard required for a HDE, and the fact that Second Sight obtained a CE mark in Europe, it would be hard to believe the FDA advisory panel will not recommend approval in a patient population that are effectively blind.

However, the FDA guidance also notes that an approval of an HDE, while allowing marketing of the device, does require it’s use to be at facilities where an institutional review board (IRB) has approved the use of the device. If approved for sale in the US, the market for Second Sight will be limited as a result to academic and hospital settings that have an IRB able to provide the necessary oversight and review.

“An approved HDE authorizes marketing of the HUD. However, an HUD may only be used in facilities that have established a local institutional review board (IRB) to supervise clinical testing of devices and after an IRB has approved the use of the device to treat or diagnose the specific disease. The labeling for an HUD must state that the device is an humanitarian use device and that, although the device is authorized by Federal Law, the effectiveness of the device for the specific indication has not been demonstrated.”

For those interested in more information, background material on the HDE application will be available on the FDA website no later than 2 days prior to the September 28 meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee.


After I wrote my previous blog post about the emerging biotechnology region around Austin, TX, one of the comments I received was about the importance of networking opportunities within a cluster or region.

So I am pleased to have been invited to a medical technology-life science networking event in New York City (NYC) organized six times a year by Ted King of Saddlerock Advisors, Wendy Brown of Merrill Lynch and John Lieberman of Perelson Weiner.

The event, later today, has a format of a featured speaker and presentations by three emerging companies that provides them with the opportunity to network and showcase their technology, new drugs or medical devices to investors, industry partners, academics and researchers.

This evening there is a presentation on the proposed changes to the FDA’s 510(k) clearance process for medical device approval.  This is the route by which the majority of medical devices come to market by showing they are comparable to an existing approved or marketed product.

The three featured companies include BioView (an Israeli technology company involved in cell imaging and automation of genetic testing), Cel-Sci (a Virginia based biotech company that has as immunotherapy product in development about to enter a global phase III clinical trial in head and neck cancer) and PatienTech (a company that develops elastic-sheet, pressure sensing systems that can be used with medical devices).

It will be interesting to see who attends, and whether the presentations by the companies are what I consider to be the typical investor “puff and fluff” presentations, or whether there is any meaningful discussion of science, marketing strategy and new product development.

Following on from my blog post last week that discussed the use of iPads and other tablet computers in clinical trials, MIM Software have just received FDA 510(k) clearance to market their iPhone and iPad medical imaging app in the United States. This is the first such approval by the FDA, and the app will be sold in Apple’s itunes store.

This new mobile radiology application will allow physicians to review medical images on their iPhone and iPad.  The FDA in their press release indicate that it is not intended to replace full work stations, but to provide the ability to view images and make diagnoses when a workstation is not readily available.

The FDA reviewed luminance, image resolution quality, and results from demonstration studies with radiologists that showed that images could be safely interpreted for diagnostic purposes under appropriate lighting conditions.

What is more, using software from MIM, the images can be further analyzed and distance measurements made.

The ability to have wireless access to medical images will be particularly useful to physicians working remotely, in emergency situations and in clinical trial networks where the central imaging review facility may not be local.

As the screen resolution of iPad’s and other tablet computers increases, perhaps we will see advanced visualization software available on the iPad?  It is certainly an area where innovation is taking place, and one that I think will impact clinical research in the biotechnology industry before too long.

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