DRDO Science Spectrum, March 2009,DHAR:DIFFERENT APPROACHES TO THE BIONIC EYE pp.

79-83 2009, DESIDOC

Different Approaches to the Bionic Eye

Vikram Dhar
Solid State Physics Laboratory, Lucknow Road, Delhi-110 054

1.

INTRODUCTION

There is optimism regarding the bionic eye due to the successes of: Cardiac pacemakers as neural prosthesis Cochlear implants to restore hearing to the deaf Dr Kalam initiated a multi-lab multi-disciplinary DRDO programme to develop an affordable cochlear implant. Rapid developments in VLSI design and in Microfabrication technology imply the next step: developing the bionic eye as well as suggest that SSPL should be involved. What is the bionic eye? It is a bio-electronic device that replaces functionality of part or whole of the eye or adds functionality to it. The approach is to bypass damaged photoreceptors and directly stimulate undamaged neurons. It cannot work on the congenitally blind - trained neurons are needed or with damaged optic nerves, glaucoma or diabetic retinopathy. The human eye is similar to a camera. The part of the retina that provides the highest resolution of the image. Less than 100 microns thick, the retina is comprised of 10 layers of cells which process the initial analoglight energy entering the eye into digital electrochemical impulses. The human eye has ~126 million photoreceptors: 6 million cones (that provide colour perception i.e. red, green and blue, respond to high light intensity levels, provide sharp high resolution images and are mostly in the central part of the field of view) and 120 million rods ( that provide black and white images, respond to low light intensity levels, provide low resolution images and are mostly in the peripheral field of view). Thus, if you want to see a faint star at night you look at it sideways so it is focused away from the optic axis, whereas if you want to read the fine print in a lawyers contract you look at it dead center in bright light. Interestingly, the optic nerve carries only 1 million connections, implying a significant amount of pre-processing of information before it reaches the brain. The bionic eye is largely intended to help patients of macular degeneration and of retinitis pigmentosa. The former is genetically related but occurs mostly in old people (age related macular degeneration, AMD). The cones in the macula degenerate leading to a loss of up to 70% of photoreceptors leading to a loss, or damage of, central

vision, while peripheral vision is spared. Retinitis pigmentosa is a hereditary genetic disease in which up to 95% of peripheral rods (and cones) are lost. This results in tunnel vision and the tunnel shrinks as the disease progresses to the center of the eye (although the foveal region is spared). There are no proven therapeutic remedies for these diseases. Various approaches have been, and continue to be, attempted: Use of Intravitreal injection of certain growth factors. Identification of specific gene mutations has led to the development of the gene therapy approaches. Transplantation can be effective in rescuing the photoreceptors from degeneration Stem cell based treatments are being developed Photodynamic therapy to repair damaged photoreceptors has had some success in arresting loss of photoreceptors. There are also attempts to create light-sensitive neural cells by: a) genetic engineering b) photolysis of caged agonists near native cell surface receptors c) photoswitching of special ligands attached to ionchannel receptors However, in this article we shall restrict ourselves to bionic eye approaches. Before doing this however, we shall briefly examine the forerunner to the bionic eye: the bionic ear or the cochlear implant. This has some similarities, although clearly we must substitute light for sound and different nerves in the two cases. In the cochlear implant, the following processes occur: (i) a microphone picks up sound from the environment (ii) a speech processor selectively filters sound to prioritise audible speech and sends the electrical sound signals through a thin cable (iii) a r.f. transmitter - a coil held in position by a magnet placed behind the external ear - transmits the processed sound signals by magnetic induction (iv) a r.f.receiver and stimulator (secured in bone beneath the skin) converts the signals into electric impulses and sends them through an internal cable (v) an array of up to 22 electrodes, or as few as 6 electrodes 79

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(wound through the cochlea) sends the impulses to the auditory nerves. Since no wires penetrate the skin (no transcutaneous wires), the possibility of infection is much reduced. The cochlea is a spiral with has 2.5 turns, and the hair cells that respond to sound are organized spatially in a way that the high frequency sounds are picked up by those cells closest to the outer end (the base), while the cells that respond to low frequency sounds are located at the innermost end of the spiral, the apex. The cochlea is approximately 35 mm long. From base (20 kHz) to apex (20 Hz), the characteristic frequencies decide electrode placement. The characteristic frequency CF in terms of distance x along the cochlea from the apex (of length L=35 mm):
ax

CF = A(10 L K ) = 164.5(10

2 .1 x 35

1 .0 )

The details of the transcutaneous power telemetry for biomedical implants (G.Wang et al IEEE T-Circ. & Syst.52 (2005)2109) are that an inductively coupled coil pair transfers power to medical implants.To accommodate factor of 3 load variations, adaptive control is used (just needed power). This results in more than 2X greater power transmission efficiency versus the open loop case, and thus, increased battery life and implant safety. The prototype system delivers up to 250 mW of power over a coil distance of 0.7-1.5 cms. The frequency used is ~ 1 MHz since there is increased absorption of r.f. by human tissue above a few MHz. The back telemetry link sends data at 3.3 kbps at packet error rate <10-8 from implant to external unit. Custom chips fabricated in 1.5 m technology include analog: ADC, derivative circuitry, shunt & series regulators, class E control & digital: packet encoder, decoder & power controller using FPGA. For the cochlear implant, ANURAG has designed an ASIC using 0.7 ?m technology with 5V power; a newer design caters to the 10 ? electrode resistance that needs 12V. Switching logic drives an 8-bit ADC for reverse telemetry. The audible range for human speech is 100-3500 Hz, but low frequency sounds (<~500 Hz) are not picked up by the cochlear implant because the electrodes cannot be positioned deep inside the cochlea. The number of hair cells in the cochlea is ~3,000 while the number of electrodes is usually <22. However, increasing the number of electrodes may not help much because of the problem of crosstalk. Crosstalk may be reduced by using lower currents with an implanted microphone but that may require surgery to replace the implanted battery. An alternative approach: midIR lasers (1.95 mm, 5300 ms, 2 Hz repetition rate) are used to more precisely stimulate particular neurons than by using electrodes: animal trials conducted (Izzo et al Biophysical J. 64 (2008) 3159) Initial estimates for an effective cochlear implant suggested as many as ~2400 electrodes; however, some commercial models today have as few as 6 electrodes and allow 90% comprehension/telephone talk (i.e. with 6 out of 3,000!) in a trained user. 80

Thus low level, functuonal vision may be provided by the bionic eye even though the number of photoreceptors in the eye is millions and current electrode counts are ~60 in the clinical human trials of Dr.Mark Humayun, U.of Southern Calif. The present status is that patients can detect motion, identify shapes and avoid obstacles while walking around in the lab and differentiate different grey levels. For the sake of completeness, it is necessary to mention two extraocular approaches. The first is the Cortical Prosthesis (Dobelle Inst., Zurich & Univ.of Utah) which sends input directly to the visual cortex through wires like in the scifi film Matrix either by surface or by intra-cortical stimulation. However, the implantation approach is too invasive and risky to the brain. It results in a limited visual Field and with 64 Pt electrodes a visual acuity of 20/1200. The other alternative is a penetrating micro-electrode array at the optic nerve (C-Sight, SJTU, China) which is supposed to be less invasive and the surgery less complicated. In this approach an implanted micro-camera and electrode array to penetrate optic nerve and high density electrodes and a large perception field are possible. At present, the problems are that how the information is coded is not clear, so just 4 and 8 electrodes have been implanted, ringing the optic nerve. Preliminary animal experiments have been done and biocompatibility and clinical evaluations remain to be addressed. This number of electrodes would allow a patient to decide which quadrant is being stimulated. More than 20 groups are working in the bionic eye field, with two major approaches: the epi-retinal and the sub-retinal with many publications and patents. In the former, the electrodes are placed on the retina, in the latter, below it, in the sub-retinal space. A third approach is also adopted: electrodes are kept in the supra-choroidal space. SubRetinal Prosthesis Optobionics Inc. Chow (Alan & Vince) Loyola Univ.: US patent 6,839,317 &7,139,612 TuebingenUniversity: Southern German Consortium: E.Zrenner EpiRetinal Prosthesis USC & NCSU: Wentai Liu and Mark Humayun: FDA clinical trial & US patent 5,109,844 German Consortium: EpiRet Programme E.Zrenner MIT/Harvard: Wyatt and Rizzo Nagoya Univ., Japan: Yagi NSWU, Australia: G.Suaning Others John Doorish of Doorish Opthalmic Tech.: US patent 5,865,839 & 5,836,996 Dean Scribner: US patent 6,647,297 Daniel Palanker of Stanford: The photoreceptors the rods and the red, green and blue cones - send signals to the processing cells: amacrine and horizontal cells, that feed into the neural ganglion

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cells of the optic nerve. The Epiretinal Approach involves a semiconductor based device positioned on the surface of the retina to try to stimulate the retinal ganglion cells (RGCs) of the retina. The Subretinal Approach involves implanting the artificial silicon retina (ASR) or microphotodiode array (MPDA) chip behind the retina to stimulate amacrine, horizontal and bipolar cells. The requirements placed on the components of the bionic eye are to: (i) Minimize size and power needs: ~1V, ~10 mA-mA ? ?W-mW power (ii) Deliver wireless signals and power to reduce infection (iii) Manage data transfer between internal & external components (iv) Microelectronics should survive in the saline environment of the eye & be biocompatible with the body. In the epi-retinal approach The bionic eye consists of the following elements: A miniature camera worn in a pair of dark glasses, which transmits images to a radio receiver (telemetric inductive link) implanted next to the patients eye. This then sends a signal (and power) on to intraocular parts (signal transceiver, stimulation unit & electrode array): a tiny chip of silicon and platinum, about 4mm square, that sits on the retina. The chips Pt electrodes stimulate the ganglion cells that transmit visual information to the optic nerve and onwards to the brain, which can then construct a visual image. A low-power CMOS camera mounted on eyeglass frame captures image and transfers visual information and power to intraocular components via r.f. telemetry. A 5x5 Pt electrode array fabricated on silicone rubber; square 5.4 mm side, is stuck with Ti tacks and cyanoacrylate glue on the retina. It creates a 5x5 pattern with 16 grey levels. Upgrades of the processor do not require surgery since it is outside the body, and the electrodes are far from the retina so heat damage is less likely. Epi-retinal implants stimulate RGCs directly, & they expect pre-processed, filtered info that they would have gotten from bipolar cells. Using the sub-retinal approach, the first patent was taken by Tassicker in 1956 who implanted a single Se photodiode, ~ 3 mm in diameter, behind a blind persons retina. Current approaches involve a microphotodiode array (MPDA), comprised of a regular array of individual photodiode subunits, each approximately 2020-m square and separated by 10-m channel stops. The resulting micro photodiode density is approximately 1.1x105 cm-2 and the array contains ~5,000 P-i-N microscopic solar cells that respond to light in the 0.5-1.1 m range. The process flow for a MPDA follows standard steps: (i) Implant shallow P+ wells in N-Si wafer, separated by channel stops: front side (ii) Implant N+ layer on back-side of wafer (iii) Deposit Si nitrate on front, except for well openings (iv) Deposit Cr/Ti bonding layer: front & back sides

(v) Deposit Au, Ir/IrOx or Pt transparent electrode: front & back sides (xii) Square devices, 2 mm on a side, 50 mm thick, were made by diamond sawing, and then polished to produce the final round implants There were problems with MPDAs. Firstly, devices need fenestrations so that nutrient flow to neurons is not stopped, and charge-balanced biphasic stimulation must be enabled. Although devices implanted sub-retinally in cats functioned electrically and were powered only by incident light (Chow et al IEEE Trans.Neur.Systems (2001), according to later reports (e.g. Javaheri et al Annals Acad.Med. 35(2006)), Chows approach was not feasible because it lacks a source of viable power and was abandoned. Chow now believes that the stimulation achieved by the ASR could only be therapeutic. Optobionics Co. was liquidated in 2007. Passive MPDAs, powered only by incident ambient light have given way to active MPDAs which require an external source of power. Another group at SVEC, Texas has made ceramic thin film 30 ?m sized microdetectors in a 100,000 hexagonal array. These photoferroelectric PbLaZrTiO3/BVMnO3 detectors are so thin that they are mounted on a 1 mm x1 mm polymer substrate (that will later dissolve in the eye) to enable handling by surgeons. The ceramics are considered to be bio-compatible and rabbit trials have been done and nutrient flow is compatible with these devices. The suprachoroidal retinal prosthesis (Zhou et al J.Biomed.&Biotech.2008) has the advantages of less invasive surgery (no retinal tears) and that higher choroidal blood flow should efficiently remove heat. However, it has the disadvantage of a higher threshold current for stimulation because of greater distance between electrodes and inner retinal cells, and thus lower resolution is achievable. The chip uses a 0.8 m CMOS process, data is transmitted at 125 kbps and 2.5 MHz with PWM via a class E tuned power amplifier. 7 current sources are used, 8 mA and 8bit. The polyimide based Au electrode array consists of 750x300 m2 strips. At Stanford, the group of Daniel Palanker has devised an approach that is suitable for both epi- and sub-retinal implants. A portable wallet-sized computer processor, a solar or RF-powered battery is implanted in the eye. A tiny video camera is mounted on VR style pulsed IR goggles, and a 3-mm diameter light-sensing chip is implanted in the retina. Electrodes stimulate the cells in the retina to perceive images. Tested in rats, the retinal neurons migrate into the porous interface with the subretinal implants this provides intimate proximity between the stimulation sites and the neural cells - essential for high resolution stimulation. Gen I of the system is designed for visual acuity (VA) of 20/ 400, Gen II for 20/200, and the ultimate target is 20/80 vision. Only NIR 850 nm laser diodes (not LEDs) can deliver enough light intensity to stimulate the chips to drive the neurons. Tracking the implant in real time (using a tracking 81

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camera) will allow position-dependent image processing that may be needed to translate visual information into electrical signals that can be properly interpreted by the brain. (Any image stabilized on the retina for >100 msecs fades from perception). Palankers group has exhaustively studied many of the design aspects of retinal implants. Biphasic 0.5 msec a.c.voltage pulses (negative phase cancels the positive phase) avoid charge buildup, chemical products and corrosion that would occur with d.c. pulses. For functional sight one needs: a) a minimum FOV of 10, corres.to 3 mm dia on the retina is needed b) a Snellen visual acuity (VA) of 20/ 100, corres.to 1600 pix/mm2 in the central 2-3. Visual acuity of 20/80 needs a pixel size of 20 m or an array density of 2500 pixels/mm2 (20/200= 400 pixels/mm2) and the separation of electrodes and target cells should be <7 m. Smaller electrodes deliver more localized stimulation, and thus a sharper image, but higher charge density may burn the retina. Larger electrodes will be safer, but images less distinct. The tradeoff leads to an optimum electrode size of 200-400 m still 10-20X the neural cell size. Based on studies of strength-duration products, it was found that as the stimulus duration decreased, the threshold strength for stimulus increased exponentially. The stimulus is set at 0.5 msec long with a max current of 20 mA and a max charge density of 0.8 mC/cm2. Activated Ir oxide film (AIROF) electrodes are used since the charge density exceeds the electrochemically safe limit for Pt electrodes of 0.4 mC/cm2 and also allow smaller electrodes than with Pt. Cornea and lens are transparent in the 800-850 nm range, and with a max 45 mW NIR power, for 0.5 msec at 50 Hz, will heat the retina by ~0.2 C which is deemed acceptable. The closer the electrodes are to the neural cells, the lower the stimulating currents that are needed thus reducing crosstalk and tissue over-heating. Pillar electrodes allow retinal cell migration that reduces separation. The pillar electrodes have been fabricated by photolithography (analogous to In bumps), and are 50 m high, 10 ?m in diameter: SU8 polymer implant. (Palanker et al J.Neural Eng. 2 (2005) S105). Similar approaches were followed by Yagi of Nagoya University and A.Murray (U.of Edinburgh): Guided growth of neurons on microfabricated patterns of Parylene-C on SiO2 Biomaterials (2009). Wyatt and Rizzo of the Harvard/MIT group started with an epi-retinal approach but later abandoned it for sub-retinal work. The patients spectacle holds the CCD camera and power source a laser diode (820nm wavelength) and a microelectrode array replaces damaged photoreceptors. The electrodes are mounted on 10 ?m thick polyimide strips. Electrodes on other end of polyimide strip attached to epiretinal surface by small Au weight and viscoelastic hyaluronic acid. The extraocular unit mounted on a pair of glasses: i) CCD camera (ii) signal processing unit (iii) laser. Battery pack is also external to the eye. Photodiode panel captures processed signal transmitted by the laser pulse (from the glasses) and the stimulator chip passes this information to the microelectrode array on the epi-retinal surface of the eye. 82

A novel approach has been proposed relying on tactile stimulation by an opto-mechanical array (Palanker Proc.BIOS SPIE 5688A-37 (2005)). It is known that human skin is sensitive to deformations of ~0.3 ?m amplitude. Mechanical stimulation of neurons is more natural than electrical stimulation for tactile-sensitive cells. A thin (0.15 m thick) conductive, flexible membrane covers a photo-diode array with 10 m pixels. The membrane electrostatically deflects by 1 m if 10V is applied. Neural cells, grown on the membrane, are mechanically stimulated by optical illumination of the photodiodes. Electric charge, transmitted through the illuminated photodiode, induces an opposite charge on the membrane and the attraction deflects it. An air-gap capacitance of a 10 ?m pixel, 1 ?m electrode spacing is 1 fF; energy stored at 10V is 50fJ, power consumed 2.5 pW @ 50Hz frame rate. A 3 mm diameter implant is equivalent to 700,000 pixels, and 1.8 mW power would result in 20/40 VA. Dean Scribner has worked with Dr.Mark Humayun of Second Sight, and holds an interesting patent. Nanochannel glass (NCG) channels are filled with microwires, and one surface of the NCG is ground to a spherical shape conforming to the inside of the retina (r~12.7 mm). The NCG array is hybridized to a Si demultiplexer chip. The In bump technology, used to couple the Si MUX to the retina, is of interest to SSPL. An SEM of NCG shows 0.8 m diameter channels. Another group has fabricated a 100-electrode retinal prosthesis using a multiplexer (Terasawa et al IEICE Electr.Exp. 5 (2008) 574). The reason a multiplexer is needed is that activities of daily life (ADL), walking and recognizing faces, needs >100 electrodes. Terasawa proposes a MUX mounted by flip-chip bonding by a 10x10 array of Au bumps (h = 30 m, dia = 200 ?m) on to a 4.9 x 3.2x0.57 mm board for stimulating electrodes. Each Pt electrode (w: 25m, t: 0.1 ?m, l: 200 m) has R>10 K - which is ~ impedance of typical of biological tissue. The MUX is coated with silicone moulded to a curve fitting the eyeball. The device is double coated with 1 m of parylene N and 5 m of parylene C. The symmetric biphasic pulses were 100 ms long at 100 Hz repetition rate and 600 mA amplitude. A novel retinal prosthesis (K.Nikolic et al Proc.29th Intern.Conf. IEEE EMBS Lyon Aug.2007) is needed since metal electrodes have major issues such as: dielectric tissue build-up and electrolytic degradation, and also have problems with accuracy and retention of position, apart from being invasive even if biocompatible. The proposed alternative, optical stimulation, has many advantages but it presupposes that the RGCs/bipolar cells have been light-sensitized by viral re-engineering them. Granted that has been achieved, optical stimulation would involve minimal damaging surgery, would not involve an implanted cable or power supply, would allow better spatial and temporal resolution as well as flexible spatial control (the ability to target individual receptor fields and cells) and, lastly, would have the potential to both excite and inhibit action potentials. This approach, called biochemical retinal prosthesis, is also followed by Poher et al (J.Phys.D.41(2008) 94104). Some additional features:

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Head-mounted microLED arrays used to excite the photo-sensitive cells Minimum number of photons needed to excite one cell:~105-106 Cell size~100 m2 & Energy flux needed ~5 pW/ mm2???5 nW per optical electrode of size 200 m2 Assuming 1000 electrodes, P~5 mW: tolerable value. 8x8 LED array used; upgrade to 128x128 GaN LEDs planned There are 12 different ganglion cell types that differ in their characteristics Optical stimulation will allow flexibility in choosing which RGC to stimulate; for how long; and with what intensity. The status of optical stimulation is that animal studies planned in 2009. Another biochemical method involves light-sensitive molecules made by bacteria that are similar to those analogues found in the human eye. In the proposed hybrid bacteriorhodopsin (bR) protein- Si CID neuro-morphic photosensor (Martin et al 1997 Proc. Symp. Biocomput. pp. 268-297), bR is similar to a X-type RGC with differential photosensitivity that allows edge detection and motion enhancement as well as having no response to static image just like the human eye.The illuminated bR polymer on top of the CID drives it further into accumulation. The bR has a quantum yield of 65% to green light. Ge nanomembranes, been recently fabricated by Yuan et al (Appl.Phys.Lett.94 (2009) 013102), allow one to make cameras that mimic the human eye. In the eye, light enters though a single lens, but at the back of the eye, the image falls upon the curved retina, eliminating distortion. Curved photodetectors with specially fabricated light-sensitive Ge nanomembranes are attached to any polymer substrate. The nanomembranes, so far, are curved cylindricallyneeded are hemispheric nanomembranes. An earlier report has succeeded in just that: fabricating a Hemispherical Detector Array H.C.Ko et al (Nature 454(Aug.2008)748-53). A Si 16x16 photodetector array, each element 500x500 m2, ~1 m thick, was fabricated on a hemisphere of r~1 cm, with stretchable interconnects 360 m long and 50 ?m wide, using hemispherical elastomer transfer element. Advantages over planar detector arrays: a) more uniform focus from centre to edge b) wider FOV c) more homogenous intensity - cos() variation, instead of cos4() d) reduced geometric distortions e) reduced number of optical elements needed, which means a brighter image. However, a readout has not been integrated as yet with the detector array. In a recent article, Current & future prospects for optoelectronic retinal prostheses, J.Dowling (Nature Eye Dec.2008) has reviewed the status of the bionic eye. 3 epi-retinal companies (Second Sight, Intelligent Medical Implants & EpiRet GmbH): ongoing clinical trials with chronic implants. 3 groups (Boston, Osaka & Australian Bionic Eye Foundation) have completed acute clinical trials.

Epi-retinal approach (Second Sight, Humayun) has the short-term advantage of being proven. Long-term problem is spatial resolution. Increasing number of electrodes is constrained by safety, potential crosstalk and increased power required. The suprachoroidal approach will deliver low resolution and require high charge thresholds. Hermetic encapsulation, biocompatibility and electrode degradation are problems for all intraocular devices. Passive microphotodiode arrays (MPDAs) as proposed by the Chows of Optobionics appear to have failed. Active MPDAs in the sub-retinal form show promise long-term. Biochemical retinal prostheses are promising (animal trials planned). Sensate Liner: combat casualty bodysuit monitoring a) BP, heart rate, blood loss, etc.b) projectile impact, motion, position using piezoelectric film gauges and ultrasonic detection of wound track. BLEEX: Berkeley Lower Extremities Exoskeleton: 40 sensors, strap-on legs, hydraulic mechanism, carrying 100 lbs feels like 4 lbs. All defense agencies are working towards the Bionic Man: unlike prosthesis, bionic implant mimics original function, to surpass power of the original organ or other body part. Work is proceeding on: the Bionic ear (cochlear implant); Bionic eye (ability to get HUD or telescopic/IR/UV or polarizationsensitive vision); Bionic brain (memory to replace damaged areas); neuroprosthetics to allow telekinesis, brain-circuit interface (BCI); Bionic tongue: detect pollution & CW agents; Bionic nose: ditto; Bionic heart: increased strength and endurance; Bionic lung: ditto; Bionic arm: ditto; Bionic leg: ditto; Bionic kidney; Bionic liver; Bionic Stomach CONCLUSION DRDO is interested in the bionic eye as a follow-up to its work on the bionic ear (the cochlear implant). DRDO is interested in the societal mission of helping patients of Retinitis pigmentosa (RP) and age-related macular degeneration (AMD). DRDO is also interested in bionic devices are being developed to do more than replace defective parts e.g. can the bionic eye enable HUD or telescopic/IR/UV vision? SSPL will be interested in the bionic eye since it has expertise in the wide variety of materials and areas that are involved: CCD/CMOS sensors and multiplexers, In bumps/pillars, microelectrodes fabricated by MEMS, conducting polymers, piezoelectrics, ferroelectrics, the e-nose, thermoelectrically-cooled garments, laser diodes, thin layers by Si knife, light-sensitive nanoparticles, microfluidics etc The bionic eye is a multi-disciplinary project that will involve ANURAG, DEBEL, DIPAS, CAIR, NSTL, IRDE & SSPL. DRDO will in future work on bionic arms, tongues, noses etc.: the bionic person. 83