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PARTNERSHIPS IN DRUG DELIVERY OPPORTUNITY

9/29/14   The annual Partnership Opportunities in Drug Delivery (PODD) is a perfect place to network with other companies in the medical and pharmaceutical industries as well as listen to some innovative speakers. This year the event will be held on October 14-15, 2014 at the Renaissance Boston Harbor Hotel 606 Congress St in Boston.

The event has three purposes:
•Provide drug delivery and specialty pharmaceutical companies with a platform to present their technologies and get the latest insights on what the delivery and formulation needs are
•Present a strategic level program pharmaceutical and biotechnology business development professionals with a detailed overview of the latest drug delivery technologies along with opportunities to improve therapies and extend the lifecycle of a drug
•Offer a productive networking opportunity to establish new business contacts and enhance existing ones

The event is a place that inspires innovation and advancement of drug development and delivery as well as provide support to the leaders behind the movement. There is a schedule of speakers you can listen to, an expo to attend where you can meet reps from other companies as well as ample meeting space so you can meet one-on-one to discuss your ideas. Donna Bibber of Micro Engineering Solutions will be attending the conference and speaking with potential business partners. She will be discussing partnership opportunities for the DoseOne product as well as offering her micro expertise to medical and pharma businesses who have the need for micro products. If you would like to schedule a meeting time with Donna please contact her at DonnaBibber@MicroEngineeringSolutions.com.

 

MICRO TRANSIENT ELECTRONICS

9/24/14   No-one could ever accuse the medical device sector of standing still when it comes to innovative product development, and as manufacturers grapple with the demands of designing and manufacturing “traditional” bioresorbable devices, the drive is on to add power to implantable resorbable devices, which opens up the potential for implantable or ingested products that can undertake therapeutic or diagnostic tasks, and once the desired effect or results have been achieved, dissolve in the body.

Here we are dealing with a relatively new area called transient electronics, and while the potential for such devices in the medical sphere is obvious and has potentially huge positive patient and treatment outcomes, transient electronics have a use in many sectors of industry. In the medical arena we are looking at powered devices that can be implanted in the body to relieve pain or fight infection for a specific period of time. In consumer electronics, transient electronics would mean the advent of products with a predetermined service life. For many involved in the area of micro-electronics and the chip industry — where the struggle has always been to build more and more durable components — the idea of transient electronics is somewhat counterintuitive.

For the devices to work in situ in the body, the electronics are wrapped in bioresorbable materials, the amount of wrapping and the degradation time of the bioresorbable material determining the life-cycle of the product. As the wrapping is dissolved, the electronic connections melt away in a matter of minutes, and the device ceases to function. For many such devices under development, power sources are still external, although research is focused on making and powering devices internally, perhaps through the use of thin and flexible zinc oxide which heats when bent or twisted, which could be controlled by the beating of the heart or movement of muscles.

Such transient electronics work through the use of “man-made” electronic constituent parts (typically high performance electronic systems made from magnesium and magnesium oxide on thin silicone sheets), the breakdown of which has obvious challenges in terms of toxicity and compatibility issues. How much better, then, if the electronics used in such implantable, bioresorbable, powered devices are organic.

MES has considerable experience in dealing with a variety of medical bioresorbables. Bioresorbables demand extremely precise processing controls, and their high relative cost when compared to nondegradable polymers means that manufacturers must use high-yield, low waste molding technologies. MES is one of only a very few micro molding companies that has the experience and knowledge to deal with bioresorbables efficiently.

NANO LAYERED DRUG DELIVERY SYSTEM PROLONGS LIFESPAN DRUGS

9/16/14   Controlled release drug delivery employs drug-encapsulating devices from which therapeutic agents may be released ranging from days to months. Such systems offer numerous advantages over traditional methods of drug delivery, including tailoring of drug release rates, protection of fragile drugs and increased patient comfort and compliance.

Polymeric micro features and devices are ideal vessels for controlled delivery applications due to their ability to encapsulate a variety of drugs, biocompatibility, and sustained drug release characteristics.

Research discussed in this article is focused on a new method developed at MIT for controlling the release rates of encapsulated drugs.

Micro Engineering Solutions micro fabrication techniques further advance systems for delivery of single or multiple-shot, vaccines, DPI, and transdermal drug delivery to name a few.

Why is all of this necessary? Chronic pain sufferers often face the choice of either enduring their pain or accepting the consequences of taking large volumes of drugs at once. Researchers at MIT have developed a technique that may lengthen the lifespan of targeted drug delivery systems for up to 14 months.

In a study published in Proceedings of the National Assembly of Sciences, MIT explains how their layered system of nano-scale films will enable the controlled release of medicines over a much longer period of time that previously possible. The benefits of this are:

  • It maintains relevant concentrations of medicines in an affected area
  • It minimizes exposure of vital organs to large doses of medicines
  • It decreases the number of implantations of the device to about once a year

In the article the researchers state “Drug release from implants and coatings provides a means for local administration while minimizing systemic toxicity. Controlled release can provide a slowly eluting drug reservoir to maintain elevated therapeutic levels. Devices based on degradable polymer matrices can control drug release for multiple weeks, but longer durations typically require bulky, non-degradable devices. Using a combination of a polymer–drug conjugate and its electrostatic thin film assembly, we discovered a predictable long-term sustained release of more than 14 months, far exceeding the duration noted in most previous reports, especially those from biodegradable matrices. Because of the substantial drug loading, nano-scale films were able to maintain significant concentrations that remained highly potent. We report a versatile, long-term drug delivery platform with broad biomedical implications.”

 

EDIBLE ELECTRONICS

9/10/14    MES has reported before on such developments which open up massive potential for medical device OEMs, and could truly revolutionize countless area of existing treatment, and open up new areas of medical intervention.

Edible electronics are made from basic edible materials and naturally occurring precursors that are consumed in common diets. Using such techniques, up to 0.6 V and currents in the range of 5–20 μA can be generated routinely. Inexpensive, non-toxic, sodium-ion batteries can be made that power sensors, drug delivery systems, or tissue stimulating tools made from biodegradable of bioresorbable shape-memory polymer. These devices can be folded down and encased within a gelatin capsule, allowing for a timed-release at a key point in the body. When the capsule dissolves, the polymer hydrates, thus initiating electrical current flow from the battery, and causing the device to open into its operational form.

Such technology could power sensors that could be used in undertaking internal surveillance for metabolic procedures (blood values, temperature, wound healing processes, etc.) and these devices would disintegrate after a certain time in the human body without any health risks. The palatable circuits could also be used in tablets to examine whether or when they were taken by a patient. If, for example, the circuit is no longer transmitting, it implies the medicine was ingested.

Developments in the area of biotechnology like this have the ability to overcome a particular issue that surrounds the burgeoning area of biologic drug development, and could present numerous options for leading pharma players. These drugs have been found to offer huge benefits in the treatment of a variety of debilitating and chronic diseases, but as they are protein-based, they are destroyed when coming into contact with gastric acid. So saying, the administration of biologic drugs is somewhat complicated by the necessity for various injection technologies.

However, edible electronics open up the possibility of being able to administer such drugs, and allow them to be ingested via oral administration. This could make therapies such as arthritis drugs that currently have to be given intravenously much easier to take. Smart pills could carry sensors and circuits and release drugs only after they have passed the harsh environment of the stomach and reached the intestine, where the drugs could be absorbed into the body.

It is impossible to overstate the potential that exists using such technology, but the basic principles of design and manufacture using delicate polymers are still present, and indeed are exacerbated by the sensitivity of the organic electronic elements that need to be incorporated with the bioresorbable polymers.

MES remains extremely well-informed of developments in this area, and is eager to discuss projects from OEMs that look to exploit “conventional” resorbable materials, or the more ground-breaking advances in edible electronics.

 

MICRO MANUFACTURING NEUROLOGICAL DEVICES

9/3/14     Ultra Precision Manufacturing Drives Medical Advances & Innovation. In niches of industry where ground-breaking technological developments seem to occur every other week, it is always tempting to focus on what’s next rather than the potential of what is available now. Nowhere is this more obvious than in the area of micro manufacturing, where with alarming frequency, what was impossible yesterday is becoming possible today. This presents massive opportunities for OEMs that are looking to innovate and produce more and more precise products and components. But it can also become confusing, as it can often seem as if today’s “go-to” technology solution will soon to be replaced by something quicker, more-cost effective, or more precise tomorrow.

What is vital is that OEMs partner with companies like Micro Engineering Solutions (MES) early in the design cycle in order to find the best fit technology for their project. MES has been working in the dynamic micro manufacturing niche for years, and is therefore aware of the potentials to exploit and the pitfalls to avoid, as well as areas of innovation that are dawning and which provide huge potential for product development and market exploitation. What is obvious to all involved in the micro manufacturing arena today is that recent ground-breaking manufacturing solutions offer the potential today for efficient and cost-effective mass manufacture. Technologies that yesterday were being proved and tested, and were seen at best as prototyping technologies, are now scalable and delivering millions of parts a year.

Neurological Device Development. One specific medical niche that focuses the requirement for an array of skills in the area of ultra-precision device development is neurological products and implants. Whereas today, the integration of nanometer-sized devices into biological systems is an everyday occurrence, a couple of years ago, this was not the case. The reason for this recent success is the development of ultra precision fabrication technologies, combined with the development and use of innovative materials that can be completely implanted and are biocompatible for extended periods of time.

Neural implants effectively communicate with the nervous system, and in many instances contain electronics that stimulate 37_neuro_implant_2healthy neurons, allowing for signals to bypass damaged areas of the brain or the central nervous system (CNS), thereby restoring function, easing pain, or preventing seizures. Much recent focus has been on the development of smaller and smaller electrodes, which are now implantable in the body without causing any adverse reactions. Here research is centered on the material within which the electronics are contained, often now a flexible polymer (instead of brittle silicone) which allows the device to conform with the live tissue in which it is implanted.

Non-electrical neurological products are also being developed due to advances in ultra precision manufacturing, such as micro-guide wires that allow surgeons to work on previously impossible to reach intracranial vessels. Today advances in micro manufacturing technologies make possible the manufacture of guide wires that are passed through catheters with internal lumens of 0.015 inches.

A huge challenge for such devices is the fact that the human brain and CNS are not a hospitable place for implants. Often the body attacks foreign materials in the CNS or surrounds it with a sheath, which can interfere with the device functionality, especially if it contains electrodes. The focus now is on neuro-protective coatings that make such micro devices implantable and efficacious for their proposed life. The fact that many of these neurological devices also cross the blood/brain barrier is another area that requires attention, as it is obviously vital that such implants don’t introduce pathogens or other materials that could induce an immune response.

For medical device OEMs, the burgeoning field of neurological surgery and treatment is a key sector, as the ability for micro manufacturing practitioners such as MES to assist in the production of smaller and smaller devices in an array of materials means that previously impossible neurological interventions will rapidly become the first line of treatment for many diseases, opening up huge commercial opportunities.