MICRO MINIATURIZATION & ADVANCES IN NEUROMODULATION part 2
10/28/14 The market for neuromodulation devices is divided into three broad segments: internal neurostimulation, which involves implanting an electrical pulse generator; external neurostimulation where the mild electrical impulses are provided from outside the body; and drug delivery devices such as pumps. The former market is subdivided into spinal cord stimulation, deep brain stimulation, sacral nerve stimulation, vagus nerve stimulation, and gastric electrical stimulation. The external stimulation market is subdivided into transcranial magnetic stimulation and transcutaneous electrical nerve stimulation.
The demand for neuromodulation treatments is increasing as the medical industry becomes more and more sophisticated in the ways in which it approaches patient care. Conventional medicine often uses the biomedical model of disease management whereby the underlying cause is searched for and treated to relieve symptoms. But what happens if the underlying cause cannot be treated. Neuromodulation involves directly treating the nervous system itself to rebalance the activity of neural circuits and thereby manage symptoms. This ability is driving more and more medical device OEMs into the field.
But none of this would be possible without the huge advances in micro manufacturing, miniaturization, material advances, and the manufacture of reliable and compact power supplies.
Neuromodulation devices show just how far the medical sector has embraced the potential for micro manufacturing and miniaturization.
Look at deep brain stimulation, for example.
A leader in this field is Medtronic, which has effectively migrated its expertise in heart electrical stimulation to treat conditions involving the nervous system, and indeed many refer to deep brain stimulation devices as “brain pacemakers”. Heart pacemaker technology has been scaled down and scaled down to make it appropriate for neuromodulation applications, which is extremely challenging on many fronts.
To manufacture devices that are not only small enough to be inserted in the brain, but which have the necessary encapsulation to protect against unwanted electrical transmission, which are biocompatible, and which can function in (and not be degraded by) the in-vivo environment, obviously throw up a myriad of potential problems.
As such, many of the leading OEMs in the field work alongside and partner with leading micro manufacturing experts such as Micro Engineering Solutions (MES) which combine an in-depth understanding of the technologies and techniques in the micro engineering field with an innate understanding of the unique regulatory and manufacturing issues that pertain to the medical device sector.
When looking more specifically at the area of targeted drug delivery systems within the neuromodulation sector, again a profound understanding of the micro manufacturing technologies and processes available (as well as un understanding of material advancements) is vital. For neuromodulation drug delivery devices, pain medication is delivered by implantable pumps that are surgically implanted into the area to be treated and deliver the medication directly to the desired target. It enables a lower dosage to be administered, and decreases — if not eliminates — the side effects seen with systemic absorption.
These devices use drug infused pumps and catheters, requiring that manufacturers not only access technologies that allow the manufacture of such small, complex, and feature-rich devices, but also understand the regulatory environment surrounding combination medical products. Again, MES has navigated the manufacturing and regulatory issues surrounding the production of such devices for numerous medical device OEMs, and can provide a cost-effective, timely, and efficient route to market for products under development.
Neuromodulation sees the coming together of a number of important trends in the area of manufacturing and medical intervention. First, the ability to manufacture tiny, powered, biocompatible devices and drug delivery systems, and second the ability to treat chronic diseases with a one-time implanted device that negates the need for monthly, weekly and sometimes daily medicines or injections.
The knock on effect of this in terms of savings in national budgets for healthcare, and also in the enhancement of patient life styles are huge, and will ensure that the area of neuromodulation will grow and grow in the short, medium, and long term.
Call MES today and let’s discuss the ways in which we can realize your objectives in this exciting area quickly and cost-effectively. The rewards in terms of patient outcomes and your bottom line really are extraordinary.
If you are interested in partnering with MES for the development of neuromodulation devices or for other medical applications, please email Donna Bibber at donna@microengineeringsolutions.com.
MICRO MINIATURIZATION AND ADVANCES IN NEUROMODULATION (part 1)
10/22/14 One area in the medical arena is attracting unprecedented interest at the moment. Not only is this because of the dramatic predicted revenue growth rates in the particular sector, but — from a less commercially-minded point of view — because of the huge positive impact it could have on patient treatment and standard of life.
The area in question is neuromodulation, which as a sector has been around for a while, with various treatments centered around the electrical stimulation of the spinal cord, brain, and peripheral nerves to help alleviate pain going back 40 or 50 years. Now, though, the focus is on applying the treatment to a wider range of ailments.
Huge advances in micro manufacturing and miniaturization are driving neuromodulation, which obviously relies on the ability to make tiny, often complex, but always perfectly functioning medical devices and components, very often delivering electrical impulses.
The global neuromodulation devices sector is expected to grow to $6.8 billion by 2017. This makes it the fastest growing part of the broader medical devices sector, its growth being driven by greater and greater demand for less invasive and minimally invasive alternatives to the treatment of chronic pain, epilepsy, obesity, urinary incontinence, and stroke and brain injury among other conditions.
An aging population together with the rise in age-related diseases like Alzheimer’s, epilepsy, Parkinson’s disease, and spinal cord injury is also fuelling the market year after year.
Neuromodulation includes treatments that involve the stimulation of various nerves in the central nervous system, autonomic nervous system, or deep cell nuclei of the brain that lead to the “modulation” of its activity. By definition, neuromodulation is a therapeutic alteration of activity either through stimulation or medication, both of which are introduced by implantable devices.
As a therapeutic route, its key advantage is that it is a reversible treatment option, in other words it can be turned off, and once turned off its therapeutic effect is halted.
Many of the leading OEMs in the field work alongside and partner with leading micro manufacturing experts such as Micro Engineering Solutions (MES) which combine an in-depth understanding of the technologies and techniques in the micro engineering field with an innate understanding of the unique regulatory and manufacturing issues that pertain to the medical device sector.
In a future blog we will discuss the three broad segments of market for neuromodulation. Stay tuned for more info…
PARTNERSHIP IN DRUG DELIVERY CONFERENCE – FROM Affreza-ZebraFish
HIGHLIGHTS FROM BOSTON, 2014
10/15/14 A wicked good conference was held in Boston this week with several hot products/technologies in drug delivery. Dr. Barbara Lueckel of Roche led off the event and her overview of the Partnering in the industry was extremely promising for 2014-2015 that the need for micro devices will continue to be on the rise. Inhalation and dry powder inhalation was deemed the largest area of growth this year. Afreeza®, MannKind’s DPI was high up on the holy grail charts when it was purchased by Sanofi earlier this year. The other end of the alphabet had MIT studying Zebrafish as an injecting agent to determine if their efficacious nature can be translated into humans. Highlights of other micro devices presented and discussed were:
• Targeted Devices: In-vitro delivery systems such as BioCardia’s Helix (see photo below), Parkinson’s treatment devices, pain management, and intrathecal (wearable) devices
• Transdermal Delivery- Dissolving Micro Needle Treatment, Hollow Micro Needles, Solid Micro Needle Arrays, Laser Ablation Devices for inflammatory skin diseases
• Ocular Delivery- Nano particles through membrane
• Vaginal Delivery- Nuva ring, EVA & Silicone, large molecule diffusion
• Implantable- microspheres, stents, biopolymers decreasing delivery rates over time, degradable chips triggered remotely
• Inhalation-DoseOne™ single dose disposable, Civitas, Skyepharma, and Astra Zeneca were DPI highlights and side discussions
Dr. Bob Langer of MIT introduced a micro needle capsule for the use in the gastro intestinal tract. The audience and reverence was evident in the crowd of hundreds as Dr. Langer was chatting about his 250 companies, 1,000 publications, 26 founded companies, multiple patents, and highly decorated career to date (and that was just in 2014!) All kidding aside, he is a highly acclaimed scientist/engineer with a heart of gold and is inspired by “using science to help people”. His advice for partnering in drug delivery, “Write a great paper in a hard to get into magazine like Science and Nature, have compelling animal data and animal model, and have a firm list of patents before going to big pharma or VC for a deal. The biggest mistake you can make is to do it (go for partners) too soon. The longer you wait, the more value you create.” Additional questions to ask were “Is it safe, can you manufacture it, are timelines possible, and can someone else do it better.”
Interesting and thought provoking questions that many medical and drug delivery start-ups miss out on. Going it alone vs. finding experienced micro device manufacturers saves energy and resources that could focus on design, regulatory, and critical path milestones to allow the development and manufacturing team to be mutually successful. In my experience this is the number one reason why companies fail in micro devices as they underestimate the challenges with metrology, validation, tooling, and handling micro sized parts and features. Dr. Langer ended his chat with another gem from his long and illustrious career, “In our youth our success is gauged by how well you answer questions. Later in life we are gauged by how well we ask questions.
A truly phenomenal conference with several interesting topics of interest in drug delivery! More on Day 1 and Day 2 in a future blog……
ENCAPSULATED MICRONEEDLES MAY MAKE SKIN INJECTIONS OBSOLETE
10/07/14 The Partnership in Drug Delivery Conference (PODD) will be held next week on Boston, MA. Donna Bibber from Micro Engineering Solutions (MES) will be attending. She will be networking with companies and meeting new businesses to inform them of how MES can help with their micro projects as well as look for partners for the DoseOne single dose powder inhaler device.
PODD is a great place for drug delivery and pharmaceutical companies to gather to discuss innovative ideas. PODD just blogged a great article about a drug delivery capsule that may replace todays needle injections. Researchers at MIT and Mass General Hospital have developed a pill coated with microneedles that would deliver drugs directly into the lining of the digestive tract.
The researchers tested this capsule using insulin and found that it delivered the insulin more efficiently than the current injection under the skin method that we use today. It was also found that the needles did not harm the lining of the digestive tract while it passed through the animals system. This could change the future of how vaccines and cancer treatments are delivered. Further research is currently being done on this capsule to see what else it can be used for and to minimize safety risks.
This is the type of exciting cutting edge technology that will be discussed at the PODD next week. It is an event that shouldn’t be missed if you are in the drug delivery or pharmaceutical fields.
PODD will be held at the Renaissance Boston Harbor Hotel 606 Congress St in Boston from October 14-15, 2014.