6/24/14 Advances in micro manufacturing techniques and materials are constantly driving innovation in the area of pharmaceutical devices, combination devices, and drug delivery.
Without a doubt, it is the medical device sector that is constantly pushing the drive towards miniaturization. In the medical device industry, the usual advantages of making smaller parts (such as reduced material usage, reduced weight, and reduced cost) are exacerbated by the requirement for less invasive treatments. In addition, the opportunities for diagnosis and treatment that are available if functioning devices can be swallowed, ingested, or inserted in the body are huge, and constantly stimulate innovation in the micro manufacturing field.
Also, in the area of drug delivery, where the pressure is for treatments to be cost-effectively and efficiently self-administrated (reducing the burden on healthcare practitioners and therefore reducing costs) micro manufacturing is enabling product designers to think out of the box, and makes available to them fabrication technologies that allow for the mass production of parts and devices previously impossible.
Micro manufacturing technologies, materials, and techniques are moving on apace, and today much of the onus on experts in the micro field — such as Micro Engineering Solutions (MES) — is to educate and inform clients of the possibilities, often times reinforcing the fact that many technologies that OEMs perceive as prototyping technologies are now capable of being scaled to mass production quantities.
Applying these capabilities to the dynamic area of drug and device development presents such a huge array of commercial possibilities, but at the same time opens up possible pitfalls for the uninitiated, or those who do not have the expertise to best utilize what is available today, or foresee what is just around the corner. So many recent and imminent device and pharmaceutical developments are being driven by companies that embrace and partner with micro manufacturing experts right at the beginning of the design cycle.
So where does the combination of drug, device, and micro manufacturing development stimulate innovation. Well, broadly speaking, it is fair to say that pharmaceutical companies do and will rely on developments in micro and nano manufacturing for new drug discovery (producing miniaturized products such as microarrays that help in analysis and ingredient synthesis) and reduced drug development time (producing lab-on-a-chip devices that help assess which drug compounds are likely to be most efficacious).
However, once the drug is developed, micro technologies also facilitate new drug delivery options (which can also extend drug lifecycles), and better treatment performance. Many pharmaceutical companies look for ways to extend the lifecycle of their drugs, especially when competing with the burgeoning generics market-place, and one way of doing this is by developing delivery options that are novel, stimulate the possibility of non-invasive drug delivery, increase the efficacy of the drug, and are as small as possible to allow the possibility to be implanted in the body or be easily portable.
Micro manufacturing technologies have facilitated the possibility for cost-effective mass production of a number of innovative inhaler systems for treatment of asthma and COPD, and have also opened up the possibility of inhaler-based drug delivery devices being used where previously injectables were the only cost-effective option. In many instances, this opens up not only the possibility of self-administration, but also increases drug efficiency, due to the immediacy of drug action when inhaled.
Again, targeting the sometimes cumbersome, costly, and non-patient friendly area of injectables, micro manufacturing has opened up the possibility of drug delivery via micro molded needles arrays and transdermal drug delivery. For a number of years, despite the fact that it was considered potentially the best mechanism to administer insulin, incretin mimetics, and other-protein-based pharmaceutical agents (biologics), microneedle-mediated drug delivery for transdermal delivery was frustrated by the poor performance of the microneedles due to inappropriate available materials and poor fabrication techniques.
Today, micro molding technologies have developed to the point where microneedle structures with appropriate structural, mechanical, and biological properties have opened up a huge number of possibilities for transdermal drug delivery in numerous treatment areas. These micron-sized needles have been shown to dramatically enhance skin permeability, and have opened up the possibility of not just therapeutic drug delivery, but also transcutaeous immunizations and cutaneous gene delivery. The nature of the micro needles is also such that they are minimally invasive and painless, and have numerous safety advantages and patient compliance advantages over traditional injection technologies.
Success in many of the micro manufacturing projects that are applied to medical device and drug delivery development also demand an understanding and working knowledge of some innovative and — in certain instances — difficult to use materials. MES has a proven track record working with degradable polymers such as Polylactide (PLA), Poly-l-lactide (PLLA), Polylactic-co-glycol acid (PLGA), and water soluble Polyvinyl alcohol (PVOH) among others.
In many drug and non-drug related applications, device development is driven not just by advances in micro manufacturing capabilities, but also by the introduction of such innovative degradable, soluble, and bioresorbable polymers. It is now possible to undertake intricate micro molding operations using these and many other innovative materials.
But once again, there are challenges to confront when working with some of these polymers (which are often very expensive). It is vital to understand that many of these materials are both moisture, heat, and shear-sensitive, and the only way to use them economically is to dramatically minimize runner and sprue scrap. The sensitivity to heat and moisture makes them liable to degradation during typical melt processing through compression molding, injection molding, and extrusion. Micro molding has focused on the design of molds and control of processing conditions to overcome these issues, but processing costs are still very high.
are also numerous validation hoops that need to be adhered to, which requires an innate understanding of the regulatory requirements for medical devices, bioresorbables, and cleanroom manufacturing.
Partner selection with all these considerations is obviously critical for medical device OEMs, but the commercial opportunities are huge if device development is optimized. Today, swallowable medical devices exist for diagnosis and surgery (including wireless camera pills), and under development are a range of “micro” swallowable medical devices that can enable advanced diagnostics and even directly deliver surgical tools and therapy non-invasively to interventional sites deep within the GI tract. Also, devices that include electronic components that dissolve in the body are being developed, as are absorbable stents.
The industry is tantalizingly close to being able to address some fundamental issues in healthcare. It will soon be possible, for example, to ensure that all “sharps” used in a medical setting such as needles, scalpels, trocars, and pins are made from resorbable or erodible polymers, meaning that a simple wash cycle would render them harmless.
MES is happy to discuss ways in which its expertise and that of its OEM medical device clients can be combined to develop new and innovative products taking advantages of the huge advances in micro fabrication technologies and new materials.
Please contact Donna Bibber at [email protected]