MedicalChain International Corporation (MCI) started as an incubation project in 2002 at the In⁶ IncuVestor^® Inc., the first private incubator in Taiwan. The company was incorporated in 2003 and spun off in 2005 from said incubator.

To be the most favored supplier for sharp safety medical devices.

To supply user-friendly and inexpensive medical devices with built-in sharp safety mechanism via innovative design and automated mass production, so that health-care workers’ risk of exposure to the sharp injuries can be substantially reduced. Bear this goal in mind, MCI is dedicated to research, develop and manufacture safe, innovative and economic medical devices for better human life.

The first product line is “Auto-Retractable Safety Syringe” with the registered trademark of . These syringes, employ same administration technique as that of conventional syringe, feature with user-activated automatic needle retraction and containment, syringe disabled functions to prevent needlestick and syringe reuse.

The 3ml safety syringe got FDA 510(k) clearance in October, 2005 and ISO 13485 and CE marked in May 2007. The 1ml safety syringe for general purpose got FDA 510(k) clearance in September, 2011, and CE mark in May 2012. The 1ml safety syringe for insulin use got CE mark in May, 2012 and FDA 510(k) clearance in August 2012.

Integrated Plastic Pre-fillable Safety Syringe, iPPFSS (aka )

Rapid growth and increased competition in the biotechnology industry are driving the need to differentiate among products. Improvements in product presentation form, evolving from vials to pre-filled syringes (PFS), and other quality attributes are key strategic factors one must consider in order to succeed in an increasingly competitive marketplace. Prefilled syringes offer several advantages for drugs requiring parenteral injection. On one hand, pharmaceutical companies can benefit from reduced cost of goods by eliminating overfill that are required by traditional packaging of vials/ampoules. On the other hand, patients and healthcare workers can benefit from a dosage form that is ready-to-use, improved dosing accuracy, and reduced risks associated with filling and using a syringe. Importantly, all these benefits can reduce overall healthcare cost by improving patient compliance.

In the years 2005 through 2007, unit sales of PFS have risen about 22%¹. The worldwide market for PFS has increased to an estimated 2.7B units in 2010 and the total revenues in this market are predicted to reach $3.9B in 2015, $4.6B in 2018 and $5.2B in 2021^2,3. The growth in PFS market along with the adoption of the needle-stick safety and prevention laws worldwide have stimulated the Needle Safety Device (NSD) market in the past decade. However, despite its growing popularity, development of PFS as a method of drug delivery also has its own hurdles and risks.

Prefilled syringes act both as drug delivery vehicle and the primary container for drug products. Therefore, they are required to provide seal integrity, drug compatibility and stability throughout the shelf life of the drug product. Glass, the traditional material of construction for PFS has also been challenged. There have been cases of huge financial loss and damaged corporate reputation in the pharmaceutical industry associated with recalls of valuable combined products due to glass breakage⁴. Apart from its heavy and brittle nature, residual tungsten in the glass barrel from the bore opening process can cause protein degradation. Drug stability under high pH value also presents another risks associated with glass barrel.

Furthermore, prefilled syringes currently available on the market do not have integrated needle-stick prevention function; they all require certain add-on sheaths or other devices to render the syringe sharp safety, retrofitting of said external device onto the glass barrel also comes with additional risks of subjecting an expensive drug through another assembly process.

In order to address the unmet need for a PFS that is break-resistant, free of heavy metal, and features an integrated safety system, MCI is developing an innovative Integrated Plastic Pre-fillable Safety Syringe (iPPFSS) made of COC or COP polymer. The design is fully integrated with MCI’s patented user-controlled automatic needle-retracting mechanism which has been proven in automated mass production of safety syringes for clinical use. Although the same technology platform is employed for prefillable version, certain configurations have been fine-tuned to enhance container closure integrity. Furthermore, the dimensions of the prefillable syringes are adjusted to accommodate conventional ready-to-use fill/finish system as well as sterilization process so that manufacturing switching cost is eliminated or minimized..

In order to shorten the time required for product development and commercialization, standard and FDA compliant products from leading suppliers will be used for all the components that in contact with the active pharmaceutical ingredient, such as plunger (stopper or piston) and needle shield.

iPPFSS takes advantage of innovative material design and manufacturing flexibility, eliminates glass breakage and provides a great life cycle management tool for drug products in PFS. It could ensure the quality of syringes before fill and reduces waste of precious drugs due to added assembly process which is occasionally needed with the add-on devices. Its compact design saves costs in cold storage, shipping, handling (lower density/weight) and waste disposal.

Ref:

1. http://www.ondrugdelivery.com/publications/Prefilled_syringes_%2007.pdf
2. PREFILLED SYRINGES: Drugs, Devices and Disease Therapeutics (Greystone report, May 2009)
3. Pre-Filled Syringes: World Market Outlook 2011-2021 (Visiongain report)
4. http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm247463.htm