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Leading the Strategy
Published in Anthony Graffeo, Leading Science and Technology-Based Organizations, 2018
I asked a leading medical device expert for an overview of the biotechnology market. In the pharmaceutical industry, biotechnology drugs have revolutionized the treatment of many diseases, including cancer, cardiovascular disease, and autoimmune disease. These drugs are often delivered parentally, either through an intravenous or through a subcutaneous injection, to avoid degradation in the digestive tract. To help ease the burden of injection, the delivery of these drugs has evolved from a syringe filled from a vial, to a prefilled syringe, to an autoinjector, which automatically depresses the plunger to deliver the drugs.
Autoinjector and Pen Devices: Combination Product Design and Use
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Autoinjector and pen devices are developed for use by healthcare providers, patients, and caregivers. For each of these targets, the requirements of use and scenario of use can feature unique considerations related to environment, physical abilities, cognitive abilities, and comfort with medical device use. Consider vaccine administration by a nurse practitioner, where administration counts may be in the hundreds in a given day, in contrast to a patient who administers a rheumatoid arthritis therapy weekly. These two users view the experience from different perspectives. Each sees different answers and priorities related to how many, how frequently, how deep, and how large a dose volume among other factors that influence their confidence and comfort with administration. The experience and training of each is unique and influential. These two users would each be best served by combination product design suited to their unique preferences, ergonomic, and economic considerations. Whereas the healthcare provider might have preference for a syringe-type device for its simplicity, visibility, familiarity, and ease of handling, the rheumatoid arthritis patient may prefer consideration of discretion, ergonomics, needle anxiety, and an overall design which guides administration given relatively infrequent use. Even within a user population, varied preferences might dictate multiple commercial presentations. We find that in the case of rheumatoid arthritis, there are several presentations for a given therapeutic. By example, many of the tumor necrosis factor-alpha biologics are marketed in prefilled syringe and autoinjector presentations. This offers an individual user greater options to address their unique preferences and considerations.
Comparison of the slow, fast, and flash pyrolysis of recycled maize-cob biomass waste, box-benhken process optimization and characterization studies for the thermal fast pyrolysis production of bio-energy
Published in Chemical Engineering Communications, 2022
B. O. Adelawon, G. K. Latinwo, B. E. Eboibi, O. O. Agbede, S. E. Agarry
A Gas Chromatograph from USA hyphenated to a mass spectrophotometer (GC-MS) (5975 C) with a Tripple axis detector equipped with an autoinjector (10 µL syringe) was employed to analyze the chemical compositions of the maize-cob-derived bio-oil. The carrier gas utilized in the GC-MS was helium gas. All chromatographic seperation was performed on a capillary column having specification; length, 30 m; internal diameter, 0.25 µm; and thickness, 250 µm treated with phenylmethyl siloxane. The other conditions employed in the GC-MS include, 1 µL injector; pressure of 16.2 psi; ion source temperature (EI) of 250 °C; interface temperature of 300 °C; and cut-time of 1.8 min. The column temperature started at 35 °C, for 5 min and changed to 15 °C, at the rate of 4 °C/min and the temperature was raised to 250 °C at the rate of 20 °C/min and held for 5 min.
A review of use errors reported in human factor validation studies of biological combination products
Published in Journal of Medical Engineering & Technology, 2021
Ronak Patel, Miten Mehta, Meghana Dahiya, Vinu Jose
Biological products are administered parenterally to avoid gastric degradation following oral administration [1]. Subcutaneous administration offers reduced cost and time plus increased patients compliance and convenience than intravenous administration [2]. Therefore, majority of biologics developed or are being developed as a drug-device combination products, are for subcutaneous administration and can be self-administered by patients for their chronic conditions [2–4]. Prefilled syringe (PFS), prefilled pen and autoinjector (AI) are common examples of drug-device combination products for biological drugs that allows self-administration of drugs outside clinical settings [5]. Regulatory health authorities such as United States Food and Drug Administration (US FDA) require substantial evidence of safe and effective usage of these drug-device combination products by intended users for intended uses under intended use environment conditions [6]. Biopharmaceutical companies provide the evidence of safe and effective use of the drug-device combination products through human factor (HF) studies. The term “human factor studies” is commonly used in the US whereas, the term “usability studies” is more frequently used in the other parts of the world. For purpose of this article, the term “human factor (HF) studies” is used since it focuses on products approved in the US. Human factor studies apply the knowledge of human behaviour, abilities, and limitations to the design of a medical device to create the evidence and maximise the likelihood of the safe and effective usage of these devices for the intended users and use environments [7]. Human factor studies help to improve device design and development process which ultimately lead to reduced use errors and patient harm, and improved product usability and efficiency with enhanced user satisfaction [8]. The US FDA published guidance “Applying Human Factors and Usability Engineering to Medical Devices” to assist device manufacturers to implement HF or usability engineering (HFE/UE) to the medical device development process [6].