Month: June 2023

Have you ever experienced or heard of adverse effect after contact or exposure to a product? What if the product was tested prior to check for chances of adverse effect? Would it not have prevented you from experiencing discomfort or risk while using the product? The same holds true in case of medical device usage where safety of patients is uncompromisable and of paramount importance.

What is a medical device?

A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.

We often find use of medical devices in clinical settings and daily lives. Products ranging from catheters, IV tubes, cardiac stents, dental implants to glucose monitors, optical contact lenses, intra-uterine devices etc. are categorized as medical devices.

The medical devices are classified into three categories (as per US FDA) for ease in imposing regulations based on levels of risk they exhibit:

Class I

Non-invasive medical devices that carry a low degree of risk. These devices pose minimal or zero risk to patients even if they malfunction.

Devices like: Bandages, wheelchairs, walkers, crutches, enema kits, latex gloves, and other common supplies and medical equipment used in healthcare facilities or homes come under Class I.

Class II

Invasive medical devices which pose moderate to intermediate risk come under Class II. Devices used in or outside of the body with potential risk to patients are included in this class. Devices like: Pregnancy test kits, scalpels, needles, syringes, bone-fixation implants, dental implants, electrically powered wheelchairs, respiratory equipment etc. are some Class II medical devices.

Class III

Invasive medical devices that bring a significant risk to the patient by malfunctioning or incorrect usage fall under the Class III of medical devices.

Devices like: Artificial heart valves, cardiac stents, pacemakers, breast implants etc. are Class III medical devices.

The medical device classification varies vaguely according to the regulatory setting in each country. In India, as per the regulatory body, CDSCO (Central Drug Standard Control Organization), the medical devices are classified into four classes based on levels of risk –

• Class A – Devices posing low risk to the patient (cotton wool, surgical dressing, swabs)
• Class B – Devices posing low to moderate risk to the patient (thermometer, BP monitor, disinfectants)
• Class C – Devices causing moderate to high risk to the patient (implants, haemodialysis catheter, CT scan equipment)
• Class D – Devices posing high risk to the patient (heart valves, angiographic guide wire)

Why should medical devices be preclinically evaluated?

The risk a medical device carries can range anywhere from the toxicity of materials used to fabricate it to its eventual biodegradation. Hence, it is critical to evaluate medical devices prior (preclinical trial) to testing on humans (clinical trial). The preclinical evaluation involves investigating the performance, biocompatibility, and safety of the medical device. This provides an insight into how the materials of the medical device interact or react with the human tissuesand in vivo environment (inside the body). Taking the preclinical data insights together, a medical device can be passed or modified for reconsideration. The preclinical tests to be performed for a medical device differ based on its nature of body contact and contact duration and user country’s regulatory requirements.

How are medical devices preclinically evaluated?

The biocompatibility and toxicity would be tested at various layers/ parameters depending on the type of medical device, its usage and degree of risk. The materials used in the product are tested by performing some preclinical assessments like –

• Cytotoxicity – To check for the biological reactivity of material of the medical device with the mammalian cells
• Sensitization – To check for potential of a material or product to cause a delayed hyper-sensitivity reaction
• Irritation test – To check potential of test materials and their extracts, using appropriate site or implant tissue such as skin and mucous membrane in an animal model
• Material mediated pyrogenicity – To check for the potential of material in/on the medical device to elicit systemic febrile responses
• Acute and repeated dose toxicity – To check for general health hazards due to acute or repeated exposure to the extracts from the medical device material
• Implantation – To check for the local effect of the materialat the site of the medical device implantation (intramuscular, bone, subcutaneous)
• Hemocompatibility – Evaluates any effects of materials in contact with blood on hemolysis, thrombosis, plasma proteins, enzymes, and the formed elements
• Genotoxicity – To check for effect of substances in/on the medical devices to cause genetic damage via either gene mutations or chromosomal damage

What is the Medical Device Scenario in India looking like?

The medical device scenario in India is encouraging given the significantly increasing demand and investment in the sector.  India is the 4^th largest Asian medical devices market after Japan, China, and South Korea, and among the top 20 medical devices markets globally. To amp this up, the Government of India laid initiatives like 100% foreign direct investment in the sector, “Promotion of Medical Device Parks” programme, launch of production-linked-incentive (PLI) scheme for domestic manufacturing of medical devices and most importantly, the National Medical Device Policy 2023. Read more about NMD Policy 2023 here.

As of 2020, the medical devices market is estimated to be at USD 12 billion in India, and it is expected to grow at a CAGR of 15%, which is 2.5 times the global growth rate. On the other hand, the export of medical devices from India stood at USD 2.90 billion in FY22 and is expected to rise to USD 10 billion by 2025.

Conclusion

Preclinical testing plays a crucial role in ensuring the safety and effectiveness of medical devices. By assessing parameters such as biocompatibility and toxicity, these preclinical evaluations help mitigate risks and prevent adverse reactions in patients. As the demand for medical devices continues to grow, thorough preclinical testing becomes increasingly important in maintaining patient safety and improving healthcare outcomes.

GVRP offers Medical Devices Testing Services. Connect with us at info@gvrp.in to learn more about our testing services portfolio.

Written by: Supriya Avatapalli
Sai Supriya has a 2 year experience in academic research and fair exposure to transition into industry. She enjoys delving deep into the new developments in the biotech, pharma industry and collaborating with people. She is zealous and keen to direct her best strengths to the role by being receptive to new ideas and challenges.

Importance of Lab Animal Diet in Research

A well-formulated lab animal diet is essential for maintaining the health and well-being of laboratory animals, which ultimately affects the quality and reliability of experimental results. Researchers need to ensure that the diets of their test subjects are balanced, consistent, and free from harmful substances to limit potential confounding variables in their experiments.

The Influence of Diet on Experimental Results

The diet of a lab animal can directly impact the outcome of an experiment. For instance, certain dietary components can affect gene expression, metabolism, and immune function, potentially altering the response to experimental treatments or interventions. It is crucial to consider the specific nutritional needs of the animal models used and the desired research outcomes to design appropriate diets.

History of Rodent Diets

Before the 1960s, there was no standard formulation for rodent food, and researchers had limited information about their nutritional content. In the 1970s, the American Institute of Nutrition (AIN) developed AIN-76A, the first widely accepted, publicly available diet formula for rats and mice. Since then, there have been further advancements in the formulation of rodent diets to better meet the nutritional requirements of different species and strains.

Advancements in Rodent Diet Formulations

Over the years, researchers have recognized the limitations of early diet formulas and have made significant improvements. The development of standardized formulas such as AIN-93 and AIN-2016 has provided researchers with more reliable and consistent diets for rats and mice. These formulas take into account specific nutritional needs, growth stages, and genetic backgrounds of different laboratory animal models.

Considerations for Diet Formulation

Formulating lab animal diets involves considering various factors, including species-specific nutrient requirements, energy needs, growth rates, reproductive demands, and health conditions. Researchers also need to consider the sourcing of ingredients, the avoidance of potential contaminants or allergens, and the ethical considerations related to the treatment and welfare of the animals.

Modern lab animal diets focus not only on meeting basic nutritional requirements but also on optimizing animal welfare. They aim to provide appropriate enrichment, palatability, and texture to enhance the animals’ overall well-being. Researchers strive to strike a balance between meeting research objectives and ensuring the health and comfort of the animals throughout the study.

Importance of Transparency and Standardization

To conduct high-quality nutrition research with lab animals, it is crucial to use diets with known ingredient compositions. This transparency allows researchers to replicate studies and better understand the effects of specific nutrients on lab animals’ health. Standardization in diet formulations and reporting enables better comparison of results across studies and enhances the credibility and reproducibility of research findings.

Teklad® Diets

 A High-Quality Solution Teklad® diets continue to be recognized for their stringent quality control measures, extensive research, and expertise in manufacturing laboratory animal diets. These high-quality diets help researchers minimize dietary confounding variables and ensure reliable, repeatable research results.

In addition to standard natural ingredient diets, Teklad® now offers a wider range of specialized diets tailored to the specific needs of different laboratory animal models. These diets can address particular health conditions, mimic certain human diseases, or support specific research objectives.

Teklad®’s experienced nutritionists can collaborate with researchers to evaluate their specific needs and design customized diets for their research purposes. By considering the desired endpoints of a study, Teklad® can create diets that optimize the nutritional composition, minimize non-nutritive compounds, and meet the specific requirements of the laboratory animal models used.

Continued Research and Advancements

The field of lab animal nutrition continues to evolve as researchers gain a deeper understanding of the complex interactions between diet, genetics, and environmental factors. Ongoing research focuses on optimizing nutrient profiles, exploring the microbiome’s role in nutrition, and investigating personalized nutrition approaches for laboratory animal models.

Translatability from Animal Models to Humans

A well-formulated lab animal diet can improve the translatability of research results from animal models to humans. Researchers are increasingly aware of the importance of aligning diet compositions and nutrient profiles with human diets and nutritional recommendations. This consideration enhances the relevance and applicability of research findings, ultimately benefiting human health and well-being.

By staying informed about the latest advancements in lab animal diet formulations and considering the specific needs of their research projects, scientists can ensure the highest quality and relevance of their experiments in the field of biomedical research.

Where can you get Teklad® Lab Animal Diets in India?

GV Research Platform is the authorized distributor of Teklad® Lab Animal Diets from Envigo in India. The inventory is now available in Hyderabad and can be immediately dispatched based on requirement and availability.

We go the extra mile to provide you with additional reassurance. For our rodent diets, we offer a Phytoestrogen Certificate for every batch, demonstrating our attention to detail and commitment to transparency. Additionally, we provide a Certificate of Analysis for every batch, allowing you to verify the nutritional content and quality of the diets you receive.

Your order for Teklad® Lab Animal Diets is just an email away with no waiting for weeks to receive your order. Place your order at info@gvrp.in 

Written by: Dr. Nidhi Khurana
Dr. Nidhi Khurana holds a Ph.D. in Biotechnology and leverages her knowledge of science and marketing to build thoughtful partnerships with industry leaders. Currently, Dr. Khurana serves as the Head of Marketing at GV Research Platform, where she is responsible for driving growth and building the company’s brand. Alongside, she is passionate about writing and uses it as a medium to educate the community on the latest trends and technologies in the drug discovery and development space.