In Brief

• Medicines and devices that are supposed to be launched are based on industry composition where above 80% small and medium-sized companies require medical devices and large multinational organizations seek new medicines
• One of the fundamental variations refers to the active components within medical devices (similar components are used in electrical and mechanical engineering tools). On the other hand, drug development involves knowledge of chemical, pharmacological, genetic engineering and biotechnology.  

Healthcare industry has undergone various transformations every time to launch a new medical device and medicines. In order to achieve the approval, these products are subjected to few general rules to prove their efficiency through a thorough supervision and evaluation and then finally step into the biotech market (Management, 2020). Every patient struggling to overcome or manage the chronic disease survives with a hope that a day may bring better medicines that can permanently cure the disease. In a survey it was found that America’s biopharmaceutical research companies are tremendously working towards the invention of new medicine which can gradually improve patient’s health and save many patients life. However, it was estimated that since 2000, FDA has sanctioned and approved more than 500 new medicines helping patients to live longer and healthier. Many medicines are potential to cure various diseases like cancers cardiovascular disease and offering new options for patients suffering with diseases like Alzheimer’s and Parkinson’s (Pharma, 2019).

Akin to prescription of medicines, medical devices are approved and regulated by the Food and Drug Administration (FDA). However, the regulatory framework established by the Congress for the medical devices is flexible in various aspects, which could be due to the underlying differences between medical devices and prescription of the drugs (Parliament, 2017).

The FDA play a key responsible role in regulating and supervising the safety of drugs, foods, vaccine, blood products, medical devices, biological medical products, dietary supplements, radiation emitting products, cosmetics and veterinary products. Another department Within the FDA is the Center for Devices and Radiological Health (CDRH) which ensures the effectiveness of medical devices and its safe use. It also suggests to eliminate the products that emit various radiations which are hazardous to human kind (Sutton, 2011).

When a new medical device or medicine is about to launch in market it undergoes few stages that validate the product. However, there are some basic existing differences between the new medical device and new medicine which has to be launched and are based on industry composition where above 80% small and medium-sized companies require medical devices and large multinational organizations seek new medicines. In general the active components in medical devices are materials used in mechanical and electrical engineering tools, whereas, to produce a new medicine the pharmacology and chemistry composition are essential and biotechnology, genetic engineering techniques are essential. However, the pharmacologic properties and action of active ingredients in medicine is understood based on pre-clinical and clinical studies, standardised batch sizes, manufacturing processes and starting materials products that are stable and generally stored at room temperature with a long shelf life.

Figure 1 Different stages of Medical device development and drug development

Source: Mahapatra et al.,(2018)

Another important difference is product development where, medical devices are manufactured by varieties of products by the healthcare professionals, which is approved based on their specific function, safety and efficacy. On the other hand, based on trial and discovery basis medicine preparation which is usually in the form of pills, ointments, aerosols and solutions are developed by chemists and pharmacologists in the laboratories (Australia, 2020; Devices, Vitro, & Medical, 2012) . Apart from the above mentioned differences, U.S. Drug and Device Development have listed major developmental features which are crucial. The pre-market approval is essential for the high-risk medical devices which are grouped under Class III medical devices. With Class III medical devices, the rate of technology change, ease of in vitro assessment, influence of physician technique and ability to visualize performance were found to have high output than the new medicine which is usually low. A single pivotal study is enough to evaluate the efficacy of Class III medical devices, but for a new medicine two studies are required to cross check. For Class III medical devices, a variation in voltage is found through comparators and for new medicine it was concurrent control (RCT). It is difficult for Class III medical devices to show its ability to blind treatments than new drug which is easy. In order to evaluate the Class III medical devices, the study population size required is small in 100’s when found with new medicine which is large in 1000’s. Moreover, to evaluate the total product life cycle of Class III medical devices consumes months-years and for new medicine it takes years to decades.

Pertaining to pre market data use, the New Devices follows 21 CFR 860.7(c)2 quotes that “Valid scientific evidence is evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use. The evidence required may vary according to the characteristics of the device, its conditions of use, the existence and adequacy of warnings and other restrictions, and the extent of experience with its use.”

New Drugs follow 21 CFR 314.126, refers to sufficient reports obtained through well-controlled investigations which provided the proof of “substantial evidence” in order to provide the information on the effectiveness for the new drug. However, a sufficient and well-controlled study uses a design that permits a valid comparison with a control to provide a quantitative assessment of drug effect • Historical control designs are usually reserved for special circumstances • Uncontrolled studies or partially controlled studies are not acceptable as the sole basis for the approval of claims of effectiveness.

Common Key Regulatory Decisions for Approval: Is the drug/device safe and effective in its proposed use(s), and do the drug/device benefits outweigh the risks. What should the label contain? Is the proposed labeling (package insert) appropriate for the drug/device, are the methods used in manufacturing the drug/device and the controls used to maintain the drug’s/device’s quality adequate to preserve the identity, strength, quality, and purity of the drug or the durability, performance, sterility and biocompatibility of the device (Laschinger, 2019).

References

1. Australia, M. T. A. O. (2020). Difference between medical devices and pharmaceuticals. Retrieved from https://www.mtaa.org.au/devices-vs-drugs


2. Devices, M., Vitro, I., & Medical, D. (2012). Differences between medical devices and drugs Medical Devices In Vitro Diagnostic Medical Devices Drugs. 1–3. Retrieved from http://globalmedicaltechnologyalliance.org/papers/GMTA_Differences_Between_Devices_IVD_Drugs_RevFINAL_17July12-pdf-pdf.pdf


3. Laschinger J. (2019). Regulatory Pathways Devices vs. Drugs Are there roles for registries? 1–17. Retrieved from https://www.ctti-clinicaltrials.org/files/session1-2_laschinger_regulatorypathways_regtrial_march30.pdf


4. , I., Clark, J. R. A., Dobson, P. J., Owen, R., Lynch, I., & Lead, J. R. (2018). Expert perspectives on potential environmental risks from nanomedicines and adequacy of the current guideline on environmental risk assessment. Environmental Science: Nano, 5


5. Management, H. (2020). Health Management and Leadership promotion, cross-collaboration amongst key disciplines. Retrieved from https://healthmanagement.org/


6. Parliament, E. (2017). Medicines and Medical Devices. Retrieved from https://www.europarl.europa.eu/factsheets/en/sheet/50/medicines-and-medical-devices#_ftnref1


7. Pharma. (2019). Medicines in Development. Retrieved from https://www.phrma.org/en/Science/In-The-Pipeline/Medicines-in-Development


8. Sutton, B. (2011). Overview of Regulatory Requirements: Medical Devices – Transcript. Retrieved from https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript

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