Tag Archives: Turacoz Healthcare Solutions

Borderline Medical Devices – European Commission Update (December 2017)

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When a device seems to fit onto the definitions of two or more product types, and cannot be clearly classified as a medical device, an in vitro diagnostic medical device, or an active implantable medical device, it is referred to as a borderline medical device. The 18th version of the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (Borderline Manual) was issued by the European Commission’s Medical Devices Expert Group (MDEG) on Borderline and Classification in December 2017. The manual complements MEDDEV 2.1/3 Rev. 3, which provides guidance on borderline products and other medical devices that incorporate pharmacological or biological substances. The appropriate classification of a medical device is important as it determines the device’s authorization process and marketing strategy. From a regulatory standpoint, the classification is usually based on its primary mode of action, intended use, and product claims.

The updated Borderline Manual includes recommendations on a total of 94 devices, including guidance on the classification of 12 additional product types; however, these recommendations are not legally binding. It is important to note that the decisions on the classification of a product remain a competence of the Member States, which may lead to different interpretations among different countries within the EU. However, to ensure a uniform approach, difficult cases may be discussed in the informal MDEG; the consensus statements from this meeting are published in the Borderline Manual.

The revised Borderline Manual indicates that the following products should generally be classified as medical devices:

  • Mobile application for the assessment of moles (Class I)
  • Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purpose (Class IIa)
  • Alum styptic pencils (Class IIa)
  • Dura guard for use with a craniotome (Class III)
  • Heart bypass cannulae (Class III)
  • Tissue expanders used in the breast (Class III)

On the contrary, the following products should, in principle, not be considered as medical devices:

  • Mobile application for managing pictures of moles
  • D-mannose for the prevention of urinary tract infections
  • 8-MOP solution in extracorporeal photochemotherapy
  • Products intended to reduce the effect of alcohol
  • Radiation shields
  • Microplate washers

It is important to note that based on criteria proposed by the Court of Justice of the European Union (CJEU) for borderline determinations, each product’s assessment should include several elements and be very factual; however, the guidance provided in the Borderline Manual often lacks such a detailed and balanced review. Moreover, some of the positions taken in the Borderline Manual may require reconsideration due to potential reclassifications brought by new European Commission Regulations. The new Regulations broaden the definition of a medical devices and also include some products without medical purpose within the purview of the new rules (especially products for aesthetic use). Although changes introduced by the new regulations may help resolve some of the existing borderline questions, divergent views on the classification of more complex products may persist.

Turacoz Healthcare Solutions, a medical communication company, specializes in various kinds of medical writing documents (Publication, Regulatory and Medico marketing) which covers a vast arena of clinical trials, drugs, medical devices, health economics and outcome research, observational studies etc.  We take pride in providing customized, guideline compliant documents which are well within the committed timelines.

Writing an Original Research Article

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What is an Original Research Article?
Original research articles, the primary sources of scientific literature, are considered to have the highest level of evidence/quality of evidence. An article is considered an original research if;

  • It is an article by the researchers who have conducted the study
  • It is a report that elaborates the methodology and results of a randomized controlled trial/observational study/survey/real world evidence study
  • It is an article that describes a hypothesis or research question

Overall, the goal of an original research is to answer the question about specific scientific method, compare two treatments (experimental vs comparative), or establish a hypothesis.

How to Plan a Manuscript?
Conception of a manuscript to submission, has several steps in between. Before we discuss the content that must go in each section, let us read through the steps that must be followed to plan, draft, and complete a manuscript draft as illustrated in Figure 1.
Among the steps involved in drafting a manuscript, understanding the therapeutic area and conducting a literature search appropriately are the most important steps. Literature search is usually done based on the research question of the study. Identifying relevant articles during the literature search is dependent on picking the right search terms, electronic databases to be searched, region of the study, and time duration in which the articles are required.

Figure 1: Steps Involved in Planning and Completing a Scientific Manuscript

What is the Format to be Followed while Writing an Original Research Article?

Drafting an original research article requires adequate knowledge of the different sections in it along with the relevant guidelines. The uniform requirements for manuscripts submitted in biomedical journals by International Committee for Medical Journal Editors (ICMJE) has defined a standard format for presenting information in an original research article. As per this guideline, the IMRAD (Introduction, methods, results, and discussion) format must be followed.
IMRAD defines the overall format of the manuscript. However; the equator (Enhancing the QUAlity and Transparency Of health Research) network is an international initiative that aims to improve the reliability and value of published health research literature (http://www.equator-network.org/).

What goes Where: Know the Sections and their Content
Although IMRAD broadly defines the format of an original research article. One must be clear, and specific about the information that must be added in each section for a well written manuscript (Figure 2). This not only makes the manuscript clear to understand but also increases the chances of it getting accepted in the journal the author plans to submit it to.

Figure 2: IMRAD, Section-wise Description of a Scientific Manuscript

Turacoz Healthcare Solutions (THS), a medical communication company, offers services to healthcare professionals in clinical research, regulatory writing, medico marketing writing, publication writing and support for conducting medical advisory board meetings. The aim of the blog was to appraise its readers regarding the importance of following guidelines and their importance for writing and getting original research articles published.

Relationship Building at Workplace

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Our current lifestyle revolves around our workplace duties and responsibilities. Every day we spend the major part of our time at our workplace. In order to have a satisfying job, we must enjoy the work. Maximum output and increased productivity can only be achieved if we have a healthy working environment. Work becomes burden if we don’t have people around to talk to or discuss and brainstorm ideas. Also, it is okay to trust our colleagues, provided we don’t cross our limits and disclose confidential matters.

Let us look at the various impacts of relationship building at workplace:

  • A knowledgeable individual is one who on one hand improvises on the negative qualities of his/her colleague and on the other glorifies their strengths. This trait helps in resolving conflicts. Conflicts at work place lead to no solutions whereas on the other hand nice gesture sets things straight.
  • As a mature professional, one needs to keep a check on his/her emotions. One must learn to ignore negative people or sit with him/her and try to mutually sort out their differences.
  • Managers must have a healthy relationship with their subordinates. Listening to them closely, helps the subordinates to strive hard and perform better. Doing this, a good manager can ensure their team’s performance is the best under all situations.
  • Knowledge sharing is important factor governing career excellence. Sharing with the team is a two-way learning process.
  • An individual need to be a team player and pay attention to other team member ideas as well.
  • Unnecessary conflicts and misunderstandings at workplace lead to stress. An individual would never be able to deliver his/her level best if she/he is under stress.

Importance of Relationship Building

  • Healthy relationship is the key to positive ambience at workplace.
  • Healthy relationship goes a long way in extracting the best out of individuals.
  • Healthy relationship leads to mental peace. One tends to enjoy his/her work if he/she has a trustable environment.
  • Healthy relationship leads to people from varied backgrounds and expertise come together on a common platform, exchange ideas and reach to best possible solutions and strategies.
  • Healthy relationship among employees also goes a long way in inculcating a sense of pride and loyalty for the organization. People tend to enjoy their work and office.
  • Healthy relationship among employees plays a crucial role at the time of crisis. Emergency situations are unpredictable and can arise anytime. It is necessary that people help each other for increased productivity and better output.

Relationship Building Approaches at Workplace:

  • Be honest in your relationships. Never lie to people you are close to.
  • Respect others. Superiors ought to respect their subordinates if they expect the same in return.
  • Never misguide If you feel your team member is going on the wrong track, guide him/her immediately. Give others the right suggestion.
  • It always pays to be straight forward in relationships. Never speak ill about someone behind their back.
  • Be transparent in relationships. A senior need to be transparent with his/her subordinates and vice a versa. Favoritisms should be avoided.
  • One needs to communicate effectively for successful relationships. The other person must understand what you intend to communicate.
  • Learn to say a polite yet firm ‘NO’ to people.
  • Leave your ego behind the moment you step inside the office. Be kind to each and every-one. It pays in the long run.
  • Learn to forgive
  • Motivate each other and avoid being jealous. Help each other at the times of crisis.
  • Develop a habit of working in teams. Responsibilities ought to be distributed equally among employees as per their expertise and work experience.
  • Do not open any of your team member’s personal files, couriers or letters just because he/she is your friend. Such an approach is unprofessional and unacceptable.

Turacoz Healthcare Solutions (THS) strongly believes in a transparent and healthy workplace environment. We understand the benefits of relationship building in today’s world and encourage everyone to be a team player. If you have the zeal for writing and enjoy working with a dynamic team visit us at https://turacoz.com/careers/.

 

World Malaria Day (25th April 2018)

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“Ready to Beat Malaria”

World Malaria Day has become a global phenomenon and is celebrated on 25th April every year since its inception in 2007. This year’s global theme for World Malaria Day is ─ “Ready to Beat Malaria”. This theme encloses the universal goal of developing a malaria-free world. Further, it emphasizes the progress achieved in the past to tackle one of humanity’s oldest diseases; and at the same time grabs our attention towards the escalating trends reported in the 2017 World Malaria Report. After a remarkable period of success in controlling the spread of malarial cases, the progress appears to have slowed down. Hence, this year, World Health Organization (WHO) demands a greater expansion and investment of recognized tools that can prevent, diagnose, and treat malaria.

Malaria is an infectious disease caused by Plasmodium parasites that are transmitted to people through bite of infected female Anopheles mosquitoes (malaria vector). Initial symptoms include mild fever, headache, and chills, which might become lethal if left untreated for more than 24 hours. Severe malaria often leads to development of cerebral malaria or severe anaemia or involvement of multiple organs.

Statistical Facts according to the 2017 World Malaria Report:

  • In 2016, 216 million cases of malaria were estimated in 91 countries, corresponding to a surge of 5 million cases over those reported in 2015.
  • A total of 445,000 fatality cases were reported in 2016 compared to 446,000 in 2015.
  • In 2016, African regions shared a high global malaria burden, with 90% of malaria cases and 91% of mortality cases.
  • In 2016, India reported 6% of the world’s new malaria cases.

Prevention:

Transmission of malaria can be prevented and reduced with effective vector control. Vector control can be achieved in the following ways:

  • Insecticide-treated mosquito nets: WHO recommends the use of long-lasting insecticidal nets (LLINs) for people residing in areas at high risk of malaria. Pyrethroids are the only class of insecticides presently recommended for use in LLINs.
  • Indoor residual spraying with insecticides: This is a powerful method for rapid reduction of malaria transmission. The effect of indoor spraying persists for 3-6 months, depending on formulation of the insecticide used.
  • Antimalarial drugs: The travelers can use chemoprophylaxis as an effective method for prevention of malaria, as it suppresses the blood stage of malarial infections. WHO recommends the use of sulfadoxine-pyrimethamine for pregnant women at risk, and monthly courses of amodiaquine in addition to sulfadoxine-pyrimethamine for children at risk below 5 years during high transmission season.
  • Vaccines: Partial protection in children can be achieved by administration of an injectable vaccine “Mosquirix”. The vaccine is a complementary malaria tool rather than a replacement for treatment strategies.

Diagnosis and Treatment:

The diagnosis and treatment of malaria at an early stage limits transmission of the disease, reduces the risk of complications, and prevents death. Parasite-based diagnostic testing (either microscopy or rapid diagnostic test) is suggested by WHO prior to administering the treatment. Post-parasitological confirmation, artemisinin-based combination therapy (ACT) is used for treatment of Plasmodium falciparum malaria.

Turacoz Healthcare Solutions aims to spread awareness about malaria and strategies for its prevention, to aid ‘World Health Assembly’ achieve the global target of reducing 90% of incidence and mortality rates by 2030. Turacoz is a medical communications agency, which offers services to healthcare professionals in clinical research and regulatory writing, publication writing, medico-marketing writing, and support for conducting medical advisory board meetings.

Role of a Medical Writer in Advisory Board Meetings

Medical Writing, ,

Medical writing is a multidimensional profession which requires creating numerous scientific/non-scientific documents for various phases of a drug life-cycle. Different types of documents prepared by a medical writer are later utilized by the pharmaceutical companies in procuring approval from the regulatory bodies and for knowledge sharing with the healthcare stakeholders. These documents may include (but are not limited to) documents for pre-clinical studies, clinical trials, and post-marketing studies,reports of advisory board meetings, patient educational material, and promotional material. Among all the above-mentioned documents, writing reports for advisory board meetings is an integral part of the medical writing profession.

What is an Advisory Board?

Advisory boards are considered as an important tool for understanding the unmet medical or healthcare needs of a drug/product. By forming an ‘advisory board’, the pharmaceutical companies or medical societies aim to engage their key opinion leaders (KOLs)in order to get better insights on the various medical benefits/limitations of their products from the medical fraternity. Productive discussions held during the advisory board meetings are used to gather visions on possible research opportunities, including guidance on the clinical development and trial protocols, as well as unmet health care needs of current clinical practices that might drive future clinical strategies. The organizing body usually involves a medical writer during an advisory board meeting for capturingevery detail of the discussion held at the medical advisory board meeting and later drafting an objective-driven report which is shared at different knowledge sharing platforms.

What is the Role of a Medical Writer?

The responsibility and role of a medical writer vary according to the objective of the advisory board and according to the type of report required by the organizing body. This may include:engaging KOLs for an advisory board, preparing questionnaires, conducting online surveys (for understanding unmet needs), preparing a pre-meeting report to be shared with KOLs, preparing presentations for the advisory board meeting, hosting an advisory board, capturing minutes of meeting, preparing draft for meeting report, and modifying the report into a publication-ready literature. Hence, it is very important that a medical writer has a prior understanding of the objective of the meeting and nature of deliverable.

Turacoz Healthcare Solutions provides end-to-end support for conducting an advisory board and preparing high-quality scientific reports of the meeting. We have successfully conducted several national and global advisory boards related to preclinical research and product positioning in the past two years and look forward to partnerships in future. Turacoz has experienced medical writers who understand the requirements of our clients and efficiently capture the body and soul of an advisory board meeting.