Category Archives: Medical Writing

Ghostwriting in Medical Literature

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With the advances in medical technology and innovations in field of medical sciences and drug development, there has been widespread increase in scientific research papers. These scientific papers not only add volume to the medical literature, but also greatly impact the decision making of doctors and regulatory authorities. Doctors might make decisions pertaining to treatment planning based on the updated information available. Regulatory authorities, on the other hand, use this literature for drug approval process or for formulating new policies. Thus, it is important that the scientific articles should be written and published in an ethical manner and should uncover all the advantages and disadvantages/side effects of newer treatment modalities/drugs so that the medical literature is free from bias.

Concept of Ghostwriting

Ghostwriting in medical literature is an awful breach to the ethics in dissemination of information obtained from scientific/medical research. This practice of ghostwriting has widely attracted the attention of medical writers and scientific community and has been greatly criticized by them. Ghostwriters are the ones who are hired by pharmaceutical companies for drafting scientific articles for purpose of marketing their product. Such papers incorporate good effects of product while making exaggerated promises and omit its side effects that might adversely affect its usage/ approval/marketing. The articles written in this manner are credited with the authorship of physicians and academicians in the field to enhance the credibility of given information projecting the same as an unbiased source.

As per a review paper by Górski A et al in 2010, approximately 10% of papers published in reputed journals were estimated to be ghostwritten. Furthermore, this rate was suggested to be even higher for some of the medical specialties. Ghostwriters have been defined by The International Society for Medical Publication Professionals as “individuals who contribute substantially to a medical publication but do not appear on the byline and are not acknowledged for their contribution.”

Concept of Authorship

Authorship makes a person/writer accountable for the published information. The onus of the integrity of information presented in the paper lies on its authors. A person/writer is considered an author as per ICMJE guidelines (available at http://www.icmje.org/) if he has substantial intellectual contribution towards the research or content of publication. For being an author to a document, one must fulfill four important authorship criteria. First criterion is substantial contribution to work either in form of its conception and design, data acquisition or its analysis and interpretation. Secondly, the author should have either drafted the manuscript or made critical revisions necessary for its intellectual content. Thirdly, the final version of the paper to be published should have been approved by the individual to qualify as an author. Lastly, the accuracy or integrity of the work should have been adequately investigated by the authors and issues if any should have been resolved by them. The European Medical Writers Association (EMWA) guidelines clearly state that a medical writers can be listed as an author, if they fulfils the authorship criteria; otherwise they must be acknowledged for their work.

Medical Writing vs. Ghostwriting

Medical writing is a dignified professional service provided by the medical writers from diverse fields of life sciences having a background knowledge of medical and allied sciences. Medical writing services can be utilized by pharmaceutical companies, researchers, doctors, and academicians as a process to disseminate their workloads thereby preventing wastage of research resources. It has been estimated that 6% of all papers in medical literature are developed by the help of medical writers and are based on studies sponsored by “nonprofit organizations”. Professional medical writers with their skills and expertise, can support the research by collating data, analyzing and interpreting it, and presenting the results in a clear and concise manner. They can provide intellectual help by writing publication manuscripts. Additionally, they can be hired by pharmaceutical companies for developing regulatory documents required for drug approval or research protocols, clinical trials and their results etc. In addition, professional medical writers can be hired for writing publication documents like original research articles, review papers, consensus statements, expert opinions, and clinical practice guidelines etc. While medical writers are hired for their skill, efficiency, speed, and expertise in the field, ghostwriting is perceived by scientific community as an intent to deceive.

Acknowledgement of Writing Services as a Solution to Ghostwriting

Acknowledgement of contribution by medical writers to the document/paper is believed to be the best method to tackle problematic ghostwriting in medical literature. Considering this, numerous journal’s, editor’s and medical writer’s associations including ICMJE, World Association of Medical Editors (WAME), EMWA, and American Medical Writers Association (AMWA) allows professional medical writers to contribute to the writing of papers even if they are not listed as authors provided their role is adequately acknowledged along with the funding source to receive these services, to improve transparency. Thus, medical writers can legitimately contribute to manuscripts and their contribution should be adequately acknowledged as recommended by ICMJE, EMWA, and AMWA. Ideally, the acknowledgement should reveal the necessary information to maintain transparency viz. name of the aiding writer and name of the person/company/organization who funded for the writing assistance.

It is the responsibility of authors to ensure that the medical writers whose help was sought while preparing manuscript do not remain as ghosts in the underworld. Instead, they should be brought into light by giving them adequate acknowledgment.

Turacoz Healthcare Solutions understands its professional responsibility and take an initiative to make authors and medical writers aware about drawbacks of ghostwriting and method of acknowledging dignified professional services. Turacoz is a medical communication company that provides scientific/medical writing support to the industry and academicians.

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.

Healthcare Advertising

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“Are you into healthcare advertising?”

“Yes!”

“Oh! It involves so much medical jargon, and little opportunity for creativity! Do you enjoy your job?”

I have been part of several such conversations, and through this blog, I would like to touch upon some facets of healthcare advertising that may partly undermine (and partly reinforce!) the stereotypes associated with this field.

Based on data from a 2015 US-based study, nearly $10 billion is spent by the healthcare industry into advertising and marketing. Despite the huge amount of money involved, the healthcare advertising segment is often typecast as “lacking in creativity/innovation” and “boring”. Well, this is not surprising considering that every print, website, banner, and video advertisement gets scrutinized by a medical review team and needs to pass a rigorous risk mitigation assessment. In fact, dissemination of safety information takes up almost half of a 30 second TV spot and rules for short-form messaging may run up to 10-15 pages. With such extensive regulations in place, it is often difficult to be creative! Most advertising professionals, therefore, create campaigns that are safe and obvious to avoid getting caught in the legalities of the system.

In addition, creating advertisements from data provided by doctors, is quite challenging. The key is to understand the underlying motivation behind the drug/campaign from an emotional perspective, including purchasing decisions and consumer behavior.

Future of healthcare advertising

How can healthcare advertising evolve in the near future? Here are a few pointers:
1)  Optimizing advertisements for mobile phones (smartphones) and using social media apps, such as Facebook and Twitter, as marketing platforms
2)  Developing smart (read: social-media shareworthy) content that is interesting, fresh, reliable, and authoritative
3)  Individualizing marketing delivery systems using digital marketing tools: Contemporary marketing methods identify user interests and deliver timely, personalized and relevant content on a one-to-one basis
4) Target patients by location: Such a strategy can adapt the advertisement according to social and personal preference of the audience, and also inform them about nearby facilities
5)  Going live! “Programmatic video” is the new buzzword in the field, and according to some estimates, it will account for the majority of digital video spending over the next couple of years. Programmatic video basically uses real time data and presents video advertisements to precisely qualified customers at exactly the right time.

Overall, it can be concluded that healthcare advertising may not be as creative as the fast-moving consumer goods (FMCG) segment; however, the challenges it poses make it all the more interesting to work in this field. With the evolution of new marketing strategies, the constraints of healthcare advertising can prove to be an asset in a non-conventional marketing set-up of the future.

Turacoz Healthcare Solutions provides high quality end to end scientific/medical writing support to the industry and academia. We expertise in different kinds of medicomarketing solutions like leave behind literature (LBL), slide-decks, posters, newsletters, patient education materials, customized books/booklets, visual aids etc. Turacoz strongly follows good marketing practices backing every product claim with scientific relevance and ensuring that the message rightly resonates with the target audience.

Evidence-Based Practice

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Evidence-based practice (EBP) is defined asthe conscientious, explicit and judicious use of current best evidence in making correct, prompt and individualistic patient care decisions. (Sackett D, 1996)
EBP integrates the clinician’sown expertise, the best available scientific evidence, and the patient values and preferences (Figure 1).

Figure 1: Elements of Evidence-Based Practice (EBP)
Inability of current medical practice to cape pace with the available evidences generated interest in the use of evidence-based practice while a varied number of steps have been defined to be applied for the use of EBP (Figure 2).

Figure 2:Steps Involved in Evidence-Based Practice (EBP)
1. Problem definition: Clinician formulates an answerable clinical question based on the most updated and relevant data to solve individual patient problem. Defining the problem may provide answers to certain areas ofdisease prevention, diagnosis, prognosis, therapy, causation, cost-effectiveness, etc.
A defined PICO (Population, Intervention, Comparison, Outcome) approach which directly focuses on the clinical question may ensures that it will be helpful in finding the relevant evidences to bridge the prevailing clinical gap.
2. Search for information sources:
After formulating the clinical question, search for appropriate scientific evidences in various databases including PubMed, EMBASE etc. must be done. Firstly, a search for the relevant evidence-based guidelines is done and if it is not available, scientific evidences including systematic reviews or individual studies are referred too.
3. Appraise the information for validity and applicability:
After literature search,each review/study needs to be critically appraisedfor relevance, reliability, validity, and applicability to the persisting clinical question. A clinician can rapidly appraise the study by assessing three important aspects which are:
Validity of study results: It should include assessment of research methods (randomization or non-randomization), characteristics of patients prior to intervention, and instruments used to measure outcomes.
Results and their importance: It should include effectiveness of the intervention, its impact on outcomes, and probability of getting similar results in the clinicians’ own practice settings.
Applicability of the results in patent care: Clinical considerations of the study results such as similarity between study subjects and one’s own patients, benefits/risks ratio, and patient values and preferences, and feasibility and cost-effectiveness needs to be incorporated.
4.Integration of the evidence with one’s clinical expertise and patient preferences and values:
As discussed above, EBM is not solely based on appraising scientific evidences. In the integration step, the relevant scientific evidences are combined with clinical expertise andalso the patient’s perspective. This step requires answering to several questions on: similarity between study patients and one’s own patient; availability of the treatment; alternative treatments available; side effects of the treatment, outweighing risks and appropriateness of the patient outcomes.
5. Evaluating the effectiveness of EBP for individual patients
The last and the final step in EBP is to assess the effectiveness of evidence-based approach when applied to a specific patient. It assesses the clinical improvement of the patient achieved with the evidence and whether it is comparable and as found in the research study.
Level of Evidence
The Level-of-Evidence pyramid represents the types of studies which represents their research quality and risk of biasness. As we move up in the pyramid, the research quality increases while risk of biasness decreases.Studies are assigned to specific hierarchy in the pyramid based on their methodological design quality, results validity, and applicability to patient care. Levels of evidence for different subjects including therapy, diagnosis, prognosis etc. can be viewed at the Oxford Centre for Evidence-based Medicine website (http://www.cebm.net/blog/2009/06/11/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/) Researchers practicing EBP should have an understanding of level of evidences to prioritize all the information collected. EBP holds a strong ground in the top-order of the pyramid as shown in Figure 3.
Current Status of EBP Application
Presently, the implementation of EBP is not sufficient in making healthcare decision. A recent survey assessed the factors which facilitates or hinders the application of EBP in the clinical context. Respondents stated that in clinical healthcare currently EBP is underused and explained this shortcoming with several practical and structural barriers, which they felt can be better monitored by individual organization and directors. In the survey, only 11% of the respondents used EBP and 20% stated that they worked ‘in the way they always had’.
It was also highlighted that increased awareness about EBP and implementation systems for the same in future will be useful in providing evidence-based, best quality and cost-effective healthcare to individual patients.

Figure 3: Level-of-Evidence Pyramid
Evidence based practice is central to providing high-quality care and decreasing unwarranted variation in practice. Turacoz Healthcare Solutions aims to spread awareness about the latest offerings of evidence based practice so that we are able to do our bit and contribute more towards patient healthcare.

Pharma Mergers and Acquisitions

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Mergers and acquisitions (M&As) refer to consolidation of companies or assets. Merger means combining two companies into one, while acquisition refers to taking over of one company by the other one. In pharmaceutical world, mergers and acquisitions are quite common. According to the insights, M&As help the pharmaceutical companies in achieving their goals easily by acquiring it, instead of making it. Moreover, the companies with products which are soon to be off-patent also seek for companies with high revenue potential to acquire. Moreover, the expenditure involved in research and development has also attracted the investors to merge with or acquire other companies.

Indian pharmaceutical industry, which is known for its highly skilled core players and low-cost manufacturing, has also been highly influenced by M&As. Many domestic and cross-border M&As have been witnessed by the Indian Pharma companies. The major reasons which have drawn the attention of Indian pharma companies towards M&As are presented in Figure 1.

Figure 1: Major reasons of Pharma Mergers and Acquisition in India

Some of the major M&A Deals that took place in India recently (2015-2017) are:

  1. Mergers of Ranbaxy and SunPharmaceuticals
  2. Acquisition of Primal Healthcare by Abbott
  3. Acquisition of Ranbaxy by DaiichiSankyo
  4. Acquisition of US-based Gavin by Lupin Ltd.
  5. Acquisition of Russian Biocom by Lupin Ltd.
  6. Acquisition of Taro by Sun Pharmaceuticals
  7. Acquisition of UCB by Dr Reddy’s Laboratories
  8. Acquisition of Beta Pharma by DrReddy’s Laboratories
  9. Acquisition of Elder Pharma by Torrent Pharma

It is apparent that such M&As have become essential for the pharmaceutical industry to grow. Moreover, the trend does not seem to slow down due to their necessity to meet the expenditures. However, the loss of expected R&D and thoroughness associated with M&As warrants development of comprehensive guidelines for successful M&As.

Turacoz Healthcare Solutions keeps a tab of the latest healthcare update and studies Pharma mergers and acquisitions in detail. We extend our services in assisting pharmaceutical companies by providing them end-to-end writing support in both the publication and regulatory arena.

World Diabetes Day

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The term diabetes mellitus is defined as a metabolic disorder which is characterized by hyperglycemia with disturbances of carbohydrate, fat and protein metabolism resulting from defects in insulin secretion or insulin action or both.The long-term effects of Diabetes Mellitus include retinopathy with potential blindness, nephropathy that may lead to renal failure or neuropathy with the risk of foot ulcers and autonomic dysfunction which may lead to sexual dysfunction.

There are various treatment strategies for diabetes mellitus which are successful in recovering clinical status but cause a variety of complications such as cardiomyopathy, retinopathy, neuropathy, etc.The most promising approach for diabetes mellitus is restoration of insulin-secreting pancreatic beta cells. This approach controls the blood sugar level and helps in the regeneration of insulin-secreting pancreatic beta cells from adult cells.

Diabetes poses a major heath issue for women who tend to face the same joys and problems, but with an added element where theyhave to battle a chronic disease with various social and personal challenges every now and then. In 1983, the American Assistant Secretary for Health established the Public Health Service Task Force on Women’s Health Issues. In 1985, this task force reported the health issues intervening in women’s life stages. Diabetes in pregnancy is a serious condition that is unique to women as it affects the health of both the mother and her unborn child.The most common complication attributable to diabetes is the risk of cardiovascular disease which is more serious among women than men. Also, it has been reported that women with diabetes lose their premenopausal protection from ischemic heart disease and have risk for this condition as great as or greater than that of diabetic or nondiabetic men. Women are also at greater risk for blindness due to diabetes than men.

In India, gestational diabetes mellitus (GDM), which affects pregnant women, is of major concern for women and gynaecologists. Fig.1 mentions the management of gestational diabetes. The incidence of GDM has grown fourfold in the past 10 years, according to Dr B Rajkumar, a doctor of Indian systems of medicine at the Keezhariyoor government ayurveda dispensary in the state’s northern coastal district of Kozhikode. According to few medical researchers, the disease that was earlier considered an ailment of the rich, is on the rise in India. Nearly 70 million people, half of them women, in a population of 1.21 billion have diabetes, and the number is predicted to rise to 101 million by 2030.According to a 2012 report published by the Brussels-based International Diabetes Federation,about 60% of diabetics in India have never been screened or diagnosed due to lack of awareness.

 

Figure 1: Management of Gestational Diabetes

As we know, diabetes mellitus is one disorder that has no cure till date. IPSC (Induced Pluripotent Stem Cell) is one such prodigious breakthrough to generate functional insulin -secreting- pancreatic -beta cells. However, there are a lot of lacunas and challenges that have to be addressed in case of IPSC based diabetic therapy. One of the major limitations of this therapy is the lack of supply of pancreatic islets.Moreover, awareness and management of the diabetic condition is becoming more crucial after reports stating the rise in the incidence of gestational diabetes.

Turacoz Healthcare Solutions wishes to spread the awareness on World Diabetes Day, i.e., 14th November. World Diabetes Day is the primary global awareness campaign focusing on diabetes. There are few ways by which this disease can be prevented such as having a balanced diet, exercising regularly, maintaining ideal body weight, avoiding alcohol and tobacco. Also, having regular health checks should be a priority for every individual over the age of 40.

Diabesity

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When the balance of body’s metabolic processes is disrupted, certain conditions arise which are known as ‘metabolic conditions’, of which diabetes and obesity are at top of the list. These two metabolic conditions go hand in hand and are putting a major burden on global healtheconomy. The co-existence of these diseases is collectively known as ‘Diabesity’.According to WHO, the global burden of obesity has raised three times between the year 1975 and 2016, with more than 650 million obeseadults reported in 2016.The number of diabetics has grown from 108 million to 422 million from the year 1980 to 2014. WHO reports that around 50% of deaths in diabetic patients occur before the age of 70 years and it is predicted to be the seventh leading cause of mortalityby 2030. Hence, both diabetes and obesity are counted as the biggest concerns to human health and well-being.

Major reasons behind the raising epidemic status of diabesity include adoption of modern or sedentary lifestyle, fast food habits and relying on technology.Both diabetes and obesity come in a package with other health complications, reduced quality of life, and reduced life expectancy. The major associated challenges include myocardial infarction, cerebrovascular stroke, and renal diseases.

The pathophysiological mechanisms of diabetes and obesity are strongly inter-connected.Insulin resistance and beta cell dysfunction lead to diabetes. Body mass index, the direct measure of obesity, has been found to have positive association with insulin resistance, and consequently with diabetes. In obese people, non-esterified fatty acids, glycerol, hormones,cytokines, and proinflammatory markers are increased, which further lead to development of insulin resistance.Each kilogram rise in bodyweight has been reported to increase the risk of diabetes by 4.5%.

Various medical treatments that improve insulin sensitivity and beta cell functionare available to manage diabetes. Apart from pharmacological approaches, it is also important to practice lifestyle modifications, which not only impart benefits to the treatment, but also improvepatient’s quality of life. Consuminglow-calorie diet,doing regular exercise, maintaining weight, avoiding smoking and regular self-monitoring are highly beneficial in successfully improvement in health status of diabetics and obese patients.

We, at Turacoz Healthcare Solutions, believe that health is real wealth. In an attempt to reduce the global burden of diabetes and obesity, we wish to remind everyone to adopt healthy lifestyle.

Alzheimer’s Disease

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Alzheimer’s Disease (AD) is emerging as one of the critical public health concerns among elderly in various countries around the world including United States (US)and India.It is the fifth leading cause of death among older individuals in US. Over 35 million people worldwide suffer from AD or other forms of dementia. This number is expected to increase over 65 million people by 2030 and 115 million by 2050. In India,14.2% of elderly population is expected to be afflicted with AD by 2020. With the intend to spread awareness about the disease globally,September was launched as World Alzheimer’s month in 2012 and since then 21st September has been marked as World Alzheimer’s Day.

AD poses a significant burden on individual’s physical, social, mental and financial well being. It is characterized by degeneration of nerves which manifests itself as episodes of memory loss in initial stages. As the disease progress, individual have trouble in planning or solving problems, becomes confused with time or place, have mood swings and changes in personality. Person may face problems in speaking or writing and has decreased judgement4. These symptoms worsen with the progression of disease. During the final stages of disease, individual’s ability to communicate is lost and often become bed-ridden, and need around-the-clock care.

The cause of disease is multifactorial, with risk factors like age, gender and genetics being non-modifiable. AD is commonly seen in older age group, prevalent among females and associated with apolipoprotein E gene. The modifiable risk factors associated with disease includes education, lifestyle factors like smoking and conditionssuch as diabetes, hypercholesterolemia,and hypertension. It has been suggested by studies that people with low educational attainment are at increased risk of developing AD. Education develops the cognitive features of individuals, thereby decreasing the risk of AD. Modification in lifestyle can further, reduce the risk of development of AD. Regular aerobic exercise and physical activity serves to improve cognitive function and decrease the risk of disease. It is further suggested that proper prevention or management of above mentioned lifestyle conditions may decrease the likelihood of AD development. Further, eating healthy diet, and specific adherence to Mediterranean diet, with adequate dietary and vitamin supplements can help prevent occurrence of AD.

Alzheimer’s Disease (AD) is an emerging threat to health amongst elderly. Turacoz Healthcare Solutions (THS) aims to spread awareness about Alzheimer’s Disease amongst masses. Let’s unite and spread awareness to prevent Alzheimer’s disease.

Clinical practice guidelines (CPGs)

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Healthcare professionals are expected to provide the best evidence based care to the patients. However, due to continuous medical advancements, it becomes challenging for the clinicians to keep abreast with the new developments and implement them in everyday practice.

Clinical practice guidelines (CPGs) have become increasingly important in the healthcare practice. They are evidence-based recommendations, intended to standardize treatment and provide high quality care to patients. These guidelines are a tool for translating research findings into clinical practice, thus, bridging the gap between what clinicians do and what scientific evidence supports. There is growing evidence that developing and adhering to CPG, can reduce practice variation, and improve outcomes and cost effectiveness of healthcare.

World over, physicians, healthcare organizations, professional societies, disease advocacy groups, government appointed workgroups etc. have been involved in developing CPG to standardize clinical practices.

Greater adherence to CPG is critical to improving healthcare processes and achieving the best patient outcomes. Now, the question arises, why these guidelines need to be followed? They are designed to:

  • Improveclinical outcomes
  • Provide easy access to quality information, so that clinicians have a wide range of options for patient care, improving efficiency and consistency of care
  • Helping clinicians stayapprised of the new developments, by use of up-to-date guidelines
  • Improve patient safety and quality of life by facilitating the treatment of patients based on the summary of benefits and limitations of interventions and procedures
  • By finding gaps in current knowledge, research activities can be prioritized

Some of the practitioners believe that guidelines are cookbook medicines, not allowing them to make their own independent decisions. The other reasons for non-adherence to these guidelines could be lack of awareness, lack of transparency in guideline development, lack of relevance to clinical practice, complex and conflicting guidelines, and lack of insufficient access to guidelines at point of care.

The development of a good guideline, includes, healthy participation of key stakeholders, access to accurate, credible, up-to-date,relevant scientific information, correct interpretation of the available evidence, clinical flexibility, and use of proper tools for implementation and monitoring in day to day practice. The guidelines must be clearly expressed in a user-friendly, logically organized format,written in anunambiguous, easy to follow language, and with clear links of recommendations to the available evidence.

To ensure improved care outcomes, emphasis should be placed on effective guideline implementation and evaluating their effectiveness in real world clinical settings. The guidelines should be evaluated for practicality and significance, projected benefits and harm,quality and strength of the scientific evidence and should be periodically updated to keep pace with latest advancements in the field of medicine.

Given the large number of guidelines, following are the key questions, one should keep in mind while reviewing any guideline:

  • Who developed the guideline?
  • Was systematic review of the literature carried out?
  • Were the recommendations valid?
  • Were all relevant outcomes (overall survival, impact on quality of life, absence of complications etc.) considered?
  • Does it report conflict of interest and how was it managed?
  • When was the guideline last updated and assessed for validity?

Turacoz Healthcare Solutions, understands the importance of clinical practice guidelines in improving healthcare standards and patient outcomes and recommends strict adherence to them.

Current Scenario of Medical Device Industry in India

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The Indian healthcare industry is on a high growth trajectory and undergoing transformation across the continuum since the last decade. Technology is redefining the possibilities in healthcare delivery and expanding global industry leadership of the healthcare sector while seeking elusive solutions for addressing India’s needs. With the recent approval of National Health Policy 2017 by the Government of India, healthcare expenditure intends to increase to 2.5% of gross domestic product (GDP)and India embarks on a planned approach to bridge the healthcare divide while maintaining industry competitiveness.

Medical device industry is rapidly moving into an era of growth driven by unmet clinical needs and greater focus on domestic manufacturing. Indian medical devices market is the 4th largest in Asia and in the list of top 20 in the world.1 The medical device sector represents 9% of the overall Indian healthcare industry. It was estimated at the value of USD 4 billion in 2014 and is growing at a compounded annual growth rate (CAGR) of 16% over the period of five years.2

Key Driving Factors of the Medical Device Industry

Key Driving Factors of the Medical Device Industry

In current scenario, there is an immense need to use medical devices effectively to address the huge gap between demand and supply of healthcare services in India. The medical devices sector in India is at a nascent stage with most of the indigenous manufacturing restricted to medical consumables. In true sense, imports still constitute over 75% of the current medical devices market. India is looking forward to improving self-sufficiency in medical devices as a part of the “Make in India” initiative.

The rapidly expanding sector presents immense opportunities to local manufacturers and startups as well global players. There is a big shift in health burden from communicable to non-communicable diseases, which in turn is driving key medical devices segment. There is a huge demand for both cutting‑edge precision technologies as well as affordable low technology. The Indian medical device innovation ecosystem is fast evolving with academic research, venture capital firms, government funding, and promising startups which are developing products specifically for the Indian market. Innovation is a transforming force across the industry to propel growth, improving value, creating sustainable business opportunities, and expanding “Make in India” drive.

Although there is robust growth across segments, new challenges abound which need attention from both policymakers and industry to sustain the momentum across segments.Major hurdles that slow the growth pace of the medical device industry arethat of price control and uncertainty about the effect of new Medical Device Rules, 2017 which will be applicable from 1st Jan 2018.Despite the above challenges, medical device represents the segment where greater change and growth is expected in coming future.

Turacoz Healthcare Solutions, as a knowledge partner of the medical device companies are well equipped to raise up to the occasion and support the industry with a wide range of service spectrum. Our regulatory experts can give consultancy services for global regulatory strategies development and medical device approval and registration, and provide support for Indian market with registration and approval in India (Form 41), manufacturing license (Form 28), import license (Form 10), CE Marking / European MDD Compliance, and FDA 510(k) Notifications / PMA Submissions.

Feel free to reach out at [email protected] for any query or RFI/RFP related to medical devices.

 

1IBEF Healthcare Report 2017

2FICCI and Quintiles IMS reports