Friday, 7 November 2014

Blood Collection Equipment and Devices: A Bright Outlook Ahead

The market is expected to witness a bright outlook on account of new techniques of collecting and processing blood, new blood screening tests, new blood products, proliferating gains in basic research, and execution of further automation in testing and collection.
Blood and blood components are widely used in treating patients with deficiencies related to blood, and are used in deriving numerous biopharmaceuticals (antibodies, blood factors, and others). Incidences of various infectious diseases such as dengue and chikungunya in the past have been primarily responsible for creating awareness about blood component therapy among clinicians and the general public. Shortage of blood components at the time of the last outbreak raised an alarming issue regarding the otherwise well-organized blood transfusion facility available in our country. The blood component therapy has been in existence since long, but technological advancement and the recent disease outbreaks finally managed to move people's attention to the life-saving therapy and encouraged them to consider it in a more scientific, well-organized, and consolidated manner.
The availability of the adequate supply of whole blood and its components plays a major role in deciding the course of a treatment. Although voluntary blood donation is not so popular in our country, there is now an increased awareness about the blood component therapy. Thus the demand for blood components has also increased, which in turn has helped the market prospects for blood bank centrifuges and separators to flourish.
Market Dynamics
The global market for blood banking and blood products is exhibiting a healthy trend. The blood banking devices market is expected to grow further in the coming years owing to the continuous developments and rising demand for better blood collection and transfusion technology. The global market for blood banking products is expected to reach Rs. 172,800 crore (US$ 36 billion) by 2015. Technological advancements in the medical devices sector have led to the development of automated blood collection devices, which make the process highly sophisticated and reduce the risk of contamination.
New infections continue to take a toll on the population across the world, fueling the demand for blood banking and blood products. Regulatory and healthcare bodies across the world are adopting stringent policies relating to blood safety. As an extension to this, manufacturers are working on developing improved, safer, and advanced blood-banking technologies for the collection, processing, and delivery of blood products, further adding fuel to market growth.
The United States constitutes the largest regional market for blood banking and blood products, where 2 percent of the population receives transfusions annually, another 15 percent undergoes transfusion at least once in their lifetime. On an average, around 50-70 million units of blood and blood components are transfused in developed countries every year. The developed markets are characterized by increased levels of public awareness, sophistication of blood collection technologies, and governmental support. While developed countries bank blood resources to suffice about 80 percent of their needs, blood supplies in the developing countries just suffice 40 percent of the requirements.
The total market for blood bank centrifuges in 2009-10 ranges between Rs. 100 and 120 crore and make up roughly 5000 units in terms of volume. The Indian market for blood bank centrifuges is estimated at Rs. 26.75 crore for the year 2010, with 210 units of blood centrifuges installed. This segment can again be further subdivided into various sub segments that include high-speed centrifuges, ultra-centrifuges, table-top centrifuges, and industrial centrifuges. The market size for ultra-centrifuges was between Rs. 24 and 34 crore (US$ 5 and 7 million), while the market size for high-speed centrifuges stood at Rs. 9.6 crore (US$ 2 million) in 2009-10.
Increasing population in developing countries such as India and China puts pressure on demand for blood on the blood bank segment. The governments of these countries are focused on enhancing healthcare delivery, which includes the blood bank segment. Resultantly, the Asia-Pacific region is projected to emerge as the fastest growing regional market over the analysis period.
Market Trends
The fear of blood-borne pathogens during blood transfusion has affected the blood bank equipment market in the past. Blood collection equipment and devices manufacturers have modified their products according to the needs of the market. Major companies are forming strategic alliances with software and computer firms for innovation in automation of their products. Automation reduces human intervention and simplifies the procedure to a great extent. The important aspect of using automated systems in blood banking is the requirement of fewer numbers of trained professionals for handling blood and its components. Collecting and processing blood through automated devices is time-saving, and increases efficiency. Quality management can also be better ensured. The manufacturing companies are targeting the drug manufacturing companies and research laboratories that experiment with blood and other organic products. The major players in this segment are broadening their product offerings through research and development partnerships with firms that are not directly involved in blood banking. The cost of development and demand for speed and quality research has encouraged firms to make strategic alliances with high-technology entities that can aid product development. The strong presence of biotechnology and pharmaceutical market has helped the blood component industry to mark its presence in the market. The government is also making considerable efforts to maintain and promote the proper use of blood components for the utmost utilization of blood.
Safety Issues
Though blood and blood products provided by blood banks are free from viruses, bacteria, and other disease-causing microorganisms, safety has become the main issue the world over. Risks involved in blood transfusion have also become a major issue in the blood banks, and blood products industry. Many companies are now visualizing blood decontamination as a step toward blood safety and availability. Though the process does not do away with the traditional blood screening, and donor exclusion programs, it is expected to prevent infected transmission. New processes are being developed to make blood supply safer. Areas such as blood filtration and pathogen passivation methods are witnessing development. The need for safe and suitable blood has been the driving force behind the blood banking and blood products industry.
The global blood banking and blood products market is dominated by blood components and plasma products. The market for blood components and plasma products comprises whole blood and cellular components, and plasma fractions. Equipment, blood tests, and other consumables are forecast to witness a compounded annual growth rate of more than 4.0 percent during the analysis period. The rising public demand for safer blood donation and transfusion services is more likely to make way for technologically competent equipment to cater to the needs of the people.
Growth Factors
The major factors driving the market growth include the increasing need for blood and blood products and popularity of cord blood. Growth is also being driven by an increase in the demand for good-quality and safe blood in the country. The high number of cases that require blood or blood components for therapeutic purposes may help in maintaining a steady demand for blood bank centrifuges as well as for the separators. The improving healthcare infrastructure is another major factor since there is an increase in the number of blood banks being set up by the government and by private organizations. There has been a drastic increase in the upgradation of equipment in government blood banking facilities in the recent years. Component collection is gaining importance in India. In the coming years, more component blood banks are expected to come up, which will act as a major boost for market growth. After-sales-service facility and trained service staff provided by the manufacturers are also key factors responsible for market growth.

The USFDA-approved device is initiating a new era of thawing and warming of blood components and it is bound to grow on a faster pace. The thawing of plasma and warming is an important process in a blood bank to ensure the proper temperature and hygiene of plasma and stem cells, issued for patients. The introduction of new devices has given due importance to various aspects of the thawing process. We are sure that there will be more such innovations toward achieving newer heights of standards for blood banking procedures.

Sunil Saraf
Executive Director,
REMI Sales & Engineering Ltd.

Bylined article in MEDICAL BUYER

Saturday, 27 September 2014

Our products meet the statutory and regulatory requirements of the EU

Sunil Saraf, Director
More than five decades old, Mumbai-based manufacturer of laboratory/ magnetic stirrers and centrifuges, and blood bank refrigerators/freezers, Remi Elektrotechnik has crossed several milestones since inception. With a small manufacturing unit in Vasai, today it claims to cater to over 50 per cent of the total Indian demand. Sunil Saraf, Director, Remi Elektrotechnik share more insights about the company, with Usha Sharma
What are Remi’s major milestones?
Remi is a well-known brand with the scientific and healthcare professionals in India for more than 50 years. REMI is a pioneer in supplying innovative products that are import substitutes thereby helping the nation save precious foreign exchange. We were the first in India to manufacture table top centrifuges, laboratory and magnetic stirrers, high speed (20000 RPM) centrifuges, refrigerated centrifuges, blood bank centrifuge for component separation, CE marking for table top centrifuges, mixers and shakers and biggest top entry agitator in India for fluid mixing.

The company is a global manufacturer and exporter of laboratory and blood bank instruments. How far has the company been able to spread its business?

Remi has been exporting its products to more than 50 countries globally. Our products are used extensively in our neighbouring countries and in African sub-continent. We have around 50 per cent market share in Italy for bench top centrifuges and are now looking at other countries in Europe to increase our penetration. Our products meet the statutory and regulatory requirements of the European Union. We also participate in international exhibitions and trade shows to increase our presence and keep ourselves abreast with the changing technology and customer requirements, new product introductions etc.

Tell us about your certifications obtained from global authorities?

Being a global exporter of laboratory and blood bank instruments, it is imperative for REMI to get its products and processes certified by international bodies. All REMI products have certifications recognised by international organisations such as ISO-13485 : 2003: Quality management system for medical devices, ISO-9001-2008: certification for design, manufacturing and supply of laboratory and blood banking instruments, CE Marking: important conformity standards in EU, all REMI products carry a CE mark as adhering to conformity. WHO-GMP certificate: manufacturing facilities adhere to WHO – GMP guidelines as laid down by World Health organisation time to time.

Has the company conducted any research work recently? How rewarding and successful was it?
Research forms an integral part for survival of a company. Though we don’t have to involve in path breaking research like the pharma majors and CRMS, but often focus on incorporating products with new versions. Our research is based on developing user-interface and integrating maximum functions on microprocessors to eliminate human errors. Since all the products are manufactured in-house it offers us maximum flexibility to validate the products along with testing prior to launch. Lately, we launched a new product for our healthcare division ‘PRP Centrifuge’ the evolution of product was need-based to harvest platelet-rich-plasma (PRP). Been a leader in blood bank instrument industry, our sales and service team felt need to develop specific product to address this issue faced by physicians and surgeons (Used to harvest platelet-rich-plasma in pain, wound and cosmetic treatments). Presently Remi PRP Centrifuge is the only product specially focused for harvesting PRP in India.

Indian pharma companies are facing a lot of flak from global regulators like the US FDA. Does your products meet all these regulatory compliances? Do you think your products will help Indian pharma companies resolve issues faced on the regulatory front?

Our products meet the requirements of global regulators like US FDA. Instruments like incubators, stability chambers, freezers, walk in stability chambers, cold rooms etc. are supplied with proprietary “REMI Datasoft” software which comply with the requirements of 21 CFR Part 11.

Where are your manufacturing facilities located?

Starting way back in 1960 in a small shed, today our manufacturing facility is located at Vasai. The facility is spread across an area of 65,000 sq ft which houses all different departments’ like design and development, fabrication, pre-treatment, powder coating, assembly lines, quality assurance, packaging and dispatch. The installed capacity is more than 5000 units per month. We also have a dedicated test room to simulate different environment conditions to do type testing of our products internally. The manufactured products include FHP motors, laboratory and magnetic stirrers, bench top and floor standing centrifuges in refrigerated and non refrigerated versions, shakers and mixers, incubators, stability chambers, cold cabinets, deep freezers, etc. We also manufacture blood bank instruments like blood bank refrigerators, blood collection monitors, plasma freezers, platelet incubators/agitators and ultra low temperature freezers. Recently, we have introduced Clevofuge and PRP centrifuges in the Indian market. The manufacturing facility is ISO-9001:2008 certified and ISO-13485 certified for medical devices and possesses a documentary quality management system in place. All products prior to dispatch are calibrated internally with the use of calibrators which are tested in NABL accredited test laboratories. We provide all documents and test reports as per customer requirements.

Remi Manufacturing Facility at Vasai
Do you plan to set up new facilities or expand the existing ones?

Our existing facility has sufficient space to fulfil our expansion plans in the coming years. Up-gradation of facility and investment in new technologies, machinery etc. would be done in keeping with our expansion plans to cater to our customers, both in India and abroad.

Who are your major clients?

Our major clients include leading hospitals, path labs and diagnostic centres, medical colleges, educational and research institutions, pharma/ biotech/ chemical/ cement/ paint industries and CSIR labs etc. We take pride in the fact that every twenty minutes; someone in India is buying a Remi laboratory/ blood banking product for their use.

How much revenue did the company generate during the last fiscal? What are your expectations from the current year?

Due to a wide customer base using our basket of products, we have not been affected by any slowdown. In fact, Remi has been significantly growing year-on-year. Last year we grew by more than 15 per cent. Considering the feel good factor that is slowly creeping in the Indian economy, we expect to increase our growth rate substantially and double our existing turnover in a short span.

Tell us about the company’s plans for the next 25 years’?

Our historic and successful past has helped to gather profound insights on customer needs in the segments that we operate in. We introduce new products or upgrade our existing products based on our customers’ feedback. We see a lot of business opportunities in healthcare and medical devices market. In future, we will launch new products for this segment. We have already chalked out exciting plans to venture into this segment with the launch of ‘Remi Healthcare Division’ this year. You will hear more about this division in the coming years.

At the moment, Remi is also helping blood banks in upgrading themselves from a storage centre to a component preparation blood bank. We see ourselves in facilitating this changeover in a big way, in the years to come. We will also look at consultancy opportunities in the field of upgrading or establishing new blood banks, path labs and diagnostic centres.

Courtesy - Express Pharma

Wednesday, 27 August 2014

PRP Centrifuge Technology

PRP therapy is gaining popularity as single supportive treatment option for many indications to control spread of ailments. PRP therapy helps to harvest Platelets – Rich – Plasma, which help in natural healing process in the body. This therapy is safe since the platelets are harvested using the patients’ blood, hence does not have risk of infection, allergic reaction, or any other side effect.

PRP Therapy has majorly benefited in treatment of soft tissue injuries and degenerative condition of muscle, tendon, ligament, joints, bone and nerves, etc.

This therapy has been credited to treat major medical aliments related to
  • Dermatologist, Cosmetologist & Plastic Surgery: For various anti-aging cosmetic treatments, hair loss treatments, vampire facelift, etc 
  • Diabetic physicians for wound healing treatments like diabetic foot ulcer, infected wounds, severe burns, etc 
  • Dentists use it for enhance healing of treatment in tooth extractions, tooth Implant surgery, etc 
  • Orthopedic surgeons have been using it several bone growth aliments, treatment of arthritis, etc 
  • Sports medicine has found this treatment most effective in treatment of injuries like tennis elbow, tension in muscle, etc

Major advantage of using PRP therapy
  • Safe: Using autologous blood means there is no risk of infection, allergic reaction, or any other side effect 
  • Convenient: The treatment is quick and absolutely non-Invasive
  • Natural: Therapy is natural, since platelets are harvested from patient own blood cells 
  • Effective: Because the treatment uses growth factors, its effects are superior & effective