The medical device industry offers a challenging environment for medical product development. Engineers are actively involved in the design, development and manufacture of materials and devices intended for a variety of life-sustaining applications. The last three decades have seen a major growth in the number of medical devices. There is hardly any organ or part of the body that has not been touched upon by the medical device development group. Although the term `Medical Devices’ as perceived today is not very old, if we go through the definition of medical devices as adopted by the regulatory agencies like USFDA, we can without any hesitation consider existence of medical device from the time a human being has existed. Until recently, these devices were used as conventional devices. With the advent of knowledge in the field and increased concerns about the human life, the regulatory agencies started identifying devices in accordance with their impact on the body and classify them accordingly.

Today the global market for Medical Devices is close to $ 200 billion with cardiovascular and IV/drug delivery on front seat. The demand for new products and services is increasing day by day. The U.S. medical device industry has been in the forefront in developing products that make faster, less invasive diagnosis and treatment possible and facilitate delivery of care in the home and other cost-effective settings. The market in USA alone is about 42 % of the total world market. The total number of industries registered with USFDA  (16170) if not more, is equal to the total number of industries in rest of the world. In spite of all this, the medical device industry is facing a great difficult in commercialization of a new concept. 

The increasing control over the devices on one hand provides much safety and efficacy benefits to the user but at the same time does not allow many devices to come in existence. The field is therefore is not progressing as the way it should have progressed. A number of medical device manufacturers in USA are shifting research and development and manufacturing operations overseas. Places like Mexico and Ireland are providing them more cost effective alternatives. Medtronics, a giant in the field, had all 15 of its major new products or ventures developed, tested, and produced in Europe during 1993-1995 and made all of them available to patients overseas long before they were introduced in the United States. Another perceivable change is that of an spurt in the contract manufacturing facilities in USA. Presently, the ratio of contract manufacturer to finished device manufacturer is 1:3 and this ratio is decreasing rapidly.

If we look at other products like computers and mobiles, the field is changing every day. The reason is that the customer is a regulator and not the regulatory agencies. The customer is able to take decision on value for money and therefore an added function in any consumer-oriented product is acceptable. The case is just reverse in medical device field. A person who conceives new idea has to think several times before bringing that concept to the commercial level because after a long working on the development of the concept into technology, the device may or may not get an approval of the regulatory agency and even if gets approval, it is too late to make it commercially viable.

Concurrently, managed health care is transforming the marketplace for medical technology. The focus in the marketplace today is on cost-effectiveness and demonstrable patient outcomes, making it increasingly complicated to market a new technology once it has been approved. In addition, the marketplace for medical technology in this new era is becoming truly global as barriers to international trade continue to fall.

The following sequence of steps can be considered for a new concept to get into commercialization.

1. Product description

2. Medical efficacy reviews

3. Patent reviews

4. Market analyses

5. Financial analysis

6. Design reviews

7. Regulatory requirements

8. Clinical trials plan

9. Development schedule

10. Models and prototypes

11. Manufacturing plan

12. Employee training

13. Facilities and maintenance

14. Process validation

15. Packaging and labeling

16. Failure modes and effects analysis (FMEA)

17. Materials selection

18. Vendor selection

19. Quality assurance plan

20. Staff and consulting needs

The above list is although exhaustive is not limited to these steps only and therefore it is a long journey to convert concept into commercialisation. Due to this, the claim of several companies to provide mass health care at an affordable cost is just an eye wash and not a reality. The cost involved in the process is very high. In spite of this fact, fortunately, the industry is finding an increasing demand of new products and services and therefore the spending in R&D as a percentage of sale is showing a steady increase through the 1990s. Presently the figure is touching as high as13%.

In the opinion of the President of AdvaMed, the U.S. regulatory environment is particularly inhospitable to small companies, which are the sources of many of the breakthrough products and much of the innovative thinking in the medical device industry. The smallest, most fragile companies in our industry must negotiate the same labyrinthine FDA requirements that the largest medical device companies do, but without the benefit of the big regulatory affairs staffs that large companies can afford. The regulatory authorities should be a strong advocate for patients. Patients are often ill served by a regulatory process that is unpredictable and prone to delay. In recent months, some gratifying improvements have been made to this process, but much more is needed to ensure that breakthrough medical therapies will reach patients quickly. Meeting the needs of millions of patients for cutting-edge, as well as safe and effective, medical technology should be the primary goal of our industry, and it should also be a primary goal of FDA. After all, it is the patients, not the medical device companies, who suffer most when the development of an important new technology is stifled or delayed. Putting the interests of these patients first at FDA would be a major step toward revitalizing innovation and smoothing the path of product development.

In the highly regulated and competitive medical environment, accelerating product through the development cycle is critical. A faster cycle gives the developer a better chance of getting to market quickly. A six-month delay can reduce a product's life cycle profits by 33%, according to a well-recognized McKinsey & Co. study. The goal is to get the best possible product to market ahead of the competition in order to extend the product's life cycle and increase profit. 

Some useful tips for shortening this journey are :

• Before scheduling a new project, analyze a recently completed job. Compare original schedules with the actual dates achieved to identify the stages in which time was lost and why.
• The best stage in which to invest time and money to correct problems is before a project is under way. There is a great potential for improvement when representatives from ergonomics, electronics, manufacturing, management, engineering, service, regulatory, and industrial design all participate at the product development stage.
• Engineers should regularly go to trade shows, hospitals, doctors' offices, and academies where they can meet the medical professionals who will use their products. They should also obtain competitors' products so they can dismantle them for analysis.
• Remember, three rules of product development : feedback, feedback, and feedback.
• Don't be obsessed with computer-aided design (CAD) systems. Use a glue gun and cardboard, or hack up blocks of inexpensive foam. The physical models will reveal much more than the CAD system
• Schedules are often drawn in a linear fashion. However, the shortest time to market is achieved with schedule sections that overlap and with data that easily move back and forth between sections.
• Making accurate physical models of the design used to be the slow stage of the product development process. However, the new RP techniques have reduced both cost and time by about a third during the past five years. Three times as many prototypes can be made for each product in the old time frame, taking designs to a more sophisticated and complete level before committing to tooling.
• The key words in rapid prototyping and breadboarding are early, often, and appropriately. These guidelines can provide major time saving. In fact, the savings potential is so great that it can pay to buy RP machinery to gain a competitive advantage.

Another approach that can be considered worth is to look at those countries that can offer simpler regulation. It does not mean that the regulatory agencies should not take care of the safety and efficacy aspects of the device but the should provide a regulatory environment that is friendly to the industry and gives a clear direction without ambiguity.

Indian Regulatory bodies are still in the process of coming up with medical device regulation and therefore can still provide this opportunity to the industry. The medical device industry in India is of course well placed in this scenario and can offer a competitive, cost effective manufacturing base for all those who are facing problems of regulation, cost and market.

About the Author

Dr. G. L. Jain ( 46 years) is M.Sc. in Chemistry, Gold Medalist from Rajasthan University & Ph. D. in Biomedical Engineering from IIT Delhi. Dr. Jain has received his technical training in the field of medical devices and drugs in USA. Dr. Jain is a recipient of several Medals and Awards viz.: • Gold Medal for standing first class first in M.Sc. Chemistry, University of Rajasthan in 1976. • National Research & Development Corporation.(NRDC) • Republic Day 1990 Award for invention (Rs. 20,000) • National Technology Award 1990 for best invention for the handicapped (Ministry of Welfare) (Rs.20,000/-) by President of India.

Dr Jain has worked On missions of United Nations and Govt. of India, Dr. Jain visited National Drugs Laboratory, Finland in Helsinki, US FDA, Health and Welfare Canada, British Standard Institute, U.K., W.H.O. in Geneva and European Community in Brussels and France. Dr. Jain spent about 2 months with USFDA. He joined Indian Institute of Technology and All India Institute of Medical Sciences, New Delhi in 1978 as faculty in Biomedical Engineering and worked for 17 years. He left IIT as Principal Scientific Officer. He was Technical Consultant for Medical Devices, Contraceptives, Good Manufacturing Practices and TQM at Pune for two years. Presently, he is Director in Corporate Channels India Pvt. Ltd. in Udaipur.