Inventing Medical Devices – a Perspective from India

INTRODUCTION

This book is written prima rily for healthcare professionals, but can also be very useful for engineers, designers, entrepreneurs , who wish to invent new medical devices in India with low risk and higher chances for success. It aims to give the primary readers a sense of what it is like to invent new medical devices in India and provide a road map for those who would like to venture into inventing something themselves. The information is based on experiential insights of a doctor’s journey while inventing numerous medical devices in India with multidisciplinary teams over the last 5 years.

Common questions that come to mind before inventing new devices such as, How should I make this idea into an actual product?, Can I sell this idea?, How do I work with engineers and product designers?, Where do I find them?, What is the model of engagement?, How will I raise money?, Who will invest?, How will I balance this with my routine clinical activities?etc., are all answered in this book in a systematic manner with real life examples, case studies and caricatures from learnings, best practices and failures of the author during his experience.

The appendices also contain certain standard information related to grant funding opportunities in India, tried and tested processess for medical device innovations, regulatory framework, IP filing and clincial studies. This book aims to provide clarity for the readers, set realistic expectations and create awareness among healthcare professionals regarding the most effective way they can contribute to the invention of new medical devices as a multi-disciplinary team.

This book focussess on the mindset and perception towards healthcare innovations in India and attempts to clear some common misconceptions that healthcare professionals may have regarding the invention of new medical devies. Most uniquely, in this book you will find references to standard engagment models along with actual expenses incurred during these engagements (licencing terms, salaries, consulting fees etc). The intention is to provide all basic information in an easy-to-read, short, simple, experential format, so that it enables enterpreunuers to start thinking in the right direction very early when it comes to inventing new medical devices for India.

This will hopefully help doctors, engineers, designers, business professionals, scientists, institutes, organizations to all work together, in an effective manner, with realistic expectations regarding the outcomes and the process involved.

If I had asked people what they wanted, they would have said faster horses.

– Henry Ford

Chapter 1

General attitude towards healthcare innovations in India

Y ou are a doctor. Why are you inventing medical devices? I get asked this a lot—often by my colleagues who are doctors, and many times by engineers or designers right after they have heard me talk about a device that I co-invented. It makes me wonder why they always ask this? If a doctor’s responsibility is to treat patients, then isn’t contributing to the creation of a new medical device—that helps improve patient treatment—also the job of a doctor? So I ask them Who, then, should invent medical devices? The answer I get most often is Engineers, of course. They know how to make things , followed by scientists or researchers.

This is a very common quandary amongst my peers and I’ve never understood why it exists. Inventing and developing a new medical device (solution or technology) is the result of multidisciplinary teamwork that requires doctors, engineers, designers, scientists and business professionals, working together to ensure that the device successfully reaches the end user. Each discipline brings to the table a unique set of skills. It cannot be the job of any one particular discipline to develop a new solution altogether.

The role of a doctor (clinician or healthcare professional) is pivotal in helping the team understand the depths of the clinical problem, define the clinical requirements of a solution, help create a solution that the human body will accept, validate the magnitude of the problem in the society, test the new solution in a regulated clinical environment, and help in adoption of the solution in the healthcare system. The engineers and designers help in transforming the idea from its conceptual level to an actual prototype, which can be tested and improved with every iterative cycle. The technology needs to be built to meet necessary safety and quality standards. The design must take into consideration human factor analysis, usability and manufacturing requirements. Business professionals determine the market size/model, build financial projections, execute business development activities, create go-to-market strategies and handle operations for the team. Many of these activities happen simultaneously with a lot of overlaps between them.

Many entrepreneurs, today, do not realize that such a cross-disciplinary involvement at every stage of the invention is very crucial for the development of a successful medical device. A possible reason for this could be the predominant hierarchical system at workplaces that inhibits teamwork and increases competitiveness among disciplines, or due to the lack of examples that highlight the importance of cross-disciplinary teamwork among different professions. This mindset leads to entrepreneurs preferring to work as individual team units under the same discipline, rather than working together with other disciplines.

A typical scenario is when a team of engineers, developing a new device, gathers inputs from clinicians only after a decent prototype has been made, instead of involving the clinician at an earlier stage when the problem was being identified. The prototype is shown to the doctor and feedback is taken on the design and usage of the device. At this stage it is very difficult for the doctor to suggest modifications of the need, redirect the solution, or alter the concept itself, and has no choice but to provide feedback on what is being shown. I have heard engineering teams tell me that they developed a product, and despite taking a lot of clinician feedback, not many people are willing to use their solution when it is in the market.

It’s heartbreaking to tell them at that point that they should probably revalidate the need they are solving, and rethink the concept or the product that they are developing. By this time a lot of effort and money has been spent and the setback is very discouraging and disappointing for the team, often leading them to discontinue the project.

On the other hand, when clinicians think of ideas and solutions to solve clinical challenges, they look for engineering and design services after they have locked down the concept, and demand that the product be developed based on their inputs, exactly the way they have thought of it. Since the engagement is commercial and for a fee, engineers and designers are often compelled to deliver what is required of them. Many other approaches or technical methodologies—that could have been implemented to develop the same solution more effectively—are often missed because of the client-service model of engagement. The engineering and design teams also have limited information on the clinical use case and the clinical requirements for design and manufacturing.

In addition to these, since outsourced engineering and design is quite expensive, many doctors do not develop a solution beyond a proof-of-concept or early-prototype stage. This makes the device highly unsuitable for patient use and eventually it does not reach the market. This disconnected approach for developing new solutions eventually impacts fundraising, which is yet another challenge for entrepreneurs developing medical devices in India. Most MedTech (Medical Technology) investors here look for an experienced and capable team, willing to work fulltime on the project. Since innovation is not a well-recognized mainstream profession, most entrepreneurs pursue this as a part-time activity, which disinterests investors.

Most clinicians in India are underpaid and often overworked. Typically they would have spent 8–10 years and a lot of money on their training, before establishing themselves as practicing or institutional clinicians. For them, diverting their time towards non-clinical work, especially fulltime, is considered counterproductive and, as quoted by some, suicidal. Engineers, who have stable, salaried jobs, are reluctant to quit until their part-time entrepreneurial efforts lead to some source of income that will allow them to risk leaving their jobs. In addition to the lack of a multidisciplinary and fulltime team, there is generally a poor understanding of the clinical need and rationale for the technology that is being developed. These factors make it unfavorable for investors to invest in MedTech projects, as they are willing to take some market risk, but are unwilling to take risks on clinical or technological areas.

Entrepreneurs therefore pursue government grants and trust -funding for seed capital (money to kick-start project) of up to INR 5,000,000 (approximately US$100,000). Today, there are many grants available (see Appendix 1 for a list of Government and private grant funding sources for medical device innovations in India) for individuals as well as start-up companies, because of the recent interest in the Government to develop new healthcare solutions for India. These are relatively easy to get but take time as the average application-to-grant sanction cycle can take up to a year. This can substantially delay the development of the device if this time is not accounted for in the project development plan. I know of a few start-ups in the MedTech space in India, who have risen substantial amounts of grant money (INR 3–50,000,000 or US$5–700,000) but are not able to bring their devices to the market in three to five years! There could be numerous reasons for this as well. Grants generally