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Cover Focus | April '13

Innovative Thoughts on Innovation

Getting involved in innovation can be a very rewarding part of your career, but challenges and considerations exist in today’s regulatory climate.

There are many aspects of ophthalmology that continue to draw newcomers to the field like the ability to perform microsurgery and use advanced technology, to name a few. For some of us, though, the opportunity to innovate is a powerful motivator. For those interested in ophthalmic innovation, there are a number of important factors to consider, including mentorship, practice environment, and strategic matriculation early in one’s career.

Innovators fall into multiple categories, including the inventor, the translationist, the improver, the validator, the big picture person, and the early adopter. Most people know themselves well enough to figure out which category they fall into it—and it may be a few—but each serves a purpose.

THINKING LONG TERM

If you are thinking about becoming involved in innovation within the ophthalmic space, it makes sense to plan subspecialty training early on so that you have access to mentors who are also innovators. Not only will innovation become part of your training, but connections made early in your career can be the basis for lifetime relationships. You will want to take on projects and utilize your creative hunches to make a contribution. Like all things in science, the data need to be published and presented: peer-review publications are the currency of research.

After training, you will be faced with the decision to work in private practice, academia, or a hybrid of the two. Historically, innovation has occurred in academic laboratories. This paradigm has changed rapidly during the past number of years, however, with prohibitive academic policies often discouraging or disallowing collaboration with industry. Sunshine provisions dictating public disclosure of financial relationships with industry are currently mandated, and although conventional wisdom would suggest that patients want physicians who are involved in helping to develop technologies, academic institutions have been forced to overregulate these relationships to minimize risk to the institution.

Academic innovation centers with significant resources and grant opportunities are starting to become more commonplace, but the politics can be overwhelming and pushing through the required paperwork can be a slow process. Yet, the attraction of resources and multidisciplinary expertise can make navigating this path worthwhile. Interdisciplinary approaches can be fruitful; I founded an ocular biomechanics laboratory where I carry out translational research within a department of bioengineering. Recently, private ophthalmology innovation centers have been founded, perhaps representing the purest and least restrictive model. In the future, more translational research laboratories will surely pop up in the United States in both academic centers and increasingly so in the private sector.

PRIVATE PRACTICE, THE PRIVATE SECTOR, AND INNOVATION

In the private practice setting, efficiency is key, and unless the practice is aligned or fully committed to clinical trials, this is not a good fit for an innovative spirit. Participating in clinical trials is not part-time work, and it requires a practice to be fully invested with a full time clinical trial center and staff.

Academic institutional review boards or IRBs are notoriously inefficient and overregulated to a fault. These inefficiencies, in addition to the aforementioned university regulations, are a large part of why innovation has not only fled to the private sector, but also why it has largely moved outside the United States. In my experience, private-sector IRBs are certainly easier to deal with.

As mentioned, the innovation cycle is increasingly moving off shore. A variety of factors are contributing to this trend. For one, the much lengthier regulatory process in the United States has caused some companies to develop their ideas elsewhere. Companies can more easily work on approving clinical trials and planning commercial launches outside the United States where regulatory approval comes much sooner in the development process. The expanding global medical market means that companies can recoup research and development costs before they approach the FDA for approval. In many cases, companies are forgoing US commercialization altogether because the costs involved limit the potential for profitability.

REIMBURSEMENT

Contractual relationships and reimbursement vary widely depending on a person’s workplace, contractual obligations, bandwidth, and value added. Academic institutions may limit or disallow innovators from having commercial relationships during employment, or require all or part of monies to be paid to the university, all with full disclosure. Private practices may insist on part or all of your consulting monies to be contributed to the group to cover the overhead associated with your relationship and/or overhead from the practice. These points should be clearly discussed prior to signing an agreement and clearly defined in your contract.

Startup companies are often lacking in capital, but they leverage options, which may or may not develop value. On another level, however, it can be satisfying to help develop a technology from the ground up, and if it is a success, you can leverage your sweat equity. Keep in mind that there are tradeoffs to working with industry. Financially, you will make more on a busy day in surgery, but it may be more personally fulfilling to develop a new device or technique, as long as it fits your practice model, contractual obligations, and is done in a responsible manner.

CONCLUSION

Ophthalmology is an inherently innovative subspecialty. It attracts many individuals driven to create the technologies of tomorrow. There are, however, many things to think about when considering pursuing opportunities in ophthalmic innovation. As this article points out, challenges exist for the innovative ophthalmologist in both academic and private settings; however, participating in innovation can nonetheless be an enriching aspect of your career.

author
George O. Waring IV, MD, FACS

George O. Waring IV, MD, FACS, is the Director of Refractive Surgery and an Assistant Professor of Ophthalmology at the Storm Eye Institute, Medical University of South Carolina. He is also the Medical Director of the Magill Vision Center in Mt. Pleasant, South Carolina, and a Chief Medical Editor of MillenniealEYE. Dr.Waring may be reached at waringg@musc.edu.

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