The Path to Product Launch

New medical or surgical product development and manufacturing can be a challenging yet rewarding venture. Understanding the steps that go into product development and commercialization—outlined in this article—can help you avoid potential pitfalls when turning your idea into a reality.

Step 1: Research

The initial step of any medical or surgical product development is coming up with an original idea that tackles a common medical problem that currently has a poor outcome. Avoid jumping into an already competitive market with a similar product or idea. It’s important to strive to solve real clinical problems; remember that the product should always do what is right for patients and patient care. Do not focus on financial return, notoriety, or going public.

A thorough search for any product already in existence, using varied search terms, is critical. You may find that your idea has already been patented, is already commercially available, or has been tried and failed. If the idea has already been attempted and failed, study the reasons behind the failure.

Learn as much as possible about applicable technologies and potential medical applications by attending meetings, studying, practicing high-level medicine and/or surgery, and interacting with colleagues with varied backgrounds. If you don’t attend meetings and stop practicing at a high level, you can quickly become uninformed clinically. Maintaining your connections and surgical skills will provide you with increased input prior to moving to the next phase of product development: the patent application.

Step 2: Apply for a Patent

There are two important parts to the patent application process: a provisional patent application and the final application. One key difference is the duration of their terms—1 year for provisional and 20 years for final patents. The value increases when going from a provisional patent application to the final patent application. Remember that patents are business tools to protect intellectual property, not trophies or curriculum vitae entries.

Step 3: Test Prototypes

You should start creating prototypes as soon as possible to determine the idea’s feasibility and further refine the concept or product. Begin with graphical or computer-aided design models before moving to working prototypes. For surgical or medical devices, once there is a working prototype in a lab setting, you need to demonstrate feasibility in an animal model to further refine the product. If the ophthalmic product proves feasible in an animal model, the next step is testing the product with pig or eye bank eyes.

Once the product has demonstrated feasibility in both settings, human clinical trials are next. It is crucial to consult with the FDA early in this process—the FDA is your partner, not your enemy.

Step 4: Commercialization

The value of the potential product increases at each of the steps. It is important to work with the top technical people available, not your friends, throughout the product’s development. Work with the strategic business development and licensing teams at the companies involved, not the sales representatives. Approach larger companies once you have accomplished as much development as is affordable.

If you have a two-product business, you will be accused of not being focused. Alternatively, the opportunity may appear too small for a larger, strategic corporation if you have a one-product company. To get around this catch-22, consider having one piece of intellectual property with at least two clinical applications, what one author (S.C.) terms a 1.5 product company.

Do not exaggerate your market penetration rates or total market estimates; be realistic in its commercial use and expectations. One author (S.C.) has reviewed close to 100 business plans, and those with drastically inflated numbers are common and easily identifiable.

For commercialization, do not expect added reimbursement for a surgical product. It’s also important to be realistic about current market limitations. The average selling price should be market consistent, not inflated to attract investors or other financial opportunities. There is minimal likelihood of profiting from application software.

STAY FLEXIBLE

Innovators must remain willing to change the product, the people involved, and the development plan throughout the process of bringing their ideas through development and commercialization. Be flexible, yet relentless.