How to build your invention during residency

Innovation has always been an integral part of plastic surgery, from the specialty's birth beside the battlefields of World War I through today's facial transplantation procedures. Indeed, translating experiences in the O.R. into cutting-edge techniques or devices is why many choose the field.

As the specialty evolves, it faces numerous challenges – making vital the efforts to keep plastic surgery a specialty that promotes, encourages and inspires innovation. Residents and Fellows can bring innovation to the fore, with the potential to improve not only plastic surgery, but also healthcare and society at large. However, becoming aware of these opportunities – not to mention having little to no understanding of how to make an idea reality or gauge the relevancy of an idea – remains an ever-present issue.

"Innovation comes from seeing a need and trying to meet it, fixing something or having a vision and just the process of trying to make something better – a device, process or treatment," says ASPS past President Lynn Jeffers, MD, MBA, who created the Society's Technology Innovation and Disruption Presidential Task Force during her term. "There's room for innovation everywhere."

Nevertheless, for medical professionals accustomed to the healthcare environment – and particularly, residents – facing the vastly foreign world of business and innovation can seem formidable. How can residents – who spend each day training in the O.R. or clinic, with a direct view into the most pressing challenges – successfully navigate the road of innovation? As in surgery, bringing an innovation to market requires overcoming challenges, and solving intricate problems can be a daunting undertaking. That's why the Society is working on a roadmap for innovation.

ASPS help for residents

ASPS recently entered into a partnership with medical-devices accelerator MedTech Innovation (MTI) to accept applications from plastic surgeons – including trainees – to vie for up to $500,000 in cash prizes plus in-kind awards.

"You don't have to wait until you're an attending to be an entrepreneur or an innovator to pursue your ideas," Dr. Jeffers says.

The PSF President-elect Howard Levinson, MD, who with Dr. Jeffers assisted the Society in forging the MTI partnership, says the initiative is not limited to seasoned doctors.

"Residents interested in participating and contributing to the ecosystem, the growth of companies or in taking an idea and moving it forward can have a place in the new accelerator program," Dr. Levinson says. "Those who have an idea for an invention but are unaware of what to do next or how to bring it forward and get other people involved will be helped. Residents who think, 'I still want to be a plastic surgeon and I don't want to work on this project a lot, but I want to invent it,' can be involved. Whatever their spectrum is, this arrangement will provide an opportunity to learn what to do next."

"Training is the perfect time to become involved in a startup, because that's when residents generally are determining the track they want to pursue," says MTI spokesman Bill Perry. "Applying, screening, judging, connecting with companies for advising or in the companies still forming – all of which are possible through our new partnership – are great ways to get involved."

Impactful ideas

The first step toward innovation is deciding whether an idea is impactful. Can it change workflow or add new, necessary technology to a space? If so, a large number of people could be affected by the idea (market size). You may ask: What exactly is the "better something" you want to introduce, or the problem being solved? It's helpful to talk to experts in the field as well as potential users of the new technology to gauge how readily individuals might adopt it.

"By nature of your training as a resident, you'll see different aspects of plastic surgery and of practice in general – and you may conceive of many innovations," Dr. Jeffers maintains. "It might not have anything to do with plastic surgery at all, but if you look for ways to make things better, you'll always find potential opportunities for innovation."

Once committed to your idea, try to determine whether other startups or companies have tried to solve the same problem. It's necessary to examine exactly what they've done and why they've succeeded – or failed. In doing this, innovators often discover their idea is not truly novel and thus needs modification or reconsideration.

Another question to ask: Do current technology, manufacturing, resources and infrastructure allow for the creation of this product or idea – or will significant changes be necessary to create it? Higher upfront development costs and harder ideas to adopt may need to be reconsidered prior to further action.

Patents and protections

Once committed to moving forward and after the requisite background research, obtaining a patent for the intellectual property (IP) is the next logical step. If you're wondering whether to share novel ideas with others before filing a patent, the answer varies. An idea can only go so far if it's not discussed with experts or potential users. Furthermore, forming a competent team is crucial to most innovation endeavors. Speaking to people who can be trusted or can contribute is useful.

Frequently, company co-founders are brought together to discuss novel ideas, thereby creating a synergy that can be more powerful than an individual startup founder working on his or her own. Without sharing ideas, innovation often stops. Although rare, the potential downside of disclosing ideas to other individuals or groups is the possibility that the idea will be utilized by someone else.

"You might have a great idea but might not think that it's great," Dr. Jeffers says. "If it's a problem you're trying to solve, talk to other people about it – seek resources and find like-minded people who'll be passionate about your idea. If it's something you're passionate about and want to pursue it, do your homework, get good advice, find resources and go for it."

The patent process will likely be the next step, and it can be long, arduous and costly. However, investments made in developing a strong IP portfolio could be the most valuable part of the startup process. Investors and future clients alike are attracted to companies with strong IP. To assist with this step, the U.S. Patent and Trademark Office (USPTO) website provides all necessary resources (uspto.gov). Although individually accomplishing this is possible, consulting with a patent attorney is the best way to ensure that proper background research, document filing and communication with the USPTO are performed.

Company creation and fundraising

Forming a strong team is fundamental to bringing an idea to reality. Assembling individuals with expertise in various areas will strengthen the group and can avoid potential conflicts. Most residents don't have a business background, and thus it's often helpful to collaborate with others. At a certain point, a founder or group of co-founders will need to form a company and begin fundraising. A board of directors will often be created early in the process and usually consists of members from the founding team. The board acts as a governing body that meets at regular intervals and supervises the activities of the company.

Recruiting a group of core advisors who are experts in the field is another critical element. These individuals believe in the company mission and are willing to serve as a resource. Payment for these early advisers can be individualized, but this usually consists of stock options or future shares in the company. Typically, early company executives (CEO, CTO, COO, etc.) consist of founding members and may remain unpaid until a first round of fundraising has been achieved. If additional employees are hired, paying these individuals at market rates will usually be necessary and must be a part of the company's business plan.

A business plan must be thoughtfully developed as early as possible. Resources abound for creating a proper plan, but market size, revenue models, growth plans, company overhead and expenditures, and financing/fundraising considerations are a must. The business investors and should contain important milestones, which are defined as necessary achievements that the company needs to reach to make progress toward its overall business goals. Examples include developing a proof-of-concept (POC) product; performing pilot testing; achieving revenue; and scaling to a certain market size. Commercialization and up-scaling the product or service to a greater market size is usually every startup's eventual major milestone – and the driver behind revenue and profitability. The company should work toward reaching these milestones as early as possible.

Efforts to raise funds to support the company's goals and bring an idea to fruition need to be considered early. Again, having a well-designed business plan clarifies fundraising needs, and only then should early investors be approached. A "slide deck" graphical presentation is the most common way to share the information about the company and should consist of the company and market background; idea or product description; team information; any potential partnerships; current or future clients or customers; competitors; and financials.

Raising funds can be achieved by diluted or non-diluted means, with diluted investments typically requiring granting a stake in the company once certain milestones are achieved.

"Dilutive funding by definition 'dilutes' ownership of IP," according to innovation researchers Maheen Nadeem, BS, and Arnold-Peter C. Weiss, MD. "Stock... may be divided into shares that are granted to investors in cases of diluted funding. Nondilutive funding, in comparison, stands alone and does not change ownership in [the] company."

Seats on the board may also need to be granted to certain investors. If possible, fundraising with non-diluted sources such as grants or other trusted entities early on is most fruitful. Putting forth a well-positioned business plan, mission statement and team will make the venture more attractive to potential investors.

'How do I even begin?'

Residents at this point might be thinking: "How in the world can I manage all this while balancing my clinical obligations and continued training?" That's where the ASPS/MTI Innovator Accelerator Track can provide a useful assist. The goal of the program is not to make one resident do everything on his or her own to secure an investment – the goal is to build a collaborative network to make the next great idea a reality.

"The ASPS/MTI initiative is part of a greater plan to create a community and infrastructure within ASPS that will become a resource to which residents and members can go if they need assistance on literally anything from the beginning of their process to the end," Dr. Jeffers says. "To further help them in navigating the road to their innovation, this partnership also will make accelerator-based educational materials and sessions available to our members. Companies that go through the process will have access to many resources in the MTI space. Opportunities also will exist for those who are interested in this space but don't have a company or idea of their own.

"The goal is to create resources and opportunities where our members have the help and information needed to get started and see their innovation to fruition, or to participate in various aspects of innovation," she adds. "In addition, we plan to have programming at Plastic Surgery The Meeting, slated for Oct. 27-30 in Boston. We'll have had at least three companies go through the MTI program by then, and we'll be interested to learn from their experiences. We will bring like-minded people together to help create this community, and we welcome resident involvement. If residents wish to participate in the MTI accelerator or in this community, we welcome their energy, ideas and commitment."

Eyes on the prize

During residency, focus and priority should always be on the clinical training and education required to become plastic surgeons – but that doesn't mean working toward an innovation must necessarily be ignored. Surrounding oneself with individuals who share similar passions for innovation can enable residents to innovate and not only move the specialty, but also move medicine and healthcare as a whole. It can be a rewarding and exciting part of residency training.

Dr. Serebrakian is PGY-6 at Harvard Mass General Brigham Plastic Surgery.