From Concept to Clinic

Have an idea for a new intraocular lens (IOL), surgical instrument, or drug? The first step might be coffee with an engineer, according to Sorcha Ní Dhubhghaill MBBCh, PhD.

Many universities have research groups, including optical and biomaterial engineers, hungry for clinical perspectives, Professor Ní Dhubhghaill said. Informal meetings can break the ice. “You don’t always have an unfiltered approach on Zoom.” But it’s just the beginning of a complex journey to market that can take years and cost millions.

Early on, the key is bringing together ideas about what needs to be done—the unmet clinical need—with what can be done technically. “Engineers want a problem they can tackle, but you don’t always have the cross talk you need [among disciplines],” said Prof Ní Dhubhghaill, who works extensively with clinical trials and spinoff companies as head of a university ophthalmology department.

H Burkhard Dick MD, PhD agreed. “Innovations should originate from real-world clinical frustrations. Whether improving visualisation in deep-set eyes or reducing variability in IOL positioning, starting with a focused problem leads to more relevant solutions.”

Clinical input also helps ensure new products will be viable in the real world, said Luis Diaz-Santana PhD, who advises eye care product start-ups. Developing a new technology “is not a technology question per se; it needs to be profitable; it needs to live in a system of [clinical] workflows, guidelines, and regulations; and it needs to solve a problem and live in a consumer space.” Early ophthalmologist involvement also can build acceptance by often-conservative physicians, he added.

Experts in intellectual property, regulatory requirements, and business strategy should be consulted early, said Prof Dick, who also has extensive experience bringing new technologies to market. “No single person can bring a medical device from concept to clinic.”

Approval, payment, and partners

While regulatory approval may seem like a late step, it should be an early goal. Working with regulators early helps guide everything from design to preclinical testing to clinical trials. “There is a very formal structure. It’s not worth doing a clinical trial that doesn’t count [towards approval], and regulators may give you advice on animal studies,” Prof Ní Dhubhghaill noted.

Health plan reimbursement also should be considered early, Prof Dick said. “Design clinical trials that not only demonstrate safety and efficacy but also cost-effectiveness,” he advised.

Adding business partners helps, Prof Ní Dhubhghaill added. “It takes time and money. That’s why you need industry support. The FDA and EMEA make early clinical development very expensive. If you rely on grants, you’ll never make it.”

In addition, “established companies offer access to distribution networks, regulatory experience, and R&D resources that can accelerate time to market,” Prof Dick said.

“Strong intellectual property protection and publication in peer-reviewed journals build credibility with investors, partners, and regulatory bodies,” he added. Most universities provide services that help entrepreneurs balance the complex relationship between these two needs, Prof Ní Dhubhghaill said.

Business partners are not the only audience to consider: “How will customers see value in your proposition? You need to articulate this in a way your audience can understand,” Dr Diaz-Santana said. He also stressed that a new technology needs to actually solve a problem rather than push it off to someone else.

And investors want to see a continuing revenue stream, Dr Diaz-Santana noted. A product that requires ongoing supplies or a service contract is more attractive than a one-off sale. Scaling manufacturing and maintaining complex supply chains are also important partner concerns.

“Use familiar clinical environments for initial testing, but ensure your innovation has global applicability in design and scalability,” Prof Dick advised.

Building teams—and trust

Attracting investors and business partners requires answering key questions about every step in the development and commercialisation process, Prof Ní Dhubhghaill said. Achievable business and development plans are crucial. “Be realistic to the point of conservative. Most experienced investment teams will not be fooled.”

Dr Diaz-Santana recommended seeking early collaborators who will challenge assumptions. “You need to talk to people who don’t agree. […] Don’t be married to a technology—focus on the problem.”

Team members with the necessary development skills also enhance investor trust, Prof Ní Dhubhghaill said. “They don’t fund the idea; they fund the team.”

Though the regulatory and economic hurdles are daunting, the innovation climate in ophthalmology remains vibrant, Prof Dick said. “With a strategic approach based on clinical insight and multidisciplinary collaboration, ophthalmologists can continue to play a central role in the development of transformative new technologies. The future of sight-saving care depends on it.”

Sorcha Ní Dhubhghaill MBBCh, PhD, MRCSI(Ophth), FEBO, FEBOS-CR, BaO, Dip(stats) is chair and head of the Department of Ophthalmology at University Hospital Brussels, Belgium, and a member of the ESCRS Council of Management. sorcha.ni.dhubhghaill@uzbrussel.be; nidhubhs@gmail.com

H Burkhard Dick MD, PhD, FEBOS-CR is professor and chairman of the Ruhr University Eye Hospital in Bochum, Germany, and ESCRS president elect. dickburkhard@aol.com

Luis Diaz-Santana PhD is founder of LDSH Strategy, a consultancy specialising in assisting eye care product start-ups in Cambridge, UK. luis@ldshstrategy.com