MANSFIELD, MASSACHUSETTS, March 2, 2020- For vast majority of life science entrepreneurs, raising money is by far the biggest challenge they are facing. Assembling a compelling slide deck is a crucial part of the process. To assist the entrepreneurs in this important endeavor, Mansfield Bio-Incubator hosted a workshop on February 26 on what the investors are looking for in the slide deck. The workshop was led by a distinguished panel from Alira Health, an advisory firm that supports client’s business with an integrated suite of Product Development, Regulatory, Clinical, Strategy Consulting, and Transaction Advisory services.
According to David Uffer, Senior Partner and VP of MedTech, with the medical innovation flooding the market, the investors are looking for more than EBITDA. It is critical that the products provide the value to the market in the form of leapfrogging of the existing technologies as “me-too” or “me-too plus” products have very hard time exiting. Therefore, as Aude Quesanaga, Manager, a Market Access Specialist, emphasized, it is critical that the entrepreneurs work on the market access strategy early on. They need to understand who the actual patients will be. Many entrepreneurs tend to rely on market research reports to accomplish this. However, while these reports are great sources for the retrospective information, such as epidemiology and the existing treatments, very little could be gleaned from them with respect to the utility of the proposed device or a drug. This is especially true for medical devices. Therefore, the entrepreneurs need to conduct the extensive research, either on their own or by hiring a consultant, by engaging with the key stakeholders and opinion leaders such as patients, physicians, insurance companies, etc. Defining the patient population will in turn allow to optimize the clinical trial, thus leading to a more efficient capital deployment. In this way, the investors are more confident in the management team.
Another way to optimize your clinical trials, as pointed out by Chris Rao, Director, Clinical Development and Mary McNamara-Cullinane, VP of Regulatory Affairs, is to map out the regulatory pathway early on. According to Mary, the first step is to schedule a no-cost meeting with FDA prior to submission. Engaging with FDA early, will enable the entrepreneur to determine if a new 510K submission is necessary as well as negotiate the number of subjects to enroll. Chris Rao pointed out that elements of the competitors’ clinical trial design are publicly available on clinicaltrials.gov. This information can in turn serve as a guide to roughly budget the costs of the trial.
The due diligence described above is essential to be able to map your milestones and inflection points. While the making the timelines as short as possible is important, they need to be realistic. Both Aude and David strongly suggested to start from the endpoints (e.g. exit, different stages of development such as 510K, clinical trial start, etc.) to work backwards, which is contrary to how most of us have been taught.
Taken together, doing homework described above will go a long way for the investors to believe in your team. We at Mansfield Bio-Incubator are thrilled to have Alira Health conduct such an informative session and are privileged to have them as our partner. Alira Health provides free monthly open office hours to Mansfield Bio-Incubator member companies. To become a member, we invite you to contact us here.
In addition to putting together a compelling investor deck, other aspects, such as IP protection reimbursement and business strategy, ability to scale, access to the global market, and building a team are just as critical. Mansfield Bio-Incubator aims to host the educational events on these topics and other critical areas for life science entrepreneurs to succeed in commercializing their inventions. For more information, check our calendar of events here. We look forward to seeing you soon!