Healthcare is a highly regulated industry and therefore regulatory planning plays a crucial role for many life sciences startups. Most therapeutics, diagnostics, and medical devices undergo review by a regulatory agency such as the FDA in the U.S. and the EMA in Europe. For those embarking down the startup path, this may be the first time any regulatory oversight has impacted your research and certainly touched on commercialization plans. Adding to the complexity, regulations are not often straight-forward and may require an expert to help navigate the process.
So, what are some helpful ways to go about it? And how do regulatory plans impact your IP strategy?
To explore this topic, I interviewed Nada Hanafi, Chief Strategy Officer and Jessica Richter, Chief Operating Officer, from Experien Group. I became acquainted with Experien Group through attending a Medtech Women’s event several months ago. If you haven’t checked out this organization – I highly recommend it. It’s a great group of folks, very welcoming and the seminars and conferences they put on are loaded with useful content.
I spoke with Nada and Jess specifically about regulatory planning and strategy for early stage life science startups. We primarily focused on the medical device field, but also touched on issues that impact therapeutics, diagnostics and combination products.
Question: When should a startup start its regulatory planning?
Experien: Regulatory planning ideally starts as early as the ideation phase. Once the company has a grasp on the technology, device description, its intended use and its indication for use, usually two next steps are crucial: The first pertains to IP, assessing patentability and obtaining patent protection for the device and its uses. The second important step is establishing the likely regulatory pathway. Having a strategy for the anticipated pathway to market – regulatory review and clearance/approval through the governing agencies (FDA in the US and others if you plan to market outside the US) can help guide a multitude of critical decisions, including clinical studies, device testing necessities, quality system requirements, as well as the amount of funding required to undertake these activities.
Question: Is regulatory planning expensive?
Experien: The initial planning stages of a regulatory strategy are typically manageable within the constrained finances of a startup. Costs vary, depending on the risk-profile, device classification and the level of regulatory support requested. In general, as regulatory-focused activities increase, companies should work closely with their consultant or advisor to appropriately budget and stage these expenses.
Question: Do regulatory issues come up for a startup when interacting with potential investors?
Experien: Absolutely! Investors want to understand the pathway to market and what level of regulatory oversight will be required to get the product commercialized. Investors may ask about anticipated regulatory hurdles, so they can appropriately estimate the risks, time and cost involved with the investment. Defining your regulatory roadmap can be an important step in setting realistic expectations for potential investors and highlighting that your company has taken steps to fully understand what it will take to bring the device to market. For example, the costs of funding a moderate-risk class II device are significantly less than the costs involved with funding a high-risk class III PMA device. However, for an investor, the higher risk class III device may offer a greater return on investment (ROI), as the barriers to entry for competitors may provide a stronger position in the marketplace. To this end, it is critical for a startup to have a sound understanding of the regulatory requirements for its device when speaking to potential investors; this can be as early as series A or even seed funding.
Question: What are some key pointers for a startup in setting up its regulatory strategy?
Experien: There are several areas where a startup can focus to strengthen their potential commercialization pathway:
- The technology should address a clear need, preferably a clinical need. It is also important to think about all stakeholders involved in the adoption of your product (such as the patient, physician, payers). The scoping of clinical need(s) and active stakeholders is best done as early as possible. Starting too late on this type of planning is a common mistake.
- Consider the total product lifecycle of the device, from benchtop to bedside. This includes initial ideation, prototyping, and pre-clinical/bench testing, then onto clinical testing, regulatory submissions/review/clearance or approval through to commercialization and post-market surveillance. Thinking about what will be involved and required at each stage provides a plan for resourcing, budget and for envisioning the hurdles that could arise at each step along with potential solutions.
Question: How does a startup select which regulatory pathway applies to its device?
Experien: We strongly recommend partnering with an experienced advisor or consultant to aid in your regulatory journey; this is especially critical for first-timers. Regardless of the risk-profile of the device, it is always helpful to begin with a landscape assessment to find competitor or reference devices similar to your product and within the same category. Understanding FDA’s commercialization requirements for similar devices can provide a helpful general roadmap for what will likely be required. Since most devices fall under the moderate-risk 510(k) classification, appropriate predicate selection can be critical to creating a least burdensome pathway to market. A wrong selection can set a company back significantly. Individuals can conduct a comprehensive predicate search on FDA’s website to identify a range of possible devices that may be substantially equivalent to your device. This is a comparison of your proposed device to those already cleared and marketed in the US.
Ingensity comment: So, I must chime in here. Substantial equivalence is all about same, same, same, basically where can you draw parallels from your device to others to support regulatory clearance. From an IP strategy perspective, it’s all about different, different, different – meaning you want to differentiate your innovations from what came before.
How to merge these 2 strategies? In speaking with Jess and Nada from Experien Group, we came up with these pointers:
- Selecting an appropriate predicate or reference device in the regulatory world doesn’t mean you are infringing on someone else’s intellectual property.
- Some predicates may not be covered by patents at all;
- The patents related to the predicate(s) may cover only a subset of features or only aspects that are not incorporated into your device design.
- The identification of predicate or reference devices can help you map and understand the IP landscape.
- What else is out there addressing a similar market niche?
- How is it similar and different from your device?
- Are there differentiating features from the predicate or reference devices that are key to your patent protection strategy?
For more information on Experien Group visit http://experiengroup.com/ or contact Jessica Richter directly at Jessica@ExperienGroup.com.
For more on synergies with other facets of startup life, as well as general IP strategy tips, see more at http://ingensity.com/blog/.
Are you interested in other regulatory topics, such as what is coming for digital health? Let us know – post a comment to this blog on LinkedIn or Twitter.
The content of this blog is for informational purposes only and does not offer legal advice. Circumstances are fact-specific and you should consult an attorney for legal advice concerning your individual issues.
 IngensityTM IP and Experien Group are independent businesses, with no agency for profit between them.