Biomaterials can change the future of healthcare, but only if regulatory matters are considered in the early stages of development.
The Smart Biomaterials Consortium facilitates stakeholders around the development and clinical production of smart biomaterials for regenerative therapies. SBMC’s shared platforms enable product developers to address the key bottlenecks in the commercialization of regenerative medicine. The consortium brings together researchers, entrepreneurs, large and small companies, and strategic investors.
Although SBMC has a lot of in-house knowledge, there are specific fields of expertise for which the consortium looks outside, especially when such knowledge is essential for developing new products and services. One of these fields is regulatory: everything you need to know about legal issues connected to the market entry of smart biomaterials. “This is not something a researcher or a startup founder thinks about when developing their innovative products”, says Lisanne Karbaat. On behalf of Holland Innovative, she leads the three-day workshop that helps these developers open their eyes to the sometimes neglected or underestimated regulatory forces.
“Regulatory should be woven into the product development of every startup”, she adds. Karbaat is a biotechnologist and researcher in in-vitro diagnostics. At Holland Innovative, she is a project manager of Medical Devices and a specialist in regulatory matters. “Founders should be aware of the potential legal boundaries of their devices and the pharmaceutical substances within them.”
This is especially true for biomaterials, a fast-growing field of expertise for which rules and laws are still developing. “It’s no surprise that regulatory matters are not top-of-mind for researchers and entrepreneurs. They are 100% focused on developing their product. Still, they need to be aware of this in an early stage. If not, they will be encountering much bigger problems later on.”
In the biomaterials industry, regulatory issues are even more critical than in other medical fields. “This is because often two legal fields are involved: those behind the device and those behind the pharmaceutical substances in it. Think of a hip implant with a specific coating, a band-aid with a substance to help cure the wound, or a material that supports the jawbone to grow back again. These are all products that take years to develop, so it’s of the greatest importance that the owners are aware of the legal rules they need to obey after they’re ready to go to market.”
The workshop Holland Innovative offers the SBMC consortium members is divided into three parts, each consisting of a full day of training. “On the first day, we focus on the applicable conditions around going to market. Then, we look at how to apply the rules. Finally, we look at specific elements connected to their ideas and products. Participants can share their own specific cases, so they will feel what’s needed to reach their goals. At least a quarter of our time is spent on these real-life examples. This is what makes the workshop so useful.”
For the participants, the workshop is a revelation, Lisanne Karbaat remembers from the first round of training. “We show them all the things they didn’t learn at school or they thought would ever need. Of course, we can’t turn them into legal experts, but we can take them from unconsciously incompetent to consciously incompetent. This way, they can avoid quite a few unpleasant surprises halfway through. We show them where the thunderclouds are hanging and how to blow them away. Everything with one goal in mind: improving the chances for innovative smart biomaterials to reach their projected audiences, so they can deliver what the technology promises: to radically change the future of healthcare.
Are you also combining pharma and medical devices in your products? Please email me with any questions that may arise: lisanne.karbaat@holland-innovative.nl
More information about the Smart BioMaterials Consortium: www.smartbiomaterials.nl