3D Bioprinting and Biologics: A Look at Patent and FDA Market Exclusivity Strategies
By Jeff Vockrodt and Paul Gadiock
The industrialization of 3D printing opens the possibility of making products efficiently with complex structure previously thought impossible or impractical using the tools of the first industrial revolution. Early industrial applications of 3D printed metal parts lowered the weight and reduced the number of components for highly engineered components, such as jet aircraft engine parts. As innovators seek to increase applications, much effort has been underway to expand available materials to include biopolymers and even tissue or cells.
3D bioprinting employs 3D printing and similar techniques to combine cells, growth factors, and biocompatible materials to fabricate products that mimic natural materials such as printed bone, skin, arteries, and even whole organs. The promise of 3D bioprinting is to leverage the computer-controlled, layer-by-layer additive process of 3D printing to selectively deposit cells to build complex living tissues that can be used in patients. Because the cells can come from the patient, there would be no need for organ donors, and lessened risk of transplant rejection.
Bringing these 3D bioprinted products to market will require significant investment in order to gain marketing approval from the Food & Drug Administration (FDA). The question immediately arises as to whether innovators in 3D bioprinting will be able to leverage enough patent and FDA marketing exclusivity to make their investment worthwhile. Both (1) the type of patents available and (2) the regulatory pathway chosen will determine the amount of exclusivity available for first movers…
3DHEALS Influencer Interviews:
What motivates you the most for your work?
“Two things motivate me the most. First, at my core, I am a materials engineer. In the same way, mechanical or electrical engineering might enjoy tinkering to create new pieces of machinery or electronics, I get substantial joy and fulfillment from tinkering with materials and processes to create new materials with properties that didn’t previously exist. That curiosity and seeing what I can do and how I can push materials motivates me intellectually. Second, at the end of my days of designing new materials, it is extremely motivating to know that they serve a real need and can potentially make the lives of others better or save their lives outright. One needs this real motivation on the medical side of things because it is a slow process to get it to patients, especially when you are talking about revolutionary new technologies.”
What inspired you to start your journey in 3D printing (bio-fabrication/bio-printing)?
“My colleague Dr. Todd Heil is the 3d printing guru on the team, from whom I learn a little bit about 3D printing every day. My current company, Theradaptive, is using 3D printing to enable highly targeted biologic delivery to create scaffolds for protein and cell delivery for orthopedic regeneration and sports medicine. Our current product development focuses on 3D printed bioactive tissue substitutes that are custom-designed, have mechanical and physical properties similar to native tissue, and can safely deliver the most potent growth factors and cells, for tissue repair and regeneration.”
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While many have recognized and advocated the vast potential of 3D printing technology in healthcare, based on recent survey results, hesitance is palpable within the ecosystem, ranging from 3D printing entrepreneurs, device makers, healthcare organizations, to other corporations in the healthcare field. Part of this uncertainty comes from the fact that 3D printing is a relatively new and different manufacturing process from traditional ones and the existing biocompatible materials used for traditional manufacturing processes may not demonstrate similar behaviors if translated for use in 3D printing. For example, in the 3D printing manufacturing process of metal powders, there is partial re-melting and solidification of the initial powder that may change the material physical and/or chemical properties of the printed object. Also, because of the added structural complexity (often an advantage of 3D printing), the behaviors of the final device are also not well known and need to be validated for both “safety” and “effectiveness”. Another example is the 3D printing of objects with non-solid fill (e.g., a honeycomb fill) has been used to decrease their weight and create structures that more closely mimic biological materials (e.g., the internal structure of bone). The cleaning of these complex geometries and the gas or liquid within these structures needs to be evaluated for safety during the regulatory process of a medical device.
The objectives of this white paper are to provide clarification and in-depth discussion of the topics below, which are critical elements to the additive manufacturing industry in healthcare:
- Definition of biocompatibility.
onhow biocompatibility is assessed within the current regulations of materials and medical devices by major regulatory agencies.
- Summary of how different regulatory agencies are managing the introduction of 3D printing into the healthcare space to date.
- List of major available biocompatibility materials and those in development.
3DHEALS San Francisco: Happy Hour
Date: Feb 15th, 2019 | Event time: 5:30-7:30 PM, San Francisco, CA Register
3DHEALS Washington DC: Pushing Boundaries – Healthcare 3D Printing and Bioprinting
Date: Feb 27th, 2019 | Event time: 6:30-9:30 PM, Washington DC, Register
3DHEALS New York: Happy Hour
Date: March 3rd, 2019 | Event time: 5-7 PM, NY, NY, Register
3DHEALS Chicago: 3D Print Life
Date: Wednesday, March 6th, 2019 | Event time: 6:30 PM – 9:30 PM, Chicago, IL, Register
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