The Problem and Challenges of Commercialization
Curator and Reporter: Joel Shertok, PhD
As the old saying goes,
Anybody can do something once; the problem is: can you do it twice, or for that matter, over and over again?
This is the essential issue faced by those personnel in the throes of the commercialization process.
Any successful commercial process has to meet a number of criteria:
- The process must be reproducible — it must yield the same product/results given the same inputs.
- The process must be economically viable: given the constraints of raw material, energy, and labor costs, depreciation schedules for equipment, expected process failures, R/D, Marketing, and Sales support costs, the process needs to yield both a profit and positive cash flow
- The process should be implemented using readily available commercial components and control instrumentation. On occasion, successful implementation of a project will require specialized components; however these components themselves must meet the criteria for successful commercialization
- The process must be “simple” enough so that suitably trained operators can manage the process. A unit that requires Ph.D.’s to maintain operations is doomed to failure
History is replete with novel processes that worked on the lab scale, but were failures when a commercial operation was attempted. The issues that are most responsible for lab-to-production failure are listed under the general classification of “scale-up”. Scale-up principles are covered in my monograph, “The Art of Scale-up” (www.artofscaleup.com), but in general follow these rules:
- Identification of those process parameters that will have major impact on commercial viability: reaction kinetics, mass transfer vs. temperature/kinetic control; if multi-phase systems are involved, the type and energy of required stirring; heat transfer considerations; side reactions; etc.
- Materials of construction; raw material and product hazards; etc.
- Regulatory considerations: FDA, OSHA, EPA.
Failure to address any of these issues prior to commercialization will lead to surprises during commercialization.
In addition to the engineering/scale-up aspects of commercialization, there are several other criteria that may need attention:
- When to launch a product – where will the new product fit into the overall corporate product portfolio?
- Where is the proper location to launch? A product aimed at flu symptom suppression in cold-weather conditions may not do well in Florida; ….. super-sweet tea does well in the South, and not so well in New England, so that a product to replace sugar might do well in the South.
- Who is going to use the product? Are you targeting doctor’s offices, hospitals, or direct to consumer routes?
- How to launch – social media and “influencers” have given rise to new avenues of product introductions.
The old aphorism of “measure twice, cut once” has a special resonance when doing commercialization of a new process or product. The more the process is thought out ahead of time, the less issues there will be down the road. In the commercial world, there is constant pressure to rush things to meet management deadlines, which always leads to problems and extra expense. A crusty of R/D chemist once remarked, “There is never time to do it right, but always time to do it twice.” Everyone needs to keep this in the back of their mind
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