This post summarizes a Harvard Business Review article entitled “The New Logic of High-Tech R&D“, written by Gary P. Pisano and Steven C. Wheelwright. The article focuses on the revelation that few companies within the pharmaceutical industry view manufacturing and process improvement as a competitive advantage. The authors assert that manufacturing process innovation is conducive towards product innovation. Companies traditionally spend money on product R&D but tend to neglect focusing on process R&D.

For example, Sigma Pharmaceuticals refused to invest significant resources to process development until the company was confident that the drug would win FDA approval. As a result, when demand for the drug increased they could not meet the higher demand without major investments in additional capacity. During this interim ramp up period the company lost two years of potential sales. Underinvestment in process development on the front end clearly put the company in a sub-optimal position to capitalize on additional revenue.

Process development and process innovation provide a litany of benefits. The first of which is accelerated time to market. According to one drug company, the time required to prepare factories for production generally added a year to the product-development lead time. Senior management was unaware of this fact while the managers within the process development organization were fully aware.

Rapid ramp up is also invaluable because it allows companies to more quickly realize revenue, penetrate a market, and recoup its development investments. Also the faster the ramp up occurs the faster critical resources can be freed to support the next product.

Innovative process technologies that are patent protected can hinder a competitor’s push into the market. Pisano and Wheelwright state that it is easier to stay ahead of a competitor that must constantly struggle to manufacture a product at competitive cost and quality levels.

Process development capabilities can also serve as a hedge against various forces in high tech industries. Shorter lifecycles elevates the value of fast to market processes. Semiconductor fabrication facilities can cost upwards of one billion dollars and depreciate at a rapid pace. For this reason, rapid ramp up is very important. Those companies with strong process development and manufacturing capabilities will have more freedom in choosing the products they wish to develop rather than forced to stick with simple to manufacture designs.

Pharmaceutical companies traditionally operated in the following manner. They delayed significant process R&D expenditures until they were reasonably sure that the product was going to be approved for launch. They didn’t delay product launch by keeping the process R&D off of the critical path. Manufacturing and process engineering were on hand to make sure the company could bring on additional capacity and didn’t stock out. Manufacturing was located in a tax haven even if it was far from R&D and process development, while process development was introduced later in the lifecycle in order to thwart the threat of generic competition. Today however, pharmaceutical companies find themselves squeezed by shorter product life cycles, less pricing flexibility and higher costs.

The article states that the earlier that a company makes process improvements the greater the total financial return. It is costly and time consuming to rectify process design problems on the factory floor. The earlier these problems are found in the development cycle the shorter the process development lead time.

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