Ready for Prime Time?

A client (a CRO) asked two “simple” questions regarding a significant and complex technology that it was looking to commercialize:

• What would it cost to commercialize it?
• How soon could it be done?

The technology in question could, in the client’s opinion, revolutionize a certain aspect of the pharmaceutical industry. As luck would have it, however, it was developed in a most uncontrolled manner and not documented at all. As a result, the technology could not be employed “as is” from either the business or regulatory standpoints.

Our challenge was to very quickly provide answers to the two questions to help our client to determine whether it makes financial sense to go ahead with the deal. We felt that, given one day for a site visit and its objective, the primary focus should be as follows:

• Operational, development, testing and/or documentation issues with critical functionality.
• Scalability.
• Maintenance and support capabilities.
• Compliance with 21 CFR part 11 and additional applicable FDA and other (e.g., HIPAA) regulations.
• Ability to integrate with standard hardware and software platforms and applications.

After a visit to the developers and a very busy weekend, we provided a detailed project plan identifying activities, dependencies, rate-limiting factors, responsibilities, costs and times necessary to complete the effort within a timeframe acceptable to our client. The plan also provided information regarding the client, vendor and consultant resources necessary to ensure that the technology would be ready for production within 6 months.

The result? We provided our client with practical and meaningful information, which allowed him to make a business decision regarding whether he is prepared and able to get the technology ready for prime time.