A long time ago, as I was starting out my career in the pharmaceutical industry, I once heard a strange saying from my somewhat old-fashioned boss. “You can’t make a silk purse out of a sow’s ear,” he said. Since then I have heard many versions of that theme, but the original still resonates with me whenever I hear about projects going awry.
The pharmaceutical industry is unique and quite unlike any other. Here facilities and the products manufactured in these facilities both require regulatory approvals. And these products manufactured under stringent regulations are not sold directly to consumers but marketed to Doctors, who in turn prescribe them to patients.
If your business model is one where you’re in it for the long haul, then it is inevitable that you will own some manufacture. If you are starting from scratch without any knowledge of the industry, other than of the products you wish to manufacture, you must seek out the expertise of a project partner who can support your vision and objectives with the know-how and expertise that guarantees success. Choosing the right project partner to design and commission your facility is key to determining several long-term success factors.
Most ‘project management companies’ in the pharmaceutical space have not yet evolved from their trader/aggregator legacy. They will promise to deliver you the moon wrapped up in gold ribbon if you would only place your faith in them. Every single one of them will be ‘innovative’, ‘world-class’, ‘client-focused’ with the ‘best team’. How then do you pick the right one? How do you select the firm that will actually help you complete your project successfully? Here is a simple checklist I have developed over the years:
1. Do they have a broad and deep understanding of the pharmaceutical industry?
As I have said earlier in this post, the pharmaceutical industry is quite unlike any other. Projects by their very nature are unique, in pharma much more so. A facility for manufacturing inhalers is entirely different from one that manufactures parenterals as is the one in which APIs are manufactured. There is enormous value to be gained from a company that has demonstrable expertise and industry knowledge that not only is able to help you anticipate future needs but also preempt risks that can crop up from time to time over the duration of your project.
Quality by design allows you to design your facility, your equipment, your processes with the requisite quality ensuring your product is of the quality mandated. Also, intricate engineering design, driven by a User Requirement Study will ensure manufacturing can expand as desired even ten years from today without creating unused capacity right from the start.
2. Are they transparent about their processes and methodologies?
As an organisation, you place a great deal of trust in a project company to offer you the best advice and make recommendations that suit the needs of your project and your business goals. It is important that the company you choose has done their homework about you. Are they forthcoming with you about challenges they anticipate? Do they have real responses to your questions? A big red flag is if they have to consult with their vendors at every step and do not have answers to fundamental questions themselves.
3. Do they have proven evidence of their fabulousness?
It’s all fine for a company to talk about how amazing they are, but simply asserting you are the best means nothing if you do not have the relevant experience to back it up. What do their clients say about them? What projects have they worked on in your geography or geographies similar to yours? What technology, methodologies or tools do they use to enhance their deliverables to clients? What is their project track record on delivery? And what is their in-house capability to tackle issues if they are abandoned by their vendors? Can a company that depends on external vendors for all aspects of a project even be relied on to be agile and responsive when it comes to delivering your custom built solution?
4. Do they have effective fall-back strategies for every possible scenario?
We all want our projects delivered on time, to budget, with no changes in scope or conflict, everything as easy as the breeze. Never going to happen. On any project. If a project company promises you this, run fast in the opposite direction. Every project channels Murphy’s Law, and something or the other will need tweaking, amending, changing, discarding. Budgets may change, and timelines may shift. However, it’s all perfectly normal for a project.
Don’t look for a company that promises you the perfect project. Instead, pick the one that demonstrates how they proactively address potential issues. How do they limit scope creep and address timeline and budget changes? Do they have clear examples of how they managed these conflicts on previous projects in your geography and in others? The tougher, the better. Are they the right company for you if they don’t come to the meeting with clear strategies to manage commonly occurring issues? What are their strategies when things go badly wrong? The right company will never abandon you even when things go badly awry but instead will work with you to resolve issues and deliver on their promises.
5. Are they good with jigsaws?
Every project has a significant number of moving pieces. From vendors to equipment to project management skills to the field force on the ground, there are several players involved in every project. It’s a battle on several fronts. Look for a company that demonstrates how they control every aspect of the project delivery from start to finish. Some will have a reliable network of vendors whom they rope in on their projects to deliver all the myriad elements. Others will have a set of retainer consultants and partner manufacturers on hand.
However, the truly brilliant, truly reliable ones will have 360-degree control over EVERY SINGLE stage of the project cycle – from in-house engineers to design every single aspect of your facility to local project teams to execute and commission your project. They will also control the entire infrastructure and equipment manufacturing process in-house, enabling them to seamlessly dovetail physical manufacturing infrastructure with the know-how of optimised manufacturing processes. There will be no flying in and out of vendors when a problem arises, but their teams on hand will know everything there is to know about the proper installation and functioning of the equipment. If upgrades or spec changes are called for they will be able to address them efficiently without having to go back to consult multiple source points.
As my former boss said when he spoke of silk purses and sows ears, you cannot turn something inferior into something of value. So it is also for project management in the pharmaceutical industry. Pick a partner that offers you value that is greater than the sum of all their parts. You’ll sleep soundly at night.