Medical device and BioTech manufacturing and distribution, when compared with non-FDA regulated manufacturing, is often faced with 3 unique real estate challenges:
1. Clustering
What city and why? Clustering of BioTech site selection projects begin with a focus on locations in few select US cities to take advantage of embedded infrastructure such as talent, investors, consultants, and heavy outsourcing of major functions through use of design, contract manufacturers, packaging, sterilization, and other pharma focused support firms. In addition to location, wise real estate decisions are weighed against broader pharmaceutical industry trends to increase efficiency and achieve faster commercialization, saving time and money. These include navigating business goals, funding sources, milestones, clinical trials, and exit strategy.
2. Quality Compliance
Which building? What does the building support for infrastructure and utilities? Pharma facilities are subject to quality compliance such as ISO 13485, NEBB cleanroom standards, and FDA 21 CFR 211 outlining Good Manufacturing Practices (GMP). It is crucial to have the ability to locate building options that either meet or exceed requirements necessary to support cleanrooms such as:
- First floor location
- Required clear height
- HVAC capacity
- Electrical and other mechanical requirements
- Roof support
- NEBB Procedural Standards
- Other cleanroom considerations for common ISO Classes (5 – 8) for MedTech and Pharma companies
Finding a real estate broker with this background is extremely rare, but if you can find, it helps alleviate the burden on operations and quality staff in evaluating existing and expanding space requirements. It also helps ensure building is capable of supporting core functions and maintaining compliance to avoid ISO noncompliance, FDA Form 483, or FDA Warning Letter due to facility issues. Finally, it really does save time and money by finding the right property the first time and eliminating the need for heavy capital investment to retrofit for cleanroom or GMP purposes.
3. Flexibility
How do we get the deal done? How to negotiate and structure purchase, lease, or space planning? Life any manufacturer, you must align and integrate your building and facility footprint with your business model. Establishing strategic location(s) and scalable, flexible spaces to enable future growth is vitally important for pharma organizations to ensure flexibility in manufacturing and office layouts AND flexibility in lease/purchase terms/options for maximum efficiencies.
Pick the right city, the right building, and get the deal done right the first time!
