Oftentimes I’m asked for my option on the direction where the biotech companies are heading and my response would be more patient involvement.
A year ago, I attended the FDA Town Hall Discussion With the Director of CDRH and Other Senior Center Management on September 22, 2011 in South San Francisco. During the meeting, I had expected to meet Regulatory, Quality, and Compliance professionals from all local biotech companies. Instead, I was in for a surprise.
Majority of the comment input and feedback during the meeting were from various patient advocates and patients who have traveled from various western states such as Texas to have their voice and concerns heard by the FDA. The Regulatory professionals I sat next with or interacted with before, after, and during break traveled from other parts of California such as San Diego and other states such as Seattle, in addition to the San Francisco Bay Area companies. The silence from the Regulatory professionals within the Biotech companies remained throughout the meeting was interesting, since, like myself, they may have wondered if the town hall meeting would shift focus to the regulatory/quality/compliance issues within the Medical Devices companies.
Or perhaps they were surprised on how much input and feedback the various patients have on the medical device such as hip, shoulder, or other joint replacements that have resulted in more harm, than benefit. Additional inputs were made by patients taking prescription drugs with adverse reactions.
An excellent example stemmed from my personal experience, when a family member broke a shoulder in 3 different places in mid-2011. She has an option for a shoulder replacement surgery. After lengthy consideration, she has declined this option, allowing the shoulder to heal on its own. This decision has surprised me since this family member has the final say on her own medical care and we did not interfere or looked back on this decision. In fact, I’m amazed of this loved one making a coherent and final decision. This is quite the contrary of my own decision of having an implant surgery of my own several years ago, a personal decision I’m still quite pleased with at this date.
These examples brings us back to the future of the biotech companies, where additional patient involvement will be considered. Oftentimes, during dinner table conversations at home or at friends, colleagues ‘ houses during the past several months, the constant denominator I’ve heard was the patient having insufficient voice in his/her medical care decisions or having enough patient involvement in the healthcare. Suffice to say that the opinion was that the patients were not considered as partners or final decision makers.
Additional patient involvement can be encouraged as an aspect of the Customer Feedback, which is a required stand-alone component of the ISO 9000, 9001, 13485, etc, within the biotech companies. Other ISO standards consider customer feedback as part of the complaint handling process. Bottom line, customer satisfaction has been the driving force for quality improvement within the biotech companies and I expect this trend to translate into an exceptional human factor.
Historically, doctors’ offices have been the direct customers of the medical devices and pharmaceutical companies with their prescriptive authorities and final say. With customer feedback as a stand-alone and critical component within the majority of the companies’ quality systems, the patient input is starting to carry additional weight which has started to reach the biotech companies through ease of website access, which is the future of the biotech companies.
Perhaps in the future, there will be a way that the biotech companies can include the patients and end-users within their product development, design controls, and marketing strategies, since it may be cost-prohibitive for biotech companies to materialize a concept, putting together a team and invest large sums of money, only to abandon the idea at a later time since the benefit of the product may not be sufficient when compared the risks, rather than having the product progress to fruition and revenue and investing the large sums into the judicial system, post facto. In this case, ab initio patents filings for the multitude of inventions will have to be immediately rushed, thus investing hefty sums into patent attorney retainer fees, when the biotech companies open up the research and development areas to the public by including them, thus exposing their ideas and inventions.
Thus, a balance of wholeheartedly including patients within each detail and heeding their every advice with the product design and development, and marketing may be optimized and the future of the biotech companies. This will be a delicate balance, which will benefit both the companies and the patients in the longer run.
Town Hall Discussion With the Director of CDRH and Other Senior Center Management, September 22, 2011. Website: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm258228.htm