Tag Archives: business

  • Best Practices of Smart Consultants

    … consulting company, we encounter a vast array of personalities within our client/business relations. From there we began to ponder: What kind of consultants do we consider near and dear to our heart? Is it the cruise ship director? The person who is likely to sit back and watch their team assign roles and work for each other while they help to boost the overall team’s morale? Although keeping it positive is an amazing and sometimes hard to find trait among people in this industry, there is …

  • Should we be using iPhone video procedures?

    … without it becoming a regulatory limitation. The time is right to be bold and start to employ modern ideas for a 21st century business!   Let’s keep the conversation going. What are your thoughts on this issue? Does the pharmaceutical industry need to “join the 21st century”? We would love to hear from you! Comment below or visit our social media networks to keep talking about this topic.  …

  • Consolidation Activity in the Generic Sector

    … developed to assume that products will remain available to consumers at the right price. As producers drop out, monopolies are developed and the Federal Trade Commission is obliged to step in to protect competition and consumer choice.  This involves its own level of management which can also put stress on the company to deliver products to the consumer. So beneath the economic/business surface news of an acquisition/there’s the underlying practical considerations which may be overlooked …

  • Fall Networking Event, a Success!

    On October 9th, SCG proudly kicked off a new networking event series with our friends from Walnut St. Labs. The event took place at Teca restaurant, right in the heart of the borough of West Chester, Pa. Smart Consulting Group’s president, Denise Smart, hosted events of this nature several years back, so the time had come to start off this tradition once again. SCG invited local professionals in the life sciences industries, while Walnut St. Labs opened it up to many other local business …

  • Kaizen Events

    … event. The process involves a “complete PDCA cycle performed within five business days, focusing on removing all forms of waste and bottlenecks from the process to create maximum value.” This should be normally factored into the process within 30 days of the event in order to capitalize on the work that was accomplished from there on out. It is important to note that the cost spent should be ever so modest compared to the significance of such events. Kaizen events are indeed a focused …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … Lean consultant is well placed to provide objective feedback about the program to senior management and to maintain the commitment from senior management that is required in order to deliver lasting sustainable improvements to the business. This is by no means the extent of the benefits that can be delivered using a Lean consultant, but it does effectively highlight the diverse number of areas where they can have a meaningful impact. …

  • Venturing into the Bold World of Combination Products

    – By Michael Hemenway For a traditional medical device company contemplating a decision to develop a combination drug-device product, the question of whether or not to pursue this type of product should be weighed carefully.  While there might be a benefit to the patient from such a product, the benefit should be compelling and perhaps more importantly from a business perspective, the profit uplift from having a drug associated with the product should be large enough to more than offset …

  • Do Start up Life Science Companies need Quality Management Systems?

    … their systems. This is a much misunderstood concept that is often overlooked because it takes time and expense to develop and put in place. However, given that it is the law, those ignoring the issues and failing to address the need are really jeopardizing their future business and products. Companies intending to partner with large pharmaceutical companies will find that they can negotiate better terms if they have their compliance house in order. Large Pharma likes positive results and will …

  • Metrics and their Importance in Lean Biomanufacturing

    … inoculum preparation and work up can be appropriately synchronized to assure that the tanks are ready to be re-inoculated with the next batch once they have been cleaned and re-sterilized. This should be a key area of focus for both fully integrated companies that have their own facilities or CMO’s that provides manufacturing services for client companies. In either case, lost production time has an impact on both business models, although for CMO’s there may be a greater pressure because …

  • Change Management; A Vital Part of the Lean Mechanism within the Life Sciences Industry.

    The deployment of any successful Lean initiative will be largely dependent upon the capacity of the organization to adopt the changes that are part of the overall approach and a major driver for this will be how the workforce chooses to embrace the methodology involved. Within the Life sciences Industry, this effect is often even more pronounced due to the highly regulated nature of the business processes involved. No matter how effective the methodology is, if it is not welcomed, embraced and …

  • Lean Enterprising; A term coming of age in the Implementation of Lean in the Life Science Industry

    As Lean manufacturing makes an increasingly bigger impact on pharmaceutical manufacturing and Life Science Product Companies in a wider sense, the terminology of Lean Enterprising is becoming more commonplace. Traditionally the focus has been to initiate Lean manufacturing and specifically the elements surrounding the shop floor production systems that impact this. However, today the emphasis is more on a general holistic implementation which covers the whole business “enterprise” network. …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    … margins, imminent novel healthcare reforms and increasingly heavy-handed government intervention, rapid technological advances and a growing number of combination products—all these are happening now or are on the horizon. As a result, the role of pharmaceutical consultants is both expanding in scope, as well as narrowing in response to needed specialization. According to Peakman, in the past pharmaceutical companies mostly used general consultants for large business-wide endeavors like …