Business Plan

As a R&D staff, I try to learn some more about business, market, management to know how the company runs everyday. It is certain to be benefitful to develop a new or innovative product from market need to prototype development, to manufactoring and quality managment, to sales. Finaly, I think how to write a business plan is a good way. 

I have invested in stock many year, known the basic economy knowledge and read many annual reports of listed companies. However, annual reports are mostly what have done in the company. Business plan is about what the company will do. Its main aim is  similar to the funding proposal wrote in the university, i.e. raising money.

Marketing in Customer-focused Product Development

Product is the total package of benefits (not just features of products) the customer receives when they buy. It is important for R&D staffs to understand that an industry is a customer-satisfying process instead of a goods-producing process. New product development should be market-driven and customer-focused. It will meet customer needs or creat new customers and markets. 

Marketing is about satisfying customer needs and wants. According to its definition, marketing is the activity, set of institutions, and processes for creating, capturing, communicating, delivering, and exchanging offerings that have value for customers, clients, partners, and society at large. It normally includes assessing the market (marketing strategy and marketing plan, SWOT analysis), understanding the market (consumer behavior), and targeting the market (segmentation, targeting, and positioning); creating value (product and service), capturing value (price), delivering value (place and supply chain and channel), and communicating value (promotion, advertising, public relations, customer relationship management). Developing new products is usually a charpter in marketing-related books.

Marketing plays a major role in developing a successful product. So marketing knowledge is very necessary to be learned for a R&D staff when starting a product development. Basic principles of marketing can be studied with the classic book Marketing Management by Philip Kotler. There is a good youtube playlist for marketing.

Validation of Medical Device Sterilization

Prior to beginning routine sterilization, a product with a sterile claim needs to complete a validation process to ensure the Sterility Assurance Level claimed is met. Normally, A 10^-6 SAL, or greater (i.e. 10^-6, 10^-7, etc.) is used for:

• Products intended to come into contact with breached skin or compromised tissue
• Invasive products that enter normally sterile tissue
• Products with claims of sterile fluid pathways
• Surgically implanted devices
• Components used in aseptic processing

A 10^-3 SAL, or greater (i.e. 10^-4, 10^-5, etc.) is used for:

• Products not intended to come into contact with breached skin or compromised tissue
• Topical products that contact intact skin or mucous membranes
• Products that cannot withstand a 10^-6 SAL process

Sterilization validation studies must document that the product attains the re- quired SAL after exposure to the proposed process. In the industry, sterilization validation is generally evaluated by, first, determining the qualitative and quan- titative bioburden (the type and number of viable microorganisms present on the device just prior to sterilization) after the manufacturing process, then, studying the rate of killing using fractional-run sterilization studies and, finally, deducing the time required to achieve a 10^-6 SAL. Validation studies must be done on product samples prepared under actual manufacturing conditions and exposed to the sterilization process under its final packaging configuration. 

Two methods are used in validation:

Bioburden method:

Bioburden: Population of viable microorganisms on a product. In the context of irradiation sterilization, bioburden is determined immediately prior to sterilization. The unit of measurement is CFU: Colony Forming Unit.

Broadly speaking, and validation consists of three steps: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The IQ and OQ portions are often performed ahead of time by the contract facility and provided in the form of a commissioning package to the customer. The performance qualification demonstrates that the sterilization equipment consistently operates in accordance with predetermined criteria and that the process produces product that is sterile.

Over-Kill Method:

The overkill method is the most commonly used method for gas/vapor phase sterilization modalities. This method uses a biological indicator with a population of 10⁶ of the most resistant organism (MRO).  A fractional (Sub-lethal) cycle(s) is run to determine the D-Value of the product in a given sterilization process. The D-Value determines the amount of time needed to kill one log of the MRO.  The half cycle is determined my multiplying the D-Value determined in the fractional cycle by six, plus a safety factor. The calculated half cycle is then tested to verify that a six log reduction is achieved in all locations within the load. A full cycle is double the time/injection of a half cycle. This provides you with a SAL of 10^-6 or 12 log reduction.