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. 

Material and Packaging Compatibility in Medical Device Sterilization

When designing medical device products, sterilization should be considered as early in the development as possible to ensure the material challenges of the sterilization process on the product and packaging. AAMI TIR 17:2008 titled "Compatibility of materials subject to sterilization" is a very important reference.

EO is highly compatible with polymer-based, single-use medical devices, procedure kits and surgical trays. PVA, PGA, and PLA is not compatible with EO sterilization.

The Gamma irradiation process can modify polymers, add an ozone odor to the package contents, or cause some discoloring and embrittlement. Gamma irradiation also has undesirable consequences due to the potential production of toxic degradation products such as 4,4’-methylenedianiline (MDA) that can be produced when a high-molecular-weight polyurethane material decomposes as a consequence of irradiation. Polypropylene, PTFE, and polyacetals is not compatible with radiation sterilization.

A good summary of materials which can be used in Gamma ray irradiation is from Steris Company and Nordion.

Sterilization Methods of Medical Device

Sterilization of medical devices plays an important role in the product development although it is not heavily invovled or nealy not involved in academic research in universities. It need to be considered in the earlier stage of prototype development, which can avoid the complex or even failure in the later stage.

Sterilization is defined as a “validated process used to render product free from viable microorganisms.” Terminal sterilization is defined as the “process whereby product is sterilized within its sterile barrier system.” The terminal sterilization process is considered a manufacturing process step itself and usually takes place at, or near, the end of the manufacturing process.

The presence of microorganisms is expressed as a probability. While the probability can be reduced to a very low number, it can never with certainty be reduced to zero. This is why we use the term Sterility Assurance Level (SAL) to express a sterile claim. SAL is the probability of a viable microorganism being present on a product after sterilization. Normally expressed as 10^-n. 10^-3 or a 10^-6 value being used most frequently for sterilization. Common SAL for medical devices is 10^-6.

Sterilization is accomplished principally by radiation, chemical sterilants, steam under pressure, dry heat, and filtration or combinations thereof. General application and method of sterilization can be learned in Wiki. A more detailed Guideline for Disinfection and Sterilization in Healthcare Facilities can be found in Centers for Disease Control and Prevention (CDC)

It is important to distinguish sterilization from disinfection, which does not ensure the same security level and does not necessarily inactivate all forms of microorgan- isms – bacterial spores, for instance. 

A sterile medical device is one that is free of viable microorganisms. For a sterile medical device this can be achieved through:

• A terminal sterilization process
• Sterilization of components, followed by sterile filtration and aseptic filling into a sterilized container
• A combination of chemical/physical sterilization and aseptic processing
 

The choice of the sterilization method for medical devices depends on a number of factors including the type of material used in medical devices, the type of packaging materials (product packaging and final packaging), the number and type of microorganisms involved, and the classification of the item.

Medical Device Exhibitions

Although company website, online searching, and FDA database can provide a lot of information on the medical device company, exhibitions are still traditional and rich sources to learn medical device industry. Main exhibitions of medical devices are:

• Medica and Compamed
• FIME 
• Medtec
• China International Medical Equipment Fair
• Arab Health

More exhibition information can be found: http://10times.com/top100/medical-pharma