Meeting Manufacturing and Medical Marketing Needs

The past decade has been witness to dramatic changes in the health care industry. There have been exceptional advances in the drugs and technologies available to treat illness and disease.

There has also been, however, an everincreasing awareness among health care professionals of the dangers associated with treating any patient because of the risks associated with potential exposure to serious or deadly viruses or infections. Accidental contact with a patient's blood or accidental needle pricks can be potentially life threatening in any occurrence.

The safety of health care professionals has led to significant changes in the way patients are treated and the devices used in that treatment. Many of the most commonly used medical devices such as catheters and syringes have been reengineered to make them safer. Many devices that were once sterilized and reused are now single use and disposable. These new products have created new challenges in the medical disposable device industry, as traditional assembly methods and systems are no longer applicable to these new, more complex assemblies.

Many manufacturers who may have traditionally produced assembly systems internally, now find themselves looking to independent assembly system builders to solve their increasingly complex, high volume assembly requirements.

Manufacturers are facing ever increasing customer demands and constantly rising competitive pressures. More than ever before, new products require the shortest possible time to market. The traditional decisionmaking chain where new products move from product development to engineering, through marketing, to material purchasing to manufacturing and on to sales is no longer valid. Everything needs to happen at the same time in a productive, cohesive program, which brings the best product to the marketplace seemingly overnight. More than ever before manufacturing engineers are challenged to acquire the very best in process and assembly automation equipment within program budget and timeframe windows that are constraining at best and at worst, impossible.

In higher volume new product projects, the highest level of project risk and complexity is in the acquisition of the required assembly automation equipment. What makes the process so complex is a combination of factors that are difficult to package into a one size fits all solution. Every assembly automation project is in its own way unique. Every solution or system is also unique, however there are often many solutions that are as equally good as they are different.

Most assembly automation systems purchased by medical device manufacturers are for new products. That is to say for products that are not currently being produced and marketed and will not be produced in any significant volumes prior to the installation of the completed assembly system and all other required peripheral equipment.

Projects begin with the identification of a product, which for any number of reasons requires assembly automation as opposed to hand assembly. These reasons vary from high volume requirements to individual piece part quality verification, to process verification, product functional testing and others. In terms of the individual piece parts, all but the most unusual parts are generally produced from an assortment of standard machine tools, processing equipment and tooling (dies, molds, etc.) or are purchased. Generally, the costs associated with the manufacturing or acquisition of component piece parts are easily identifiable and become known early on. This part of the overall product production process is in many respects generic. But the acquisition of required assembly automation and other related special machinery is not.

The assembly automation procurement process must begin with an indepth knowledge of the types of equipment produced and the capabilities of the suppliers. There are many ways to acquire this knowledge, but by far the best is a personal visit. Such visits are particularly important in medical applications, as the builder's ability and experience in producing the types of systems suitable for clean room operation may be critical. Small investments in travel to prospective vendors prior to requesting proposals can avoid the enormous costs of poor vendor selection later on.

Given a thorough knowledge of the potential builder's capabilities and areas of expertise, it is usually clear, as proposals are analyzed, where the best technical solution can be realized. Obviously system pricing must also be considered.

Price must be assigned its proper place on the level of importance ladder. Price is not irrelevant, but it is certainly not in the top three. Areas far more critical in the vendor selection process are:

1. Builder's ability to adequately address product process and production requirements.
2. Builder's experience and financial condition.
3. Cost of system ownership.

Overall system price is often a moving target until the project is very nearly complete. The principles of concurrent engineering dictate that vendors of special manufacturing and assembly systems be selected before final product design and before final firm price proposals. The normal process associated with more standard capital purchases of creating a project budget and having funds (fixed) allocated, does not work well.

Today's globally competitive manufacturing environment dictates that real life partnerships between product manufacturers and equipment builders must be established at the earliest possible point in a project. There must be a mutual respect and active twoway dialogue from project inception to completion. Project managers must be joined at the hip to both their own product design group and the equipment builder's.

A final comment on price. Traditional capital ROI formulas rarely work with custom assembly automation, and attempts to cram the cost of special manufacturing systems into these formulas is generally unsuccessful. Most products destined for automated manufacturing and assembly systems have product lives of five years or more. Corporate purchasing policies must allow for product life to be considered when determining ROI on customengineered systems. Many assembly automation systems are not purchased because of corporate insistence that overall system costs fit one or two year ROI formulas. These failures to purchase are most often mistakes closely linked to the issue of price is the cost of ownership. The price of an assembly system and the cost of owning and operating that system tend to be mutually exclusive. In the real world, some types of equipment outperform others. Some builders are better than others. The goal must always be to own a system that, day in and day out, year in and year out, has the lowest amount of scheduled or unscheduled maintenance (downtime) and yields the maximum in net production. Relatively small percentages of higher yield can make seemingly large differences in initial purchase price insignificant very quickly after installation.

When assembly systems perform at or above expectation levels, no one ever asks how much it cost. When systems perform poorly, people always ask how much they cost. It is incumbent upon manufacturing engineers responsible for system builder selection to do as much homework as possible in the cost of ownership area before final selection is made.

With the growing volume requirements in today's marketplace for newly designed, safer disposable medical devices, manufacturers of these products face many new challenges. Development to market time frames are constantly shrinking. Assembly automation providers are acutely aware of the market sector, and are devoting increasing amounts of their resources in order to be able to produce highly productive systems suitable for clean room environments in very compact delivery time frames.