Category — Operations

There is no doubt that with the strengthening dollar, costs for homecare products are set to rise in Europe. Most manufacturers and distributors of wheelchairs and other homecare products extensively source wheelchairs or components from China, where products are usually procured in US Dollars.

A quick glance at a ten year chart will show that a 10% or more swing in a relatively short time is not outside of the realm of possibility. It is also interesting to note the close linking of the Yuan (despite the US wish that that it will be allowed to float more in the future).

Of course with the largest revenues derived from Government reimbursement business, increasing prices is not going to be that easy. So it seems that the industry may be in for another round of restructuring, standardizing on lower featured products, or perhaps worse.

There are of course better ways to run sourcing and supply chain operations that are mostly dependent on China, but in an industry largely driven by cost, many companies have largely ignored these options – maybe at their peril.

Here is Business Week’s take on the fluctuating exchange rates.

Dollar Rises for Sixth Week Versus Euro After Fed Rate Increase – BusinessWeek.

Frank Barlin is Managing Partner at Sibaya LifeScience!

Permobil has announced that they will be establishing a brand new 120000 sq ft facility in the US – 80000 of this will be dedicated to manufacturing.

This comes at a time where National Competitive Bidding, Medicare cuts and China outsourcing are the norm for several wheelchair manufacturers.

Lebanon, TN (October 20, 2009) — Permobil, Inc., an international company that is the world’s leading manufacturer of custom-made powered wheelchairs, will build its new $12 million North American Operations Center in Lebanon on a 17-acre site located in Park 840. The project is the largest, single capital investment that Permobil has ever made since it was established more than 40 years ago. Permobil’s new 120,000 square foot building will be the company’s second largest and most technically-advanced manufacturing facility. It will include over 80,000 square feet of manufacturing space and nearly 40,000 square feet of corporate office space. Construction of the new building will begin in late October 2009 and is slated for completion in summer 2010.

Thomas Rossnagel – former head of Sunrise’s Europe business and operations has been promoted to President and CEO of Sunrise Medical. Michael N. Cannizzaro – former CEO will continue as Chairman of the Board of Directors.

Rossnagel who worked out of the companies German operations is recognised in Europe for his leadership – and his most notable performance in driving efficient and effective operations for Sunrise Europe over the past several years.

With this latest move Sunrise continues to demonstrate it’s ability to take a global management perspective to it’s business.

The full press release is here.

May

There is no doubt that the economic recession which has now touched all parts of the world is taking it’s toll on most industries.

One of the most resilient however is the healthcare industry. Sibaya LifeScience! recently interviewed several companies supplying services to “big pharma” in the form of contract manufacturing – especially drug delivery – at ICSE, P-Mec, Cphi – Frankfurt, Germany. While this was not a scientific study, anecdotally we were told that it was business as usual, in fact for some, business was clearly on the increase as manufacturing was being outsourced to contract manufacturers.

Not the case though for small and medium sized biotech companies according to this report in the IHT which lists companies in the Biotech hub in Massachusetts struggling for cash and laying off employees. Biotech companies need cash to fund research while waiting for their revenues to hopefully arrive one day, but in the US biotech companies have only been able to raise about half of what they did in the prior year.Technorati Tags: biotech, contract manufacturing

The United States FDA has just issued a new

Guidance for Industry: Process Validation: General Principles and Practices

This is an important new proposed guideline document and the FDA is inviting comments within 60 days of it being published in the register.

Our initial observations at Sibaya LifeScience! are:

Aligning process validation activities with the product lifecycle concept and with existing FDA guidance, this guidance now includes biological products and active pharmaceutical ingredients.

It also specifically provides recommendations with the Risk-Based Approach for technological advances in pharmaceutical manufacturing.

It clearly defines process validation ‘as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products’

From our perspective one of the most interesting guidance points is the consideration of having an integrated team composed of a variety of specialties to cover process knowledge, facility design and equipment selection among others.

The full text is available from the FDA or it is available as a PDF file from their site.

We would be interested in your views which you can add below by clicking on the comments link.

Bruno Cocheteux is a Managing Partner at Sibaya LifeScience!

Sialkot is an area in Pakistan that is noted for the production of medical products, most notably surgical instruments. Over the years there has been an increasing number of manufacturers from this region leading to a higher degree of competition as well as higher quality performance.

There is a high degree of interest from Sialkot surgical product manufacturers in search or international distributors and international distributors looking for surgical products on this blog.

We are therefore creating this separate post which hopefully will become a central point for both manufacturers from Sialkot and international distributors to meet.

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