5 questions to ask when transitioning from medtech product development to manufacturing

Touring a contract manufacturer’s clean rooms and other spaces will help you pick the right partner. [Photo courtesy of HS Design]

Choosing a contract design or manufacturing partner is the beginning of a long, two-way relationship.

Tor Alden, HS Design

No matter what type of medical product you are designing, at one point you will be faced with deciding which design house or contract manufacturer is right for you. OEMs though highly funded startups all face the same issues when preparing to transition from design to manufacturing.

The design-through-manufacturing cycle is getting quicker. On average, the typical product development launch is two years from concept to regulatory approval. This two-year period may initially seem like a long duration, and you might not feel an urgent need to engage a medical solution partner, letting the selection decision wait until the development cycle matures…

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U.K. private equity firm buys out SteriPack

SteriPack announced that United Kingdom-based private equity firm Inflexion Private Equity Partners led a buyout of the company.

According to a news release, the strategic partnership poises SteriPack — which provides holistic and integrated product life-cycle management services — for accelerated growth, geographical expansion and an enhanced service offering to better support current and future customers.

Funding from the buyout will support the business’ efforts to scale globally as it benefits from market growth and further international expansion opportunities. The company added that it is well placed to undertake further acquisitions with the support of Inflexion.

Florencia Kassai, partner and head of Inflexion’s buyout fund, said in the release that SteriPack is an “extremely successful niche market player” and the company is excited to bring its experience to help management accelerate growth.

“We’re very prou…

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Does your human factors drive design, or does your design drive human factors?

A solid commitment to human factors in the design process can be critical to a medical device’s success.

MaryBeth Privitera, HS Design, a SteriPack company

[Image from Pixabay]

In some early education circles, there is a philosophy that one can learn from testing. If you want a child to know vocabulary words, you can have them briefly study, then give them a quiz, show them what they missed and do the quiz again — all in hopes for a better score without a concerted effort towards improvement. In medical devices, some may approach human factors as simply a test to meet a regulatory imperative. It’s a test that must get done but not one that truly informs design. The testing becomes the focus, the driving force viewed as another task rather than a powerful tool.

Ultimately it is the device design that matters. Through innovative technology design, we have new opportunities to advance clinical c…

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