We asked our new product introduction (NPI) team to reflect on Production Readiness and their collective experiences transferring medical devices from design to production. Their top tips for production readiness are listed below.

Pick the right-minded engineer for the product phase

Engineering is a varied field. The skills needed to develop a product are different from the skills utilized for researching technology. Taking a product from a few unit build to a successful production run requires yet another set of engineering skills.

Choosing who is on the team, and when to get them involved, is an important aspect of successful production readiness. There should be an overlap of skills. Each stage of design and development should pull skills from other areas. Bringing in the right expert at the right moment is key.

Making one device work is difficult. Making one hundred work exactly the same is a different challenge. Even if the design works once, a lot more refinement is required until it can be produced to work exactly the same as the previous 100 devices. That is manufacturing in a nutshell.

Don’t forget about the Design History File (DHF) and regulatory documentation

Pushing a schedule has risks. Starting production transfer to coincide with regulatory approval can have expensive consequences. For example, what if critical components identified by the regulatory body do not have traceability controls in place. Additional testing may need to be incorporated into the workflow for regulatory approval.

A lack of controls could result in product rework and verification testing being invalidated.  Biocompatibility testing may not be straightforward. Repeats of biocompatibility testing can add six to twelve weeks to a schedule and even longer if design changes are needed.

The importance of a pilot run cannot be overstated.

A pilot run is the manufacturing and NPI team’s chance to put processes in place and validate them. It is a chance to look at the product and ask questions like: “Did we build exactly what the customer wanted? Did we generate any non-conformances? If yes, then why? How repeatable is the process?”

Despite lots of planning on paper, some issues only come up after the first few units are built. Part of the transfer is taking engineering knowledge, that skill in designing and building units, and transferring it to someone who doesn’t have the same kind of background – someone who is highly skilled in manufacturing and assembly.

Adding or Switching Markets May Not Be Easy

Adding or switching markets can have disastrous impacts on product design. For example, what if the initial marketing plan was to roll out devices in North America, but customer interest in the device develops faster in the EU?  Compliance with the Restriction of Hazardous Substances (RoHS) Directive and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Legislation now becomes critical for success. As a result, biocompatibility, EMC, and even functionality could need to be retested if the new design restrictions require component updates.

Power supplies that can handle a variety of inputs are commonplace, but what may be forgotten are the power cables for those new markets. Finding a cable that meets all design requirements can take time.

Labels are a big deal. The number of labels needed to conform to local language requirements can be vastly reduced by using symbols. Instructions for Use (IFU) need to be translated.  The English version IFU can be submitted as part of the regulatory approval. Electronically accessible local language translations may be permitted, depending on the country. Once all labels have been locked for approval, any last minute updates may result in devices that are built that can’t ship.

Check both devices and websites (e.g. websites used for per use licencing), for formatting changes due to language differences.

Get the Launch Strategy Right

Does the launch need 10 or 10,000 units? Knowing the quantities needed to support early production and ongoing design efforts is critical to success. For example, switching to injection moulding from low volume manufacturing is much more cost effective to complete before verification is finished. Design iteration can occur a lot faster and potential pitfalls surrounding vendor selection, design for manufacture, and ease of assembly can be identified early on. Forward thinking will yield robust designs with fewer changes required after design controls have been enacted. Consider the trade-off: Well planned, high volume production runs that take time to implement vs. low yield, fast transfer production runs that get devices to market faster.

High volumes require a deep analysis of the assembly methods, processes, and controls. More than one pilot run may be required in order to fully validate the assembly instructions. Jigs or fixtures may need to be developed. New equipment will need to go through installation, operation, and performance qualification (IQ/OQ/PQ). Cell design will need to be analyzed and level loaded. In parallel, high volume packaging needs similar considerations in order to successfully ship a polished looking device.

Low yield designs can be manufactured in low to medium volumes, but they will require more work with vendors to produce parts repeatably and a more detailed inspection process to ensure part quality. This approach drives a constant stream of change requests and non-conformances.  It can result in the need for in-field updates and service, as well as potential re-verification or regulatory hurdles.

Having a solid launch strategy is really important early on in order to make the right decisions leading up to production readiness.