An automation partnership in action

A current example of close partnering between a medical device manufacturer and an automation provider.

Recently published articles, on the theme of ‘How to effectively partner with an automation company’, have struck a significant chord with automation providers and medical device manufacturers alike.

Stirling Medical Innovations (SMI) is a case in point, having recently gone through the process of assessing several automation suppliers. From the outset, SMI identified the need not just to choose a company capable of building automation but to select an organisation with which they could develop a close and effective partnership.

SMI evolves products in a concurrent development program in which the assay technology, test device and automation are all developed at the same time. David Lang, Managing Director at SMI, commented, “There are many unknowns and we go through a high number of iterations quickly to get the designs right. We therefore required an automation ‘partner’ rather than ‘supplier’, who would be flexible, working alongside us at the same pace through the changes and actually feeding into the designs to ensure that whatever we came up with could be manufactured using high-volume automation.”

Following thorough assessment and quality system audits of a number of prospective companies within Europe, Sussex-based Horizon Instruments emerged as the best-placed to enter into such a partnership with SMI. David Lang explains, “Horizon were experienced in many aspects of automation such as transport systems, highly precise deposition, laser cutting and high speed pick & place.

We found that they had all the capabilities that we required and demonstrated an eagerness to search out new technologies as solutions to our needs.  In addition they were results and delivery focused and had a dynamic culture similar to our own which completed the match.”                                                                                           

And SMI were not disappointed. David continues, “Whenever we have made changes to our product or test device design, we have never been held up by changes required to our automation equipment.  Horizon are working so closely together with us that changes are made in a fast, robust and compliant manner.”

Such a close relationship requires a high level of mutual trust and a strong understanding and when this is established between the partnering companies the focus shifts from the commercial concerns across to the real challenges of overcoming technical hurdles, minimising ‘time to market’ and ensuring regulatory compliance.

The significance of the need for compliance with FDA requirements and current good automated manufacturing practice (GAMP) guidelines when specifying and designing the production line should not be underestimated. Compliance must be planned and designed-in from the outset in order to avoid delays and setbacks later in the project. Sharon Jackson, Quality Manager at Horizon Instruments, reflects on the value of the partnering relationship, “Early involvement in the overall product development process allows our previous experience to be usefully shared with medical device producers. Jointly determining the project lifecycle is the first activity we undertake.  The lifecycle forms part of our Quality and Project Plan. This top-level document sets out the approach to be taken to validation and clarifies in detail the division of responsibilities between supplier and customer, listing the validation documents to be produced and detailing which company is to author and approve each document.”

Andrew Solly, Business Development Manager at Horizon, remarked, “Many of the points made by SMI and our other clients, have been borne out time and again in our own experience.

Increasingly, over the last two to three years, we have found that medical device companies enquiring about our services are now seeking levels of cooperation and assistance which ultimately develop into an effective partnership. Although there are many challenges in concurrent development programs, we have found compliant routes to accommodating these. From our perspective, the strength of the relationships that have been formed as a result, bode very well for long-term continued business.”                                                         

Asked if SMI would recommend the partnering approach to other medical device companies, David Lang responded: “Definitely, if you want to enter into a fast-track concurrent development program! Investors need to see product concepts realised in only three or so years, and not the more traditional five to six years. Engaging a development partner is a must-have to enable this to happen.”