Q: As a leading medical device manufacturer, KMC is known for having a high rate of repeat business. How does your communication process play into that success?
A. Many of KMC’s new medical device design opportunities come from long-term relationships with the company’s current customers or from individuals that have worked with KMC in the past at a previous employer. And there is good reason for this “return to KMC” occurrence.
The formation of lasting relationships, whether personal or in business, is based on the fundamental elements of trust, commitment, and communication. Before a medical device company entrusts an outsourced partner with their brand for a medical device design program there must be comfort that honest behavior is intrinsic.
Early discussions with the KMC business development team are the first glimpse of the honesty and integrity of KMC as a trusted medical device design and manufacturing partner.
Q: How does asking the right questions in medical device manufacturing lead to successful supplier/OEM relationships?
A: KMC has developed a wide variety of medical device instrumentation for more than 30 years. Experience definitely plays a part in our ability to ask the right questions. Being able to precisely define the requirements before design begins is a key component of a successful product development process. Efficient communication, in the form of active listening, during the product requirements definition phase is an important learned skill by the KMC systems engineering team.
Q: Explain the importance of that initial customer information KMC’s engineers are trained to obtain for medical device product development?
A. Many times the customer is not aware of the value of the information that they have and its impact on design requirements. KMC’s experience is leveraged in the requirements definition phase which leads to a better starting point for design. The hope is that the requirements for design team will never change but that is unrealistic. However, minimizing the quantity and complexity of design changes in a medical device design program is possible by leveraging expertise and effective communication upfront.
Q. What is the key focus of your screening process with potential customers?
A. KMC follows a new opportunity vetting process to assure that both our customers and KMC have a high probability for a successful outcome. We enter new relationships with long-term interests. Once we mutually determine there is a fit, KMC and the customer then sign a bi-lateral Non-Disclosure Agreement (NDA) to protect the privacy and integrity of our exchange.
Q: What are the basic steps KMC typically follows after a NDA is executed?
A. KMC has a comprehensive six-step process that is routinely followed, as detailed below:
1) Gathering information about the opportunity, by the business development team, to include obtaining answers to an extensive list of initial questions, such as:
What type of product is it? (IVD, lab automation, surgical, therapeutic, etc.)
What are the program objectives and desired development plans?
Are there other collaborative partners?
What are the market expectations for the product?
What is the products value proposition?
What are the potential technology challenges?
What is the development timeline and prototype delivery needs?
Are there any regulatory requirements or potential compliance issues?
Is there a previous relationship?
2) A review of those answers with KMC senior management is conducted to evaluate the probability of program success, with another set of questions that includes:
Does KMC have the expertise needed?
Are the appropriate resources available?
Are there any technology risks?
Are there any schedule risks?
Is the customer financially viable?
3) If KMC senior management believes that there is a high probability of meeting the customer’s needs then a team of engineers visits with the customer team for an initial information gathering.
4) After the customer site visit, a written proposal is created. KMC’s philosophy is to provide a realistic and fair estimate of program costs and schedules. We are interested in developing a long-term relationship so a successful program is our goal.
5) If the medical device design program is awarded to KMC then a formal agreement is created to document our commitment to our customer. This promise to perform is taken seriously by the entire KMC team.
6) As the development program progresses there is constant communication between the development teams. In addition, there are scheduled quarterly meetings with the senior management teams of both organizations to assure that there is good communication of the program’s progress at all levels.
Q: Any concluding thoughts on the strength of your communication process?
A: KMC enjoys many long-term customer relationships through our continuing efforts to nurture the trust of our customers with our culture of open and honest communication. We are committed to deliver on our promises. This practical philosophy seems obvious and simplistic in principle, yet the mutual benefits are extensive, real and rewarding.
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