Is your business poised to grow as a medical device supplier?

BY: BOB JENKINS

When deciding whether to diversify into the medical device industry, there are many things to consider. Is my company, and the goods it produces, set up to easily pivot into medical devices? Could the transition be attained relatively quickly? How much work will this entail? 

Depending on the type of manufacturing operation, some candidates are better than others to make this transition. Companies in the automotive, aerospace and consumer goods industries make great candidates to grow into this now available, and growing, market.

MedAccred® can help get you there. MedAccred is an industry-managed supply chain accreditation program created by the Performance Review Institute (PRI) that aims to reduce risk to patient safety and ensure quality products are made in compliance with requirements for critical processes used in the production of medical devices. By achieving MedAccred accreditation, medical device manufacturers can gain greater operational efficiency, improve product quality and maintain a competitive advantage over manufacturers who do not have this accreditation.

UNDERSTAND THE ABCs BEFORE MAKING A DECISION

A. WHAT’S IN IT FOR ME?
Often, you will find that altruism isn’t the best motivator in a business. Operating a successful business means assessing benefit during decision making. Asking ‘What’s in it for me?’ is one of the first questions most ask. If you haven’t considered that all along, you wouldn’t be in business. There needs to be an underlying driver that is related to the success of your business. When trying to decide whether to move into the medical market, businesses should consider:

• Changing market trends. If you haven’t noticed the push to realign the supply chain and move much of it out of China and other offshore locations to the U.S., you may be living in a cave.  We are experiencing the biggest supply chain failure of our lifetime, much of it the result of not understanding product flow. Many customers, especially medical device OEM’s, are extremely focused on where they can acquire a constant flow of product. This could come from relocating a supply chain to the United States.
• Market smoothing. A large portion of manufacturers are in the automotive industry. While it may be great work, there is a certain amount of fluctuation in that market. To offset the downtime often experienced, having product with uniform orders can help alleviate some of the upset caused to your systems due to fluctuation.
• Mark up. It is common for automotive OEMs to begin working with a supplier at a set price, and as each year passes, expect reductions in product cost. Obviously, this is truer for some more than others, but they all do it. For medical devices, there is a quality requirement which expects medical OEMs to accept a price and remain consistent when they get quality product.

B. WHAT DOES IT TAKE TO GET THERE?
Assess your business. Before moving forward, you need to have an honest conversation with yourself and assess whether your current business is successful, quality driven and operating efficiently. It is not worth the risk, time or money to diversify into this new market if you don’t have a current system in place that produces relatively defect-free product. Don’t go after MedAccred accreditation unless you excel at what you currently do. Side note: If you aren’t operating as best as you want to be, The Center can help with that!

Consider the time commitment. Accreditation, on average, takes six months to a year, with several months spent aligning processes with what medical device manufacturers are looking for in a supplier. Meeting supplier criteria can be difficult. I “grew up” professionally in the automotive industry so I know how much attention a quality system - in my case IATF 16949 - required. With more criteria than most, MedAccred requires extreme dedication and a willingness to lead your team through each step. As one of seven states that participates in MedAccred, The Center can help get you there. With the cost involved being relatively minimal, most companies I have worked with regarding MedAccred have acquired new business resulting in revenue that dwarfs the cost of accreditation.

C. DOES IT FIT WITH MY BUSINESS?
MedAccred aims to ensure quality medical products are made in compliance with requirements for critical processes. Such critical processes include:

• Cable and wire harness
• Heat treating
• Plastic extrusion
• Plastic injection molding
• Mechanical assembly
• Printed circuit boards (bare boards)
• Printed circuit board assemblies
• Sterile device packaging
• Sterilization
• Welding

If you have any of these processes, you are ready. If you don't, but are interested, it's time to make the next step. New processes are being added frequently. Opportunity and luck come to those who are ready and prepared for it.

To take your business to the next level – whether you are contemplating joining the medical device industry or already a part of it – The Center can help you. As part of the Medical Manufacturers MedAccred Accreditation Pathway (MedMMAP) program, The Center’s quality experts can help close the gaps that keep your company from becoming exceptional to ultimately earn your accreditation and gain additional business in the process. Learn more here or contact us at inquiry@the-center.org.
 

MEET OUR EXPERT:

Bob Jenkins, Quality Program Manager
Bob Jenkins is a Quality Program Manager at The Center. In his role, he manages and delivers training and implementation assistance to organizations in the field of quality improvements. As an Exemplar Global Certified Auditor, Bob assists clients with Quality Management System implementations such as ISO 9001:2015 and IATF 16949. He provides internal auditor training and consulting services for various groups, including production, production management and corporate management, in disciplines involving the automotive core tools of quality systems consisting of FMEA, PPAP, APQP, SPC, MSA, and Root Cause Analysis/Problem Solving. 

Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at www.the-center.org.