Challenges

Apical Instruments is a medical device contract manufacturer. They needed to establish efficient processes with superior communication to handle the design, prototyping, and manufacturing of their customer's products and ensure FDA compliance.

 

Why Quality Execs Prefer an All-In-One Product Development Platform

ABOUT THE COMPANY

Apical Instruments is a medical device company located in Redwood City, California, on the San Francisco Peninsula. They have partnered with companies to design, develop, and manufacture quality medical device products. The benefits of utilizing Apical’s services include real dividends in production of effective products, reduced development time, lower overhead count, and quicker regulatory approvals—all to enable a delivered complete project.

With over 30 years of experience in the medical device regulatory affairs and quality assurance fields, Apical Instruments Director of Regulatory Affairs & Quality Assurance, Kim Khoe, knows a thing or two about the keys to quality success.

BUSINESS CHALLENGES

Kim’s quality experience includes setting up companies’ quality management systems, hosting FDA and third-party audits, and auditing medical device manufacturers, having been a lead auditor for a European Notified Body. She has also filed a handful of FDA 510(k) submissions resulting in clearances and obtained CE marks for various products.

According to Khoe, the benefits of contracting with Apical include real dividends in production of effective product, reduced development time, lower overhead count, and quicker regulatory approvals—all to enable a delivered complete project.

“Contracting with Apical to efficiently handle the design, prototyping, and manufacturing eliminates your need to organize a staff to support these efforts,” says Khoe. Khoe, who has been using Arena since 2004, has implemented the solution for several international companies with great success.

To meet FDA and other regulations, Khoe knew she must be able to manage information professionally to show evidence of compliance and avoid costly penalties and brand damage. Early in her career, she experienced firsthand the pain and burden of inefficient paper-based manual processes and the risk of compliance exposure caused by misplaced critical documentation that impeded her ability to prove mandatory compliance.

Khoe and CEO Bruno Strul agree that having a product lifecycle management (PLM) system by itself—while an upgrade from manual processes—can still present problems if the solution is a siloed system that requires linking to another solution. Khoe points out that due to the lack of visibility with siloed systems, problems can start snowballing fast. The classic case is when key cross-functional team members are unaware of changes due to insufficient transparency—and a problem only presents itself just before shipping to market.

THE SOLUTION

To ensure superior product lifecycle visibility and enhanced collaboration among team members, Khoe turned to Arena Solutions because of its all-in-one solution with an embedded quality management solution (QMS) and connection to powerful component databases.

“I always insisted upon Arena,” says Khoe. “Arena can do it all: manage your bill of materials (BOMs), quality system, documents, device returns, nonconformance, and your entire CAPA.”

Another benefit is Arena’s superior customer service. “Where Arena stood out was that it seemed the response time of all other PLM systems was lacking,” says Khoe, “I’m not a software person, but Arena made it so easy for me. Arena’s customer service has always been there. I know someone at another life science company who was evaluating PLM systems and I recommended Arena. Customer service at Arena can’t be beat.”

According to Khoe, facets to the ROI that Arena provides customers are numerous and include:

  • Engineering change order (ECO) turnaround time shrunk from months to days.
  • Saved money by removing the need to scan, save, and send big documents separately via email. “Customers can just log into Arena, sign the ECO, and then they’re done.”
“I didn’t need to hire a team to manage the infrastructure associated with an on-premises siloed system anymore. I now only needed one person to help me, which kept my overhead costs low.”

– Bruno Strul
Chief Executive Officer
Apical Instruments

 

Khoe also experienced an ROI with reduced costs to meeting compliance mandates. According to Khoe, Arena makes audits easier and less time-consuming with a cloud-based solution that consolidates all compliance information in one centralized system. The solution streamlines management of BOMs, the design history file (DHF), the device master record (DMR), and change orders.

“I can give an example that a complete audit trail is in Arena. We had a customer that needed proof that the product was RoHS compliant,” says Khoe. “And pulling the RoHS documents could have cost us $20,000 for this particular job. But with Arena, it saved us all that money because we had the documentation at our fingertips.”

KEY BENEFITS

But the bottom line for Khoe, who sings the praises of Arena to her colleagues at other medical companies, is that Arena provides an all-in-one solution that not only saves time and money but ensures quality.

Khoe points out that even today, some medical device companies tend to operate in silos with defined stage-gate handoff points during the product design process. However, this outdated approach can have a very negative impact on new product introduction (NPI).

“Arena can do it all: manage your bill of materials (BOMs), quality system, documents, device returns, nonconformance, and your entire CAPA.”

– Kim Khoe
Director of Regulatory Affairs & Quality Assurance
Apical Instruments

Due to the lack of visibility with siloed systems, Khoe had seen firsthand how problems started snowballing fast. For instance, finding out at the very last minute that a certain part had gone end of life (EOL), or does not meet the compliance requirements, can cause a lot of problems. But if the company has a single system to manage product and quality information and an integrated electronic component database, an alternative part that would have worked just as well could have been sourced by engineering.

“With Arena, we now have BOMs and quality system documents in one place. Everybody has access to it,” says Khoe. “I am not making copies of documents throughout the whole company, even though we’re small.”